Aerami Therapeutics, previously known as Dance Biopharm, is developing a smart inhaler that delivers insulin as a gentle mist, potentially improving the convenience and efficiency of insulin administration for diabetics. Their product, Dance 501, has shown promising results in a Phase I/II clinical trial, demonstrating safety, tolerability, and a faster onset of action compared to injected insulin lispro. Despite the historical market challenges faced by inhaled insulin products like Exubera and Afrezza, Aerami's unique design and liquid formulation aim to overcome these issues. The company is now seeking a partner for a Phase III program and is expanding its focus to include other chronic diseases, rebranding itself to reflect this broader vision.

Hong Kong pro-democracy activists, now living overseas, have been targeted by the Hong Kong Police Force's National Security Department with bounties for their arrest due to alleged violations of the National Security Law. Activists such as Frances Hui, Joey Siu, and Simon Cheng, who have been advocating for human rights and democracy for Hong Kong, are among those named. Hui, now in the U.S., has been involved in promoting the Hong Kong Sanctions Act, which calls for sanctions against Hong Kong officials. Siu, a U.S. citizen, and Cheng, a former British Consulate employee now in the UK, have also been active in lobbying for sanctions and advocating for Hong Kong's independence. Despite the threats, the activists remain undeterred and continue their advocacy work, viewing the bounties and arrest warrants as intimidation tactics and publicity stunts by the Hong Kong government.

The article discusses the importance of selecting the appropriate solid form of an active pharmaceutical ingredient (API) in drug development, focusing on statins as an example. Statins, used to treat lipid disorders, can exist in multiple polymorphic forms, affecting their solubility and bioavailability. The article highlights the challenges of low bioavailability in statins and the need for drugmakers to create stable, bioavailable dosage forms. Dr. Steef Boerrigter, a senior research scientist at AMRI, shares his expertise on the subject, explaining the different types of solid forms, such as neat polymorphs, cocrystals, and amorphous materials, and their impact on drug solubility, stability, and manufacturing. He emphasizes the importance of considering solid form selection early in the drug development process and how it can influence intellectual property strategy and extend the patent lifetime of a drug. The article also touches on the evolution of drug development over the past 20 years, with new screening technologies allowing drugs with low solubility to still be viable candidates.

The article discusses a study by The Institute of Cancer Research, London, which analyzed cancer drug approvals by the European Medicines Agency (EMA) from 2000 to 2016. The study found that despite an increase in the number of cancer drugs on the market, there is a delay in making them available to patients, particularly for hard-to-treat and pediatric cancers. The study suggests that the EU Clinical Trials Directive may be contributing to this delay. It also highlights that certain cancer types, such as brain and esophageal, have seen no new drug authorizations, and only a small percentage of drugs are approved for pediatric use. The article mentions a need for more incentives for pharmaceutical companies to develop treatments for children and suggests that the EMA consider novel clinical endpoints. The overarching message is the importance of prioritizing drugs with new mechanisms of action to improve patient outcomes in the face of cancer evolution and drug resistance.

Cardinal Health, a multinational healthcare and medical device company, is dealing with sterility issues in their surgical gowns, leading to two voluntary field actions for their pre-packaged surgical kits. The US Food and Drug Administration has been aware of the potential contamination since mid-January. The gowns, produced by Chinese supplier Siyang Holymed, were made in unapproved and uncontrolled environments, raising concerns about their sterility. Cardinal Health has ended its relationship with Siyang Holymed following the discovery that 9.1 million gowns are affected, which are also part of nearly 3 million PreSource procedural packs. CEO Mike Kaufmann has issued an apology and the company is taking steps to address the shortage and prevent future occurrences. The recall is expected to cost Cardinal Health $96 million, a figure excluded from their non-GAAP financial results. The company's Q2 earnings call is scheduled for February 6, 2020.

The article discusses the Office of Prescription Drug Promotion's (OPDP) new studies on the impact of third-party endorsements in pharmaceutical advertising. One study examines how celebrity, physician, or patient endorsers affect perceptions of a fictitious acne medication ad, with a focus on payment disclosures. The article references past incidents, such as Robert Jarvik's non-licensed endorsement for Pfizer's Lipitor and Kim Kardashian's FDA warning for promoting Diclegis without proper disclosures. The second OPDP study looks at the effects of payment disclosure explicitness in an Instagram ad for a fictitious endometriosis drug. The research aims to guide industry best practices in leveraging celebrity and expert endorsements in direct-to-consumer advertising.

Biopharma companies including Johnson & Johnson, Gilead, Novavax, Moderna Therapeutics, and Inovio Pharmaceuticals are racing to develop a vaccine for the Wuhan coronavirus (2019-nCoV). The outbreak has caused over 100 deaths and infected thousands, with the virus spreading rapidly. These companies are using various technologies, such as synthetic genetic code and recombinant nanoparticle technology, to create a vaccine. Johnson & Johnson is working on multiple constructs, while Gilead is testing its experimental Ebola vaccine, Remdesivir, against the coronavirus. Vaccine development is a lengthy and expensive process, as illustrated by Merck's Ebola vaccine, which took years to be approved. The urgency for a coronavirus vaccine is high, but it remains uncertain how soon it will be available and whether it can be produced in sufficient quantities to meet demand.

The article discusses the highly regulated process of naming prescription drugs in the US, overseen by the FDA's CDER and OPDP. These organizations aim to prevent medication errors and misleading drug names. The OPDP is conducting a study to understand how drug names influence healthcare providers and the public. The study will examine reactions to ten drug names, including one called 'CureAll'. The article also highlights past issues with drug name confusion, such as the mix-up between Depo-Provera and Depo-Medrol, and emphasizes the importance of drug names in a company's brand, citing Viagra as an example of a successful drug name. The OPDP study aims to improve drug naming practices to prioritize patient safety.

FUSION IV Pharmaceuticals, operating as AXIA Pharmaceutical, has voluntarily recalled 65 unused sterile drug products nationwide due to potential sterility issues. The recall includes drugs like dexamethasone and alprostadil. No adverse events have been reported to the FDA yet. Outsourcing facilities like AXIA are regulated under section 503b of the Federal Food, Drug, and Cosmetics Act and must comply with Good Manufacturing Practices. The recall is a precautionary measure following inconsistencies with federal guidelines. The article also references past safety issues in the industry, including a fungal meningitis outbreak linked to the New England Compounding Center and a warning letter issued to Imprimis NJOF, LLC for various violations. The article highlights ongoing concerns about the safety of drugs produced by outsourcing facilities due to infrequent FDA inspections.

The article discusses the advancements and challenges in the field of liquid biopsies for cancer detection and treatment. Liquid biopsies offer a non-invasive alternative to traditional tissue biopsies by analyzing tumor material in body fluids. Despite the potential, only a few tests have received FDA approval, and the regulatory path is complex. The article highlights the importance of validation studies and FDA Breakthrough Designations in advancing liquid biopsy products. It also outlines the top 10 breakthroughs in liquid biopsy research for 2019, including new assays, clinical trials, and the potential for early cancer detection. The BloodPAC consortium's open-source collaboration is noted as a significant step towards the development and clinical use of liquid biopsy assays. The article suggests that 2020 may see further integration of liquid biopsies into clinical practice, with more validation trials and FDA-approved tests leading to improved cancer care.

Abbott has seen success with its cardiac medical device, MitraClip, designed to treat mitral regurgitation (MR). The device, approved by the FDA in 2013, has undergone several iterations and is now being tested in a new clinical trial, REPAIR-MR, to assess its effectiveness for patients who could undergo open heart surgery. The trial will enroll 500 patients across the US, Canada, and Europe. MitraClip has been shown to be cost-effective and improve quality of life in previous studies. The outcome of the trial could influence the adoption of MitraClip in clinical practice, especially with the potential revision of the National Coverage Determination for transcatheter mitral valve repair procedures by the Centers for Medicare & Medicaid.

The article discusses the entry of 23andMe, a genetic testing company, into the pharmaceutical industry through a partnership with Almirall, a Spanish biotech firm. They have agreed to develop a bispecific monoclonal antibody targeting IL-36 for treating severe psoriasis. 23andMe's move into drug development is significant as it leverages its genetic database for R&D, potentially changing the drug discovery process. The company faces competition from established pharma companies and another IL-36 blocker by Boehringer Ingelheim. The article also mentions in-license deals as a strategic approach for pharma companies to share the costs and benefits of drug development, with Almirall also partnering with WuXi Biologics for new bispecific antibodies.

The National Institutes of Health (NIH) is initiating a clinical trial to compare the effectiveness of autologous hematopoietic stem cell therapy (AHSCT) with the best available biologic drugs for treating severe multiple sclerosis (MS). AHSCT has shown promise in halting the progression of MS and potentially eliminating the need for lifelong medication. The trial, named BEAT-MS, will be led by Dr. Jeffrey A. Cohen and will enroll 156 patients across the US and UK, who will be followed for six years. The trial will also assess the cost-effectiveness of AHSCT compared to biologics, which can be expensive and have severe side effects. This research could pave the way for AHSCT to become a routine treatment for MS in the future.

The White House, under President Donald Trump's administration, is advancing a ruling to allow the importation of certain prescription drugs from Canada to reduce costs for American patients. This ruling, if finalized, would permit drugs that meet US FDA standards to be imported, excluding biologics and controlled substances. HHS Secretary Alex Azar supports the initiative as a means to lower drug prices. Canadian health groups have expressed concerns about potential drug shortages in Canada. The ruling could impact pharmaceutical companies like Gilead, which produces expensive HIV and hepatitis C medications. The NPRM will open for a 60-day comment period after publication in the Federal Register. PhRMA criticized the move, suggesting it prioritizes politics over patient care.

A recent study published in PLOS Genetics suggests that pharmaceutical companies can increase their chances of drug approval by targeting genes directly associated with a disease. The study, led by Emily King of AbbVie, found that genetic evidence is a strong predictor of drug development success. This supports a 2015 study that showed drugs correlated with specific genes had higher approval rates. Howard Jacob from AbbVie emphasized the role of human disease genetics in drug development. The study also indicated that drugs targeting genes associated with different indications were less likely to be approved due to potential off-target effects. Despite the insights, drug approval is not guaranteed and requires demonstration of safety and efficacy. The findings could guide pharma companies in making more informed decisions on which drug programs to invest in.

Shelley Epstein from Imagia and Malcolm Campbell from the University of Guelph discuss the transformative impact of artificial intelligence (AI), machine learning, and automation on the life sciences industry, particularly in healthcare and agriculture. Epstein highlights the role of AI in improving healthcare through early diagnosis and treatment, referencing Imagia's involvement in a Canadian government-funded Digital Health and Discovery Platform. Campbell discusses the application of these technologies in agriculture, from autonomous tractors to drones for crop monitoring. The article also touches on the job market evolution due to these technologies, emphasizing the need for specialized talent and partnerships with academic institutions to meet industry demands. The potential for new job creation and the positive outlook on the future of work in the context of AI and automation are also discussed.

The US Senate has confirmed Dr. Stephen Hahn as the next FDA commissioner with a vote of 72-18. Hahn, a renowned lung cancer doctor from MD Anderson Cancer Center, was nominated by President Donald Trump and has a significant medical background but lacks experience in government and health policy. As the new FDA commissioner, Hahn will face challenges such as the safety of e-cigarettes, the opioid crisis, and the regulation of cannabis-derived products. Ned Sharpless will return to his role at the National Cancer Institute, while Dr. Brett Giroir will serve as interim FDA commissioner during the Senate's assessment of Hahn. Concerns have been raised by Senator Patty Murray regarding Giroir's involvement in policies affecting women's healthcare access.

The article discusses the NFL's My Cause, My Cleats campaign, where players wear custom cleats to support various charities. This year, several players, including Orlando Brown Jr. and Jameis Winston, have chosen to represent JDRF, a leading nonprofit organization for type 1 diabetes research. The article highlights the personal connection some players, like Mark Andrews and DeAndre Carter, have with the disease. It also mentions the advocacy work of JDRF, including their support for Eli Lilly's release of a more affordable generic insulin. The campaign aims to raise awareness and funds for type 1 diabetes research while also celebrating the resilience of those living with the condition.

Canopy Growth Corp., a leading Canadian cannabis company, is expanding its presence in the United States with its US-branded product 'First & Free,' which will be sold in 31 states where cannabis is legal. The company, which has previously partnered with Battelle for product testing and research, plans to offer soft gels, oil drops, and topical cream, but not edibles as they are not yet legal in the US. Despite challenges from the FDA regarding the safety and efficacy of cannabis-derived products, Canopy continues to grow, launching 'Cannabis 2.0' products in Canada and planning a hemp industrial park in New York. Other companies like Nutritional High and Greenlane Holdings are also making significant sales in the cannabis market.

Leica Biosystems and Sectra Medical have formed a partnership to create a digital pathology platform aimed at enterprise-level customers such as large institutions and hospital networks. The collaboration seeks to combine Leica's Aperio AT2 DX digital pathology scanner, which has FDA 510(k) clearance, with Sectra's advanced software solutions that integrate with electronic medical records and pathology databases. This partnership aims to improve patient care by enabling more accurate and efficient cancer diagnostics and drug development. The companies have submitted a joint FDA 510(k) application to bring their integrated solution to the market, with the potential to set a new standard in digital pathology.

The article discusses the unique challenges faced by recruiters in the pharmaceutical industry in North America. Carly-Anne Fairlie of IQ Partners and Darren Kruszynski of Grapevine Executive Recruiters highlight the difficulty in finding candidates who combine a strong scientific background with corporate acumen and a patient-centered approach. The high vacancy rate in the industry is attributed to the specialized nature of pharma roles and the stringent regulations. The article also touches on the shift from primary-care medicines to specialized medicines, which has changed the recruitment landscape, requiring fewer but more specialized sales reps. Additionally, the importance of cross-functional candidates in today's streamlined pharma companies is emphasized, where individuals must possess a blend of education, communication skills, and adaptability.

The article discusses new research published in the journal Nature by Dr. Jeffrey Molkentin and his team, which suggests that the effectiveness of stem cell therapy for heart disease is contingent on the type of cells used and the injection site. The study found that injecting a combination of stem cells and either dead heart cells or a compound called Zymosan directly into the tissue surrounding a heart attack injury in mice can induce a strong immune response, leading to better healing and improved heart function. This method contrasts with other strategies that focus on directly differentiating stem cells into mature cardiomyocytes, which can have complications such as cell death and arrhythmias. Molkentin's research highlights the potential of enhancing the innate immune response to improve the outcomes of stem cell therapies for heart patients.

The article discusses the implications of the RACE for Children Act on pediatric oncology drug development. It highlights the historical context of pediatric drug development, noting past legislation such as the FDA Modernization Act and the Pediatric Research Equity Act, which led to significant labeling changes for pediatric use. The article emphasizes the challenges in pediatric oncology drug development, including the rarity of pediatric cancers and the complexity of safety assessments for children. The RACE for Children Act, which requires pediatric assessment of drugs for cancers with molecular targets relevant to pediatric cancer, is set to change the landscape of clinical development plans. Medpace, a clinical contract research organization, hosted a webinar with experts David Horton and Peggy Kaiser discussing the regulatory and trial design implications of the Act. The article covers various aspects of pediatric clinical trials, including the need for age-appropriate consent, assent, and re-consent processes, operational considerations, and the importance of engaging with pediatric cancer experts and stakeholders in study design. The article concludes with the assertion that early planning and alignment with standard care are crucial for the success of pediatric studies under the RACE for Children Act.

The US Food and Drug Administration (FDA) has selected twelve applications from a pool of 46 to advance in their innovation challenges aimed at transforming medical device sterilization. This comes after concerns over ethylene oxide emissions, a common sterilization agent linked to cancer risks among workers and environmental toxicity. The FDA's challenges seek alternatives to ethylene oxide sterilization and methods to reduce its emissions. NovaSterilis is one of the companies with a promising alternative using supercritical carbon dioxide. The FDA has also initiated a pilot program to encourage the adoption of non-ethylene oxide sterilization methods. The agency's actions aim to mitigate potential supply chain disruptions due to sterilization facility closures and to address health and environmental concerns.

The article discusses the completion of the acquisition of Celgene by Bristol-Myers Squibb, a significant event in the pharmaceutical industry. The merger, valued at $74 billion, faced regulatory challenges, such as the Federal Trade Commission's order to divest Otezla to Amgen to maintain competition. Despite this, the combined entity retains the blockbuster drug Revlimid. The merger positions Bristol-Myers Squibb as a leader in oncology with a strong drug pipeline. The article also touches on other industry mergers and the strategic importance of such consolidations for growth and R&D. It highlights the potential benefits of the merger, including a robust pipeline of drugs expected to generate significant revenues and cost savings.

The article discusses a report by Roche and The Canadian Pulmonary Fibrosis Foundation on the challenges faced by patients with idiopathic pulmonary fibrosis (IPF), including misdiagnosis and delayed treatment. It highlights the difficulty in diagnosing IPF due to non-specific symptoms and the lack of awareness among physicians. The report also mentions the high cost and limited access to effective drugs like Esbriet and Ofev, and Roche's acquisition of Promedior to expand its IPF treatment pipeline. The article calls for increased patient access to care and better education on IPF, noting the disease's rarity but dangerous nature, as evidenced by an uptick in cases among dental personnel.

Pfizer is merging its established medicines division, Upjohn, with generic pharmaceutical maker Mylan to create a new company named Viatris. The merger aims to expand access to medicines, innovate to meet patient needs, and become a trusted healthcare partner globally. Viatris will house products like EpiPen and Viagra and plans to penetrate global markets, including Asia. However, analysts are concerned about the new company's ability to succeed in China due to local competition and government policies favoring domestic generics. The leadership team will be Mylan-centric, with Robert Coury as executive chairman and Michael Goettler as CEO. Pfizer shareholders will own 57% of Viatris. The deal is part of Pfizer's strategy to focus on R&D, having previously partnered with GlaxoSmithKline and acquired Array BioPharma. Analysts are cautious about the cultural integration challenges and the uncertainty of who will handle capital allocation decisions at Viatris.

The US Food and Drug Administration (FDA) has issued a severe recall for Medtronic's MiniMed insulin pumps due to cybersecurity risks. Vulnerabilities in the device's wireless remote controller could allow hackers to alter insulin dosing and timing, leading to serious health consequences. The recall affects 4,000 pumps, with 1,117 already recalled in the US. Medtronic and the FDA have advised customers to switch to safer models. There have been reports of adverse events and one death related to the MiniMed pumps this year, although not directly linked to the cybersecurity issue. The FDA has called on all medical device manufacturers to be proactive in monitoring and mitigating cybersecurity risks in their products.

The article discusses the advancements in neurosurgery, focusing on the contributions of Synaptive Medical, a Toronto-based medical technology company. Synaptive has developed two main products, Modus PlanTM and Modus VTM, to assist neurosurgeons with planning and execution of surgeries. Modus Plan is a surgical planning software that helps in creating detailed 3D maps of a patient's brain fibers, while Modus V is a robotic system that enhances visualization during surgery. Cameron Piron, co-founder and chief strategy officer of Synaptive, highlights the importance of these tools in improving surgical outcomes, reducing trauma, and aiding recovery. The company's products are not only used in surgeries but also in other areas of neuroscience, such as recovery from head trauma, radiation therapy, and deep brain stimulation. Piron emphasizes the potential of these technologies to become the standard of care worldwide and the gradual adoption of high-resolution imaging and robotics in medicine.

The article discusses the upcoming EU Medical Device Regulation (MDR), which will take effect in May 2020, replacing the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The MDR aims to enhance product quality and safety by emphasizing clinical evaluations and data. Manufacturers face the challenge of assessing their product portfolios for compliance, which is a costly and time-consuming process. The article promotes five Xtalks webinars that provide insights into achieving compliance with the new regulations. These webinars feature experts from various organizations, including Kalypso, ICON, Premier Research, HILLROM, TÜV SÜD, Castor EDC, and Medrio, who share their knowledge on MDR compliance, the impact of Brexit, and the importance of clinical evaluations.

GlaxoSmithKline (GSK) has reported promising results from a Phase IIb trial for a new tuberculosis (TB) vaccine, M72/AS01, which could significantly reduce the incidence of TB in sub-Saharan Africa. The trial, which involved over 3,500 HIV-negative adults with latent Mycobacterium tuberculosis infection, showed that the vaccine group had fewer cases of TB compared to the placebo group over a three-year period. The study was co-supported by the International AIDS Vaccine Initiative (IAVI) and the results were announced at the 50th Union World Conference on Lung Health. The BCG vaccine, currently the only available vaccine against TB, has been facing shortages and is not effective against adult pulmonary TB from latent infections. GSK's new vaccine could be a critical tool in combating TB, especially in regions with high rates of TB and HIV co-infection, and could support the WHO's goal to end the TB epidemic by 2030.

The article discusses the challenges faced by medical device manufacturers due to the closure of sterilization facilities that use ethylene oxide, a carcinogenic substance essential for sterilizing half of the US's medical devices. The FDA, under acting commissioner Dr. Ned Sharpless, has expressed concern over potential nationwide shortages of medical devices. The Illinois Sterigenics facility was shut down to install new emissions control systems, leading to a shortage of pediatric breathing tubes. Similarly, Sterigenics in Georgia and Becton Dickinson (BD) faced scrutiny and temporary closures. The FDA is urging manufacturers to assess their inventory and report potential shortages, while the EPA is reviewing the Clean Air Act, which could further restrict ethylene oxide emissions. AdvaMed has raised concerns about the lack of alternative sterilization methods. The FDA plans to hold a public advisory meeting to discuss innovation in sterilization methods.

Roche's Genentech has launched a direct-to-consumer TV ad campaign for Xofluza, their prescription antiviral influenza medication. The ad emphasizes that Xofluza can effectively combat the flu if taken within 48 hours of symptom onset. The FDA has recently approved Xofluza for high-risk patients, expanding its use beyond healthy individuals over 12. The ad aims to increase awareness of prescription antivirals and their proper use, while also reminding viewers that these treatments do not replace the annual flu vaccine. Other antivirals mentioned include BioCryst Pharmaceuticals' Rapivab, GlaxoSmithKline's Relenza, and Genentech's Tamiflu. The CDC reports low national flu activity but has confirmed severe cases and two pediatric deaths.

The article discusses the impact of artificial intelligence (AI) and machine learning (ML) in various industries, with a focus on healthcare. Experts from DataArt, a global technology consultancy, including Igor Kaufman and Andrey Sorokin, talk about the role of AI and ML in processing large volumes of data for R&D, automation, and digitalization in healthcare. They highlight the use of AI in early disease detection and the reduction of manual routines for healthcare professionals. The article also introduces SkinCareAI, a DataArt project that uses computer vision to detect melanoma through a mobile application. The experts discuss the potential of AI and ML to become mainstream tools in healthcare within the next decade, aiding in diagnostics and treatment while emphasizing the continued need for human validation of machine-generated advice.

The article presents a quiz designed to test the reader's knowledge on major achievements in the field of biotechnology. It highlights the significant advancements that have been made in healthcare and medicine, such as the development of vaccines, recombinant DNA technology, genome sequencing, genome editing, and stem cell therapy. The quiz aims to engage readers and encourage them to stay informed about the latest news in biotechnology.

The US Food and Drug Administration (FDA), in conjunction with the Federal Trade Commission (FTC), issued a warning to Rooted Apothecary for making unproven health claims about their CBD products. The FDA has stated there is no solid science to back claims that CBD can treat conditions such as autism, acne, ADHD, and various other diseases. Rooted Apothecary, based in Naples, Florida, has been cited for illegal sale of unapproved products, misbranding, and making unsubstantiated advertising claims. The FDA is working to clarify regulations for cannabis-derived products and stresses the importance of protecting public health by monitoring the market. Rooted Apothecary has been given 15 days to address the violations related to the FTC Act and the FD&C Act.

The US FDA has approved Vertex Pharmaceuticals' new cystic fibrosis drug, Trikafta, which treats the root cause of the disease in patients 12 and older with the most common mutation, F508del. Trikafta is a combination of elexacaftor, tezacaftor, and ivacaftor, and its approval is based on positive results from two Phase III trials. Vertex's CEO, Dr. Jeffrey Leiden, expressed the significance of this approval, which could treat up to 90% of cystic fibrosis patients. Despite the fast approval process and the potential impact on patients, the drug's high annual cost of $311,000 has drawn criticism. Vertex, which has dominated the cystic fibrosis drug market since 2012, is also seeking approval in Europe and conducting studies for patients under 12.

Worldwide Clinical Trials has adopted Foundry Health's ClinSpark eSource platform to enhance the efficiency of Phase I clinical trials. ClinSpark is designed to streamline data collection, organization, and analysis, offering features such as multi-site support, remote data monitoring, and integration with other electronic data capture systems. Dr. George Atiee of Worldwide Clinical Trials highlighted the platform's benefits in improving logistics, patient communication, and data reporting. The platform has already been used in over 40 studies and received positive feedback from Worldwide staff. The adoption of digital technologies like ClinSpark is part of a broader trend in clinical trials to improve clinical development through better data management and patient-centric trial designs.

Cleveland Diagnostics has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for their new prostate cancer screening test, IsoPSA. This test differs from traditional PSA tests by measuring structurally altered PSA proteins indicative of cancer, rather than overall PSA levels, which can be affected by various factors not related to cancer. The company's CEO, Dr. Arnon Chait, expressed gratitude for the FDA's recognition and the company's commitment to providing simple, affordable, and accurate cancer tests. The American Urological Association has guidelines to reduce overdiagnosis and false positives associated with PSA screening. Cleveland Diagnostics' IsoPSA test has shown greater specificity in validation studies and is part of a broader effort to improve prostate cancer diagnosis, which remains a leading cause of cancer death in men. The company aims to commercialize IsoPSA in the US by the following year.

The Association for Frontotemporal Degeneration (AFTD) and Target ALS have announced a partnership with a $5 million grant initiative to promote research into ALS and FTD. These diseases share clinical, imaging, and pathological features, and the partnership aims to foster collaboration between academic and industry scientists to discover and validate drug targets and biomarkers. AFTD's CEO, Susan L-J Dickinson, and Target ALS' CEO, Manish Raisinghani, have both expressed enthusiasm for the potential of this collaboration to advance treatment and diagnosis. The initiative includes a Request for Proposal (RFP) period for scientists and industry partners, building on the success of similar past efforts by Target ALS.

The 2019 Nobel Prize in Physiology or Medicine was awarded to William Kaelin Jr., Gregg Semenza, and Sir Peter Ratcliffe for their research on how cells sense and adapt to oxygen availability. Their work has significant implications for understanding various physiological processes and could lead to advancements in treating diseases such as anemia, cancer, and heart disease. Semenza discovered the oxygen-dependent regulation of the EPO gene and identified the hypoxia-inducible factor (HIF). Kaelin and Ratcliffe furthered this by elucidating the role of oxygen in the interaction between the VHL protein and the HIF complex. Pharmaceutical companies like Merck and AstraZeneca are investing in HIF inhibitor-based therapeutics, highlighting the potential for new drug discoveries stemming from this research.

The article discusses a new photobiomodulation device developed by LumiThera, aimed at treating dry age-related macular degeneration (AMD), a common cause of vision loss in older Americans. The device, called the Valeda Light Delivery System, is currently undergoing a clinical trial called Lightsite III to evaluate its effectiveness. Dr. Allen Hu, the principal investigator, expressed optimism about the device providing a new treatment option for patients with limited alternatives. The device has already been approved for commercial use in the European Economic Area, and if successful in the trial and approved by the FDA, LumiThera could enter the US market for dry AMD treatment. The article also briefly mentions other companies like Novartis and Regeneron Pharmaceuticals, which dominate the wet AMD market, and NovoTHOR, which offers a photobiomodulation device for pain relief.

Medrio, an eClinical technology expert, and Bioforum, a data-driven CRO, have announced a partnership to enhance clinical data standardization. This collaboration will provide Medrio customers with access to Bioforum's data standardization platform, JET-Convert, which ensures data is collected and formatted in compliance with US regulations and CDISC standards. The article discusses the importance of clinical data standardization in improving research dissemination, data quality, and regulatory approval processes. It also highlights the challenges posed by disparate data forms and the need for standardization to improve clinical trials. The partnership aims to improve efficiencies in clinical development stages and facilitate better decision-making and information exchange among trial stakeholders.

Kitov Pharmaceuticals has developed a bispecific inhibitor, NT-219, targeting two key pathways in cancer drug resistance. Isaac Israel, CEO of Kitov Pharmaceuticals, discussed the challenges of drug resistance in cancer treatment and the potential of NT-219 to block signaling proteins STAT3 and IRS1/2, which are involved in resistance pathways. Preclinical studies have shown that NT-219 can delay the acquisition of resistance to therapies like PD-1 inhibitors and can reverse resistance even after it has been established. The company plans to file an IND application with the FDA and proceed with clinical trials for head and neck cancer in the US. Israel believes NT-219 could be a general solution to cancer drug resistance.

The US FDA has approved Novo Nordisk's Rybelsus, the world's first oral semaglutide tablet for type 2 diabetes, offering a needle-free treatment option. Rybelsus aims to improve blood sugar control in adults when used alongside diet and exercise. With over 30 million Americans affected by type 2 diabetes, this oral medication provides an alternative to the existing injectable treatments. Novo Nordisk's product will compete with other diabetes drugs, including Oramed Pharmaceuticals' oral GLP-1 analogue and Eli Lilly's half-priced insulin, Humalog. Rybelsus has been tested in over 9,500 adults and comes with an FDA warning about the risk of thyroid C-cell tumors. The cost of Rybelsus is expected to be similar to Novo Nordisk's injectable semaglutide, Ozempic, and the company plans to negotiate with insurers to lower out-of-pocket costs.

The FDA has introduced draft guidance documents for four medical device types eligible for its new Safety and Performance Based Pathway. This pathway, an evolution of the former 510(k) pathway, allows device approvals based on FDA-defined safety and performance criteria rather than comparisons with older predicate devices. The four device types include conventional Foley catheters, cutaneous electrodes, orthopedic non-spinal metallic bone screws and washers, and spinal plating systems. The pathway aims to streamline market approval and encourage competition by setting modern benchmarks. Critics have concerns about the reliance on consensus standards, which do not cover all devices. The FDA will need to update and develop performance criteria continually. This comes as the EU prepares to implement its Medical Device Regulation (MDR) in May 2020, which contrasts with the FDA's approach by emphasizing the demonstration of substantial equivalence to predicate devices.

Health authorities including the FDA, EMA, and Health Canada have alerted patients about the contamination of the heartburn medicine ranitidine with N-nitrosodimethylamine (NDMA), a probable human carcinogen. While the FDA has not advised patients to stop taking ranitidine or its popular branded version Zantac, Health Canada has requested a halt in distribution and a recall by Sandoz Canada. The contamination echoes a larger issue with drug safety, particularly with recalls of angiotensin II receptor blockers due to impurities traced back to API manufacturers in China and India. The FDA is working on enhancing drug safety measures, and regulators are urging patients to report any adverse reactions to ranitidine.

Ventrix, a spin-off company from the University of California San Diego, is advancing in the field of heart failure treatment with its product VentriGel. The injectable hydrogel, derived from porcine cardiac connective tissue, has completed a Phase I trial, showing promise in treating patients with heart failure post-heart attack. The trial, led by Jay Traverse, involved 15 patients and aimed to assess safety and feasibility, not efficacy. However, improvements in patient mobility and heart function were observed. VentriGel is designed to be delivered minimally invasively and acts as a scaffold for new cardiac tissue growth. The company plans to conduct a Phase II trial to evaluate efficacy. The study's completion has implications for the biotech industry's approach to heart disease treatment.

Researchers from Queen Mary University of London have investigated the prevalence of nonvalidated surrogate endpoints in drug approvals by the EMA and FDA. Their study, published in PLOS Medicine, found that 90% of drugs approved through expedited programs between 2011 and 2018 used surrogate endpoints that were not validated. The study highlights concerns about the effectiveness of drugs approved on this basis, as surrogate endpoints do not always predict clinical outcomes. The article also discusses the controversy surrounding the use of surrogate endpoints, such as progression-free survival in cancer drug approvals, and cites examples like Genentech's Avastin. It emphasizes the need for more research and better reporting practices to ensure drug efficacy and patient safety.

Abbott has launched the TRILUMINATE pivotal trial to evaluate its TriClip device, a non-invasive, catheter-based tricuspid valve repair system for severe tricuspid regurgitation (TR). TR affects the right side of the heart and has limited treatment options, often leading to heart failure and death if untreated. The TriClip device, based on Abbott's successful MitraClip technology, aims to reduce the backflow of blood by pinching the valve leaflets together. The trial will enroll 700 patients across the US, Canada, and EU, with a five-year follow-up. Competitor Edwards Lifesciences has also developed a TR treatment device, the Cardioband Tricuspid System, which is available in Europe. Early-stage device developer CroiValve has received funding for its percutaneous TR treatment. The article highlights the need for more data to support the efficacy of transcatheter TR treatments.

Giovanni Caforio, the chairman and CEO of Bristol-Myers Squibb, has been appointed as the new chairman of the board of directors for the Pharmaceutical Research and Manufacturers of America (PhRMA). He succeeds Oliver Brandicourt, the former CEO of Sanofi. PhRMA is a key pharmaceutical lobbying group in the U.S., and it has been active in discussions about drug pricing and importation policies. Caforio has been recognized for his role in the significant merger between Bristol-Myers Squibb and Celgene, which included the sale of Celgene's drug Otezla to Amgen. As the new PhRMA board chairman, Caforio aims to focus on improving patient access and affordability to medications, advocating for policies that support patient benefits from biomedical innovations. His experience and leadership are expected to guide PhRMA through challenges related to drug pricing and industry regulations.

Allergan has received FDA approval for a new cannula delivery method for its dermal filler, Juvéderm VOLUMA XC, which is designed to be less painful and more precise than traditional needle delivery. The product addresses age-related volume loss in the cheeks for adults over 21. Dr. Dee Anna Glaser, a dermatologist and clinical trial investigator, supports the new method, citing its effectiveness and safety. The article also mentions a market growth prediction for dermal fillers and Allergan's marketing strategies targeting younger demographics. Additionally, it notes that Galderma, a rival company, received FDA approval for a similar cannula delivery system for its product, Restylane Lyft, less than a year prior.

Oklahoma won a landmark case against Johnson & Johnson, with the company being fined $572 million for its role in the opioid crisis. The state's Attorney General, Mike Hunter, accused Johnson & Johnson and its subsidiaries of misleading marketing practices regarding the effectiveness and addictiveness of their opioid drugs. Despite the company's defense, citing lawful prescriptions and minimal market share, Judge Thad Balkman ruled in favor of the state. The judgment highlighted misleading sales campaigns and undue influence on advocacy groups. Johnson & Johnson, disagreeing with the ruling, plans to appeal. The case is seen as a precedent as more lawsuits are pending in the upcoming federal trial.

Pfizer's nerve pain treatment, Lyrica, has lost its patent, allowing nine generic drug companies to produce their own versions. The patent expired on June 30, 2019, and by the end of July, Pfizer saw a 35% drop in Lyrica's market share. Over 15 years, Lyrica has been a significant revenue source for Pfizer. The company had managed to extend the original patent expiration date from the end of 2018 to mid-2019. The FDA has approved generic versions from companies including Alembic Pharmaceuticals and Teva Pharmaceuticals, among others. The entry of generics is expected to lower drug costs, with potential discounts of up to 20%. Pfizer is responding to this setback by launching an oncology biosimilar and expanding its rare disease portfolio.

Parexel, a biopharmaceutical services provider, has appointed Gavin Nichols, former EVP of technology at Bioclinica, as EVP of informatics and IT. Nichols is tasked with advancing technology-enabled services to improve clinical development and regulatory processes in drug development. His experience includes roles at Quintiles, Perspectum Diagnostics, and Cetara, with expertise in wearable technology, data analytics, and electronic health records. Parexel has been expanding its team, including hiring former FDA executives and specialists in oncology and Asian markets. Nichols' role will be pivotal in enhancing Parexel's informatics business and technology infrastructure.

Researchers at Carnegie Mellon University, led by Professor Adam Feinberg, have made significant progress in 3-D printing human tissues, particularly components of the human heart, using a technology called Freeform Reversible Embedding of Suspended Hydrogels (FRESH). Their work, which is licensed to biotech startup FluidForm, aims to create functional organs for transplantation. The team has successfully printed various heart components with collagen, overcoming previous challenges by using a gelatin bath to support the structure during printing. This advancement could lead to the development of functional tissues and organs for patients in need, addressing the shortage of available transplants. The FDA is also recognizing the potential of 3-D printing in medical applications. However, the research is still in progress, with many challenges ahead, including the need for preclinical testing and addressing immune rejection issues.

A study by the National Heart, Lung and Blood Institute (NHLBI) of the NIH has found that biologics treatment for psoriasis can reduce the risk of cardiovascular disease. The research, led by Dr. Nehal Mehta, utilized a new method called the perivascular fat attenuation index (FAI) to measure coronary inflammation. The study involved 134 psoriasis patients, with 82 receiving biologics treatment for a year, showing significant reductions in coronary inflammation. The control group did not exhibit changes in perivascular FAI. The findings, published in JAMA Cardiology, build on previous research linking biologics treatment to reduced coronary plaque buildup. The American Academy of Dermatology recognizes certain biologics like adalimumab, etanercept, and infliximab as beneficial for heart health. This new technique may help clinicians tailor individualized treatment plans for patients with inflammatory conditions.

Bayer, a German pharmaceutical company, has voluntarily recalled its hemophilia A drug, Kogenate FS, due to a labeling error where two lots were found to contain a different treatment, Jivi. The recall has prompted the National Hemophilia Foundation and the Hemophilia Federation of America to seek further information from Bayer and the FDA on the incident and future prevention measures. The mislabeling could affect the treatment of patients, as Kogenate FS is used for both adults and children, while Jivi is for adults and adolescents over 12. No adverse events have been reported, but Bayer has recovered most of the mislabeled vials and advises patients to return affected lots to their pharmacists.

Allergan has partnered with actress Ashley Tisdale to promote reproductive health and contraception awareness through the 'Women Who Know' campaign. The campaign features Tisdale in an educational video where she interviews OB/GYN Dr. Lakeisha Richardson, a paid consultant for Allergan, about the birth control pill Lo Loestrin Fe and other contraception-related questions. The initiative aims to empower women to have open conversations with healthcare providers about pregnancy prevention and to seek credible resources. The article also discusses the general lack of knowledge among women regarding contraceptive effectiveness and the misconceptions about the health risks of pregnancy versus birth control pills, emphasizing the importance of educational interventions in this area.

The article discusses the approval of a cochlear implant system by MED-EL, which offers a new hearing solution for individuals with single-sided deafness (SSD) or asymmetric hearing loss (AHL). The device, known as SYNCHRONY, has been approved by the US Food and Drug Administration following a study at the University of North Carolina at Chapel Hill, which showed that participants experienced improvements in sound localization and speech understanding in noisy environments. The article also touches on the broader context of technological advancements and regulatory changes in the hearing aid industry, mentioning self-fitting products by Bose Corporation and upcoming regulations on over-the-counter hearing aids.

Researchers at Stanford University have discovered how a genetic mutation in the lamin gene, associated with familial dilated cardiomyopathy, disrupts the PDGF pathway, leading to cardiac dysfunction. This mutation affects the expression of many genes and results in the heart muscle becoming thin and weak. The study, published in Nature, found that two anti-cancer drugs, crenolanib and sunitinib, were effective in restoring normal heart rhythm in patient-derived cells with this mutation. Crenolanib is currently in clinical trials for other cancers, while sunitinib is FDA approved for different types of cancer. The findings suggest the potential for repurposing these drugs to treat dilated cardiomyopathy, but further research is needed to determine safe dosages that won't harm cardiac function.

Elon Musk's company Neuralink, which has been secretive for the past three years, held its first public presentation to showcase its brain-machine interface technology. The company has developed flexible threads with electrodes for recording neural activity, a robot surgeon for precise implantation, and a powerful sensor for transmitting neural signals to a computer. These innovations aim to enable paralyzed patients to control computers with their minds. Neuralink's technology, which includes over 1,000 electrodes, is claimed to be a significant improvement over the current industry benchmark, the Utah Array. The technology has been tested on rats and non-human primates, with plans to begin human trials by the second quarter of 2020. Musk also envisions a future where individuals can merge with AI.

The article discusses the launch of the SoomSafety mobile app by Soom, a Software-as-a-Service company. The app aims to provide users with reliable safety information about medical devices by drawing data from manufacturers and the FDA. It was created in response to the increasing number of device recalls and the difficulty in accessing recall information. The app allows users to scan their device's barcode to receive up-to-date recall notifications. The FDA's MedWatcher app is mentioned as a comparison, which does not connect adverse event reports to affected users. Charlie Kim, the founder of Soom and a father whose daughter suffered due to a lack of information about a recalled medical device, emphasizes the importance of the app in ensuring patient safety. The article also hints at future updates to the app, which will include pharmaceutical drug safety and recall information, as well as direct interaction between patients and manufacturers.

Kroger Health has partnered with Myriad Genetics to offer a pharmacogenomic test called GeneSight to select Prescription Plan members. This test is designed to guide treatment decisions for patients with moderate to severe depression by matching medications to their genetic profile. The initiative aims to improve patient outcomes by reducing the trial and error process of finding effective antidepressants. The partnership reflects a growing trend in precision medicine, where treatments are tailored to individual genetic profiles. The article also mentions other companies like CVS Health, Walgreens, and Amazon that are expanding healthcare services and the increasing consumer interest in at-home genetic test kits.