Regeneron seeks EUA for COVID-19 antibody as Trump vows to provide it for 'free' Merck kicks back rights early-phase RSV jab to Moderna Takeda strikes $1B biobucks deal with Arrowhead for genetic liver disease asset Sponsored: Xevinapant’s 3-year data make waves in head and neck cancer at ESMO 2020 Pfizer presents growth hormone data ahead of FDA filing How will Alkermes' schizophrenia prospect affect those on opioids? FDA raises concerns ahead of AdComm CDRH's Shuren warns of the 'canary in the coal mine' in the FDA's COVID-19 response New U.K. report shows up 'precarious' nature of restarting non-COVID-19 research Featured Story | By Nick Paul Taylor Regeneron has filed for FDA emergency use authorization of its COVID-19 antibody cocktail. President Donald Trump, who received REGN-COV2 after catching the virus, said he has “emergency use authorization all set” and will make the antibody cocktail available for “free.” read more |
| |
|---|
|
Top Stories By Amirah Al Idrus After helping Moderna push a respiratory syncytial virus (RSV) vaccine for adults into the clinic, Merck is calling it quits. The Big Pharma is doubling down on its in-house RSV antibody and will see Moderna’s jab through the phase 1 trial before handing back the rights to the program. read more By Ben Adams As Arrowhead continues its turnaround, this election cycle is looking like a new era compared to the last as it strikes a major billion-dollar deal with Takeda. read more Sponsored by: Debiopharm Xevinapant in combination with standard cisplatin-based chemoradiation therapy (CRT) reduces the risk of death in high-risk patients with locally advanced head and neck cancer by 50%.. This first-in-class molecule showed it could improve long-term outcomes in hard-to-treat patients, becoming the first in decades to demonstrate a survival benefit in this group. read more By Nick Paul Taylor A phase 3 trial has found Pfizer and Opko Health’s once-weekly growth hormone deficiency treatment imposes less of a burden than the established daily drug Genotropin. The readout comes one year after a separate study found the once-weekly drug is no more effective than Genotropin, handing an advantage to Ascendis Pharma’s rival long-acting treatment TransCon hGH. read more By Amirah Al Idrus An FDA decision is looming for Alkermes’ ALKS 3831, which adds an opioid antagonist to a well-known antipsychotic to negate the weight gain caused by the latter. An FDA panel will meet Friday to help the agency decide the treatment’s fate—and their major focus will be how the opioid antagonist will affect patients taking opioids like oxycodone. read more By Conor Hale The FDA has found itself between overwhelming public demand for COVID-19 diagnostics, ventilators and other devices on one side, and a tsunami of companies submitting over 1,200 products for review on the other—and the workload is beginning to take its toll. read more By Ben Adams A new report out this week shows that the U.K. “has been leading the rest of Europe in early stage clinical research,” but the recovery for non-pandemic trials is on a knife-edge. read more Resources Sponsored by: Salesforce Join this webinar to learn first hand why executing clinical research trials end-to-end on a single platform is the best way to successfully meet the needs of today’s market. Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Thermo Fisher Scientific Learn how to safeguard supply, improve distribution and reduce program costs and risks Sponsored by: Clinical Ink Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Sponsored by: LexisNexis Risk Solutions A complete Life Science Industry Snapshot in One Report Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Medtech Innovation Week October 19-22 Learn How To Bring A Drug Successfully To Market Oct 21-22, 2020 | Live, Online Drug Development Immersion: Live, Online Course October 21-22, 2020 | 9am - 3:30pm ET Become Fluent In Drug Development With Our Industry Expert October 21-22, 2020 | 9am - 3:30pm ET BioBasics 101: The Biology of Biotech for the Non-Scientist: Live, Online Course November 12-13, 2020 | 9am - 3:30pm ET Drug Development Boot Camp® VIRTUAL 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now | Due to COVID19 provisions – training will be conducted VIRTUALLY | Same excellent total immersion training in new medicine development will be made available to experts who want to make a difference to patients. | 