WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Pfizer’s COVID-19 vaccine is among the frontrunners, but amid pushback, the company’s CEO says the drugmaker won’t file for an authorization until late next month. Meanwhile, Roche is spending $500 million on a new global operations hub. Plus, we have a feature detailing the top 10 takeover targets in the industry. And in a new approach during the pandemic, the United Kingdom has approved a challenge study to learn more about how young, healthy people interact with the virus when deliberately infected. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Angus Liu Pfizer CEO Albert Bourla recently suggested the company would know whether its BioNTech-shared COVID-19 vaccine works by October. Criticism ensued. Now finding himself alone in the biopharma world with that bullish estimate, the Big Pharma chief is changing his tone. read more |
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Top Stories Of The Week By Phil Taylor Most if not all large-cap pharma and biotech companies are still in need of business development as they work to rebalance their operations. Cancer, rare disease, and to a lesser extent central nervous system players are targets that match up most closely with prospective buyers. read more By Kyle Blankenship Swiss drugmaker Roche made a late entry into the race for a COVID-19 therapy with an August production pact with Regeneron for a frontrunner antibody cocktail. Now, seeking to get its manufacturing house in order, Roche is splashing the pot on a new global operations hub in Canada. read more By Nick Paul Taylor Researchers in the U.K. are set to deliberately infect young, healthy volunteers with SARS-CoV-2. The challenge study, which has £33.6 million ($43.6 million) in government support, could shed light on how people react to the virus and accelerate development of vaccines. read more By Arlene Weintraub The World Health Organization is raising doubts about the rapid emergency authorization of Gilead Sciences' antiviral remdesivir for treating COVID-19. A large international trial of hospitalized patients found the drug does not lessen the need for ventilation, shorten the length of hospital stays or save lives, the agency said. read more By Amirah Al Idrus A patient has died in the global study of AstraZeneca’s COVID-19 vaccine, Brazil’s health authority, Anvisa, announced on Wednesday. Despite the death, the study will carry on as normal, Reuters said. read more By Angus Liu An inhaled neutralizing antibody cleared the novel coronavirus from infected hamsters at a far lower dose compared with other experimental monoclonal antibodies. The drug is now being developed by Aridis Pharmaceuticals and could offer a self-administered option for COVID-19 if it succeeds in human testing. read more By Ben Adams After snapping up contract research organization Covance for $6.5 billion five years ago, LabCorp is now looking to change the makeup of its drug development business. read more By Beth Snyder Bulik Pharma TV advertising spiked to hit $182 million in September, even without the usually ubiquitous fall football media to play it on. The top 10 brands spent $182 million, the highest monthly total since January, according to data from real-time TV ad tracker iSpot.tv. Four of AbbVie's brands led the way, with just under $90 million spent among them. read more By Eric Sagonowsky As Biogen gears up for next month's key FDA advisory committee meeting on Alzheimer’s drug candidate aducanumab, several other areas of its business are flashing warning signs. While executives didn't want to discuss potential cost cuts on a Wednesday conference call, they said they're possible down the line if aducanumab doesn't score an approval. read more Resources Sponsored By: Paysign This white paper outlines how one such law, Minnesota’s Alec Smith Insulin Affordability Act, has impacted the pharmaceutical industry and provides guidance about strategies businesses can employ to rapidly add support. Sponsored by: LexisNexis Risk Solutions A complete Life Science Industry Snapshot in One Report Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored By: ICON Clinical Research Ltd The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. Sponsored By: The PerkinElmer Signals Screening Team Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. 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: 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: 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 Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. 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. | 
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