| Fierce Biotech's 2021 Fierce 15 Pfizer tests oral COVID-19 antiviral for preventing infection in people living with patients Mystery suitor lines up $11B Acceleron acquisition: report Sponsored: Navigating the complexities of oncology clinical trials in an increasingly competitive landscape How to rescue Big Pharma drug castoffs from the scrap bin through nonprofit partnerships: report Sponsored: A New Reference Model for Clinical Trial Recruitment, Enrollment and Retention Success With a phase 3 fail, Biohaven learned the hard way why AstraZeneca dropped a CNS drug in 2018 Pfizer stumbles close to finish line in growth hormone race, extending the lead of rival Ascendis Delix raises $70M to test psychedelic analogs for treating brain disorders in clinical trials next year Syndax and Incyte, both reeling from cancer drug setbacks, pen chronic graft-versus-host disease collab Biogen used charity giving to illegally boost multiple sclerosis drug sales, Humana lawsuit says Novel 'nanosized' drug carriers tamp down HIV in the brain and other remote tissues in mice Novo Nordisk to smarten up its disposable insulin pens with digital diabetes devicemaker Biocorp Nominations for Fierce Healthcare's 2021 Women of Influence Featured Story | By Ben Adams COVID-19 was inevitably the focus of Fierce 15 last year. This year, it’s pretty much more of the same as we see how the sector has and continues to navigate the pandemic while raising cash, running trials, hiring staff, keeping them safe, and making deals during an incredibly difficult 18 months. read more |
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Top Stories By Annalee Armstrong Looking to be the dominant player in COVID-19, Pfizer is kick-starting a phase 2/3 clinical trial for an oral therapeutic antiviral for adults who have been exposed to the coronavirus. read more By Nick Paul Taylor Which large pharma company is preparing to splash $11 billion to acquire Acceleron? That is the question raised by an article in Bloomberg, which reports an unidentified large pharma company is in advanced talks about a takeover. read more Sponsored by: Premier Research With the shift from traditional chemotherapy agents to innovative immuno-oncology drugs and cell and gene therapies, oncology clinical trials have increased in complexity. read more By Annalee Armstrong If a potentially promising treatment sits idle in a Big Pharma's stockroom, shouldn’t patients have access to it? That’s a question asked by nonprofit think tank The Milken Institute, which is out with a new report Friday pitching a path forward for medicines that could offer hope to patients but have been shelved for business reasons. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Kyle LaHucik AstraZeneca put the breaks on the drug after midstage studies in 2016, and Biohaven thought it was good enough to continue developing. Now, the biotech is looking at a late-stage fail in multiple system atrophy, and Biohaven awaits results in a separate trial in ALS. read more By Nick Paul Taylor Pfizer’s bid to defend its growth hormone franchise against a new, more convenient competitor has hit a snag. The FDA has pushed back approval of Pfizer’s once-weekly prospect, giving rival Ascendis Pharma a longer window in which to convert physicians and patients from current daily options without competition. read more By Kyle LaHucik Delix Therapeutics wants to take the positive, neuroplasticity effects of psychedelics but quash their hallucinogenic and addictive qualities to treat brain disorders. The biotech now has $70 million to take two treatment candidates into the clinic next year to see if analogs to psychedelics can be effective therapies delivered orally and at home. read more By Ben Adams Syndax Pharmaceuticals and Incyte have both been hit by several oncology drug setbacks in the past year but are coming together with an R&D collaboration focused on a different target. read more By Eric Sagonowsky For years, federal prosecutors have gone after drug companies for allegedly using charity contributions as a way to boost sales. Biogen was among the pharma players to ink a federal settlement, but, now, insurance giant Humana is targeting the company’s charity giving with a new lawsuit. read more By Arlene Weintraub Researchers led by the City of Hope have developed a novel drug-delivery system that can carry an anti-HIV drug cargo into the brain and other remote tissues in mice, locking the virus into a dormant state. They believe the advance could ultimately be applied to a range of diseases. read more By Conor Hale Biocorp’s Mallya digital device clips directly onto prefilled insulin injectors and logs delivery amounts and times by linking to a smartphone via Bluetooth. read more By Heather Landi We are putting out the call for nominations to honor women across the healthcare industry—from physicians and CEOs to researchers and tech company execs—who are shaping the way healthcare of the future will be delivered. read more Resources Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Cascade Chemistry by Aceto Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. 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: 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. Let A Digital Sherpa Uncomplicate The Path for Patients Recorded on September 15, 2021 Sea-dumped chemical weapons: environmental risk, occupational hazard September 22, 2021 Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA The MedTech Conference 2021 September 27 - 30, 2021 Introduction to Structure Elucidation in Drug Development Sep 29, 2021 Pharma PR & Communications Summit October 4-5, 2021 | Jersey City, NJ Virtual U.S. Healthcare Compliance Certificate Program October 11 – 14, 2021 Fierce Biotech Cell & Gene Therapy October 19, 2021 | Virtual Event Fierce Health Payer Summit October 26, 2021 | Virtual Event Announcing the 9th International mRNA Health Conference November 09-10, 2021 | Mercure MOA Berlin & Online Diversity, Equity & Inclusion Summit November 9–10, 2021 | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce Biotech Forum 2022 | Virtual Event | 