| | By Zoey Becker Nearly two years after the rollout of COVID-19 vaccines, risks such as myocarditis are still being assessed. Researchers found that the risk of myocarditis is greater after a second dose of Moderna's shot compared with Pfizer/BioNTech's competing vaccine. |
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By Max Bayer Flagship-founded Repertoire Immune Medicines is completely reshuffling following news that it had laid off nearly half of its staff. The company disclosed Monday that it had culled its top two assets and was replacing its founding CEO. |
By Angus Liu GSK’s dream just turned into a nightmare. The company's BCMA-targeted Blenrep has failed in a phase 3 multiple myeloma trial, putting its accelerated approval in jeopardy. |
By James Waldron It may have made its name—and fortune—with a COVID shot, but mRNA pioneer BioNTech is thinking bigger for 2023, with up to five trials for infectious disease vaccines set to enter the clinic. |
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Thursday, November 17, 2022 | 11am ET / 8am PT Join this fireside chat as we highlight best practices, discuss strategies to overcome roadblocks, and share how new operational efficiencies yield stronger relationships with sales and increased customer satisfaction. Register now. 
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By Fraiser Kansteiner Monday, the U.S. Supreme Court declined to hear Bristol Myers Squibb's case to resurrect a $1.2 billion win in its five-year dispute over a Juno Therapeutics' CAR-T patent and Gilead’s cell therapy Yescarta. |
By Andrea Park With FDA clearance secured for its Bluetooth-connected insulin dose-tracking technology, Eli Lilly is ready to pick up the tempo. |
By Conor Hale “In diagnostics, we have come to the conclusion that the dramatically changed macroeconomic environment demands immediate and comprehensive measures,” CEO Bernd Montag said during the company’s earnings call. |
By Fraiser Kansteiner In an Oct. 31 warning letter addressed to BMS helmsman Giovanni Caforio, the FDA dinged Abraxis Bioscience—acquired by Bristol Myers’ Celgene in 2010—for a raft of production issues tied to the companies’ billion-dollar cancer med Abraxane. BMS got its hands on Abraxane—approved in breast, lung and pancreatic cancer—by way of its $74 billion Celgene buyout back in 2019. |
By Ben Adams Move over, COVID: Shots to stop RSV are providing the new must-watch trial data on Twitter as healthcare influencers on the social media platform talk up the latest readout from Pfizer. |
By Helen Floersh A highly targeted epilepsy gene therapy that impacts only hyperactive neurons and stops when the seizures go away showed promise in mice and human brain organoids. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we share some highlights from Fierce Biotech's Cell and Gene Therapy Forum in case you missed it. |
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Wednesday, November 16, 2022 | 12pm ET / 9am PT Biopharma companies are moving ever more towards continuous verification and risk-based approaches. If you manage your lab’s data integrity and traceability, tune in to learn best practices for GxP data automation. Register now. 
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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Video Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video. Sponsored by: Thermo Fisher Scientific |
Whitepaper This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent |
Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
Webinar Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics |
Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent |
Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored By: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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