| Today's Big NewsJan 3, 2023 |
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The National Biotechnology and Biomanufacturing Initiative, which channels more than $2 billion to America’s biotech sector, will have far-reaching implications not only for the domestic biotech space but industries at large, including life sciences. Where are the salient opportunities? What are the gravest risks? Read this in-depth white paper from Randstad for answers. 
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| By Nick Paul Taylor Valneva’s plans to establish its COVID-19 vaccine as a booster to Pfizer and BioNTech’s Comirnaty have taken a blow, with a clinical trial of the shot eliciting “only a marginally increased neutralizing antibody response.” |
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By Annalee Armstrong Seeds from Mayo Clinic’s cell and gene therapy accelerator Mayflower Bioventures have taken flight in a new biotech called Primera Therapeutics, which launches today with a blossoming $750 million partnership to work on therapies for mitochondrial diseases. |
By Gabrielle Masson While initial public offerings for biotech were few and far between this year, Coya Therapeutics slipped in at the last moment with a $15 million debut. |
By Max Bayer Tessa Therapeutics is entering the new year with new ambitions, shelving a phase 2 autologous cell therapy med to prioritize development of an allogeneic counterpart. The reconfiguration comes just more than six months after the company raised a $126 million series A. |
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Download this whitepaper for guidance on how to Scale your Direct-to-Consumer Microbiome Testing Company and when it makes sense to outsource microbiome sequencing to a third-party provider. 
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By Nick Paul Taylor Viking Therapeutics thinks it has rumbled a raid on its non-alcoholic steatohepatitis (NASH) trade secrets. In a lawsuit, the San Diego-based biotech has accused China’s Ascletis BioScience of using information shared under a confidentiality agreement to turbocharge its expansion into the NASH development race. |
By James Waldron While the tough funding environment has forced many biotechs to lay off staff or pare back their pipelines, Jounce has at least found a way to make some easy money in the process. The biotech has sold its remaining stake in an anti-CCR8 antibody, dubbed GS-1811, to Gilead for $67 million. |
By James Waldron It’s back to the workshop for Blacksmith Medicines as it melds with originating company Forge Therapeutics to produce a metalloenzymes-focused biotech that will initially hammer out therapies for cancer and infections. |
By James Waldron In a sign that the tough climate for biotechs will last into 2023, Connect Biopharma cited the icy funding environment for its decision to halt a global phase 3 program for its lead dermatitis asset while it seeks out a suitable partner. |
By Helen Floersh By over-expressing a special receptor, scientists have potentially found a way to trick the immune system into leaving allogenic CAR-T cells alone. |
By Annalee Armstrong Pfizer’s gene therapy for severe hemophilia B has not only matched standard of care but beat it in a phase 3 study testing whether the treatment can help patients make the protein responsible for blood clotting on their own. |
By Annalee Armstrong A scathing congressional report has detailed communications described as "inappropriate" and "atypical" between Biogen and the FDA regarding the approval of Alzheimer’s disease drug Aduhelm plus the decision-making behind the pricing and marketing of the now-benched medicine. |
By Helen Floersh Dry eye disease isn’t just uncomfortable—it also puts patients at greater risk of corneal injury. Now, scientists may have identified a new approach to protecting them. |
By Max Bayer Equillium is no longer buying Metacrine after the former's asset deal with Ono added enough new cash to press on by itself. The merger agreement originally announced in September was slated to cost Equillim $26 million. |
By Max Bayer The race to build the next great antibody-drug conjugate therapy continues to speed up, with Amgen and Merck KGaA each signing new development pacts to stake their claim. The combined value of the two deals inked ahead of the holiday weekend exceeds $2 billion. |
By Max Bayer The rocky U.S. regulatory road for Ipsen's rare disease med palovarotene has ended, for now, after its application was rejected by the FDA. The company says the denial was related to a request for additional data made in October. |
By Kevin Dunleavy Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. In 2022, however, fewer drugs were approved than was typical in recent years. Is this the result of the FDA becoming gun-shy after its much-criticized sanction of Biogen's Alzheimer's disease treatment, Aduhelm, in 2021? Or was 2022 just a cyclical blip on the approval landscape? |
By Annalee Armstrong Senior Editor Annalee Armstrong recaps her top 10 best stories of the year that the Fierce Biotech team produced. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the medtech industry’s highest paid CEOs. Plus, we cover Theranos' COO's prison sentence, highlights from the American Society of Hematology annual meeting and other top headlines from this week. |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now. 
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Whitepaper This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
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Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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