| Today's Big NewsApr 10, 2023 |
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July 18-19, 2023 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself. Save $500 when you Register Today!
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| By Annalee Armstrong Some 300 biotech executives and industry leaders are objecting to the decision from a Texas federal judge to block the FDA’s approval of the abortion drug mifepristone. The executives argue that the judicial interference will undermine the agency’s authority and endanger innovation in the industry. |
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By Kevin Dunleavy A plaintiff's steering committee guiding the multi-district litigation for talc claimants against Johnson & Johnson said that the company's $8.9 billion settlement proposal was far from adequate. The 14-person board—made up of lawyers from companies who represent talc plaintiffs—said it was unanimous in its rejection of J&J’s offer. |
By Conor Hale The company, which planted some of the earliest seeds that prescription smartphone apps could stand alongside prescription drugs, filed for Chapter 11 bankruptcy, and announced it would lay off more than 90% of its employees as it seeks a buyer. |
By Angus Liu After an approval in Europe, AstraZeneca and Sanofi’s respiratory syncytial virus prevention antibody nirsevimab is on track for an FDA decision this year. Now, a third company wants to simplify its role with the pharma giants. |
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Thursday, April 20, 2023 | 11am ET / 8am PT In this presentation, we highlight key study design challenges and considerations for rare disease CGT trials and discuss the potential for leveraging in silico approaches for generating synthetic control arms that enable a control-based comparative assessment of efficacy. Register now.
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By Max Bayer German biotech Evotec is on high alert after a late-week cyber attack prompted the company to shut down its network. |
By Andrea Park Late last year, C2N Diagnostics unveiled the second generation of its liquid biopsy technology to screen for Alzheimer’s disease, and now, it’s putting that blood test to the test. |
By Nick Paul Taylor Almost 500 days have gone by since Molecular Templates disclosed the second of two cardiac adverse events in recipients of its CD38-directed cancer candidate. The biotech dialed down the dose at the start of 2022, and the trial has progressed uneventfully since then. Nonetheless, the FDA has now slapped a partial hold on the study and asked for information such as the justification for the revised dose. |
By Kevin Dunleavy Two weeks after the World Health Organization revised its guidance on COVID-19 vaccination, data analytics company GlobalData says the future of vaccine rollouts is becoming “highly uncertain.” |
By Andrea Park After bursting out of stealth last year with the landscape-shifting claim that it had developed a whole-genome sequencing platform that can run analyses for only $100 apiece, Ultima Genomics is now working to get that technology into the hands of those who need it most. |
By Gabrielle Masson Regeneron’s first-quarter earnings are expected to take a $56 million hit tied to in-process research and development costs for a freshly inked autoimmune deal with Sonoma Biotherapeutics. |
By Fraiser Kansteiner Not content to stymie itself in endless pricing talks, BeiGene is taking a different tack in Europe, the company’s chief commercial officer Josh Neiman said in a recent interview. “We’re not interested in a two-year negotiation process,” he explained on the heels of a recent tour across the bloc. “We want to get access to our patients as quickly as we can.” |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss how this year is chock-full of blockbuster drugs headed for the patent cliff, besides the well-known patent cliff for AbbVie's Humira. We also cover Johnson & Johnson's talc settlement offer and more of this week's top headlines. |
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Thursday, May 4, 2023 | 11am ET / 8am PT Join industry experts for this insightful webinar to learn more about enzyme inhibition studies. We’ll explore how these studies drive informed decisions for drug developers, frequently asked questions from sponsors, recommendations for achieving successful regulatory submission, and more. Register now. |
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Whitepaper The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process Sponsored by: ReachBio | The Cell Biology Experts™ |
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| May 1-3, 2023 | Jersey City, NJ |
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