| Today's Big NewsMar 2, 2023 |
| By Max Bayer FDA advisers endorsed the safety and efficacy of GSK's respiratory syncytial virus vaccine in older adults. But advisers expressed concerns with some safety signals and the lack of long-term data. |
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By Kevin Dunleavy In 2018, Roche's patents protecting a method for manufacturing antibodies finally expired. But the company is still trying to collect the last bit of royalties that it believes are due. Tuesday, Roche filed suit against Biogen, claiming that it is owed royalties on sales of Biogen’s multiple sclerosis blockbuster Tysabri. |
By Andrea Park Elon Musk said in November that Neuralink was mere months away from beginning in-human trials of its brain implant—a timeline that has now been cast into doubt. |
By James Waldron In another sign that Boston continues to wear the U.S. biotech crown, Novo Nordisk will expand its R&D presence in the area at the expense of its Indianapolis and Seattle facilities. |
By Angus Liu After several market withdrawals, the FDA’s scrutiny around the PARP inhibitor class of cancer drugs doesn't seem to be abating. The agency will gather an advisory committee to review AstraZeneca and Merck & Co.’s application for Lynparza in prostate cancer. |
By Andrea Park In line with the plan it laid out last fall to curb spending and cut costs in 2023, Surgalign is doing some spring cleaning. |
By Gabrielle Masson Flamingo Therapeutics is standing on one leg no more, as Dynacure folds into the biotech in a merger agreement that will see the combined company work on RNA-targeted oncology therapies. |
By Andrea Park Bigfoot Biomedical is aiming to leave even bigger tracks across the diabetes management tech landscape. |
By Nick Paul Taylor MorphoSys’ preclinical team has paid the price for its commercial failures. The biotech, once an engine of innovation for Big Pharma, is stopping all preclinical work and laying off 17% of its staff to throw all its resources behind mid- to late-stage oncology programs. |
By Fraiser Kansteiner While 2022 was a doozy for many in the biopharma industry, 2023 isn’t looking any easier, forcing drugmakers to adapt to enduring challenges including inflation, COVID-19 and the war in Ukraine. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| WhitepaperThis paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
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| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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| Research 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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