| Today's Big NewsJul 28, 2023 |
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October 16-18, 2023 | Boston, MA
This event is designed to bring together leaders and executives within the biotech and life sciences industry to discuss the most pressing challenges around product development, bringing an asset to market and building successful companies in this complex landscape. 
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| By Max Bayer Peter Marks, M.D., Ph.D., says he trusts staff reviewers at the FDA, who do “incredibly great work”—but sometimes decisions about efficacy require a broader view. |
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| Philadelphia, PA |  |
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By Max Bayer The FDA has a better idea of the data they need to grant accelerated approvals for rare disease drugs, meaning more could soon see the light of day, according to Peter Marks, M.D., Ph.D. |
By Nick Paul Taylor It’s all change at AstraZeneca. The Anglo-Swedish drugmaker not only revealed its second quarter earnings results, but also disclosed the elimination of several pipeline programs, the purchase of a portfolio of preclinical gene therapies from Pfizer and the upcoming departure of a key, long-serving R&D executive. |
By Nick Paul Taylor Sanofi and BioNTech’s vision of using mRNA to prime anti-cancer immune attacks has failed to hold up to clinical scrutiny. After running an interim analysis of early-phase data, the partners have jointly decided (PDF) to scrap development of the candidate as an intratumoral therapy. |
By James Waldron Homology Medicines has joined the growing list of biotechs hitting a wall in 2023, with the gene therapy-focused company blaming the “current financing environment” for the move to lay off 87% of staff and seek a buyer for its R&D assets. |
By Annalee Armstrong AstraZeneca has secured the last piece to a global puzzle of licensing agreements with Ionis for the rare heart disease drug eplontersen. The partners have now extended a global licensing deal for the transthyretin amyloidosis (ATTR) therapy to Latin America, which means another $20 million for Ionis. |
By Annalee Armstrong An April cyberattack has caused Evotec to revise down its financial guidance and expectations from unpartnered R&D efforts. |
By Helen Floersh It’s a reality that patients with sickle cell disease can only wish for: Walk into a clinic, get a shot and, soon after, be free of disease. Such a scenario may seem like a pipe dream for now, but that’s not stopping scientists from trying. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Gabrielle Masson In preparation of closing the $43 billion Seagen merger, Pfizer is shaking up its research leadership team. |
By Kevin Dunleavy Biogen has revealed a proposal to acquire Reata Pharmaceuticals for $7.3 billion. The Texas-based rare disease specialist brings newly approved Skyclarys, the first treatment for the neurologic disorder Friedreich’s ataxia with peak sales potential of $1.5 billion. |
By Fraiser Kansteiner Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday. |
By Anastassia Gliadkovskaya Approved by Gov. Ron DeSantis, the law imposes restrictions on adult access to gender-affirming care. Some providers have been forced to stop serving new or existing patients in some capacity. Others are finding temporary workarounds. |
By Teresa Carey This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
By Angus Liu Daiichi Sankyo's FLT3 inhibitor has overcome an FDA rejection to win an approval. Astellas signed another protein degrader deal. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder. Plus more. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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