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When the world is changing, you need a global CDMO with a strong global presence to protect your molecule. Our team of experts help progress any molecule type, however complex, from pre-clinical to commercial.
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Today’s Big NewsSep 20, 2024 |
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Tuesday, September 24, 2024 | 2pm ET / 11am PT The transition from clinical to commercial supply chains is a pivotal challenge for life sciences organizations today. Join us for this important and timely discussion with industry experts for a deep dive into the scaling of logistics operations, and how to successfully navigate the complexities. Register now.
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| By Fraiser Kansteiner The FDA approved Zevra’s arimoclomol capsules to treat the rare lysosomal storage disorder Niemann-Pick disease type C in conjunction with Johnson & Johnson’s enzyme inhibitor miglustat. Arimoclomol, which will fly under the brand name Miplyffa, is now the first FDA-approved therapy for NPC. |
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By Conor Hale Masimo’s long-running proxy fight has come to a close, at least for now. Politan’s gains double the two board seats it claimed last year. |
By James Waldron Novo Nordisk’s $1 billion bet that it had found a cannabinoid CB1 receptor blocker that could reduce weight while avoiding the psychiatric effects that capsized Sanofi’s Acomplia faces new questions after the company revealed mid-stage headline results. |
By Kevin Dunleavy Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program. |
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Thursday, September 25, 2024 |11am ET / 8am PT In the fast-evolving field of cell and gene therapy, overcoming bottlenecks at every stage of the process is crucial. Join us to learn about best practices, innovative solutions, and strategies to enhance efficiency in cell and gene therapy manufacturing, management, and delivery. Register now.
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By Darren Incorvaia Just a couple of weeks after announcing that its Alzheimer’s candidate fosgonimeton failed to beat placebo in a phase 2/3 trial, Athira is laying off 70% of its staff and saying goodbye to several executives. The biotech is pivoting to focus on ATH-1105, an oral small molecule for amyotrophic lateral sclerosis (ALS). |
By Nick Paul Taylor Sanofi has shared data from the phase 3 HERCULES trial that could rescue its multiple sclerosis (MS) drug candidate tolebrutinib, linking the BTK inhibitor to a 31% delay in time to onset of confirmed disability progression. The drugmaker plans to seek approval this year. |
By Andrea Park As Enhertu’s reach continues to spread into additional forms of breast cancer, Daiichi Sankyo and AstraZeneca are ramping up awareness of the drug among its expanded patient pool. |
By Kevin Dunleavy Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC). The FDA has signed off on Rybrevant plus chemotherapy to treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations who have had disease progression with an EGFR tyrosine kinase inhibitor. |
By Darren Incorvaia Cataract removal is one of the oldest and most common surgeries in the world. A surgeon makes small incisions in the eye, sucks out the cloudy lens and replaces it with an artificial lens implant. Complications are rare, but can range from blurred vision and light sensitivity to retinal detachment, which can lead to blindness if untreated. |
By Conor Hale After CEO Kevin Lobo promised earlier this summer a “bullish” M&A pipeline, Stryker is following through with its seventh deal announcement of the year so far. |
By Nick Paul Taylor Slow enrollment in a key clinical trial has driven Genfit to rework the protocol to try to keep the study on track. The biotech said the changes reflect the comorbidities of people with acute on-chronic liver failure (ACLF) and the logistics of caring for the patients. |
By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. |
Fierce podcastsDon’t miss an episode |
| | In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report. |
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Who’s Leading the Way in Clinical Research? Nominate Them for the CRO Awards! The Fierce CRO Awards shine a spotlight on the organizations that are setting new standards in clinical research and development. If your CRO excels in innovation, quality, and leadership, it’s time to get the recognition you deserve. Submissions close October 3rd. SUBMIT NOW
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| WhitepaperWe interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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