Top Biopharma News for 05/28/2024

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Here are the latest stories being discussed in biopharma today:

Biotech and Pharmaceutical Industry News

FDA Unveils New Platform Technology Designation Process for Accelerated Therapy Approvals

The FDA has released a draft guidance aimed at expediting approvals for cell and gene therapies that utilize common technologies. This 15-page document outlines how biopharma companies can leverage existing data like batch and stability reports, manufacturing inspection results, or safety data, potentially eliminating the need for product-specific assessments for certain endpoints. This new procedure is expected to benefit gene therapies using the same AAV backbone from the same company. However, the FDA anticipates only about ten designations per year.

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Amplitude Ventures Raises $192M for Second Biotech Fund

Canadian venture capital firm, Amplitude Ventures, has successfully raised $192 million USD for its second biotech fund. This fund aims to invest in 14 to 16 startups in the precision medicine domain. The initial investments include inflammatory diseases biotech Evommune, AbbVie and Gilead-partnered Tentarix Biotherapeutics, as well as Vancouver-based Reverb Therapeutics and Evolved Therapeutics. A fifth investment is expected to close this week, continuing the trajectory of the firm’s first fund, which raised approximately $145 million USD.

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NIH-Funded Trials Fall Short on Diversity Targets

A new study by the HHS Office of Inspector General has found that a majority of NIH-funded trials fail to meet diversity targets. Reviewing a sample of 30 Phase 3 trials from 2016 to 2020, it was revealed that 10 out of 12 trials completing enrollment fell short of including participants from underrepresented groups. Additionally, 17 of these trials lacked clear explanations for how inclusion targets were determined. This shortfall could result in research that does not accurately reflect disease burdens or the general population, making it difficult to produce generalizable results.

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Joe Panetta to Step Down as Biocom California CEO

Joe Panetta will step down as CEO and president of Biocom California at the end of this year after a 25-year tenure. He will be succeeded by Tim Scott, Biocom’s board chair and current CEO of AustinPx, who will continue his role at AustinPx until year-end. Sabrina Martucci Johnson, CEO of Daré Bioscience, will take over as board chair for Biocom, an organization with over 1,800 members focusing on lobbying and assisting companies in securing capital.

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Louisiana Law Restricts Prescription of Abortion Pills

Louisiana is the first state to classify mifepristone and misoprostol—drugs used for abortion—as Schedule IV substances, marking them as potentially addictive and dangerous. This reclassification, which goes against the FDA’s categorization, means individuals found in possession without a prescription could face legal consequences. Doctors will also need a special license to prescribe these medications. The new law signed by Governor Jeff Landry will take effect on October 1, 2023.

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Record Demand for GLP-1 Prescriptions Challenges Eli Lilly and Novo Nordisk

The prescription rate for GLP-1 weight loss medications has hit an all-time high in the U.S., driving annual sales forecasts for these drugs above $150 billion by 2030. Despite the surge, leading producers Eli Lilly and Novo Nordisk are struggling to keep up. Stocks for both companies have climbed sharply this year, with Lilly’s shares up 36% and Novo’s up 33%. According to Jefferies, GLP-1 drug prescriptions reached 1.39 million as of May 17, with 165,000 patients prescribed Novo’s Wegovy and 103,000 for Lilly’s Zepbound during that week alone.

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