Today's Rundown Bristol-Myers forms fibrotic disease biotech, bags buyout option A16z unveils $750M fund to bankroll startups at intersection of tech, medicine After bagging $200M-plus in 2019, Passage Bio guns for $125M IPO FDA wins legal dispute with Vanda over partial clinical hold After losing its CMO last summer, CytomX Therapeutics finally nabs a replacement Abbott to test its heart device against lifetime blood thinners for reducing stroke risk High hopes dashed: HIV vaccine made from GSK, Sanofi components flops massive study The 10 most-anticipated drug launches of 2020 Featured Story | Tuesday, February 4, 2020 Bristol-Myers Squibb has created a fibrotic and inflammatory disease biotech through its partnership with BioMotiv. The biotech, Anteros Pharmaceuticals, starts life with materials from Bristol-Myers to support development of small molecules and the potential to land a takeover by the Big Pharma. |
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| Top Stories Tuesday, February 4, 2020 Four years after Andreessen Horowitz raised its first bio fund, the VC shop is launching its third biotech- and healthcare-focused fund. At $750 million, Bio Fund III is a16z’s biggest fund of its kind yet, and it will bankroll early-stage companies, though General Partner Jorge Conde said it will “selectively” participate in more mature companies, too. Tuesday, February 4, 2020 Despite pulling off two megarounds in 2019, Passage Bio is returning to the funding well—but this time, it’s going public. The company filed for a $125 million IPO, which will bankroll its three lead gene therapy programs in dementia, Krabbe disease and rare childhood disease GM1 gangliosidosis. Tuesday, February 4, 2020 The FDA has won a legal dispute with Vanda Pharmaceuticals over a partial clinical hold it imposed on tradipitant. Vanda took the FDA to court in the belief the agency's demand ran counter to scientific evidence but failed to convince the U.S. District Court for the District of Columbia. Tuesday, February 4, 2020 Rachel Humphrey, M.D., quietly and abruptly left CytomX Therapeutics last August as its chief medical officer; now, the cancer biotech has finally hired a new CMO. Monday, February 3, 2020 Abbott plans to launch a head-to-head study that puts its structural heart device up against a newer generation of blood thinners, testing its ability to lower the risk of strokes in people with atrial fibrillation. Tuesday, February 4, 2020 Researchers had high hopes for an HIV vaccine candidate made up of components supplied by GlaxoSmithKline and Sanofi. But several years into the study, researchers took a peek at the data in January. It wasn't working. We've assembled a list of the top 10 most-anticipated new drug launches of 2020 based on estimated global sales in 2024. Of those 10, eight could break the blockbuster barrier in four short years—putting a new batch of heavy hitters in pharma's ranks. Resources Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. |