| Whitepaper: Early engagement & regulatory considerations for emerging biotechs Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more. |
Featured Story By Annalee Armstrong All the biopharma world is talking about right now is M&A. Who’s going to buy? How much are they willing to spend? Who’s going to get bought? Here are our predictions. read more |
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Top Stories By Kyle LaHucik Intellia is on a deal spree. The first-in-human gene editing biotech will receive up to $920 million from ONK Therapeutics in a collaboration agreement focused on CRISPR-edited natural killer cell therapies. read more By Annalee Armstrong A phase 1 trial for Legend Biotech’s CAR-T therapy just got underway last year, and now the FDA has told the company to hit the brakes. Legend announced a clinical hold for LB1901 in a brief press release Tuesday morning. read more Sponsored by: DeepDyve For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap? read more By Nick Paul Taylor Eli Lilly has jumped back into bed with ImmunoGen. Several years after terminating an earlier deal, Lilly has struck a new agreement, paying $13 million upfront and committing up to $1.7 billion in total to pick up rights to another antibody-drug conjugate (ADC) technology. read more By Annalee Armstrong AC Immune and partner Janssen have found an early-stage Alzheimer’s vaccine spurs induction of antibodies that attack a type of tau, which is believed to tangle up in the brain and contribute to the devastating neurological disorder. read more By Kyle LaHucik Goodbye, lackluster 2021, and hello, "buoyant" 2022 for biopharma M&A. Biopharmas have $1.7 trillion to dish out on mergers and acquisitions, and the industry should expect a big year for M&A as big drugmakers must fill "innovation deficits" in their pipelines for the second half of this decade. read more By Nick Paul Taylor NMD Pharma has secured cash to muscle into the myasthenia gravis market. With Novo Holdings and Roche Venture Fund joining a syndicate led by Jeito Capital, the biotech has raised 35 million euros ($40 million) to take its lead candidate NMD670 through a phase 2a clinical trial in the indication. read more By Kyle LaHucik When former Merck Chief Development Officer Jay Galeota joined Kallyope in August 2021, the plan was to take the gut-brain axis biotech public. But for drug developers, the stock market has taken a turn down a treacherous path. The biotech has now raised $236 million and will wait for market improvement to launch an IPO. read more By Max Bayer The FDA is keeping its clinical hold on Larimar Therapeutic's leading candidate, the company announced Tuesday, as it waits for additional data from the company. The decision has forced the company to reconsider its proposed timelines for additional trials and whether or not more studies will be needed to satisfy regulators. read more By Fraiser Kansteiner Just 12% of some 162,000 people estimated to have cystic fibrosis (CF) are getting Vertex’s pricey triple-combination therapy Trikafta, the Journal of Cystic Fibrosis reports. Still, that figure may be low given the drug’s myriad reimbursement deals last year, plus a pair of recent approval to treat CF in kids younger than 12. read more By Conor Hale For February 14’s National Donor Day, the company said it would extend its paid leave policy to four consecutive weeks for staffers that donate bone marrow, liver tissue or a kidney. read more By Dave Muoio Hospital size, type and location all play a role in the pay discrepancies between nonprofit hospital workers and their top executives, according to a Lown Institute analysis that found CEOs receiving up to 60 times more than staff. read more By Kyle LaHucik Researchers at Yale School of Medicine said caloric restriction in humans over two years led to reduced expression of a certain gene. When they deleted that gene in a mouse model, the mice appeared to experience the benefits of caloric restriction, including reduced age-related inflammation. read more Resources Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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