| Today's Big NewsFeb 14, 2023 |
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As the #1 Bioscience Manufacturing Hub in the USA, Puerto Rico is the ideal location to reshore your operations. Benefit from operational stability, world-class talent, & unmatched incentives. Learn more.
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| By Kevin Dunleavy Twenty-two months after European Commission President Ursula von der Leyen admitted to The New York Times that she negotiated a COVID-19 vaccine deal with Pfizer CEO Albert Bourla, Ph.D., through text messages, the newspaper is suing the commission over its refusal to make the texts public. While the lawsuit was filed on Jan. 25 and listed on the European Court of Justice’s public website on Monday, none of the documents related to the case are available to the public. Two people familiar with the suit confirmed it to Politico. |
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By Gabrielle Masson Several biotech entrepreneurs have launched a new venture capital vehicle dubbed Curie.bio that will serve not only as a seed investor, but as a drug discovery co-pilot for founders. |
By Andrea Park Rather than risk going to a trial that could’ve ended in penalties potentially reaching into the billions of dollars, Alcon has struck a settlement with Johnson & Johnson’s eye care segment over a lawsuit concerning femtosecond laser-assisted cataract surgery devices. |
By Fraiser Kansteiner A federal judge scrapped Merck and Glenmark’s bid for summary judgment in a five-year-old lawsuit that claims the drugmakers leveraged a 2010 settlement to stifle generics of Merck’s former cholesterol blockbuster Zetia. |
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GPCRs are widely recognized as premier drug targets, but over 80% of these receptors remain undrugged. This whitepaper outlines a novel solution to revolutionize GPCR drug discovery. Learn more.
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By Nick Paul Taylor GSK is trimming its ties to Vir Biotechnology, walking away from COVID-19 antibody and vaccine research projects while continuing to collaborate on two pandemic assets and programs against other respiratory diseases. |
By Andrea Park The layoffs will affect 14% of Vicarious’ workforce, CFO William Kelly told investors this week. With 165 employees listed in its most recent annual report, that means around 23 roles could be eliminated. |
By Kevin Dunleavy An acrimonious battle has heated up in recent days between Amarin and activist investor Sarissa Capital Management. Last week, in a letter to investors, Amarin urged them to reject Sarissa’s “harmful” proposals, citing the activist's “track record of value destruction in the healthcare space.” Sarissa is trying to oust Amarin Chairman Per Wold-Olsen. |
By Andrea Park Not long after locking down FDA clearance for a device used to collect high-volume blood samples from the comfort of a user’s own home, Tasso is once again expanding its reach—both geographically and in terms of its product portfolio. |
By Zoey Becker In the latest FDA ding on India's Sun Pharma, the agency pulled 34,000 bottles of generic diltiazem hydrochloride after the pills failed impurity specification and dissolution testing at an FDA lab. |
By Nick Paul Taylor,Gabrielle Masson Sanofi's head of global R&D John Reed, M.D., Ph.D., has departed for a spot at Johnson & Johnson, where he'll serve as executive vice president of pharmaceutical R&D. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss which companies made the list of the top 10 pharma M&A deals of 2022 and what was at stake last year. We also talk about what last year's biggest deal means for M&A activity this year. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinarto hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
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