| Today's Big NewsFeb 6, 2023 |
|
April 3 - 4, 2023 | San Diego, CA Connect with leading communications professionals and have honest, open discussions about how to develop your career in the industry. Early Bird Rate Ends February 10th.
|
|
| By James Waldron When Johnson & Johnson acquired nipocalimab as part of the $6.5 billion takeover of Momenta, the hype surrounding the therapy was focused on its potential as a treatment for the hot disease area of myasthenia gravis. But a top-line phase 2 readout for the drug in a fetal disorder is a reminder that nipocalimab could have a far broader reach. |
|
|
|
By Nick Paul Taylor Add Aug. 5 to your diaries. That is the FDA's decision date for Biogen and Sage Therapeutics' zuranolone, which the agency has accepted for priority review as an oral treatment of major depressive disorder and postpartum depression. |
By James Waldron Could we see Sanofi give up on cancer? Not according to Paul Hudson, although the CEO admitted that after some struggles with its headline candidates, the French pharma might seek solace earlier in its pipeline. |
By Gabrielle Masson Things are abuzz at Bristol Myers Squibb as the Big Pharma drops an IL-12 oncology candidate back into Dragonfly’s pond. The return comes just days after the planned summer departure of BMS R&D head Rupert Vessey was announced. |
|
Conducting ADME DDI studies early on in the development process can be so much more than a simple box checking exercise to satisfy regulatory
requirements... Read More >>
|
|
By Annalee Armstrong What if the biopharma industry used epidemiology data, rather than the U.S. Census Bureau to build clinical trial rosters? GSK put the idea to the test in a 17-year retroactive study of clinical trial data from 495 trials, finding that there’s plenty of work to be done to ensure clinical research is representative of the patients who suffer from diseases. |
By Nick Paul Taylor Certa Therapeutics’ attempt to resurrect an ex-Shire drug has delivered midphase data. Nine years after Shire paid $75 million to acquire FT011, the Australian biotech has linked the candidate to improvements in the symptoms of a rare autoimmune disease in a small clinical trial. |
By Gabrielle Masson 4D Molecular Therapeutics is on shaky ground as its Fabry disease gene therapy program, dubbed 4D-310, has been hit with an FDA clinical hold. |
By Conor Hale,Andrea Park In 2021, light at the end of the COVID tunnel spurred an explosion of medtech deals. But in 2022, that exuberance waned. |
By Fraiser Kansteiner As Eisai focuses on laying the commercial groundwork for Leqembi ahead of a potential full approval, the company "will make every effort to support healthcare providers and patients for those who are able to access" the new Alzheimer's drug, Eisai's Ivan Cheung said Monday. |
By Andrea Park From the start, Bayer and Huma’s relationship has been a mutually beneficial one, with the Big Pharma contributing funding to Huma through its Leaps by Bayer VC arm and, in return, gaining access to the startup’s digital health technologies. |
By Kevin Dunleavy In five years under Kenji Yasukawa, Astellas had a successful rebound after revenues bottomed out in 2020. Now Astellas has tabbed chief strategy officer Naoki Okamura as its new CEO to "go on the aggressive." |
By Frank Diamond Broad racial and ethnic categories used by public health officials don’t consider nuances within those categories, says a new study. Such knowledge might help to cut down on preterm births and low birthrates. |
By Ben Adams,Zoey Becker,Kevin Dunleavy For the third year in a row, Evaluate Vantage’s most hotly tipped drug approval when it comes to future sales potential is an Alzheimer’s therapy, but there is far more caution in this year’s list than we have seen before. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss what we can expect from the obesity market in 2023. We also recap the drugs approved last year. |
|
|---|
|
|
|
March 14-15, 2023 | San Francisco, CA Uncover flexible partnership models, licensing deals, M&A opportunities, and innovative deal structures to maximize potential and ensure a successful and profitable collaboration. Register today to secure our lowest rates!
|
|
| 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 |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
| 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 |
| 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 |
| |
|
