| |
We explain what types of agency meetings can be sought in the EU, US, Japan, China, and Canada, and provide details to guide requesting and preparing for agency interactions. Learn more. 
|
|
Today’s Big NewsAug 7, 2023 |
| By James Waldron Sage Therapeutics is preparing to reduce its head count and pipeline in response to the FDA’s rejection of a Biogen-partnered drug as a treatment for major depressive disorder. |
|
|
|
| Philadelphia, PA |  |
|
|
By Nick Paul Taylor Nektar Therapeutics has accused Eli Lilly of botching the analysis of data from phase 1b trials in eczema and psoriasis. Lilly, which has reportedly confirmed the errors, handed back rights to rezpeg earlier this year. |
By Angus Liu Singapore set out on a journey to become a biotech hub back in 2000, when local government made biomedical research the “fourth pillar” of the city state’s economy. With the sudden collapse of Tessa Therapeutics, Singapore is still waiting for its big biotech success story. |
By James Waldron Arcus Biosciences and Gilead have decided not to advance their A2R inhibitor in prostate cancer after taking a look at some early clinical data. |
By Nick Paul Taylor Bavarian Nordic’s chikungunya virus vaccine candidate has racked up a second phase 3 victory. Weeks after presenting positive data in seniors, the biotech has revealed pivotal results in younger adults that position it to file for approval next year to challenge Valneva for the emerging opportunity. |
By Max Bayer BioNTech is trimming some €400 million from its expected R&D spend for the full year citing an ongoing cost-cutting effort. The company culled two cancer assets in the second quarter as it looks to bring a second product to market. |
By Gabrielle Masson After a bout of bad luck, Vistagen’s social anxiety spray has puffed out a phase 3 win—data that has sent the biotech's stock soaring. |
By Annalee Armstrong Japanese pharma Astellas is taking a stake in Poseida Therapeutics for $50 million to get a first shot at a solid tumor CAR-T cell therapy. But elsewhere, Poseida’s pipeline is facing delays and a regrouping after Takeda walked away from a gene therapy partnership. |
By Fraiser Kansteiner Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. |
By Conor Hale Viz.ai has received a green light from the FDA for its artificial intelligence-powered software that sifts through electrocardiograms to spot signs of a thickened or enlarged heart muscle. |
By Kevin Dunleavy Less than four months after Astellas’ $5.9 billion buyout of Iveric Bio, the FDA has signed off on the main asset acquired in the deal, the geographic atrophy treatment Izervay. |
By Dave Muoio A recent analysis of 2010-2022 data found that the year before and after closing a merger are risky for hospitals, due to their higher public profile and the marriage of mismatching data systems. |
By Eric Sagonowsky By inking a third Stelara patent settlement, Johnson & Johnson is getting more clarity around the forthcoming loss of exclusivity for its top product by sales. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines. |
|
|---|
|
|
Whitepaper In oncology, traditional methods for determining sales force size & structure are no longer appropriate. This paper describes the multiple drivers of sales strategy in oncology markets today. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research Learn how the right chemical inventory strategy helped save a mid-size CDMO millions of dollars while securing a stable supply of products with just-in-time delivery. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
Whitepaper Leading facilities practices and technologies can help improve the productivity of your research and manufacturing operations—and accelerate the journey from laboratory to saving lives. Sponsored by: JLL |
Webinar Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more. Sponsored by: Cell Signaling Technology |
Whitepaper Learn more about the current challenges and issues that eClinical technology providers are facing. Sponsored by: YPrime |
| |
|
