|  | Scout Clinical helps remove the financial and logistical burdens for clinical trial participants. We offer personalized and adaptable patient payment and travel services globally. Learn more: Scout Clinical | Services! |
Featured Story | By Nick Paul Taylor The curse of palovarotene continues. After struggling through a series of setbacks, Ipsen filed for FDA approval of the rare disease drug earlier this year, moving it a step closer to realizing some return on its $1 billion bet on the asset. Now, Ipsen has pulled the filing. read more |
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Top Stories By Amirah Al Idrus The FDA is losing a top official as the search for its new commissioner drags on. Ellis Unger, M.D., a cardiologist who led the agency’s Office of Drug Evaluation I, is retiring after 25 years at the agency. read more By Annalee Armstrong CytoDyn’s efforts to get leronlimab past the regulatory finish line in any indication has been a saga—including an incident in which the biotech sent the wrong data sets to the FDA. But now, the regulator seems to have pointed the biotech in the right direction for a filing for approval in HIV. In a brief update Friday morning, CytoDyn disclosed that the FDA has sent over some comments on the company’s recently resubmitted dose justification report. read more By Annalee Armstrong Typically, a failed clinical trial does not portend good news for a company’s shares. That’s not the case for Longeveron today, after the small, Florida-based biotech announced that a mid-stage study for an aging frailty drug had failed on one of two endpoints. Executives are nevertheless confident that the trial has revealed some efficacy signals that could inform a later trial with a higher dose. read more By Amirah Al Idrus After Atea Pharmaceuticals reported early data in June showing its Roche-partnered antiviral can slash the SARS-CoV-2 viral load in hospitalized patients, the company unveiled some changes to that phase 2 program to keep up with the “evolving COVID-19 environment.” read more By Nick Paul Taylor PureTech Health has pieced together a wholly owned pipeline in recent years, picking up a prospect from Teva while taking ownership of Ariya Therapeutics and Alivio Therapeutics. With the expansion ratcheting up PureTech’s need for clinical trial expertise, the biotech has lured Julie Krop away from Freeline Therapeutics. read more By Kyle LaHucik The commercial leader for Bristol Myers Squibb's immuno-oncology melanoma and genitourinary program is departing for miR Scientific. Erik Johnson will be chief operating officer of the company as it prepares to sell its first product. read more By Arlene Weintraub Barrett’s esophagus is a complication of chronic heartburn and a known risk factor for esophageal cancer. A University of Cambridge team found that cells at the top of the stomach can take on the properties of intestinal cells in the formation of Barrett's, and that this change in identity is controlled by two genes. read more By Beth Snyder Bulik Turns out it’s going to take more than a successful vaccine response to a global pandemic to make Americans trust pharma companies. A new study from Accenture shows a boomerang back to a familiar topic—drug costs. read more By Dave Muoio Pandemic disruptions have merged with long-term industry trends to create a slew of new opportunities for startups and other healthcare entrepreneurs, Ed Simcox said in a HIMSS21 discussion. read more By Angus Liu Seagen licensed a HER2-targeted antibody-drug conjugate from China's RemeGen, just as AstraZeneca and Daiichi Sankyo touted a head-to-head win for their HER2 ADC Enhertu against Roche's rival Kadcyla. A Takeda exec talked about how the company is taking COVID-19 lessons into its future R&D operations. And more. read more By Kyle LaHucik Merck is losing the person who led clinical development of its pneumococcal conjugate vaccine Vaxneuvance as Kara Bickham, M.D., picks up the CMO role at Affinivax to bring a rival shot to market. read more |  | Looking for a simple and cost-effective solution to scalable production of ESCs and iPSCs? Learn how growing pluripotent stem cells in suspension enables scaling up without scaling out while saving time and cost. Download our free PSC suspension culture infographic |
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