| | 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! |
Ipsen pulls FDA rare disease filing, dealing yet another blow to $1B bet on rare disease drug FDA veteran and outspoken expert Unger retires as the agency finds itself at a crossroads CytoDyn’s previous HIV filing snafu now on better course after FDA sets them straight Longeveron drug didn't help with aging frailty, but executives see late efficacy showing as a good sign Keeping up with COVID-19: Atea reveals trial amendments, new data PureTech Health, having built out internal pipeline, raids Freeline for CMO to oversee clinical trials MiR Scientific snags BMS melanoma, genitourinary commercial leader for cancer detection test Insights into the origin of esophageal cancer could boost early detection efforts Despite pharma's pandemic push, consumer trust in the industry still comes down to costs: study HIMSS21: Former HHS CTO Simcox breaks down health innovation's bright future Fierce Pharma Asia—Seagen's $2.6B bet on China biotech; Enhertu's win over Kadcyla; Takeda's R&D lessons Chutes & Ladders—Merck's Vaxneuvance lead exits to make rival vaccine at Affinivax 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 |
| |
|---|
|
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 |
Resources Sponsored By: Patheon Pharmaceutical Services Inc. Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 | 