- With $3.2B, Sanofi takes in mRNA partner Translate Bio in buyout deal
- CytoDyn catches SEC, DOJ scrutiny over public claims about COVID-19 drug's viability
- Alnylam scraps COVID-19 antiviral citing effective vaccines, alternative treatments
- Moderna’s RSV vaccine catches the fast track on heels of Pfizer’s leapfrog into the queue
- Sage Therapeutics axes 2 zuranolone trials deemed unnecessary for approval in depression
- Scholar Rock's former CEO takes the helm again as Kingsley makes another swift exit
- Arch Oncology snares AbbVie, Bristol Myers, Xencor execs to boost medical, clinical management
- Coya Therapeutics eyes IPO, but first they need some mid-stage data for ALS hopeful
- New SynOx CEO builds out his team with ex-Cristal chief as CMO, ex-Sanofi Dupixent supply leader as CTO
- Novartis back with bid for 'multibillion-dollar' Zolgensma expansion in older SMA patients as FDA lifts clinical hold
- 'Erratic' FDA and inconsistent drug decisions put doctors off new meds: survey
- Practices facing 'existential' threats, uncertainty about future of primary care, survey finds
- Kaiser Permanente, Ascension Health and 57 other health systems requiring mandatory COVID-19 vaccines for their workforces
Featured Story | By Nick Paul Taylor After being left out of the COVID-19 vaccine race despite having an early investment in mRNA technology, which would go on to give the world two vaccines in record-breaking time, Sanofi has struck a deal to buy its mRNA partner Translate Bio in a $3.2 billion deal. read more |
| |
|---|
|
Top Stories By Annalee Armstrong The blows keep coming for CytoDyn. After the FDA blasted the company for pumping up their unapproved and unproven COVID-19 therapeutic, the Department of Justice and the Securities and Exchange Commission is now subpoenaing the company and its executives. Two investigations were disclosed in an SEC filing dated July 30. read more By Kyle LaHucik The pharma said it was ending ALN-COV, its RNAi antiviral being developed for the treatment of SARS-CoV-2, because of the number of effective vaccines and alternative treatments available. Alnylam and partner Vir Biotechnology had said they would start testing patients by the end of last year. read more By Annalee Armstrong Moderna has its next act lined up: an mRNA respiratory syncytial virus vaccine, which the FDA has just put on the fast track. The biotech, which made its name in 2020 with its COVID-19 vaccine, has been granted a fast track designation for mRNA-1345, which is under investigation as a single-dose vaccine. read more By Nick Paul Taylor Sage Therapeutics terminated two long-suspended phase 3 zuranolone clinical trials after talks with the FDA led it to believe it can seek approval in major depressive disorder without data from those studies. The biotech shared the update alongside news of a delay to data from another phase 3 because of slow enrollment during the pandemic. read more By Kyle LaHucik Nearly a year to the day since starting as CEO at serious diseases biopharma Scholar Rock, Tony Kingsley has exited his post and departed from the board, leaving founding CEO Nagesh Mahanthappa, Ph.D., once again responsible for the top duties. read more By Kyle LaHucik Arch Oncology named its first chief medical officer Monday, with the hire of AbbVie's group medical director for oncology early development. The biotech also hired its first senior vice presidents of clinical development and clinical operations. read more By Kyle LaHucik Coya Therapeutics is planning a phase 2b trial to support an FDA approval for an ALS candidate as the biotech positions for another round of funding by year's end and a potential IPO down the road. The journey to a green light will be funded by a crossover financing round this year ahead of a public offering, but first Coya will need to put up some data to prove itself. read more By Kyle LaHucik As Novartis' gene therapy Zolgensma makes inroads in newborns diagnosed with spinal muscular atrophy, the company is looking to expand the drug’s reach to older patients with a new formulation. After a safety scare and a regulatory setback, the Swiss pharma is now back on track with that plan. read more By Angus Liu As Novartis' gene therapy Zolgensma makes inroads in newborns diagnosed with spinal muscular atrophy, the company is looking to expand the drug’s reach to older patients with a new formulation. After a safety scare and a regulatory setback, the Swiss pharma is now back on track with that plan. read more By Beth Snyder Bulik Stunning reversals, surprise delays and controversial approvals are the order of the day at the FDA lately—and doctors have had enough. Physicians’ trust in the agency is plummeting, according to a survey by Spherix Global Insights. read more By Heather Landi As the country makes progress on the vaccination front, primary care practices and clinicians are now more involved in COVID-19 vaccinations. But practice leaders continue to report major concerns about the stability of the sector. read more By Dave Muoio COVID-19 vaccination as a condition of employment has picked up the support of numerous industry and professional organizations. More health systems are taking a hard stance. read more |  | With the expansion of its DNA services, Cobra Biologics, a Charles River company, has capacity to offer rapid 6-week delivery of HQ plasmids as starting material for clinical evaluation of viral vector mediated immunotherapies. 2021 slots available. |
Resources 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. | 
