Leaderboard Branding, a Fingerpaint company – the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1 – announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
A patent cliff is looming once again for the biopharma industry, putting some $236 billion in pharmaceutical sales at risk between now and 2030. For context, the top 10 biopharmas in 2021 generated total global sales of $512 billion. In the next eight years, more than 190 drugs will go off-patent for these companies. Of those, 69 are blockbuster drugs.
Powered by the company’s blockbuster checkpoint inhibitor Keytruda, Merck is forecasting the potential of more than 80 new regulatory approvals in oncology through 2028.
Bayer is building an oncology powerhouse. The Germany-based biopharma leader is on a mission to become one of the top 10 oncology companies by 2030, and an ambitious mission requires an equally driven leadership team. To that end, Bayer snagged ex-GSK global oncology head Christine Roth to lead the company’s Oncology Strategic Business Unit, then dipped into GSK waters again to bring Tara Frenkl on board as head of oncology development.
Bluebird bio’s blood disorder treatment demonstrates “clinically meaningful” benefit in patients, staff reviewers at the U.S. Food and Drug Administration said in briefing documents published on Tuesday.
Weeks after announcing a significant partnership with Evotec to advance treatment for type 1 diabetes, Canada-based Sernova Corp. shared positive Phase I/II data from an ongoing clinical study of the company’s implantable Cell Pouch device that showed evidence of in vivo active insulin production following implantation of the device and islet transplantation.
Advisers to the U.S. Food and Drug Administration will consider whether to recommend Novavax Inc.’s COVID-19 vaccine for adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.
Ginkgo Bioworks, a leading horizontal platform for cell programming, announced a collaboration with Novo Nordisk, a leading global healthcare company, to create novel expression hosts for pharmaceutical products.
At the American Society of Clinical Oncology (ASCO)’s annual meeting this weekend, BioNTech and Dr. Vinod Balachandran, M.D. of Memorial Sloan Kettering Cancer Center, presented preliminary Phase I data of its BNT122, which it is evaluating with Genentech (Roche) in pancreatic cancer.
Gilead Sciences shared what seemed to be good news regarding Trodelvy in HR+/HER2- breast cancer at the 2022 American Society of Clinical Oncology’s annual meeting, but a modest survival advantage left some wondering about the clinical significance.