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Astellas Pharma Inc. President and CEO Kenji Yasukawa, Ph.D., today announced the opening of a new late-stage clinical and commercial manufacturing facility in Sanford, N.C. The facility will allow Astellas Pharma to expand the company’s resources and team to establish a robust, global supply chain and expand its therapeutic and geographic scope.

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.

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.

U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc.’s vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.

Bristol Myers Squibb (BMS) announced late-breaking data Wednesday showing that deucravacitinib, an allosteric tyrosine kinase 2 inhibitor, met the primary endpoint in the treatment of systemic lupus erythematosus.

Genentech, a member of the Roche group, announced new data on Thursday related to the company’s investigational CD20xCD3 T-cell engaging bispecific antibody glofitamab, which is intended to treat relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

Regeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.

Diversity in all clinical research—including rare disease research—is currently under scrutiny, partly because of disparities experienced with COVID-19. Rightly so, as data show that 86 percent of genomics studies to date have involved people of European ancestry, which has limited the potential benefits of genomic research for many populations. Rebecca Sutphen, Co-Founder and Chief Medical Officer of InformedDNA, and Board-Certified Genetic Counselor Karmen Trzupek analyze strategies to increase diversity in rare genetic disease trials.

Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.