Eli Lilly‘s Olumiant (baricitinib) received approval Monday from the U.S. Food and Drug Administration for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease. The approval is based on positive results from the Phase III…
Regulatory Affairs Outsourcing Market to Cross US$ 17.3 Bn by 2028
Wilmington, Delaware, United States: According to the report, the global regulatory affairs outsourcing market was valued at US$ 4.5 Bn in 2020 and is projected to expand at a CAGR of 19.0% from 2021 to 2028. Regulatory affairs outsourcing refers…
Alnylam Scores Another FDA Nod in hATTR
Almost a month ahead of schedule, the U.S. Food and Drug Administrationhas approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults. This early decision came as a surprise for many, as the FDA had…
BMS sets up Roche, Pfizer rivalry with Turning Point takeover
Bristol-Myers Squibb’s all-cash offer for Turning Point Therapeutics – which values the biotech at $4.1 billion – bolsters its position in precision oncology and gives it a lead asset that could challenge cancer medicines from Roche and Pfizer. The $76-per-share…
Merck Predicts Over 80 Potential Oncology Approvals Through 2028
Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting the potential of more than 80 new regulatory approvals in oncology through 2028. Merck showcased its oncology pipeline at the American Society of Clinical Oncology meeting in Chicago. The company presented…
Apple adds medication tracking to iPhone and Apple Watch
Owners of an iPhone or Apple Watch have a new health feature, an app called Medications, that will help them manage and track their use of medicines. The new tool works as a component of Apple’s Health app and will…
Astellas taps GO’s glycoprotein platform with $783.5m deal
Astellas has become the latest big pharma company to sink some money into immuno-oncology start-up GO Therapeutics, forging an alliance to develop antibodies targeting two glycoprotein targets. The Japanese drugmaker is paying $20.5 million upfront to get the ball rolling,…
Median Tech debuts AI-focused unit for cancer trial support
Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinical trials in oncology. The new Imaging Lab business will deploy AI, data mining, and…
FDA grants speedy review to Dupixent rare skin disease
Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority…
GSK bolsters vaccines division with $3.3bn swoop on Affinivax
GlaxoSmithKline has agreed a $3.3 billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. GSK said it is paying $2.1…
