– Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis – Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020 …
Sanofi and Regeneron begin global Kevzara® (sarilumab) clinical trial program in patients with severe COVID-19
CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 16, 2020 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. today announced they have started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the…
Novo Nordisk Pauses Three Clinical Trials Because of Non-Fatal Thrombotic Events
Denmark’s Novo Nordisk paused three clinical trials of concizumab over safety issues. The trials are evaluating the drug for hemophilia A and B. No more patients will be enrolled in the trials and current treatment “will cease” while they determine…
FDA gives Lilly’s Olumiant breakthrough status for hair loss
Eli Lilly’s Olumiant is facing tough competition in its approved rheumatoid arthritis indication, but could take the lead in alopecia areata (AA), a common cause of hair loss. The FDA has granted Lilly a breakthrough designation (BTD) for JAK inhibitor…
2 years after merger, Syneos Health ‘exploring a sale’: report
(Reuters) – Syneos Health Inc (SYNH.O), a U.S. contract research organization (CRO) that serves the pharmaceutical industry, is exploring a sale, people familiar with the matter said on Monday. A deal for Syneos would be the latest in string of…
Shionogi and Tetra expand partnership ahead of Alzheimer’s trial readout
Shionogi has expanded its partnership with its Alzheimer’s drug development partner Tetra Therapeutics, giving an option for a buyout of the US biotech ahead of a key trial milestone. The two companies will work together to develop and market BPN14770…
EyePoint Reports Long-Term Positive Results from Phase III Yutiq Trial
EyePoint Pharmaceuticals, based in Watertown, Massachusetts, announcedpositive topline 36-month follow-up data from the second Phase III trial of Yutiq (fluocinolone acetonide intravitreal implant) for treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Yutiq was approved by…
Karyopharm’s Xpovio Hits the Mark in Phase III Multiple Myeloma Trial
Shares of Karyopharm Therapeutics soared Monday after the company posted positive Phase III results in multiple myeloma and announced it is planning a regulatory submission in the second quarter of this year for its combination of Xpovio, Velcade and Dexamethasone.…
Amicus Opens New Global Research and Gene Therapy Center of Excellence in Philadelphia
CRANBURY, N.J. and PHILADELPHIA, March 05, 2020 (GLOBE NEWSWIRE) — Amicus Therapeutics, Inc. (Nasdaq: FOLD) today announced the official opening of the company’s Global Research and Gene Therapy Center of Excellence in uCity Square in Philadelphia to advance its industry leading portfolio…
Novartis Teams Up with Startup Orionis to Tackle Elusive Drug Targets
Massachusetts-based Orionis Biosciences has flown under the radar since its founding in 2015, has leaped into the mainstream this morning with a major four-year drug discovery collaboration with Swiss pharma giant Novartis. The two companies forged a collaboration to discover…
