Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.
Following decisions in 2023 to back away from its lead neurological therapies and conserve cash, Eliem Therapeutics Inc. found a vote of investor confidence and a new direction through its acquisition of privately held Tenet Medicines Inc. and its anti-CD19 antibody for autoimmune disease.
With high hopes for its LPA1R antagonist program, Contineum Therapeutics Inc. has priced an IPO of 6.9 million shares of its class A common stock at $16 per share as it seeks to generate $110 million in gross proceeds. The San Diego-based company began trading on Nasdaq under the ticker CTNM on April 5, with shares ending the day at $15.40, down 3.8%. There have been nine other biopharma IPOs so far in 2024.
Scientists from the Australian National University have discovered the gene mutation responsible for causing psoriasis, and the findings could lead to improved diagnosis and treatment for patients with psoriasis and psoriatic arthritis, a chronic inflammatory skin disease. “We were able to identify the gene that could be important in enabling this progression from a skin-only condition to a skin-and-joint condition,” lead study author Chelisa Cardinez told BioWorld.
Nearly a year after Prometheus Biosciences Inc. sold for $10.8 billion to Merck & Co. Inc., its former CEO, Mark McKenna, is back in the game with Mirador Therapeutics Inc. Many of his former Prometheus colleagues have joined McKenna. Getting the band back together, McKenna told BioWorld, “is the ultimate compliment.” Mirador just launched with more than $400 million to develop therapies for treating immune-mediated inflammatory and fibrotic diseases.
Nine-year-old IFM Therapeutics LLC has notched yet another big deal as Novartis AG will acquire all the outstanding capital stock of IFM Due Inc., a subsidiary of privately held IFM in an agreement that began five years ago. The newest deal brings IFM $90 million up front and makes it eligible for up to $745 million in milestone payments for a deal value of $835 million.
Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
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