Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies. The potential value of the transaction is over $1 billion, depending on the achievement of future development and commercial milestones. Pasadena, Calif.–based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous…
Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran
Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy. In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided…
Regeneron uncovers genetic mutations that guard against obesity
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that its Regeneron Genetics Center (RGC) has discovered rare genetic mutations associated with protection against obesity. RGC researchers learned that people with at least one inactive copy of the GPR75 gene tend to weigh about 12 pounds less than those without that mutation. In addition, those individuals faced a 54%…
Pandemic and disease burden are ‘existential’ threats, experts argue
While the COVID-19 pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and…
FDA approves Novo Nordisk’s semaglutide for weight management
FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B). The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use. In clinical trials, Novo Nordisk people…
Why Lilly’s tirzepatide has blockbuster potential
Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData. In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine. Tirzepatide is a dual glucose-dependent insulinotropic…
Novo Nordisk to test oral semaglutide as an obesity therapy
Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity. The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’…
FDA sends Novo Nordisk refusal to file letter for weekly 2-mg semaglutide
Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide). The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021. The letter indicates that…
Vertex Pharmaceuticals wins FDA fast track designation for its cell-based diabetes treatment
Vertex Pharmaceuticals announced today that FDA has granted fast track designation for its VX-880, an investigational human stem cell-derived islet cell therapy for type 1 diabetes. Vertex has begun a clinical trial for VX-880 (formerly known as STx-02) in patients with type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemia awareness. “Ours is the only…