Eisai Co., Ltd. (Tokyo, CEO: Haruo Naito) and Biogen Inc. (Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain has granted Marketing Authorization for their humanized amyloid-beta (Aβ) monoclonal…
Moderna, Inc. (NASDAQ) has announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA vaccine designed to protect adults aged 60 and older from lower respiratory tract disease caused by RSV (respiratory syncytial virus). This…
Astellas Pharma Inc. (TSE: 4503), led by President and CEO Naoki Okamura, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted approval for PADCEV™ (enfortumab vedotin). This approval allows the use…
Genmab A/S (Nasdaq: GMAB) has announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines…
Lupin Limited, a leading global pharmaceutical company, has announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. The product, to be marketed under the brand name Armlupeg®, will be manufactured at Lupin’s Biotech facility in Pune,…
Amgen (NASDAQ: AMGN) has announced that Otezla® (apremilast) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Otezla for treating moderate to severe plaque psoriasis in children and adolescents…
Eli Lilly and Company (NYSE: LLY) announced today positive top-line results from the SURMOUNT-1 three-year study, which evaluated the long-term efficacy and safety of tirzepatide (Zepbound® and Mounjaro®) for weight management and delaying the progression to diabetes in adults with…
Audax Private Equity (“Audax”) announced today that it has entered into a definitive agreement to acquire the Clinical Services business of Avantor, Inc. (NYSE: AVTR) (“Clinical Services” or “the Company”). The transaction is anticipated to close in the fourth quarter,…
Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, has announced its financial results for the second quarter of 2024. “This quarter marks a groundbreaking milestone in Duchenne muscular dystrophy (DMD) treatment, comparable to the discovery of dystrophin…
Vertex Announces Reimbursement Agreement with NHS England for CASGEVY™ Vertex has announced a new reimbursement agreement with NHS England, effective immediately, allowing eligible patients with transfusion-dependent beta thalassemia (TDT) to access CASGEVY™ (exagamglogene autotemcel), a CRISPR/Cas9 gene-edited therapy. This agreement…
Recent findings from the two-part, double-randomized GMMG-HD7 phase 3 study reveal that Sarclisa (isatuximab), combined with lenalidomide, bortezomib, and dexamethasone (RVd), significantly enhances progression-free survival (PFS) in newly diagnosed, transplant-eligible multiple myeloma (NDMM) patients. This combination therapy resulted in a…
Professional Pickleball Association (PPA Tour) player James Ignatowich has teamed up with IBSA USA to promote Licart® (diclofenac epolamine) topical system 1.3%. Licart is the only once-a-day topical nonsteroidal anti-inflammatory (NSAID) patch approved by the U.S. Food and Drug Administration…
