Industry News

Sun Pharmaceutical Industries Ltd  announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review.

Novavax, Inc a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax's vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Strides Pharma Science Limited announced that its step- down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), (EET) tablets from the United States Food & Drug Administration (USFDA).

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Exxua™ (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.

Johnson & Johnson confirmed its intent not to enforce patents it owns and controls for SIRTURO® (bedaquiline) in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries.

AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).

Biosergen AB (Biosergen) and Alkem Laboratories Ltd. (Alkem) are pleased to announce the signing of a co-development and license agreement for BSG005, an innovative polyene macrolide, through phase II and phase III trials for sale in the Indian market. 

GSK plc announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the Intracept Intraosseous Nerve Ablation System to treat vertebrogenic pain, a form of chronic low back pain. The transaction includes an upfront cash payment of 850 million USD and undisclosed additional contingent payments based on sales performance over the next three years.