Industry News

FDA halts clinical trials of Deuruxolitinib due to the potential for thrombotic events seen in subjects. FDA has placed the IND on partial clinical hold and are requiring that subjects currently on studies to discontinue the dose.

It has been noted by the FDA that pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies of Deuruxolitinib.

Astellas Pharma Inc and Pfizer Inc announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

This marketing authorisation granted to Venus Pharma GmbH, the German subsidiary of Venus Remedies, by one of the world’s most stringent healthcare regulatory agencies will enable the company to offer its affordable range of cancer drugs to the National Health Service (NHS) in the UK and neighbouring countries.

Ipca Laboratories to acquire 33.38 percent shares in Unichem Laboratories for Rs 1034.06 Crores. Ipca Laboratories announced that the company has entered into a definitive Share Purchase Agreement (SPA) for acquisition of 2,35,01,440 fully paid-up equity shares of Rs. 21- each, constituting 33.38% of the paid up equity share capital of Unichem Laboratories Ltd. (Unichem), from one of its promoter shareholder at a price at Rs. 440 per equity share aggregating to Rs; 1034.06 Crores.

Amphastar is the ideal company to continue Lilly's mission to help more people benefit from BAQSIMI

Sun Pharma and includes its subsidiaries and/or associate companies) announced that one of its wholly-owned subsidiaries has launched a novel ophthalmology treatment, CEQUA®, in India for patients who have Dry Eye Disease (DED) with inflammation, a commonly occurring condition. CEQUA® is the first dry eye treatment available in India that is delivered with nanomicellar (NCELL®)* technology.

Gamida Cell Ltd a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved Gamida Cell’s allogeneic cell therapy, Omisirge® (omidubicel-onlv), for use in adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

The University of Oxford-developed and Serum Institute of India PvT Ltd (SIIPL)- manufactured and scaled up R21/Matrix-MTM malaria vaccine, leveraging Novavax’s adjuvant technology, has been licensed for use in Ghana by the country’s Food and Drugs Authority.

Sanofi has simplified its contractual arrangements relating to the development and commercialization of Beyfortus (nirsevimab) in the United States (U.S.).

Under the new and updated arrangements, Sobi will terminate its participation agreement with AstraZeneca, and Sanofi and AstraZeneca will update the Collaboration Agreement so that Sanofi has full commercial control of nirsevimab in the U.S. Sanofi has simultaneously entered into a direct royalty agreement with Sobi to share a portion of U.S. net sales from nirsevimab.