Industry News

Dr. Reddy's Laboratories Ltd. launched Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan (Regadenoson) injection, approved by U.S. Food and Drug Administration (USFDA).

Lexiscan is a registered trademark of Astellas US LLC. It is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a duration that is useful for radionuclide myocardial perfusion imaging.

Zydus Life Sciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram (USRLD: Carafate Tablets, 1 gram).

Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).

AstraZeneca Pharma India has received a permission in Form CT-20 to Import for sale and distribution of Trastuzumab deruxtecan (Enhertu) 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India.

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.