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FDA approves Bristol-Myers Squibb’s Opdivo injection to treat mUC
Bristol-Myers Squibb’s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumour response rate and duration of response and its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The company received the application priority review and breakthrough therapy designation for Opdivo from the FDA to treat patients with locally advanced or mUC.
Sun Pharma Recalls 2.7 Lakh Bottles of Antidepressant
Sun Pharma is recalling over 2.7 lakh bottles of bupropion hydrochloride extended-release tablets used for treatment of major depressive disorders in the US due to failed dissolution specifications. The recall is being initiated by Sun Pharmaceutical Industries Inc. for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.
Mezzion Pharma has filed a suit against Dr Reddy’s Laboratories in the US
Mezzion has filed a suit for damages against Dr. Reddy’s in New Jersey State Court alleging that Dr. Reddy’s committed fraud relating to the latter hiding significant deficiencies in its Food and Drug Administration (FDA) cGMP practices, and misrepresenting its compliance to Mezzion. According to Dr. Reddy’s, they have not been served with any legal papers or legal process in the matter referred to in Mezzion’s press release. In 2015, Dr. Reddy’s had received a warning letter from the US Food and Drug Administration (USFDA) for two of its active pharma ingredients (API) manufacturing plants and a formulation facility located in Andhra Pradesh and Telangana.
Sanofi’s antibody to treat patients with rheumatoid arthritis gets Approved
Sanofi has received approval from Health Canada for Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, to treat adult patients with moderately to severely active rheumatoid arthritis (RA). The approval was based on data from about 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. The fully human monoclonal antibody Kevzara binds specifically to soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.