Pharma News

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.

Médecins Sans Frontières/Doctors Without Borders India has filed a petition before the High Court of Delhi to overturn the patent granted on the pneumococcal conjugate vaccine (PCV) to the US pharmaceutical corporation Pfizer.

One of the wholly owned subsidiaries of the Sun Pharma has agreed to increase its shareholding in Ranbaxy Malaysia Sdn Bhd, Malaysia, by way of purchase of 666,985 shares of face value of MYR 1.00 each (equivalent to 8.3%) of Ranbaxy Malaysia Sdn Bhd.

Ranbaxy Malaysia Sdn Bhd., is a subsidiary of the Company, and the total shareholding of Sun Pharmaceutical Industries Ltd., alongwith its wholly owned subsidiary is 71.2%, prior to this proposed purchase of shares

Zosano Pharma Corp a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM”) technology, announced that Cephalalgia had published the Company’s positive results from our pivotal, multi-center, double blind, placebo controlled, trial demonstrating efficacy and safety of M207, our formulation of zolmitriptan using our ADAM technology.

Antares Pharma, Inc. announced that, the Company received a letter from the U.S. Food and Drug Administration (FDA) stating that, as part of their ongoing review of the Company’s New Drug Application (NDA) for XYOSTED™ (testosterone enanthate) injection, they have identified deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.

The U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for Mylan´s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

The U.S. Food and Drug Administration approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.

Zydus Cadila has received the final approval from the USFDA to market Dutasteride Capsules, 0.5 mg and Amitriptyline Hydrochloride Tablets USP in strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg.

Janssen Research & Development, LLC (Janssen) announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease. The application also applies to INVOKANA®’s fixed-dose combinations, INVOKAMET® and INVOKAMET® XR, and is based on findings from the landmark CANVAS clinical trial program, which were presented at a special symposium at the American Diabetes Association 77th Scientific Sessions in June 2017 and simultaneously published in The New England Journal of Medicine.

Users of statins, widely prescribed for prevention of cardiac disease, have a 27% lower risk of contracting a Staphylococcus aureus (S. aureus) bloodstream infection outside of a hospital, according to a new study in Mayo Clinic Proceedings. Researchers report that statin use, especially among elderly patients with preexisting chronic conditions such as diabetes, kidney, or liver disease, may be protective against this serious bloodstream infection. As the western world's population is aging and more people live with chronic medical conditions, any potential preventive effect of statins could have important clinical implications.

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