Pharma News

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.

 Ministry of Health and Family Welfare, Government of India signed a Letter of Intent with the Norwegian Ministry of Foreign Affairs, Government of Norway to extend the cooperation within health sector through the Norway India Partnership Initiative (NIPI) for a period of three years starting from 2018, here today. Shri C K Mishra, Secretary (HFW) and His Excellency, Mr. Nils Ragnar Kamsvag, Ambassador of Norway signed this Letter of Intent. Shri Manoj Jhalani, Additional Secretary & Mission Director (AS&MD), Ms. Vandana Gurnani, JS (RCH), Dr. Tore Godal, Special Adviser to Prime Minister of Norway, Dr Maha-noor Khan, Ministry of Foreign Affairs, Norway were also present during the signing ceremony.

Fibrocell Science, Inc a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today reported interim results in its Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

While immune cells called neutrophils are known to act as infantry in the body’s war on germs, a National Institutes of Health-funded study suggests they can act as medics as well. By studying rodents, researchers showed that instead of attacking germs, some neutrophils may help heal the brain after an intracerebral hemorrhage, a form of stroke caused by ruptured blood vessels. The study suggests that two neutrophil-related proteins may play critical roles in protecting the brain from stroke-induced damage and could be used as treatments for intracerebral hemorrhage.