Industry News

The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

The U.S. Food and Drug Administration  approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.

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U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud. The FDA is warning consumers to be alert, and try and steer clear of fraudulent flu products, which may be found online or in retail stores. The agency protecting consumers of unapproved products claiming to prevent, treat or cure influenza, or flu.

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, today announced that the previously announced Notice of Allowance of our patent application titled “Method of Rapidly Achieving Therapeutic Concentrations of Triptans for Treatment of Migraines” has resulted in the issuance of a U.S. patent 9,918,932.  The inventors were Dr. Mahmoud Ameri, Dr. Don Kellerman, Dr. Yi Ao, and Dr. Peter Dadonna, all of whom are current or former employees of Zosano.

MSD and Viralytics Limited  announced that the companies have signed a definitive agreement under which it is proposed that Merck, through a subsidiary, will acquire Viralytics, an Australian publicly traded company focused on oncolytic immunotherapy treatments for a range of cancers by way of a scheme of arrangement (Scheme) for AUD 1.75 cash per Viralytics share. The proposed acquisition values the total issued shares in Viralytics at approximately AUD 502 million (USD 394 million). The cash consideration of AUD 1.75 per share represents a premium of 160% to the one month volume weighted average price (VWAP) of Viralytics shares.

The European Medicines Agency (EMA) has published that the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) – to support the implementation of the so-called 3Rs principles for more ethical use of animals in medicine testing across the European Union (EU).

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Amglidia (glibenclamide), a medicine indicated for the treatment of neonatal diabetes mellitus (NDM), for use in newborns, infants and children.

U.S. Customs and Border Protection (CBP) announced a new formal partnership arrangement with Procter & Gamble (P&G), as part of the Donations Acceptance Program, to prevent counterfeit P&G products from entering the United States. As part of the partnership, P&G will donate testing devices to verify the authenticity of various P&G products.

Celgene Corporation announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).

Sumitomo Dainippon Pharma Co., Ltd filed patent infringement lawsuits jointly with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”) on February 13, 2018 (U.S. Eastern Time) in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Ltd. and in the U.S. District Court for the District of Delaware against Amneal Pharmaceuticals LLC regarding their submissions of Abbreviated New Drug Applications (“ANDAs”) for generic copies of LATUDA® (lurasidone HCl tablets). The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 9,815,827 (“the ’827 Patent”). These lawsuits are separate and different from the pending lawsuits, filed on January 14, 2015 in relation to Sumitomo Dainippon Pharma’s U.S. Patent No. 5,532,372.