Industry News

Technavio’s market research report on CAR-T cell therapy for liver and lung cancer provides comprehensive insights about pipeline molecules across this approach of treatment. The key objective of the report is to establish the understanding of all the pipeline molecules, which fall under CAR T-cell therapy for liver cancer and lung cancer.

The U.S. Food and Drug Administration authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants).

U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

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.