Pharma News

Zydus Cadila, a leading global healthcare provider announced that it has acquired Sentynl Therapeutics Inc., a US based specialty pharma company specialized in marketing of products in the pain management segment. The transaction will be EPS accretive. With this acquisition, Zydus makes a foray into the specialty pain market in the US valued at $ 8 billion.

NPPA issues revised internal guidelines on discontinuation of production of scheduled formulations under paragraph 21 (2) of the DPCO, 2013.

Tuberculosis is without doubt a deadly disease that requires serious and constant attention. To address the growing incidence of drug-resistant tuberculosis, its survivors and various public health groups have written to the Department of Health for the incorporation of the patented drug Delamanid into the RNTCP(Revised National Tuberculosis Control Programme). Delamanid has been shown to be effective in the treatment of drug-resistant TB. In a letter to the Union Ministry of Health, the organizations urged the government to order Ostuka Pharmaceuticals Co. Ltd. (Otsuka), the company holding the drug monopoly, to register the delamanid in India without further delay.

The health ministry asked the Supreme Court to challenge an order of the Delhi High Court that had quashed its ban on more than 300 fixed-dose drugs. The health ministry last year had banned 344 FDCs, estimated to affect about 6,000 drug brands and shave over Rs 3,000 crore on the Indian pharmaceutical market, which is estimated to be over Rs 100,000 crore.

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uniQure N.V. announced that AMT-060,  its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).  This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show sustained increases in Factor IX (FIX), reductions in FIX replacement usage and a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up. 

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PhytoPain Pharma Inc. (“PPP”), a subsidiary of Tetra Bio-Pharma Inc. a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has completed its pre-IND meeting with the USA Food and Drug Administration (“FDA”) for its PPP001 dried cannabis drug product.

SCIEX, a global leader in life science analytical technologies, announced its latest solution in the X-Series Quadrupole Time of Flight (QTOF) mass spectrometry (MS) platform. The newest X-Series model, the X500B QTOF System, brings simplicity, high performance and robustness for biotherapeutic analyses to one of the most compact MS system footprints on the market.

Allergan plc , a leading global pharmaceutical company,  announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ® (ceftazidime and avibactam) with clinical data from two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.

The European Commission has approved an update to the Jardiance® (empagliflozin) label to include a change to the indication statement. Jardiance® is now indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise.The approved product information now includes data on the reduction of risk of cardiovascular (CV) death in patients with T2D and established CV disease in addition to data on the improvement of blood sugar control.Jardiance® is the only oral diabetes treatment shown to reduce the risk of CV death in a dedicated CV outcome trial to date. Jardiance® is marketed by Boehringer Ingelheim and Eli Lilly and Company (LLY).