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- Read more about Cytokinetics to sell Royalty on heart failure drug
Cytokinetics, Inc and Royalty Pharma announced that Cytokinetics has agreed to sell to Royalty Pharma a portion of the potential royalty due to Cytokinetics from Amgen on worldwide sales of omecamtiv mecarbil. Cytokinetics has also agreed to exercise its option to co-invest with Amgen in the Phase 3 development program of omecamtiv mecarbil in exchange for increased royalties from Amgen on worldwide sales of omecamtiv mecarbil outside Japan and co-promotion rights.
- Read more about Zydus acquired US based Sentynl Therapeutics
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.
- Read more about NPPA publish revised guidelines to halt scheduled formulations production under para 21 (2) of DPCO, 2013
NPPA issues revised internal guidelines on discontinuation of production of scheduled formulations under paragraph 21 (2) of the DPCO, 2013.
- Read more about Impact of Budget 2017 scheme on pharma sector
The life sciences sector had high expectations of the budget not only from the point of view of tax incentives, but also from a regulatory point of view. Expectations were based on the Government's vision of making India one of the top three pharmaceutical markets by 2020. This year too, no specific impetus was given to the sector.
- Read more about Health organization call on government of India to urgently put in place anti-tuberculosis drugs
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.
- Read more about Health Ministry move to Supreme Court to challenges the revocation of the drug ban by FDC
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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- Read more about UniQure’s AMT-060 receive FDA Breakthrough Therapy Designation
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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- Read more about Tetra Bio-Pharma Inc. Completes Pre-IND Meeting with FDA on PPP001
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.
- Read more about SCIEX launch new X500B QTOF mass spectrometry system for standardised biotherapeutic characterisation
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.
- Read more about FDA Approves Allergan's sNDA to update the label for AVYCAZ® (ceftazidime and avibactam)
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.