The capitalization of export opportunities in regulated and semi-regulated markets was the way forward for the Indian pharmaceutical sector. The government's ease of driving policy should benefit several Indian drug manufacturers.
Pharma News
Get the latest news from world and India’s leading pharmaceutical companies Pharma Industry, pharmaceutical marketing, generic drugs, and Complete news for Pharmacy and Life Sciences professionals.
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The US FDA has published guidance for the pharma industry on reference listed drug standards for ANDA (abbreviated new drug application) submissions. The guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission for an ANDA submission.
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Antibiotic resistance is the result of environmental and behavioral causes. Indiscriminate antibiotic prescribing and lax enforcement laws are the main causes of antimicrobial resistance. This may be due to reckless use of antibiotics in hospitals as well as in private practice outside the easy availability of prescription drugs in the country.
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Hundreds of scientists and academics from around the world are offering laboratory and office space to researchers stranded by the U.S. travel ban.
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Cytokinetics, Inc announced that it is scheduled to report fourth quarter results on Thursday, February 16, 2017 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.
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Portola Pharmaceuticals, Inc.announced that it has signed a $150 million royalty agreement with HealthCare Royalty Partners (HCR). Under the terms of the agreement, Portola received $50 million at closing and may receive an additional $100 million upon U.S. Food and Drug Administration (FDA) approval of AndexXaTM (andexanet alfa) in exchange for a tiered, mid-single-digit royalty based on worldwide sales of the agent. The agreement is subject to a maximum total royalty payment of 195 percent of the $150 million funded by HCR, at which time the agreement would expire.
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According to information provided by the Medical Council of India, there are a total of 9,88,922 allopathic doctors registered with the state medical council or MCI as of June 30, 2016.
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The Union health ministry has notified the Medical Devices Rules, 2017. The rules will come into effect from January 1, 2018. This rule has been introduced for the first time in the world.
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Ferring Pharmaceuticals and Enteris BioPharma, Inc. announced that the companies have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence™, to engineer an oral formulation of a peptide-based injectable therapeutic developed by Ferring.
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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.
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