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30 March 2017

Alkem got EIR from the US FDA

US FDA has issued an Establishment Inspection Report (EIR) for Alkem Labs's Ankaleshwar API Facility which was inspected in December 2016. The inspection has now been closed by the US FDA.

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- Read more about Aurobindo Pharma receives USFDA approval for Meropenem Injection
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. Aurobindo’s Meropenem injection is a generic equivalent of AstraZeneca Pharmaceuticals’ Merrem® Injection. The product will be launched immediately.
- Read more about USFDA to lift ban from Mohali Plant of Sun Pharma
“Sun Pharma” and includes its subsidiaries or associate companies) was informed by the US FDA , that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.
- Read more about 47,000 bottles of antidepressant capsules Recalling by Aurobindo Pharma in US
Aurobindo Pharma USA Inc. recalls 47,040 bottles of Venlafaxine hydrochloride prolonged-release capsules in the 37.5 mg strength in a national recall in the US, the latest USFDA enforcement report said. The drug was manufactured by Aurobindo Pharma Ltd, Hyderabad
- Read more about Nemaura Pharma secures funding to advance its Micro-Patch™ solid dose microneedle system for a hormone Biologic
UK biotech company Nemaura Pharma has announced a commitment from private investors of up to £5m for the development of a hormone Biologic using its Micro-Patch™ solid dose delivery platform. The fast-growing company has made significant progress in the reformulation of liquid vaccines administered through the skin using its solid dose delivery system. The funding is being used to accelerate Nemaura’s commercial research and development of clinical programmes to prepare the drug-device combination for market.
- Read more about US FDA published guidelines for Pharma industry on RLD standards for ANDA submissions
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.
- Read more about Trump’s U.S. travel ban distract the work of scientists
Hundreds of scientists and academics from around the world are offering laboratory and office space to researchers stranded by the U.S. travel ban.
- Read more about Cytokinetics to announce fourth quarter results
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.
- Read more about Portola Pharmaceuticals Signs $150 Million Royalty Agreement with HealthCare Royalty Partners for Development and Commercialization of Andexanet Alfa
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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- Read more about Ferring Pharmaceuticals and Enteris BioPharma joined to produce an Oral Formulation of a Peptide-based Injectable Therapeutic
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.