Industry News

- 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.
- 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 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.