US FDA blocks drugs from Indian facility | Debiopharm to market triptorelin 6-month formulation to 22 EU countries | Actinium gets EMA nod for AML drug
March 23, 2017
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US FDA blocks drugs from Indian facility
The US FDA banned imports from Divi's Laboratories' pharmaceutical plant in Vizag, India, for violations of good manufacturing practices. The agency also cited repeated manufacturing violations by a Dr. Reddy's facility in the same city.
The Economic Times (India) (3/22) 
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The Global Orphan Drug Conference & Expo is back
World Orphan Drug Congress USA is back on April 19-21 in Washington D.C. The event will feature 4 tracks, with over 1,000 attendees from around the world, coming together to discuss the latest trends. Download the brochure to see the 170+ speakers, conference agenda and registration information.
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Europe
Debiopharm to market triptorelin 6-month formulation to 22 EU countries
Switzerland-based Debiopharm International will market its Decapeptyl and Pamorelin 22.5 mg, a triptorelin 6-month formulation, to 22 European countries after the drug received approval for use in treating central precocious puberty. The formulation was already registered as a prostate cancer treatment to the same countries.
European Pharmaceutical Review (U.K.) (3/20) 
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Actinium gets EMA nod for AML drug
The European Medicines Agency has provided positive guidance for Actinium Pharmaceuticals' Iomab-B for treatment of acute myeloid leukemia. The agency said the company's data from a late-stage study of the drug was sufficient for filing a marketing authorization application.
Seeking Alpha (free registration) (3/21) 
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MDxHealth, Lab21 reach nonexclusive distribution agreement
An agreement has been announced by MDxHealth allowing Lab21 to become a nonexclusive distributor of its SelectMDx prostate cancer test in the UK. The deal calls for Lab21 to deliver liquid biopsy samples for testing to MDxHealth's clinical diagnostic lab in the Netherlands and provide the diagnostics company with reimbursement for testing services; the companies did not disclose additional terms of the deal.
GenomeWeb Daily News (free registration) (3/21) 
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Asia Pacific
University licenses brain cancer drug to Lin BioScience
Lin BioScience has been granted exclusive worldwide rights to develop and market the University of Sydney's blood-brain barrier permeable, small-molecule drug LBS-002 for brain cancer treatment. Financial details of the deal were not disclosed.
Genetic Engineering & Biotechnology News (3/21) 
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North America
FDA delays implementation of final rule affecting off-label communications
The FDA has postponed implementation of a rule affecting off-label communications between medical device makers, drugmakers and health care providers until March 19, 2018, to respond to a petition that challenges the inclusion of a "totality of the evidence" standard in the rule's definition of "intended use." Khatereh Calleja, senior vice president for technology and regulatory affairs at AdvaMed, said "provisions added late in the process to the final rule are expansive, unwarranted and raise interpretational issues."
Bloomberg BNA (free content) (3/20) 
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Health Canada: Unauthorized, seized products could pose health risk
Health Canada has seized 10 unauthorized health products from British Columbia-based EPCA Shipping, which distributes products for Extreme Peptides, an online health products retailer. The agency said the products, which were labeled to contain prescription drugs for breast cancer, erectile dysfunction and respiratory diseases in horses, posed a serious health risk.
CTV.ca (Canada)/The Canadian Press (3/21) 
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Senate panel holds hearing on FDA user fee reauthorizations
A hearing was held Tuesday by the Senate Health, Education, Labor and Pensions Committee to discuss reauthorizing the FDA user fee programs and their importance in streamlining approvals of medical products, days after the Trump administration proposed a 2018 budget seeking higher user fees than what the industry agreed to.
Medtech Insight (free registration) (3/21),  Regulatory Focus (3/21) 
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Latin America
WHO: Travelers to areas of Brazil should get yellow fever vaccination
The World Health Organization urged travelers to rural areas in the Brazilian states of Rio de Janeiro and Sao Paulo to be inoculated against yellow fever due to an outbreak that has been tied to 137 deaths since December. WHO already urges vaccinations for travelers to the state of Espirito Santo. Health officials have 424 confirmed cases and 933 suspected cases.
Reuters (3/20) 
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Global
X-Chem partners with Ono on cancer drug-discovery programs
X-Chem and Ono Pharmaceutical have entered into a collaboration to develop cancer drugs using X-Chem's DNA-encoded DEX libraries. X-Chem will receive an upfront payment and research and licensing fees, and is entitled to development and regulatory milestone payments, while Ono gets the option to license certain compounds and develop and market programs arising from the collaboration.
Genetic Engineering & Biotechnology News (3/21) 
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DIA News
DIA CMC Workshop, April 24-26, Rockville, Md.
Co-sponsored with the American Association of Pharmaceutical Scientists, DIA's CMC Workshop offers an opportunity to discuss in depth new regulatory, technical and GMP/Quality processes, innovative products, and global perceptive to help you start resolving CMC challenges. Featuring three parallel tracks, the workshop includes four plenary sessions on accelerated programs, innovative technologies with a focus on continuous manufacturing, life cycle management using ICHQ12 and the global regulators update. Download our new eBook for content resources and in-depth detail about the DIA CMC Workshop.
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Upcoming Events:
DIA 2017 update: DIA 2017 is just four months away, and DIA has been busy putting together its largest life science event of the year! Sessions have been launched, and there's a new feature at this year's annual meeting: DIA Venture Summit. DIA 2017 boasts 11 featured tracks, 15+ hot topics, 160+ sessions and more! Check out the Featured Tracks at DIA 2017 and take a deep dive into topics that interest you most.
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