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    FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday called on Sanofi-aventis and Celgene to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature. The similar letters, which were the sixth and seventh untitled and warning letters issued by OPDP in 2016, both say: ““The presentation of these compelling and attention-grabbing visuals, all of which are unrelated to the risk mes...
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    Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval

    Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government t...
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    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    EMA Recommends Nine Drugs for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...
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    Updated: EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu

    Fifteen batches of Sanofi’s chemotherapy Taxotere (docetaxel) have been recalled due to a problem in the manufacturing process that could have led to vials being too concentrated, the European Medicines Agency (EMA) said in an updated alert on the possible shortage on Thursday. A failure in the filling process at Sanofi’s manufacturing site in Germany has led to Taxotere vials being up to 5% over-concentrated, EMA said. The drug is used to treat breast cancer, non-s...
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    Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA

    Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the  Biologics Price Competition and Innovation Act  (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period. The provision in the BPCIA in question states that: "An approved application for a ...
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    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
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    Former FDA and NIH Heads Call for Regulatory Harmonization

    Former US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and former National Institutes of Health (NIH) Director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine . The call comes as nearly 40% of drugs and half of all medical devices used in the US are made elsewhere, while 80% of the active pharmaceutical ingredients in US drugs are manufactured in f...
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    Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Committee Rejects Sanofi’s Request for Dengue Vaccine Trial Waiver A top-ranking Indian health committee has rejected Sanofi’s request to bring its dengue vaccine to market without data from locally run Phase III trials. The ruling by the health apex committee follows positive responses from two other panels, which felt the waiving the requirement for a local Phase I...
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    European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. NICE Takes Sides in Fight for PCSK9 Market, Recommending Amgen While Rejecting Sanofi The National Institute of Health and Care Excellence (NICE) has recommended using Amgen’s PCSK9 inhibitor Repatha in certain indications, while rejecting the use of Sanofi and Regeneron’s rival drug Praluent. While both manufacturers offered discounts of undisclosed magnitudes, only A...
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    Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

    As part of Health Canada’s transparency push , the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016. Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker , and specific details on the...
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    India Fines GSK, Sanofi for Alleged Anti-Competitive Practices

    The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...