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    FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

    The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion). "This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and commen...
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    Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

    Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...
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    GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits

    Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern. Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products. Background Under the  Orphan Drug Act  of 1983, Congress sought to incentivize the d...
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    Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

    In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to transfer the patents to a Native American tribe to prolong the launch of Restasis generics. In the order on the agreement ...
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    Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council

    Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements. J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the dec...
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    Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule

    The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices. The industry groups call for this final rule to be stayed indefinitely and reconsidered because FDA failed to give fair no...
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    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
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    Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition

    The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive. Teva is currently the largest generic drug company in the US, with an overall market share of about 13%, while Allergan is ranked third, accounting for about 9% of generic ...
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    Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Japanese Regulators Receive Orphan Drug Training from EMA Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP). Mariz has worked on the committee since ...
  • US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing

    If there's one device that global medical device regulators have spent much of the last year worrying about, it's breast implants. But now, and with a nod to safety critics, US regulators have approved a fourth breast implant product for marketing in the US. Background Late in 2011, French regulators began to receive reports that breast implants manufactured by Poly Implant Prothese (PIP) were failing at an alarmingly high rate. The ensuing fallout was in many ways th...