• Regulatory NewsRegulatory News

    FTC to Bar Teva From Making Reverse Payment Patent Settlements

    The Federal Trade Commission (FTC) late Tuesday announced a settlement resolving pending claims in three separate federal court antitrust lawsuits involving subsidiaries of Teva Pharmaceuticals. If approved by the various courts, the settlement, which does not include a fine, will prohibit Teva from engaging in reverse-payment patent settlement agreements that can restrict access to cheaper generic drugs. FTC Chairman Joe Simons said: “This broad settlement prevents ...
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    Recon: EMA Loses Bid to End London Lease; Merck’s Keytruda Fails Late-Stage Liver Cancer Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CVS Needs More Expensive Drugs ( WSJ ) ( Forbes ) US top court rejects bid to block Indivior opioid drug copycat ( Reuters ) Indivior launches generic version of its Suboxone opioid drug ( Reuters ) Merck's Keytruda fails late-stage study in liver cancer patients ( Reuters ) ( Endpoints ) ( Press ) FDA chief says feds might intervene if states continue allowi...
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    US Intervenes in False Claims Suit Against Alere, Arriva Medical

    The US Department of Justice (DOJ) announced Tuesday that federal prosecutors intervened in a lawsuit under the False Claims Act whistleblower provisions against a former supplier of blood glucose monitoring supplies. The case alleges that Arriva Medical and its parent company Alere “submitted or caused false claims to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment w...
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    UK Offers No-Deal Brexit Guidance for Biologics Manufacturers

    In the event of a no-deal Brexit, the National Institute for Biological Standards and Control (NIBSC) will be a stand-alone National Control Laboratory, and the UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market, according to guidance released Tuesday. The only caveat for such a requirement, according to the guidance, is if a batch has an EU Official Control Authority Batch Release (OCABR) certificate ...
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    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...
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    FDA Warns Ocular Therapeutix Over Failure to Comply With Postapproval Requirements

    Ocular Therapeutix drew a US Food and Drug Administration (FDA) warning letter for failing to comply with post-approval study requirements (PAS) set as part of its ReSure Sealant’s conditional approval. The warning letter, dated October 2018, cites the company’s failure to collect any data for its FDA-approved protocol—identified as a Device Exposure Registry (DER) study—as part of the PAS requirements in the 4.5 years since the conditional approval. Ocular Therapeutix’...
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    CDRH Classifies Auto Titration Device for Oral Appliances

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto titration device for oral appliances into class II with special controls. The final order sets the new regulation on the dental device type based on the regulatory review of the 2017 de novo classification request CDRH granted to Zephyr Sleep Technologies’ MATRx plus, classifying the device into class II in August 2018. I...
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    Study Evaluates How an Opioid’s REMS Did Not Work as Intended

    Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. The study, conducted by researchers from the Johns Hopkins Bloomberg School of Public Health and the Center for Science in the Public Intere...
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    Recon: Intercept to Seek Approval for NASH Drug After Mixed Phase III Results; Philippines Revokes License for Sanofi’s Dengvaxia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Intercept's fatty liver drug meets late-stage main goal, shares soar ( Reuters ) ( STAT ) ( Endpoints ) Stealth player is poised to win a CRISPR patent that could speed the development of therapies ( STAT ) Here’s how prosecutors say generic drug makers schemed to fix prices ( STAT ) Throwing in the towel, troubled antibiotic maker Aradigm files for Chapter 11...
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    Asia Regulatory Roundup: TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda   Australia’s Therapeutic Goods Administration (TGA) is considering disclosing when it is evaluating a filing for approval of a prescription drug. TGA currently only shares details of submissions once it has finished evaluating them, but is open to changing its position to make the process more...
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    FDA Cautions Over Young Donor Blood Transfusions to Treat Aging, Memory Loss

    In a warning to consumers on Tuesday, the US Food and Drug Administration (FDA) said consumers should be cautious about establishments offering infusions of plasma obtained from young human donors with the claim that the infused plasma will prevent aging or memory loss. At a cost of up to thousands of dollars per infusion, FDA said these establishments, located in several different states, are currently offering such infusions of plasma with no proven clinical benefit. ...
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    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...