• Regulatory NewsRegulatory News

    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
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    FDA Reassures Public that MMR Vaccine is Safe and Effective

    Amid multiple measles outbreaks across the country, the US Food and Drug Administration (FDA) on Monday released a statement reassuring the public that the measles, mumps and rubella (MMR) vaccine is safe and effective.   In recent years, misinformation about the safety and efficacy of vaccines has led to low vaccination rates in certain communities. Despite efforts in some jurisdictions to close loopholes that allowed parents to avoid vaccinating their children, many ...
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    FDA Approves First Pediatric ADHD Device

    The US Food and Drug Administration (FDA) granted marketing approval to California-based NeuroSigma for the first medical device to be indicated for attention deficit hyperactivity disorder (ADHD) treatment. The decision to authorize marketing of the Monarch external Trigeminal Nerve Stimulation (eTNS) system was reached and announced last Friday, marking the first approved non-drug ADHD treatment. The cellphone-sized Monarch eTNS system was evaluated based on NeuroS...
  • Feature ArticlesFeature Articles

    Optimizing Clinical Trial Data to Support Biosimilars for Market Approval

    This article discusses the differences between biologics and biosimilars and focuses on their molecular dissimilarity. In covering efforts to gain market approval for biosimilars, the author reviews uncertainties associated with biosimilars, the value of pharmacokinetic data as well as therapeutic equivalence trials and their design. The author suggests the time is right for regulators and industry to engage in a critical evaluation of the clinical development of biosimila...
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    ICT Report Highlights MedTech Positives in USMCA Agreement

    The US International Trade Commission (ICT) issued a new report on the likely impacts of the US-Mexico-Canada Agreement (USMCA) on the US economy and specific industry sectors—which include medical devices and technologies, pharmaceuticals and biotechnologies. USMCA has received mixed reactions since the agreement between the US, Mexico and Canada was signed last November. Device industry group AdvaMed was quick to welcome the latest report, while the generic drug indus...
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    More NDAs, BLAs Filed in Q1 2019 Than Any Quarter in 2018

    More new drug applications (NDAs) and biologics license applications (BLAs) were filed in the first quarter of FY 2019 than in any quarter in FY 2018, according to new real-time reports for pharmaceuticals that were mandated by the user fee legislation known as the Food and Drug Administration Reauthorization Act (FDARA). The latest report shows that 53 NDAs and 4 BLAs (57 total) were filed as of 31 December 2018, whereas the highest total for any quarter in FY 2018 w...
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    How Biopharma Companies Use NIH and Vice Versa

    An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings. With the help of a new Congressional Research Service (CRS) report published Friday and some other m...
  • ReconRecon

    Recon: Lilly, Avidity Team up on Immunology Drugs; FDA Approves Keytruda Combo for Kidney Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's Keytruda wins FDA approval as combination therapy for kidney cancer ( Reuters ) ( Endpoints ) ( FDA ) Lilly, Avidity to Partner on Immunology Drugs in Up-to-$440M Collaboration ( GEN ) ( BioPharmaDive ) ( Endpoints ) Poseida Therapeutics Raises $142 Million in Series C Financing ( Reuters ) ( Fierce ) ( Endpoints ) ( Press ) Second death in Novartis ge...
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    FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

    Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday. The life-saving medication is indicated for stopping or reversing the effects of an opioid overdose and the approval forms part of the agency’s ongoing efforts to combat the nation’s opioid crisis. Generic injectable naloxone products are already in use at health care settings, but...
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    Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

    In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition. The comment period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others. SDOs, in general...
  • ReconRecon

    Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal judge scolds Purdue, Endo and Mallinckrodt for stall tactics in opioids case ( Fierce ) ( Law360 -$) 'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst ( Fierce ) Judge rejects challenge of New York City's mandatory measles vaccination order ( Reuters ) Washington State Senate Passes Bill Removing Exemption For Measles Vaccin...
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    DTC Drug Advertising: Study Finds Mixed Impact on Patients, Prescribers

    A new literature review of studies of direct-to-consumer (DTC) prescription drug advertising identifies potential positives and negatives for DTC advertising on the patient-prescriber relationship and highlights gaps in the current medical literature on the topic.   The review, authored by researchers at RTI International and the US Food and Drug Administration (FDA), looked at 38 studies published between 1982 and 2017 that examined outcomes reported by patients, pres...