• ReconRecon

    Recon: Novartis, NHS Reach Deal on Yet-to-Be Approved Heart Drug Inclisiran; Roche Aims to Undercut Rivals With SMA Drug Pricing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US All talk, no M&A makes for a down JPM Day ( STAT ) ( Pink Sheet -$) Roche aims to 'underwhelm' on SMA drug price to challenge rivals ( Reuters ) ( Endpoints ) GlaxoSmithKline CEO expects to get ‘at least’ six drug approvals from the FDA in 2020 ( CNBC ) Eyeing more data, Livongo will integrate continuous glucose monitor into diabetes coaching program ( STAT ) ...
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    Do FDA’s Reforms Need Reforming? Report Looks Back on 4 Decades

    A new report appearing in JAMA on Tuesday outlines why the reforms at the US Food and Drug Administration (FDA) over the past four decades may need further changes.   The most significant of those changes, according to the authors, include FDA’s commitment to review applications for new drugs and biologics in less time; the creation of expedited review programs at FDA, including priority review, fast track, breakthrough therapy designations and accelerated approval; ...
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    Stryker Petition Pushes FDA to Exempt Powered Wheel Stretchers From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday issued a final order exempting powered wheeled stretchers from premarket notification (510(k)) requirements in response to a citizen petition filed by Stryker Medical last July.   The agency previously exempted certain products under five different product codes from premarket notification requirements in October. In 2017, FDA finalized an order exempting 1,003 types of Class II devices from premarket notificati...
  • ReconRecon

    Recon: Startup EQRx Raises $200M in Effort to Bring Cheaper Drugs to Market; Incyte Buys Rights to MorphoSys CAR-T Rival

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US JPM health conference kicks off ( Politico ) High Drug Prices? Pharma Startup Thinks It Has the Right Medicine ( WSJ ) ( Axios ) ( STAT ) ( Endpoints ) ( Financial Times ) ( Fierce ) FDA and NIH let clinical trial sponsors keep results secret and break the law ( ScienceMag ) Biogen to buy early-stage potential Alzheimer's, Parkinson's treatment from Pfizer ( R...
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    FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete

    In the latest update in the years-long investigation into the safety of Bayer’s permanent birth control device Essure, the US Food and Drug Administration (FDA) on Friday said that nearly all unused Essure devices have been returned to Bayer and that the company has wrapped up enrollment in an FDA-mandated postmarketing study.   Since Bayer announced it would stop marketing and distributing the devices in the US in July 2018, the company has sought to collect all rem...
  • ReconRecon

    Recon: Lilly to Acquire Dermira for $1.1B; Idorsia, Neurocrine Pair for $400M Epilepsy Drug Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly to acquire Dermira for $1.1 billion, adding eczema drug to its pipeline ( STAT ) ( Endpoints ) Blackstone raises three-quarters of targeted $4.6 billion life sciences fund ( Reuters ) ( Endpoints ) BMS confident of approvals linked to higher Celgene investor payout: Bristol executive ( Reuters ) FDA approves Blueprint's stomach cancer therapy priced at $...
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    EMA Recommends Fewer New and Orphan Drugs in 2019

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 30 new active substances (NAS) for marketing authorization in 2019, down from 42 the previous year.   The agency also recommended just six new orphan medicines for authorization, the fewest in recent years and a drop from the 17 new orphan medicines recommended in 2018.   In comparison, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Re...
  • ReconRecon

    Recon: California Looks to Sell its Own Line of Generics; Boehringer Signs With Singapore’s Enleofen to Develop Anti-Fibrotic Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US California eyes selling its own brand of generic prescription drugs to battle high costs ( LA Times ) ( Sac Bee ) ( WSJ ) ( The Hill ) Merck's Keytruda wins FDA approval for bladder cancer ( Reuters ) ( Endpoints -$) ( FDA ) ( Press ) Amag Pharmaceuticals to divest two women's health drugs, CEO to step down ( Reuters ) ( Press ) Two Big Drug Flops Show How Hea...
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    FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports

    The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for the generic drugs.   FDA says the manufacturers will have the opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn.   “A request for a hear...
  • ReconRecon

    Recon: AbbVie to Split Allergan Cosmetics Into Separate Unit; Pharmacy Chains Sue Prescribers in Opioid Spat

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie to house Allergan Botox business in separate unit ( BioPharmaDive ) Less Is More for Big Pharma in 2020 ( WSJ ) Why Humira’s price keeps rising despite FDA approval of generic competition ( Washington Post ) At 2020 deadline, progress in Patrick Soon-Shiong’s ‘cancer moonshot’ is hard to find ( STAT ) Pharmacies say prescribers bear opioid crisis respo...
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    TrackersTrackers

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
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    New Guidance Explains How Regulators Can Begin the Process to Join PIC/S

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week released a new guideline explaining its pre-accession procedure for competent authorities wishing to join the inspection scheme.   Membership in PIC/S is open to any competent authority “having the arrangements necessary to apply an inspection system comparable to that enforced by” existing members.   “The scheme is primarily based on mutual confidence between participating authorities (PA). Such c...