• Regulatory NewsRegulatory News

    CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed its negative opinion of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys (eteplirsen).   Among the thirteen drugs recommended for approval are three orphan drugs, three Neulasta (pegfilgrastim) biosimilars, two anti-cancer drugs and a new antibiotic.   The three orphan medicines include...
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    Recon: Medtronic to Acquire Mazor Robotics for $1.6B; Dozens Lose Sight After Being Injected with Compounded Eye Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Medtronic to Acquire Mazor Robotics ( Press ) ( MassDevice ) We Can’t Afford the Drugs That Could Cure Cancer ( WSJ ) At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs ( BuzzFeed ) Why Former Novartis CEO Joe Jimenez Joined A Microbiome Startup's Board ( Forbes ) ( Endpoints ) Sloan Kettering’s Cozy Deal With Start-Up I...
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    Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

    Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on field alert report (FAR) submissions. The draft guidance, released for comment in July , describes FDA’s current thinking on submitting FARs for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). In the guidance, FDA calls on applicants to submit a FAR within three working days ...
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    Recon: Amicus Buys Celenex Gene Therapy Portfolio for $100M; EU Approves 5th Humira Biosimilar

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amicus Therapeutics acquires portfolio of gene therapies targeting neurologic disorders ( STAT ) ( Endpoints ) ( Forbes ) ( Xconomy ) In the battle for life sciences companies, one state shows up behind enemy lines ( STAT ) Life sciences industry rallies behind Calif. bill to prevent a nightmare scenario for clinical research ( STAT ) Shares in Molecular Templ...
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    Device Makers Call for Changes to FDA’s Biliary Stent Guidance

    Medical device makers Boston Scientific and Cook are calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on 510(k) submissions for metal expandable biliary stents.   The 27-page draft guidance, which was released in July, revises the agency’s 1998 guidance on expandable biliary stents and includes new recommendations for shelf life and packaging, MRI compatibility and non-clinical bench testing.   In comments submitted to the public ...
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    Recon: NICE Rejects Novartis’ CAR-T Kymriah for Adults; CA Insurance Regulator Sues AbbVie Over Alleged Humira Kickbacks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US California insurance regulator sues AbbVie alleging Humira kickbacks ( Reuters ) ( STAT ) ( Endpoints ) ( Financial Times ) Clovis Oncology, execs to pay $20 million to settle SEC charges ( Reuters ) ( Endpoints ) In unlikely alliance, PhRMA sides with landlords in Calif. referendum on rent control ( STAT ) Clarus spearheads a big, $150M raise so Galera can fl...
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    Recon: Senate Passes Opioids Package; Viking Spikes on Positive Ph. II Results for NASH Candidate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Viking shares surge after fatty liver drug trial ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) What’s in, what’s out, and what’s still on the table in the opioids package passed by the Senate ( STAT ) Final opioid bill may come by Friday ( Politico ) Senate passes bill to ban ‘gag clauses’ and free pharmacists to discuss drug pricing options ( STAT ) Senate Pa...
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    Recon: NICE Backs Novartis’ Tafinlar/Mekinist Combo for Skin Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Teva migraine drug, shares rise ( Reuters ) ( Endpoints ) ( Press ) DOJ grants clearance to Cigna's acquisition of Express Scripts ( Press ) US senators query pharma chief over drug price rise ( Financial Times ) ( Letter ) Allergan says revenue from aesthetics unit may double by 2025 ( Reuters ) FDA May Start Missing ANDA User Fee Goals – In Ord...
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    Dutch, Swiss Regulators Forge Agreement on Data Exchange

    The heads of the Netherland’s Medicines Evaluation Board (MEB) and Swissmedic on Tuesday signed a memorandum of understanding (MoU) allowing for greater collaboration between the two regulators.   According to a joint release by both regulators, the agreement “provides a formal basis for stepping up collaboration on bilateral initiatives and the exchange of data” and adds to their ongoing participation in international efforts such as the International Coalition of Med...
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    Recon: FDA Approves AstraZeneca’s Lumoxiti for Hairy Cell Leukemia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche steps up efficiency drive to take sting out of biosimilars ( Reuters ) ( Endpoints ) Top Sloan Kettering Cancer Doctor Resigns After Failing to Disclose Industry Ties ( NYTimes ) ( Endpoints ) Regeneron maps a dramatic expansion with 1,500 new jobs ( Endpoints ) FDA approves AstraZeneca's drug for rare form of blood cancer ( Reuters ) ( Endpoints ) ( FDA...
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    FDA Issues 54 New and Revised Product-Specific Guidances

    The US Food and Drug Administration (FDA) on Thursday issued a batch of 54 new and revised product-specific draft guidances detailing its expectations for companies looking to develop generic versions of those products. Among the documents are 42 new and 12 revised guidances providing specific recommendations for the studies FDA believes are necessary to demonstrate that the products are therapeutically equivalent to their reference listed drug (RLD). Many of the pro...
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    Recon: Oxford Study Finds Half of EU Clinical Trial Results are Unreported; Boehringer Acquires ViraTherapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Global Blood’s FDA filing plan for a sickle cell drug is riskier than you think ( STAT ) Takeda Is Said to Weigh Sale of Shire Eye Drug to Cut Debt ( Bloomberg ) ( Endpoints ) Acorda’s awful, no good, just plain bad week gets worse as FDA hands execs another delay on Inbrija ( Endpoints ) ( Xconomy ) ( Press ) Genentech team does some cutting-edge work on a ne...