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    MR Coils: FDA Details Safety and Performance Based Pathway Criteria

    The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance (MR) coils under the agency’s safety and performance based pathway.   Background   Earlier this year, FDA finalized guidance explaining its new safety and performance based pathway, which allows device makers to seek 510(k) clearance for certain devices base...
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    FDA Launches App for Reporting new Uses of Infectious Disease Drugs

    The US Food and Drug Administration (FDA) on Thursday launched a new app called CURE ID that allows health care professionals around the world to report novel uses of existing drugs to treat difficult-to-treat infectious diseases.   “The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infectious caused by antimicrobial-resistant organisms,” said FDA Principa...
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    Recon: Novartis, Gilead CAR-T Therapies Win Swiss Coverage; FDA Reviewers Express Concerns About Correvio Heart Drug Ahead of Advisory Panel

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Is Green-Lighting Drugs at Breakneck Speed and Raising Alarm ( Bloomberg ) FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns ( Reuters ) ( Fierce ) ( STAT ) Correvio slumps after FDA staffers say benefits of heart drug do not outweigh risks ( Reuters ) Activists seek to block a Gilead patent extension on a lucrative HIV drug (...
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    Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sage depression therapy fails much-awaited trial, stunning investors ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Eli Lilly to put Loxo executives in charge of new cancer research unit ( Reuters ) ( STAT ) ( Press ) Biogen to make case to skeptics for its controversial Alzheimer's drug ( Reuters ) Acadia Pharma's psychosis drug proven better than placebo in de...
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    FDA Drafts Recommendations for IC/BSP Drug Development

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations for the clinical development of new drugs to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).   According to FDA, “IC/BPS is a complex, poorly understood syndrome of unknown etiology,” that is diagnosed based on symptoms including chronic bladder pain or discomfort and frequent urination or nocturia and the exclusion of other conditions with s...
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    Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fixing Case

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A second generic drug maker admits to price fixing as part of a far-reaching probe into generics ( STAT ) ( Law360 -$) ( The Inquirer ) ( DoJ ) Roche wins FDA approval for immunotherapy cocktail against lung cancer ( Reuters ) ( Endpoints ) ( Press ) White House claims Speaker Nancy Pelosi’s drug-pricing bill would result in 100 fewer drugs over a decade ( CNBC...
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    Tax Foundation, AdvaMed Warn Return of Device Tax Will Cost Jobs

    A new report from the Tax Foundation, a Washington, DC based think tank, warns that if the 2.3% excise tax on medical devices is not repealed, it could lead to a loss of more than 21,000 jobs over the next two years and reduce US gross domestic product by $1.7 billion.   The tax, which was put in place under the Affordable Care Act , was only collected from 2013 to 2015 as a result of two two-year moratoriums passed by Congress in 2016 and 2018.   However, the sec...
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    Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Committee Advances Nomination of Hahn as FDA Commissioner ( Focus ) US Considers Easing Drug Protections to Break Logjam Over Trade Pact ( WSJ ) ( Reuters ) Medical Device Failures Brought To Light Now Bolster Lawsuits And Research ( KHN ) Merck Cyberattack’s $1.3 Billion Question: Was It an Act of War? ( Bloomberg ) States fight bonus pay for CEO of O...
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    FDA Finalizes Guidance on Adaptive Trial Designs

    The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics.   The 33-page guidance, which finalizes a draft version released for comment in September 2018 and replaces an earlier guidance from 2010, sets out FDA’s recommendations on adaptive trial design principles and the information FDA will review from adaptive studies submitted as part of investigational new drug applications (INDs), new drug ...
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    Recon: Drugmakers Cut Prices to Make China’s Reimbursement List; Baxter Buys Sanofi’s Seprafilm for $350M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Baxter picks up Sanofi's Seprafilm adhesion barrier for $350M ( MedtechDive ) ( Endpoints ) Lexicon Pharma shares plummet after FDA denies appeal against drug rejection ( Reuters ) Incyte claims FDA priority review for bile duct cancer drug ( PMLive ) AstraZeneca's Imfinzi gets speedy FDA review for small cell lung cancer ( Reuters ) ( PMLive ) Merck’s Keytru...
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    ICH Updates After Singapore Assembly Meeting

    The International Council for Harmonisation (ICH) on Wednesday provided an update on some of the milestones achieved following the ICH Assembly meeting in Singapore earlier this month.   Guidelines   During the meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while several working groups advanced early stage efforts toward the development of new topics and upcoming revisions to existing guidelines.   The newly adopted guidelin...
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    Recon: Pfizer, Novartis Lead Global Gene Therapy Manufacturing Investment; US Prosecutors Open Opioid Criminal Probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen will offer discounts to a health plan if patients say its multiple sclerosis drugs don’t work ( STAT ) Judge partly vacates convictions of opioid maker Insys' founder, executives ( Reuters ) SEC charges ex-MiMedx execs with defrauding investors ( Fierce ) ( Endpoints ) US prosecutors open criminal probe of opioid makers, distributors ( Reuters ) ( WSJ )...