• ReconRecon

    Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves TB pill that cures more hard-to-treat patients ( AP ) ( Reuters ) ( NYTimes ) ( FDA ) Nonprofit under pressure to make new TB drug affordable ( BioPharmaDive ) ( MSF ) The Creation Of Biotech Startups: Evolution Not Revolution ( LifeSciVC ) Compass Therapeutics and these three other biotech startups got venture funding a year ago. Where are they n...
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    Osteoporosis: FDA Finalizes Nonclinical Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on designing long-term nonclinical bone quality studies for drugs and biologics to treat osteoporosis.   “In addition to the pharmacology and toxicology studies required to support development of a new drug or biologic, long-term nonclinical studies, including bone-specific pharmacologic and toxicologic endpoints to evaluate the effects on bone quality, need to be conducted in appr...
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    Recon: Cummings, Sanders Question Mylan, Teva & Heritage for Obstructing Price Fixing Probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cummings, Sanders investigate drug companies for 'obstructing' probe ( The Hill ) ( STAT ) ( Politico ) ( Reuters ) ( House Oversight ) Novartis ousted top scientists over Zolgensma data manipulation ( STAT ) ( Endpoints ) ( Reuters ) Novartis violated FDA’s sacred principle: In God we trust, all others must bring data ( STAT ) Novartis chooses internal replac...
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    Child Resistant Packaging: FDA Finalizes Guidance on Labeling Statements

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on child-resistant packaging (CRP) statements that should be included in the labeling of prescription and over-the-counter (OTC) drugs.   The seven-page final guidance comes two years after FDA released the draft version for comment. FDA says it considered the comments submitted to the public docket and has edited the guidance for clarity.   Under US Consumer Product Safety Commission (CPSC) ...
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    Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to Depart

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Deciphera shares skyrocket as cancer drug improves progression-free survival ( Reuters ) ( Endpoints ) ( Press ) Trump’s Canada Drug Import Plan Can’t Happen Without Big Pharma ( Bloomberg ) Trump's key drug pricing advisor O'Brien makes HHS exit ( Endpoints ) Senator Grassley seeks info on Novartis's Zolgensma data issues ( Reuters ) ( Endpoints ) ( Letter ) ...
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    Amgen Wins Enbrel Patent Suit Preventing Sandoz Biosimilar Launch

    A US District Court Judge in New Jersey on Friday upheld the validity of two of Amgen’s patents for its blockbuster arthritis treatment Enbrel (etanercept), preventing the launch of a biosimilar developed by Novartis’ Sandoz division.   So far, the US Food and Drug Administration (FDA) has approved two Enbrel biosimilars, Sandoz’ Erelzi (etanercept-szzs) in August 2016 and Samsung Bioepis’ Eticovo (etanercept-ykro) last April, but neither have launched commercially...
  • ReconRecon

    Recon: Two Promising Drugs Emerge in Congo Ebola Trial; NHS Scotland Denies CF Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biotech faces a crisis in credibility fueled by boom-era hubris ( STAT ) US patients struggle to obtain Eli Lilly’s half-price insulin ( Financial Times ) These health-tech veterans want to avert the next Theranos disaster with ‘medical diligence’ ( CNBC ) Deals Give Drugmakers Rights to DNA Data ( WSJ ) Drug Shortage Leaves Patients Without Immune-Disorder T...
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    Recon: China NMPA Approves Gilead’s Biktarvy for HIV-1; FDA Rejects Kala Eye Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sarepta says adverse event report for DMD gene therapy erroneously submitted ( Reuters ) ( STAT ) ( Endpoints ) Senators blast Novartis over data manipulation before approval of Zolgensma ( STAT ) ( The Hill ) ICER closely monitoring FDA’s Zolgensma investigation ( PMLive ) Potential new PrEP drug exposes gaps in data for women ( Politico ) House GOP unaware ...
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    GAO Pushes FDA to Improve First Cycle Generic Approval Rate

    In a report released Wednesday, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to take steps to improve the rate of first cycle approvals for generic drugs by increasing the clarity and consistency of reviewer comments.   GAO notes that FDA has worked to increase first cycle approvals in recent years but points out that the average generic applicant goes through three review cycles and that only 12% of generics were approv...
  • ReconRecon

    Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRock

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bayer to buy rest of US biotech company in rare offensive move ( Financial Times ) ( Endpoints ) ( Press ) CMS finalizes long-sought rules for Medicare CAR-T coverage ( STAT ) ( WSJ ) ( Reuters ) ( CMS ) Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma ( Bloomberg ) Bausch Health CEO: Big Pharma will survive US drug regulations ( CNBC ) FD...
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    Fabry Disease: FDA Drafts Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on clinical trial design and eligibility criteria for products to treat Fabry disease. Fabry disease is a rare inherited disorder caused by a deficiency of the lysosomal enzyme alpha-galactosidase A (α-Gal A). According to FDA, patients with Fabry disease experience chronic gastrointestinal and neuropathic symptoms and progressive organ damage that eventu...
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    Recon: AZ Claims Phase III Success for Lynparza in Prostate Cancer; NICE Backs Nerlynx in Adjuvant HER2+ Breast Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amag's female libido injectable therapy to sell at $899 ( Reuters ) Patient groups push back against Gilead's pricey HIV prevention treatment ( Reuters ) Opioid Distributors Propose $10 Billion to End State Claims ( Bloomberg ) ( CNBC ) US Judge Expresses Support for Novel Opioid Settlement Talks Framework ( Reuters ) Boom in overdose-reversing drug is tied t...