• ReconRecon

    Recon: FDA Rejects Vanda’s Jet Lag Drug; Roche and AbbVie Price New Cancer, RA Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie prices new rheumatoid arthritis drug at $59,000 a year ( Reuters ) Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakv ( Reuters ) Minority racial groups continue to be dismally represented in cancer trials ( Endpoints ) ( STAT ) ( JAMA ) Vanda shares slide after FDA spurns their big endpoint and rejects a pitch on jet lag relief ...
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    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...
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    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
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    MDIC Kicks Off Framework on Patient Input in Device Trials

    The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year. Overall, MDIC seeks to use this framework to better integrate patient input and preferences into the design of device trials and seek to reduce the burden on patients participating in such trials. The white paper published Wednesday, which is o...
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    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...
  • ReconRecon

    Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis ( MassDevice ) ( FDA ) ( Press ) Edwards, Medtronic win expanded indications for low-risk TAVR patients ( MedtechDive ) ( FDA ) ( Press ) ( Press ) FDA approves AbbVie's new rheumatoid arthritis drug ( Reuters ) ( Press ) Trump health official: Controversial drug pricing move is 'top priority' ...
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    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
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    FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. This is the third time FDA has approved a cancer treatment based on a common biomarker across different tumor types rather than the location in the body wher...
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    Growing Numbers of Priority and Competitive ANDAs Under Review as Approvals Trickle In

    The US Food and Drug Administration (FDA) on Wednesday released quarterly data on two of its programs aimed at increasing generic competition and speeding the approval of priority generic drugs.   Background   The FDA Reauthorization Act of 2017 (FDARA) included provisions to shorten the reviews of certain abbreviated new drug applications (ANDAs) by two months under a new priority review program as well as a new competitive generic therapy (CGT) designation inte...
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    Drugmakers Seek US, EU Harmonization on NASH Drug Development Guidance

    Novartis, Gilead, Regeneron, Novo Nordisk, Boehringer Ingelheim and others recently told the US Food and Drug Administration (FDA) to better align its draft guidance on drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis with the European Medicines Agency (EMA). They also took issue with the way that the latest NASH draft guidance, released in June , does not seem to allow for the use of the accelerated approval pathway. The draft guidance fol...
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    Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices

    With an eye on post-Brexit drug and medical device shortages, the UK’s Department of Health and Social Care said Thursday that it’s established a £25 million contract to set up a 12-month express freight service to deliver medicines and medical products into the country. The UK is seeking proposals until 21 August and will select providers in September. “The service is intended to deliver small parcels of medicines or medical products on a 24-hour basis, with additio...
  • 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...