• ReconRecon

    Recon: FDA Approves Lilly’s Emgality as First Drug to Treat Cluster Headaches

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Lilly's migraine drug as first ever cluster headache treatment ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world? ( Washington Post ) ( Endpoints ) Welcome to the Age of One-Shot Miracle Cures That Can Cost Millions ( Bloomberg ) Ned Sharpless weighs in on gene...
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    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
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    Recon: Bayer Signs Deal With US Biotech Arvinas to Develop Protein Degradation Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bayer teams up with biotech firm Arvinas in deal worth up to $750 million ( Reuters ) ( Endpoints ) ( Fierce ) ( Press ) What you missed at ASCO? A lot, as cancer research hastens on ( STAT ) Congress weighs dropping ban on altering the DNA of human embryos used for pregnancies ( STAT ) Updated Apple Watch will track your menstrual period and aim to protect yo...
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    FDA Launches Expanded Access Pilot ‘Project Facilitate’

    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.   “The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not fami...
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    Recon: Merck’s Keytruda Raises Survival Standard for Advanced Lung Cancer; Amgen KRAS Drug Shows High Response Rate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugs make headway against lung, breast, prostate cancers ( AP ) Who Won and Lost at One of the Year's Biggest Medical Meetings ( Bloomberg ) ( CNBC ) Moderna makes ASCO debut with an early look at a personalized cancer vaccine ( STAT ) ( Press ) Amgen drug shows high response rate in small lung and colon cancer trial ( Reuters ) ( STAT ) ( Endpoints ) ( Finan...
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    Continuous Manufacturing: Industry Calls for Changes to FDA’s Draft Guidance

    Drugmakers and industry groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance, Quality Considerations for Continuous Manufacturing .   The 27-page draft guidance was released for comment in February and is part of FDA’s effort to encourage the adoption of continuous manufacturing, which the agency believes can improve consistency and reduce the risk of drug shortages.   While there is great interest in con...
  • ReconRecon

    Recon: China Approves Third Domestic PD-1 Drug; Fosun Rethinking US Deals Amid Trade Tensions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grail, a deep-pocketed startup, shows ‘impressive,’ if early, results for cancer blood test ( STAT ) ( Fierce ) ( Press ) Turning Point Therapeutics drug shows benefits for patients with rare lung cancer gene ( STAT ) ( Endpoints ) Epizyme seeks early approval for drug to treat ultra-rare tumors ( STAT ) US drugmaker charged in generics price-fixing investigat...
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    OPDP Issues Second Untitled Letter of 2019

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week issued its second untitled letter of the year to California drugmaker Vivus because of claims made on the company’s website about its weight-loss drug Qsymia (phentermine and topiramate).   With just two enforcement letters sent so far in 2019, FDA is continuing a years-long trend of declining enforcement action over prescription drug promotion. In 2017 OPDP issued a re...
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    Recon: NICE Backs Merck’s Prevymis for CMV; China’s Hansoh Pharma Eyes $1B IPO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck’s R&D boss sees more promise in his big drug and a $1 billion deal ( STAT ) Biologic medications for arthritis and psoriasis have flooded the market — and been linked to 34,000 deaths ( Journal Sentinel ) California may make anti-HIV drug available without prescription for 30 days ( SF Chronicle ) Groupon Cofounder’s Cancer Startup Is Now Worth $3.1 Bill...
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    FDA Officials Call for Patient-Friendly Terminology in Oncology

    Officials from the US Food and Drug Administration’s (FDA) oncology offices say they plan to develop a glossary of patient-friendly terms and definitions for oncology clinical trial endpoints.   In a paper published earlier this month in The Oncologist , officials from FDA’s Oncology Center of Excellence and Office of Hematology and Oncology Products make the case for working with patients and patient advocacy groups to develop resources to help patients understand th...
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    Recon: Allergan to Recall Textured Breast Implants in Canada; FDA Expands Revlimid Label

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J's greed helped fuel US opioid crisis, Oklahoma claims at trial ( Reuters ) ( NYTimes ) BioMarin says data shows hemophilia gene therapy effects could wane ( Reuters ) ( Xconomy ) Seniors' spending on cancer drugs has soared ( Axios ) FDA first as agency expands label on Celgene's Revlimid in previously treated follicular or marginal zone lymphoma ( Pharmaf...
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    Indian Drugmaker to FDA: Dance Festival to Blame for Cleaning Lapses

    The US Food and Drug Administration (FDA) last month warned Indian drugmaker Centurion Laboratories over good manufacturing practice (GMP) violations observed at the company’s Gujarat facility last October.   During the five-day inspection, the FDA investigator observed multiple deficiencies related to laboratory records, computer system controls and cleaning and maintenance. Due to the deficiencies observed during the inspection, FDA placed Centurion on import alert o...