• RoundupsRoundups

    FDA Approvals Roundup: Xaciato, cutaquig, Rituxan

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xaciato okayed for treating bacterial vaginosis Daré’s Xaciato (clindamycin phosphate vaginal gel ) has been approved to treat bacterial vaginosis in patients aged 12 years or older.   The approval was based on findings from the Phase 3 multicenter, double-blind, placebo-controlled DARE-BVFREE study in which 307 patients from the indicate...
  • Regulatory NewsRegulatory News

    Consensus lacking on ‘value’ for new anticancer drugs

    The high price tag of new anticancer drugs has fueled debate about the value of these treatments, given the marginal clinical benefit of some newly approved treatments. But that debate is complicated by a lack of consensus around the definition of value and the different views of stakeholders in cancer care.   In a recent perspectives article in Nature Reviews , authors from the European Medicines Agency (EMA) and the Karolinska Institutet in Sweden explored the diffe...
  • Regulatory NewsRegulatory News

    PhRMA, AdvaMed weigh in on safety reporting draft guidance

    Two industry trade associations and a pharmaceutical company are asking for some adjustments and clarification on the US Food and Drug Administration’s (FDA’s) draft guidance on safety reporting or investigational drugs and devices. The comment period on the guidance closed at the end of November.   FDA’s draft guidance includes details of how the agency believes investigators should report serious and non-serious adverse events in investigational new drug applicatio...
  • ReconRecon

    Recon: Pfizer says vaccine neutralizes Omicron after three doses; FTC settles with Vyera over Daraprim practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech vaccine neutralises Omicron with three shots ( Reuters ) ( STAT ) Studies suggest Pfizer shot may protect only partially against Omicron ( Reuters ) Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says ( CNBC ) AbbVie settles New York opioid case as trial winds down ( Reuters ) U.S. FTC settles with Vyera ov...
  • Regulatory NewsRegulatory News

    FDA rolls out more guidance on 'N of 1' gene therapies

    Developers of individualized investigational antisense oligonucleotide (ASO) therapies for ultra-rare diseases received additional guidance from the US Food and Drug Administration (FDA). In two draft documents, the agency has provided new information for sponsor-investigators and for those overseeing manufacture of these so-called “N of 1” therapies for people with severely debilitating or life-threatening genetic disease.   "Progress in individualized medicines provi...
  • Regulatory NewsRegulatory News

    EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns

    The European Medicines Agency (EMA) on Friday responded to an inquiry from several members of the European Parliament (MEPs) concerning the agency’s reviews of the mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, as well as a report published last month in The BMJ that raised concerns about data integrity at a US trial site for Pfizer’s vaccine.   In her response to the inquiry, sent by MEPs Michèle Rivasi, Piernicola Pedicini and Tilly Metz, EMA Exec...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 2: Quality, safety and efficacy, and postmarket surveillance

    The article compares and contrasts the regulatory requirements for herbal medicinal products (HMPs), herbal-based medical devices and botanical food supplements in the EU. It is part 2 of a two-part article – Part 1 presented the definitions, main regulations, and documentation requirements for placing the products on the market; Part 2 will address quality, the strength of evidence supporting the safety and efficacy, and postmarket surveillance (PMS) requirements across...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA adds remote and hybrid GMP inspections to guidance on licenses and certification

    TGA has added information about remote and hybrid inspections to its guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification.   The update affects a section on determining the inspection typeand scheduling the inspection. In older versions of the guidance, the section only covered scheduling the inspection as there was only one type of inspection: in person. Now, with COVID-19 necessitating remote and hybrid inspection...
  • ReconRecon

    Recon: EU agencies recommend mix-and-match COVID vaccines; Biden touts drug pricing plans in social spending bill

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden touts drug pricing plan in push for social spending bill ( Politico ) ( NYTimes ) J&J squares up to Big Pharma rivals with extra RSV vaccine data ( Fierce ) Former Pharma Executive Charged With Embezzling Millions ( AP ) Flagship to launch a new startup focused on neurodegenerative conditions, including Parkinson’s ( STAT ) Targeting prices for accelera...
  • Regulatory NewsRegulatory News

    ICMRA, WHO take stock of regulatory flexibilities

    A global regulatory group is mapping out a strategy for regulatory alignment as countries around the world plan their responses in the face of the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.   The International Coalition of Medicines Regulatory Authorities (ICMRA) met on the first two days of December to discuss a host of regulatory challenges. Thirteen World Health Organization (WHO) and EC officials joined representatives from ICMRA’s 24 health aut...
  • Regulatory NewsRegulatory News

    Legislators have mixed views on whether to classify fentanyl as a schedule I substance

    Members of the House Energy and Commerce’s Subcommittee on Health heard testimony 2 December from a US Food and Drug Administration (FDA) official urging congressional support of an administration plan to permanently place fentanyl in the most restrictive category allowed under the Controlled Substances Act (CSA).    The plan addresses the “pressing need” of the public health crisis posed by fentanyl and its related compounds by placing them by default into schedule ...
  • Regulatory NewsRegulatory News

    Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending

    Policymakers looking to rein in Medicare spending should look beyond the lens of the accelerated approval pathway, as drugs that exclusively fall under this indication make up a small percentage of overall Medicare spending, according to a recent research letter written by Benjamin N. Rome, of the Program on Regulation, Therapeutics, And Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital, and colleagues.   “Medicare is spending more an...