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  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...
  • ReconRecon

    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
  • ReconRecon

    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...
  • Regulatory NewsRegulatory News

    EMA: Thumbs up for 11, down for 2 new medicines

    At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.   Dapirivine Vaginal Ring is meant to reduce the risk of infection with HIV, in situations where oral pre-exposure prophylaxis is not used, ...
  • Regulatory NewsRegulatory News

    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...
  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Regulatory NewsRegulatory News

    EMA recommends eight new medicines, refuses one

    A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.   The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about dur...
  • Regulatory NewsRegulatory News

    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
  • Regulatory NewsRegulatory News

    EMA offers free orphan drug advising to academia

    Academic organizations working on drug development for rare diseases will now be eligible for waiver of fees for scientific advice from the European Medicines Agency (EMA), according to an updated Executive Decision issued by the agency. “The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with the potential to benefit patients with rare d...
  • Regulatory NewsRegulatory News

    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...
  • Regulatory NewsRegulatory News

    EMA affirms ACE inhibitors, ARBs safe during COVID-19

    The European Medicines Agency (EMA) has issued a statement reiterating that people should continue to take certain blood pressure medicines during the COVID-19 pandemic. Recent observational studies, the agency said , have not shown that taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) increases the risk of contracting the novel coronavirus or worsening illness for people with COVID-19. The statement reaffirms EMA’s previous...