• ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...
  • Regulatory NewsRegulatory News

    EMA addresses comparative quality assessment methods

    An updated reflection paper from the European Medicines Agency (EMA) tackles how statistics should be used in drug development when a comparative assessment of quality attributes needs to be made.   The paper touches on issues that arise both in the development of small molecules and in work being done in the area of biosimilars, where tricky manufacturing challenges and mutable organic molecules make defining the concept of “similarity” a challenge.   EMA’s human ...
  • ReconRecon

    Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug ( STAT ) AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push ( Fierce ) Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder ( STAT ) CDC to reverse ind...
  • ReconRecon

    Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 ( NYT ) Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues ( Biopharma Dive ) Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player ( Endpoints ) House Democrats expand probe into political interference ...
  • Regulatory NewsRegulatory News

    Nouryant garners negative CHMP opinion for Parkinson's disease

    The human medicines committee of the European Medicines Agency (EMA) recommended two new medicines for approval during its July meeting; the committee also recommended four extensions of therapeutic indication and issued a negative opinion on one medicine.   Genzyme’s Nexviadyme (avalglucosidase alfa) was recommended by the Committee for Medicinal Products for Human Use (CHMP) to treat glycogen storage disease type II, also known as Pompe disease. Nexviadyme had receiv...
  • Regulatory NewsRegulatory News

    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...
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    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
  • Regulatory NewsRegulatory News

    EMA begins rolling review of Sanofi Pasteur COVID vaccine

    The European Medicines Agency (EMA) has taken a fifth COVID-19 vaccine candidate into its rolling review scheme, evaluating data as they become available to speed a regulatory decision amid the ongoing public health emergency of the COVID-19 pandemic.   EMA’s decision to evaluate Sanofi Pasteur’s Vicprevtyn vaccine by rolling review is based on non-clinical data and early clinical studies “which suggest that the vaccine triggers the production of antibodies that target...
  • ReconRecon

    Recon: $26B Opioids lawsuit deal imminent; Amylyx closes $135M ALS financing deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How an Unproven Alzheimer’s Drug Got Approved ( NYT ) States and Cities Near Tentative $26 Billion Deal in Opioids Cases ( NYT ) Drug distributors settle New York opioid claims for up to $1.18B  ( Reuters ) Pharma CEOs, lobbyists showered Democrat with cash after his attempt to torpedo Pelosi’s drug pricing bill ( STAT ) Advocates urge Biden to name patent of...
  • Regulatory NewsRegulatory News

    Kineret under review by EMA for some COVID patients

    The European Medicines Agency has begun a new evaluation of an immunosuppressive drug to treat certain patients with COVID-19.   The agency announced Monday that it is reviewing an extension of indication for Kineret (anakinra, Swedish Orphan Biovitrum AB), to treat people with COVID-19 pneumonia at risk of developing severe respiratory failure. The human interleukin-1 (IL-1) antagonist was first authorized for use in the EU in 2002 and is currently authorized for th...
  • Regulatory NewsRegulatory News

    EMA's PRAC weighs in on more vaccine side effects

    The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.   At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis....
  • ReconRecon

    Recon: Biotech's 'coolers of cash;' Slipping pharma halo?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position ( Pink Sheet ) ( Biocentury ) The Delta Variant Is The Dominant Coronavirus Strain In The U.S. ( NPR ) ( Reuters ) COVID-19 cases up in nearly half of US states: analysis ( The Hill ) Maryland says 100 percent of COVID-19 deaths last month were among unvaccinated ( The Hill...