Recon: Germany, Italy, France halt AstraZeneca shots; Roche buys GenMark for $1.8B

| 15 March 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US data for AstraZeneca vaccine under review by independent advisers - U.S. official (Reuters)
  • Roche buys GenMark for $1.8 million to challenge test rivals (Reuters) (Press)
  • Gilead, Merck collaborate to develop long-acting HIV treatment (Reuters) (BioPharmaDive)
  • AstraZeneca to seek U.S. authorization for COVID-19 vaccine this month or early next (Reuters)
  • Elevate Bio raises $525M to fuel cell, gene therapy expansion (BioPharmaDive) (Endpoints)
  • U.S. limits supply of Eli Lilly's COVID-19 antibody therapy in three states (Reuters)
  • Moderna doses first patient in study on its COVID-19 booster vaccine (Reuters)
  • Biden readies campaign to combat vaccine skeptics (Politico)
  • Lilly Alzheimer's drug shows benefit on cognition, function in mid-stage trial (Reuters) (STAT) (Endpoints) (Press)
In Focus: International
  • EU defends vaccine distribution as nations complain it is uneven (Reuters) (FT) (EC)
  • AstraZeneca finds no evidence of increased blood clot risk from vaccine (Reuters)
  • WHO examining AstraZeneca vaccine reports, says no evidence of causality (Reuters)
  • Germany, Italy, France to halt AstraZeneca shots (Reuters) (AP)
  • Netherlands halts use of AstraZeneca COVID-19 vaccine (Reuters)
  • Ireland latest country to suspend AstraZeneca COVID-19 vaccine (Reuters)
  • The EMA covid-19 data leak, and what it tells us about mRNA instability (The BMJ)
  • BioNTech Recruits Rivals to Boost Covid-19 Vaccine Production (WSJ)
  • Unthinkable? EU considers getting a vaccine boost from Russia's Sputnik (Reuters)
  • China's ambitious COVID-19 vaccination plan to test its production capability (Reuters)
  • Malaysian rubber glove group says demand to oustrip supply until 2023 (Reuters)
  • Bombshell analysis traces new Ebola outbreak to survivor of West Africa crisis (STAT) (NYTimes)
Coronavirus Pandemic
  • Regular booster vaccines are the future in battle with COVID-19 virus, top genome expert says (Reuters)
  • EU's Breton says Pfizer can help offset AstraZeneca vaccine delays (Reuters)
  • Can the World Learn From South Africa’s Vaccine Trials? (NYTimes)
  • Three people in Norway treated for "unusual symptoms" after AstraZeneca COVID-19 shots (Reuters)
  • Dane who died from blood clot after AstraZeneca shot had `unusual symptoms', agency says (Reuters)
  • Dutch watchdog says 10 reports of possible side effects after Astrazeneca vaccine (Reuters)
  • Italy's Piedmont region stops use of AstraZeneca vaccine batch (Reuters)
  • Pharma Co. Seeks J&J Virus Vaccine License — Or Else (Law360)
  • MHRA response to Irish authorities’ action to temporarily suspend the AstraZeneca COVID-19 vaccine (MHRA)
  • After Mesoblast COVID-19 drug flop, Novartis tries again with Molecular Partners (Fierce)
  • Takeda and IDT Support Manufacturing of Johnson & Johnson’s COVID-19 Vaccine (Press)
Pharma & Biotech
  • Money, talent flowing into mRNA sector after COVID-19 success (Reuters)
  • DMAP: Focusing on a Fundamental Challenge (Alliance for a Stronger FDA)
  • Insitro raises $400M for machine learning-powered drug discovery efforts (Fierce) (FT)
  • Sanofi, Regeneron's Libtayo looks for new cervical cancer use with first-in-class survival win (Fierce) (Pharmafile)
  • Blown off course, Bluebird shares tick up on positive gene therapy readout (Fierce) (Endpoints)
  • Specialty drugmaker ANI to boost CDMO work, generics portfolio with $210M Novitium buyout (Fierce)
  • Orphan drug designation and development in Japan: 25 years of experience and assessment (Nature)
  • Vivek Ramaswamy's LNP delivery tech play Genevant scores $600M licensing deal from Takeda for nucleic acid therapies (Endpoints)
  • Next-gen gene editing upstart is grabbing the brass ring with a $150M crossover play to back its bid on a cure for sickle cell disease (Endpoints)
  • Rubius chief lays out the first human data on their lead red cell drug in a comeback play. And the stock skyrockets (Endpoints)
  • Backed by Indian biosim giant Biocon, bispecifics player Bicara debuts with $40M and solid tumors on the radar (Endpoints)
  • New Zolgensma data demonstrate age-appropriate development when used early, real-world benefit in older children and durability 5+ years post-treatment (Press)
  • Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance) (Press)
  • 'Painless' glucose monitors are popular but little evidence they help most diabetes patients (NBC)
  • Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth (MedtechDive)
  • Cardiac wearables, iRhythm, under a cloud as reimbursement questions linger (MedtechDivev)
  • Blood Transfusion Kits Used By US Military Subject Of Class I Recall (MedtechInsight)
Government, Regulatory & Legal
  • Decision Dismissing Claims Against Generic Drug Manufacturer On Implied-Preemption Grounds Also Helpful In Other Contexts (Drug & Device Law)
  • The Patent Trial and Appeal Board Returns to the Supreme Court (Harvard Bill of Health)
  • Consultation: Electronic media in prescription drug labelling draft guidance document (Health Canada)
  • NJ Court Skeptical Of FCA Claims Against Gilead, Shire (Law360)
  • Minn. AG's Insulin Suit Against Sanofi, Eli Lilly Gutted (Law360)
  • Fed. Circ. Calls Route To PTAB Denial Appeals 'Very Narrow' (Law360)
  • Fed. Circ. Affirms Letting J&J Reveal Manufacturer In IP Row (Law360)
  • Law Firm Admonished For 'False' Ads In Gilead HIV Drug Suit (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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