Regulatory Focus™ > News Articles > 2021 > 5 > Recon: WV opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

Recon: WV opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

Posted 03 May 2021 | By Michael Mezher 

Recon: WV opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Feds rethink vaccination strategy as slowing demand reveals stark divide (Politico)
  • US to launch trade talks on COVID-19 vaccine distribution (AP) (CNBC)
  • Drug distributors face off against West Virginia in billion-dollar opioid trial (Reuters) (Law360)
  • Roivant valued at $7B in blank-check merger, bucking SPAC slowdown (BioPharmaDive) (STAT)
  • Next Generation of Covid-19 Vaccines Could Be Pill or Spray (WSJ)
  • Sarepta’s more potent Duchenne treatment shows promise, greater toxicity, in small study (STAT) (Endpoints)
  • Amgen’s KRAS cancer drug had a bad week, but worry about pricing, not safety (STAT)
  • Detecting Rare Blood Clots Was a Win, But US Vaccine Safety System Still Has Gaps (KHN)
  • CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined (KHN)
  • An FDA official who led the approval of OxyContin got a $400,000 gig at Purdue Pharma a year later, a new book reveals (BI)
  • AstraZeneca's big CKD promises come to fruition as Farxiga wins approval in patients regardless of diabetes status (Endpoints) (FDA)
In Focus: International
  • WHO’s Tedros plans to seek reelection, setting up referendum on his leadership (STAT)
  • Moderna deal, Swedish donation boost COVAX vaccine-sharing platform (Reuters)
  • WHO gives emergency use listing to Moderna’s COVID-19 vaccine (Reuters)
  • Pfizer in talks with India over expedited approval for COVID-19 vaccine (Reuters)
  • Novavax plans to ship COVID-19 vaccines to Europe from late 2021 (Reuters)
  • Chilean regulator sees no clouds over Sputnik vaccine despite Brazilian rejection (Reuters)
  • Brazil pharma flags 'retaliation' risk over bill to drop vaccine patents (Reuters)
  • Canada’s regulator holds Johnson & Johnson vaccine over Emergent link (NYTimes)
  • AstraZeneca has drawn criticism for saying it can't share its vaccine tech with the WHO because it has no engineers available 'to brief people and train them' (BI)
  • Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims (STAT)
  • Congo declares end of Ebola outbreak that killed six (Reuters)
Coronavirus Pandemic
  • India’s vaccine shortage will last months, biggest manufacturer warns (FT)
  • Japan to approve Moderna's COVID-19 vaccine as soon as May 21 – Yomiuri (Reuters)
  • Pfizer to supply 4.5 mln doses of COVID-19 vaccine to South Africa by June (Reuters)
  • As Schools Spend Millions on Air Purifiers, Experts Warn of Overblown Claims and Harm to Children (KHN)
Pharma & Biotech
  • Designing an Independent Public Health Agency (NEJM)
  • How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects (STAT)
  • Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market (Endpoints)
  • Mental health/psychedelic drugs: mushrooming investor interest fuels research (FT)
  • Avrobio changes course after FDA closes path for speedy gene therapy approval (BioPharmaDive)
  • ICH plots major overhaul of good clinical practice guideline (Endpoints)
  • Amid JAK safety uncertainty, AbbVie says latest data support its key launch Rinvoq (Fierce)
  • UK Could Become ‘World Leader’ On Biosimilar Regulation (Pink Sheet)
  • Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue (Pink Sheet)
  • Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine (Press)
  • Despite FTC's harsh words for biopharma M&A, Bristol Myers CEO Caforio still enthusiastic about dealmaking (Fierce)
  • Avrobio retools Fabry gene therapy plans after competing drug's full approval shuts pathway to an accelerated nod (Endpoints)
  • Alkermes hands a board seat to Alex Denner's Sarissa after facing renewed proxy pressure to 'refresh' directors (Endpoints)
  • Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions (MedtechDive)
  • Orthopaedic companies project 'return to normalcy' as electives recover in Q1 (MedtechDive)
  • Labcorp to pick up Myriad's Vectra rheumatoid arthritis diagnostic blood test (Fierce)
  • Siemens raises outlook as COVID-19 antigen tests blast past original sales target (MedtechDive)
  • Motus GI gets FDA nod to expand colonoscopy cleansing system into upper GI endoscopies (Fierce)
  • Pew Urges Biden Administration To Rescind Trump Era Rules, Reform Diagnostics Regulatory Regime (MedtechInsight)
Government, Regulatory & Legal
  • European Health Union: Commission publishes open public consultation on the European Health Data Space (EC)
  • Schumer backs Sanders push on drug prices, lowering Medicare age (The Hill)
  • Mass. Judge Says Heart Monitor Patent Validity Isn't Clear Yet (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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