Regulatory Focus™ > News Articles > 2021 > 9 > Recon: FDA approves Incyte's eczema cream with boxed warnings; Biden pledges 500M doses of Pfizer va

Recon: FDA approves Incyte's eczema cream with boxed warnings; Biden pledges 500M doses of Pfizer vaccine

Posted 22 September 2021 | By Michael Mezher 

Recon: FDA approves Incyte's eczema cream with boxed warnings; Biden pledges 500M doses of Pfizer vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden pledges 500 mln more COVID-19 vaccine doses as U.S. pressured to do more (Reuters)
  • A CDC panel is meeting to decide who should get Pfizer boosters. (NYTimes) (Reuters)
  • FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer (PMLive)
  • FDA approves Incyte's eczema cream with boxed warnings (Reuters) (Endpoints)
  • Lawmakers, Biden official call for bipartisan action on opioid addiction (The Hill)
  • House leadership looks to jam holdouts on drug pricing (Politico)
  • U.S. government to buy rapid COVID-19 tests from Abbott, Celltrion -official (Reuters)
  • Device maker Cardiovascular Systems warns of hit to sales from Delta variant (Reuters)
  • Pharma companies defend dismissal of terror case at D.C. Circuit hearing (Reuters)
  • Biogen’s Aduhelm sales slower than disclosed, forcing company to consider cost-cutting measures (STAT)
In Focus: International
  • Biden announces 'partnership' with EU on global vaccine distribution effort (Politico) (NYTimes)
  • Government report finds serious over-prescription issues in England (Pharmafile)
  • Lilly to supply up to 220,000 COVID-19 antibody combo doses to European countries (Reuters)
  • Clover's vaccine 67% effective against COVID, 79% against Delta variant in large trial (Reuters)
Coronavirus Pandemic
  • Pressure Grows on U.S. Companies to Share Covid Vaccine Technology (NYTimes)
  • Remdesivir reduces Covid hospitalizations when given early, study shows (STAT)
  • Slow enrollment delays study of Pfizer vaccine in pregnant women (The Hill)
  • Covishield: UK recognises Covid jab after India outcry (BBC)
Pharma & Biotech                                                                                                     
  • Activist Bluebell takes stake in GlaxoSmithKline to push for change at top (FT)
  • FDA objects to Summit's midstudy pooling of pivotal trials (Fierce) (Endpoints)
  • Walgreens Boots takes a controlling stake in Shields Health Solutions (Boston Globe)
  • Bluebird officially asks FDA to approve gene therapy for rare blood disorder (BioPharmaDive)
  • EMA’s Emer Cooke On The Future Of Rolling Reviews & The End Of Remote Meetings (Pink Sheet)
  • Merck women's health spinoff Organon debuts first awareness campaign, taking on unplanned pregnancy (Fierce)
  • So what happened with Novartis Gene Therapies? Here's your answer (Endpoints) (Fierce)
  • Blackstone Unit To Invest £850M In UK Lab Space (Law360)
  • Inside look: How a potential partnership turned into a $1.9B buyout for Sanofi (Endpoints)
  • Drug Rejection Hearings Are Having A Moment At US FDA (Pink Sheet)
  • 'This is the time to double down': Top Vertex executives defend research plan as pressure builds (BioPharmaDive)
  • Luxturna inventor Jean Bennett starts a new gene therapy company to tackle rare diseases left behind by pharma, VCs (Endpoints)
  • Hexagon Bio raises $61M to continue efforts to turn fungi into drugs (Endpoints)
  • Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors (Pink Sheet)
  • Takeda snaps up the Japanese rights to an old Shire cast-off; Boehringer Ingelheim acquires Abexxa Biologics (Endpoints)
  • Boston Scientific to spend $269M for remaining stake of Devoro in latest deal (MedtechDive)
  • FDA Authorizes Software that Can Help Identify Prostate Cancer (FDA)
  • ESMO: Owkin's deep learning AI predicts chances of metastatic breast cancer relapse within next 5 years (Fierce)
  • Why The European Pharmaceutical Strategy Matters So Much For The Devices Sector (MedtechInsight)
Government, Regulatory & Legal
  • Former Theranos patient testifies blood test gave her false miscarriage (CNBC)
  • Paragard IUD Maker Wants 'Shotgun' MDL Claims Tossed (Law360)
  • Pharmacies Win Remand Of FDA's Compounded Drug Memo (Law360)
  • AbbVie Calls Retailers' Bystolic Generic Delay Claims Flawed (Law360)
  • FDA’s bans on flavored e-cigs create chaos for small vape shops (Politico)
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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