Regulatory Focus™ > News Articles > 2021 > 10 > Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young childr

Posted 18 October 2021 | By Michael Mezher 

Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

2764 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters (Reuters)
  • FDA delays decision on Moderna's COVID-19 vaccine for adolescents (WSJ) (Reuters)
  • FDA declines to approve Revance's frown-line treatment (Reuters) (Endpoints)
  • Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes (Reuters) (Endpoints)
  • Biogen trial of ALS drug fails main goal, but company says data are encouraging (Reuters) (STAT)
  • Roche's Tecentriq crosses the finish line first in adjuvant lung cancer, potentially kicking off gold rush (Endpoints) (FDA)
  • FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira (FDA)
  • U.S. FDA declines to approve United-MannKind's lung disease therapy (Reuters)
  • Ex-Theranos project manager testifies that Holmes told him to conceal parts of testing lab (CNBC)
In Focus: International
  • Merck COVID-19 pill sparks calls for access for lower income countries (Reuters)
  • EU evaluating use of Pfizer's COVID-19 vaccine in young children (Reuters)
  • EU has exported over 1 bln COVID-19 vaccines, von der Leyen says (Reuters)
  • EU approves two sites for making Pfizer's COVID-19 vaccine (Reuters)
  • India's vaccine effort slows as dose gap trumps output jump (Reuters)
  • Valneva jumps on positive results for COVID-19 vaccine candidate (Reuters)
  • WHO says it 'cannot cut corners' in approving India's Covaxin shot (Reuters)
Coronavirus Pandemic
  • Lawsuits demand unproven ivermectin for COVID patients (AP)
  • TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE) (TGA)
  • TGA grants provisional determination to Roche Products Pty Ltd COVID-19 treatment tocilizumab (ACTEMRA) (TGA)
Pharma & Biotech
  • Third time's the charm: Adamis nabs approval of high-dose naloxone injection after two CRLs (Endpoints)
  • Two drugmakers hit with PDUFA date delays from FDA amid backlog of inspections (Endpoints)
  • Phathom's old Takeda drug bests Prevacid in a PhIII GI trial. Next stop? The FDA (Endpoints)
  • Omeros plunges deeper after FDA rejects rare disease drug, asking for more information (Endpoints)
  • Vertex gets much-needed win with ‘extraordinary’ first patient results on potential diabetes cure (Endpoints)
  • UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug (Scrip)
  • Esperion gets out the budget ax, chopping 170 staffers as its big drug launch sputters (Endpoints)
  • Langer, Ciechanover godfather the latest AI upstart; Ipsen forges $446M AML development pact (Endpoints)
  • Illuminating the black box: Five ways the FDA could build transparency into AI devices (Endpoints)
  • Philips CPAP recall still chips away at earnings, with nearly 40% drop in Q3 connected care sales (Fierce)
  • Medtronic misses bid for early FDA OK in renal denervation, stock slides (MedtechDive)
  • ReCor Medical's renal denervation device misses blood pressure endpoint after European launch (Fierce)
  • Natera launches lung DNA test for catching transplant rejections (Endpoints)
  • Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report (Fierce)
  • Philips recalls, supply chain challenges dim 2021 outlook (MedtechDive)
Government, Regulatory & Legal
  • Most Cancer Claims Survive In Suit Over Weight Loss Drug (Law360)
  • Zydus Infringed AstraZeneca's Diabetes Drug IP, Judge Rules (Law360)
  • Nimbus, Bristol-Myers Can't Sell Psoriasis Drug Amid Dispute (Law360)
  • UK Watchdog Probing Thermo Fisher's $21B PPD Deal (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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you