Recon: EMA recommends boosters targeting Omicron BA.4/5; FDA funding negotiations heat up as deadline looms

ReconRecon | 12 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • FDA funding negotiations heat up ahead of September deadline (STAT)
  • Amgen says Lumakras cuts risk of lung cancer progression by 34% (Reuters) (STAT) (Endpoints)
  • U.S. starts enrollment in trial testing Siga's antiviral for monkeypox (Reuters)
  • Biden appoints former government scientist as first leader of ARPA-H (STAT) (NYTimes)
  • Biden to tout next steps on 'Cancer Moonshot' in speech at JFK library (NBC)
  • Alphabet spinout Verily raises $1 billion as it looks to harness health data (STAT) (MedtechDive)
  • U.S. FDA to review Perrigo's birth control pill for OTC use in November (Reuters)
  • BMS’ preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod (Fierce)            (BioPharmaDive)
  • How a top FDA official’s words helped push a closely watched ALS drug toward approval (BioPharmaDive)
In Focus: International
  • EMA recommends boosters targeting Omicron BA.4/5 (EMA)
  • Novartis drug shown to ease symptoms of painful skin condition (Reuters)
  • In the middle of an R&D shakeup, Novartis makes a $300M investment in early-stage biologics research tech (Endpoints)
  • New cell-based therapy for melanoma more effective than existing treatment, trial finds (NBC)
  • Monkeypox Shots, Treatments and Tests Are Unavailable in Much of the World (NYTimes)
  • J&J reaches $205 million settlement in Australian pelvic mesh class action (Reuters)
Pharma & Biotech
  • Cancer treatment devised in the 1980s has proven effective (again). Will it finally get approval? (STAT)
  • Pretzel Therapeutics, eyeing diseases caused by broken mitochondria, launches with $72.5 million (STAT) (BioPharmaDive)
  • Microsoft sinks deeper into drug AI, inks collab with diabetes giant Novo Nordisk (Endpoints)
  • Relay kicks off public offering, seeking $300M after laying out robust ESMO data (Endpoints)
  • Brand name inhalers are very good at blocking competition, better even than nebulizers, study finds (Endpoints)
  • Pfizer among investors flooding Nimbus with $125M for TYK2 programs, phase 3 launch (Fierce)
  • Gilead settles 5 more Descovy patent feuds, pushing copycats to its PrEP successor out to 2031 (Fierce)
  • ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq (Fierce)
  • ESMO: In crowded kidney cancer space, Exelixis faces uphill battle with modest Cabometyx-BMS triplet showing (Fierce)
  • #ESMO22: 'End of the beginning': As PD-(L)1s press on, how far can combo therapies take immuno-oncology? (Endpoints)
  • ESMO: BioNTech's CAR-T response rate falls in fresh cut of early-phase data (Fierce)
  • ESMO: It's early days for Pfizer's EZH2 inhibitor, but there's a glimpse of hope for some (Fierce)
  • ESMO: Daiichi dazzles in lung cancer to dial up hopes for next ADC (Fierce)
  • ESMO: AstraZeneca spinout Dizal planning phase 3 NSCLC study in US before year-end (Fierce)
  • ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer (Fierce)
  • Arcutis' roflumilast clinches win in seborrheic dermatitis trial, proving it's no one trick pony in itch (Fierce)
  • ESMO: Multi-cancer blood tests show promise, but questions remain (Fierce)
  • RADx reloaded: NIH puts out the call for more effective, easier-to-use COVID tests (Fierce)
  • #ESMO22: Grail puts its cancer test to a real world trial — but it's 'not ready for prime time yet' (Endpoints)
Government, Regulatory & Legal
  • Colorado to seek FDA approval by fall on Canadian drug imports (Endpoints)
  • J&J settles gender discrimination and retaliation allegations involving former CEO and R&D head (Endpoints)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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