Recon: Pfizer, Moderna seek EUA for bivalent boosters for kids; Daiichi Sankyo wins Japanese approval for blood cancer drug Ezharmia

ReconRecon | 26 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Moderna asks FDA to authorize omicron Covid boosters for children as young as 6 years old (CNBC) (Reuters)
  • Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11 (CNBC) (Reuters)
  • Biden to announce $1.5 billion to fight U.S. opioid crisis (Reuters)
  • Monkeypox Appears to Recede, but Risks and Uncertainties Linger (NYTimes)
  • Seagen, amid deal rumors, spends $50M on a dual-targeting cancer drug (BioPharmaDive)
  • Prime Medicine becomes the next high-profile biotech to test the IPO waters (BioPharmaDive)
  • FDA adcomm takes down Secura Bio's leukemia drug after final trial results show potential OS detriment (Endpoints)
  • Four corners reach deal on package to reauthorize FDA user fee programs (Politico) (The Hill)
  • Inflation caused another big drop in net drug prices, analysis finds (STAT)
  • Medical device makers see little impact from Fiona on Puerto Rico operations (Reuters)
In Focus: International
  • GSK Will Be Helmed by Two Women as Drugmaker Hires Brown as CFO (Bloomberg) (Reuters)
  • Some European regulators are starting to take steps to ensure clinical trial results are reported (STAT)
  • Daiichi Sankyo bags an industry first with Japanese nod for blood cancer drug Ezharmia (Fierce)
  • Valneva in talks with potential partner on second-gen COVID-19 vaccines (Reuters) (Endpoints)
  • Fujifilm continues CDMO expansion, breaking ground on $435M UK site (Endpoints)
  • EMA warns of shortages of two Boehringer heart drugs due to a spike in demand (Endpoints)
  • 'Blood on your hands' if world steps back on tackling COVID now, WHO official says (Reuters)
  • U.S. cutting global donations of Pfizer COVID shots as demand slows (Reuters)
  • WHO-backed Afrigen plans a charge toward the clinic with Africa's first Covid-19 vaccine (Endpoints)
Pharma & Biotech
  • Cancer-killing virus shows promise in patients (BBC)
  • Biotech turns to new and strange viruses to overcome gene therapy’s limitations (STAT)
  • Another Cipla site lands a Form 483 over cleaning issues and QC controls (Endpoints)
  • Seeking sibling for Vyvgart, argenx files for FDA approval of subcutaneous efgartigimod (Fierce)
  • Novartis wins on quantity, but Eli Lilly takes the cake on value of new launches: report (Fierce)
  • AstraZeneca, Merck cull one Lynparza indication in heavily pretreated ovarian cancer patients (Endpoints)
  • Liver-focused startup nabs $115M in exchange for rare disease drug royalties (Endpoints)
  • They’re going for it: David Liu’s preclinical biotech shoots for a (maybe $200M) IPO (Endpoints)
  • Novo Nordisk, Gilead, BMS and AstraZeneca will feel the most pain from Biden's pricing bill: analysts (Fierce)
  •  The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions (Pink Sheet)
  • Pharma Disappointed By New Extension Of EU Signal Detection Pilot (Pink Sheet)
  • Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham (MedtechDive)
  • Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA (MedtechDive)
  • Precisis lines up EU approval for 'brain pacemaker' to treat epilepsy (Fierce)
  • Novel Negative Pressure Wound Therapy System Cleared By FDA (MedtechInsight)
  • Hospital procedures have remained steady since H2 in boost for medtechs, survey finds (MedtechDive)
  • Iterative Scopes goes a step further with FDA clearance in AI colonoscopy (Fierce)
  • MIT ‘human radar’ device tracks movement, gait speed of Parkinson’s patients at home (Fierce)
  • Smith+Nephew brings robotic assistant to knee replacement revision procedures (Fierce)
  • UK’s Early Value Assessment Pilot Is ‘Catalyst’ For Wider Change – NICE (MedtechInsight)
Government, Regulatory & Legal
  • Should SCOTUS hear Amgen's Repatha case? Solicitor general says no (Endpoints)
  • Jury Says LabCorp Owes $272M For Infringing Prenatal Test IP (Law360)
  • Judge Cuts Some Of Atum's Claims In Gene Therapy IP Row (Law360)
  • J&J Wants 'Rapid Release' Tylenol Class Claims Tossed (Law360)
  • Jury Puts Stryker Biz On Hook For $17.2M In Bone Screw Fight (Law360)
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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