Regulatory Focus™ > News Articles > 2021 > 9 > Recon: FDA approves BeiGene's Brukinsa for rare blood cancer; House Committees request records from

Recon: FDA approves BeiGene's Brukinsa for rare blood cancer; House Committees request records from FDA's Aduhelm review

Posted 02 September 2021 | By Michael Mezher 

Recon: FDA approves BeiGene's Brukinsa for rare blood cancer; House Committees request records from FDA's Aduhelm review

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna seeks US authorization for COVID-19 vaccine booster (Reuters)
  • House Committees Demand FDA Records on Alzheimer’s Drug Approval (NYTimes)
  • Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims (NYTimes) (STAT) (Reuters)
  • FDA warns of heart-related events, cancer, blood clots, and death for JAK inhibitors (Endpoints 1, 2) (Reuters) (FDA)
  • Rulemaking authority restored at FDA as a show of support in a tumultuous time (Endpoints)
  • FDA approves BeiGene's Brukinsa in rare blood cancer amid company's US expansion plans (Endpoints)        (FDA)
  • Drug industry banks on its Covid clout to halt Dems’ push on prices (Politico)
In Focus: International
  • Vaccination reduces risk of long Covid, even when people are infected, UK study indicates (STAT)
  • EU health body says no urgent need for vaccine boosters (Reuters) (EMA)
  • Moderna to recall COVID-19 doses in Japan after stainless steel contaminants found (Reuters)
  • J&J vaccine shipments from S. Africa to Europe halted, AU says (Reuters)
  • Aspen eyes Serum Institute model as it seeks licence to make J&J vaccine (Reuters)
  • Britons with weak immune systems to be offered third Covid jab (FT)
  • Advent and GIC offer $8bn to take Swedish biotech private (FT)
Coronavirus Pandemic
  • The debate over Covid-19 vaccine boosters, what to call them, and whether they’re needed (STAT)
  • How Covid data gaps allowed Delta to proliferate (Politico)
  • Pfizer, Merck launch large new trials of oral COVID-19 drugs (BioPharmaDive)
  • NIH funding studies into reports of abnormal menstruation after vaccines (The Hill)
  • Thailand cites positive results from Sinovac-AstraZeneca vaccine formula (Reuters)
  • WHO warns new mu coronavirus variant could be more vaccine resistant (The Hill)
  • American Medical Association calls for 'immediate end' to use of ivermectin for COVID-19 (The Hill)
Pharma & Biotech
  • FDA posed a sprawling set of questions for two-day gene therapy hearing. Here's what companies and experts will be watching for (Endpoints) (BioPharmaDive)
  • Astellas again hits pause on gene therapy trial (BioPharmaDive)
  • Sobi deal could reignite Pfizer and Biogen interest (FT)
  • Novartis finalizes deal to make new heart drug widely available in England (BioPharmaDive)
  • Roche schizophrenia drug that failed PhIII gets a new life in rare disorder as OrbiMed leads $90M for startup (Endpoints)
  • Takeda slammed with surprise PhIII failure on 'breakthrough' blood cancer drug, imploding launch plans (Endpoints)
  • Scoop: Inspired by the late Tachi Yamada, Jim Wilson launches new nonprofit targeting underserved ultra-rare diseases (Endpoints)
  • Assembly Bio ditches hepatitis B drug on liver toxicity concerns in mid-stage test (Endpoints)
  • Innovent and GenFleet reach deal for KRAS Inhibitor; TCR2 receives FDA's ODD on gavo-cel (Endpoints)
  • Sanofi pulls Epilim website after U.K. regulator points out consumer complaint (Fierce)
  • GSK’s shingles vaccine Shingrix gains UK license (PharmaTimes)
  • Zolgensma Provides No Proven Benefit Over Spinraza In SMA, Says German HTA (Pink Sheet)
  • UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients (PMLive)
  • Asensus Surgical nabs 3rd FDA clearance of 2021, this time for upgraded AI tools for its Senhance robot (Fierce)
  • Philips gets green light to begin repairing millions of recalled sleep apnea machines (Fierce)
  • COVID test maker Cue Health takes aim at public debut with $100M IPO (Fierce)
  • Baxter's deal for smart hospital bed maker Hill-Rom swells to $10.5B (Fierce)
Government, Regulatory & Legal
  • Ex-Drug Distributor CEO Slated For January Opioid Trial (Law360)
  • Indivior's Suboxone Patent Fight Faces Wary Fed. Circ. (Law360)
  • Fed. Circ. Teva Ruling May Shake Up Skinny Label Strategies (Law360)
  • Laboratory Owner Pleads Guilty to $73 Million Medicare Kickback Scheme (DOJ)
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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