Recon: HHS OIG criticizes FDA’s EUA policies for COVID tests; ODAC votes against Spectrum’s lung cancer drug

| 22 September 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • U.S. FDA panel votes against Spectrum's lung cancer drug (Reuters)
  • FDA Approves Drug for Cisplatin Ototoxicity in Kids With Cancer (MedPage Today) (Reuters)
  • Lilly’s Retevmo Gets FDA OK for RET Fusion-Positive Solid Tumors (Bloomberg) (Endpoints)
  • Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules (MedTech Dive) (Reuters)
  • Outlook Dim for Trio of Cancer Drugs Ahead of ODAC Meeting (MedPage Today)
  • Fecal Microbiome Treatment for C. Diff to Face Scrutiny of FDA Panel (MedPage Today)
  • FDA slaps hold on DBV peanut allergy, trial in call for protocol changes (Fierce)
  • Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines (STAT) (FDAnews)
  • FDA Warns TikTok’s Nyquil Chicken Challenge is Dangerous (Bloomberg) (NYT)
  • Medicare Mental Health Bills Get Boost From House Committee (Bloomberg)
  • ‘On-And Off-Ramps’ For Cancer Accelerated Approvals: FDA Suggests Earlier Randomized Trials (Pink Sheet)
  • GDUFA Research Impacting Generic Development, ANDA Approvals (Pink Sheet)
  • Energy and Commerce panel approves bill to update vaccine injury program (Politico)
  • MedPAC’s Message To Congress: Drug Pricing Still Needs Attention (Pink Sheet)
  • NIH launches the next stage of its ‘human genome project’ for the brain (STAT)
In Focus: International
  • Decentralized Clinical Trials: EU To Demystify Differences Between Member States (Pink Sheet)
  • International Trial Organizations Address Reporting Of Unforeseen Disruptions (Pink Sheet)
  • Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine (Reuters)
  • World leaders pledge billions to fight AIDS, tuberculosis, malaria on UN sidelines (Reuters)
  • PAHO says Brazil, Dominican Republic, Haiti, Peru at very high risk for polio as vaccination dwindles (Reuters)
  • Pfizer to supply up to 6M COVID pill courses for lower income countries (Reuters)
  • Uganda has confirmed seven Ebola cases so far, one death (Reuters)
Pharma & Biotech
  • Novartis to prioritise U.S. market, unfazed by drug pricing pushback (Reuters)
  • Bayer’s venture arm ramps up, seeking to invest $1.3 billion (STAT)
  • Biogen says ALS drug shows clinical benefit in new data analysis (Reuters)
  • GSK plays the white knight, paying $66M to rescue Spero’s oral antibiotic after FDA rejection (Fierce) (Biospace)
  • Are $3M gene therapies the new normal? Experts say bluebird will be a test case for a market ready for prime time (Endpoints)
  • AbbVie invests €60M, plots 70 hires to bolster aesthetics manufacturing in Ireland  (Fierce)
  • Puma pounces on failed Takeda drug, snapping up cancer prospect for knockdown price (Fierce)
  • Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates (Fierce) (Biospace)
  • Inventiva signs over China NASH rights to Sino Biopharm in possible $300M+ deal (Endpoints)
  • Remote Work Opportunities Abound at Pfizer, GRAIL, Regeneron and More (Biospace)
  • Small molecule stimulates axon growth in mice with severe spinal cord injury (Fierce)
  • Medtronic drug-eluding stents net FDA approval for treating complex clogs at coronary artery junctions (Fierce) (MedTech Dive)
  • FDA Finalizes Electronic Submissions Guidance (MedTech Insight)
  • Some Medtronic insulin pumps are vulnerable to hackers, FDA warns (Endpoints) (Reuters) (MedWatch)
  • French Government Will Tell Commission To Give Notified Bodies Time To Process All Files (MedTech Insight)
  • MedTech Europe’s 2022 Report: Germany Top For Medical Device And IVD Sales (MedTech Insight)
  • MicroTransponder grabs macro funding round with $73M for stroke rehab neurostimulator (Fierce)
  • Clock is ticking on post-Brexit UK medical equipment laws (MedWatch)
Government, Regulatory & Legal
  • Novartis takes Gilenya fight to Supreme Court as generic competition looms (Endpoints) (Reuters)
  • AbbVie Gets Shareholder Class Suit Over Allergan Merger Tossed (Bloomberg)
  • CVS, Walmart reach $147.5M opioid settlement with West Virginia (Reuters)
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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