Recon: EU approves two Sanofi treatments for rare diseases; Novartis to cut 8,000 staffers as part of global reorganization

ReconRecon
| 28 June 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short (The Pink Sheet)
  • Four months after CRL due to contaminant worries, Gilead returns to FDA for next-gen HIV drug (Endpoints)
  • A decade after its first approval, FDA expands weight loss pill's label for use in adolescents (Endpoints)
  • Biden and G7 nations offer funds for vaccine and medical product manufacturing project in Senegal (Endpoints)
  • Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too (The Pink Sheet)
  • FDA releases final guidance on developing drug for bladder cancer (Federal Register)
  • FDA final guidance addresses treatments for renal cell carcinoma (Federal Register)
  • The next epidemic may be here. The U.S. isn’t ready for it (STAT)
In Focus: International
  • Sanofi Bags EU Approvals But Fumes At Regulator (Scrip) (Fierce)
  • EU begins review of Bavarian Nordic’s vaccine for monkeypox (Reuters)
  • Planning all-oral, once-daily regimen, J&J gets EMA backing for Imbruvica-venetoclax combination (Fierce)
  • Korea’s First Home-Grown COVID-19 Vaccine To Speed Hub Ambitions (The Pink Sheet)
  • Nigeria says at current rate, monkeypox infections in 2022 could be highest in five years (Reuters)
Pharma & Biotech
  • Novartis details plans to ax 8000 staffers as Narasimhan begins second phase of a global reorg (Endpoints)
  • ‘Welcome to scrutiny’: BIO chair mounts defense against more rigorous accelerated approval process (Fierce)
  • Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug (Endpoints)
  • COVID-19 tracker: Drugmakers come up short on foundation’s human rights scorecard (Fierce)
  • Clinical trial data surge driving demand for management tech, Medidata says (Fierce)
  • Jazz reports surprise PhIII flop for cannabinoid drug from $7.2B GW buyout (Endpoints)
  • Astellas pays Sutro $90 M to hit cancer with one-two punch from new ADC modality (Fierce) (Biospace)
  • Roche scraps one of two schizophrenia PhII trials after failing the primary endpoint (Endpoints)
  • How prepared is biopharma for the cyber doomsday? (Endpoints)
  • Titans Of Pharma 2022: Johnson & Johnson Pays Highest Exec Compensation Again (Scrip) (Fierce)
  • Amgen takes next step with its China ambitions, out-licensing drugs to Fosun Pharma (Endpoints)
  • New Study: COVID-19 May Cause or Accelerate Neurological Diseases (Biospace)
Medtech
  • Go-Ahead For Appointment Of European Union Reference Labs For IVDs (MedTech Insight)
  • U.S. FDA classifies recall of GE's ventilator batteries as most serious (Reuters)
  • Philips says tests on recalled ventilators 'very encouraging' (Reuters) (MedTech Dive)
  • Cue Health cuts 170 jobs amid ‘economic challenges,’ decline COVID-19-testing (MedTech Dive)
  • P&G Worker Shortage Puts a Third of US Tampon Market at Risk (Bloomberg)
Government, Regulatory & Legal
  • With SPAC merger looming, Scilex sues Apotex to block generic copy of key pain patch (Fierce)
  • Bausch, Insud’s Chemo Sue Encube to Block Copies of Nuvessa Drug (Bloomberg)
  • Patent Office Extends Covid-19, Cancer Therapy Pilot Programs (Bloomberg)
  • Opioid Distributors Cut $250M Deal With Holdout Okla. AG (Law360)
  • Juul and Its Courtroom Foes State Down FDA Ban as Trial Nears (Bloomberg)
  • CVS, Rite Aid Ration Contraceptive Pills as Demand Surges (Bloomberg)
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

5;6;11;18;20;25;31;