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