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

• 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)