Recon: Becerra signals more time needed to nominate FDA chief; CureVac vaccine disappoints in pivotal trial

• More Time Needed on FDA Pick, Becerra Says (Bloomberg) (Endpoints)
• US Supreme Court rejects Republican challenge to Obamacare law (Reuters) (KHN) (NYTimes)
• Vaccine Maker Earned Record Profits but Delivered Disappointment in Return (NYTimes)
• ACIP readies Friday meeting on vaccine safety, boosters (Politico)
• Blueprint Medicines nabs 4th approval in bid toward profitability (Endpoints) (FDA)
• Pfizer's rheumatoid arthritis drug shows benefit in COVID-19 pneumonia (Reuters)
• Novartis prostate cancer drug receives US FDA breakthrough designation (Reuters)
• A Pill to Treat Covid-19? The U.S. Is Betting on It. (NYTimes) (Endpoints)
• Costly Brain-Cancer Drug No Longer Covered by Medicare (WSJ)
• Grassley meets with moderate House Democrats on lowering drug prices (The Hill)
• Covid-fueled boom in at-home tests may next extend to STDs (Politico)
• Danaher strikes deal to buy booming next-gen manufacturer Aldevron for $9.6B (Endpoints)
• Trial failure dashes Biogen hopes for next Alzheimer's drug (BioPharmaDive) (Endpoints)

• European regulator EMA says it won't set 50% efficacy threshold for COVID shots (Reuters)
• Brussels’ Teva probe reveals dark side of patent protections (FT)
• CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy (Reuters 1, 2) (NYTimes)
• Low dosage may be behind low efficacy of CureVac vaccine -study leader (Reuters)
• Britain extends approval for rapid COVID test after US rebuke (Reuters) (MHRA)
• Hundreds of vaccinated Indonesian health workers get COVID-19, dozens in hospital (Reuters)
• EU antitrust regulators set July 27 deadline for Illumina, Grail deal (Reuters)

• Australia limits use of AstraZeneca COVID-19 vaccine to people over 60 (Reuters)
• Sen. Warren presses major pharma trade group on efforts to block Covid vaccine patent waivers (CNBC)
• UAE launches Sinopharm vaccine trial for children under 18 (Reuters)
• Not All Experts Are Ready to Vaccinate Kids Against Covid (KHN)
• AstraZeneca vaccine price pledge omits some poor countries, contract shows (The Guardian)
• AstraZeneca’s Thai deal brings renewed controversy (FT)
• Antibody screening could transform Covid-19 vaccine distribution (FT)

• US plays catch-up with Europe over biosimilar patents (FT)
• Life sciences is poised to be Boston’s dominant industry. Has the area become the Silicon Valley of biotech? (Boston Globe)
• Argenx's drug effective against muscle-weakening disease myasthenia gravis (Reuters)
• A UK biotech looks to bring alliance between GSK, J&J, AstraZeneca, and top universities stateside with its first megaround (Endpoints)
• Anthem joins insurer-backed generics effort CivicaScript (BioPharmaDive)
• US FDA Plans To Get Tougher On Oncology Dose Optimization (Pink Sheet)
• Epilepsy drug receives MHRA marketing authorisation (Pharmafile)
• NICE backs Lilly’s Taltz for axial spondyloarthritis (PharmaTimes)
• New NICE guidance supports shared decision making (PharmaTimes)
• China's CARsgen Raises $400m In Third-Largest Biotech IPO This Year (Scrip)
• Biotech Startup Ochre Bio Lands Seed Financing to Combat Liver Diseases (WSJ)
• Kite partners with Shoreline Biosciences to develop allogeneic cell therapies (PMLive)
• PureTech adds potential IBD therapeutic to pipeline after buying out Alivio Therapeutics (PMLive)
• Scientists unshelve a decades-old antibiotic to fight a new foe — ovarian cancer (STAT)
• Planned changes at Soros’ Open Society has access-to-medicines advocacy groups on edge (STAT)
• Rick Klausner's crew of T cell specialists wraps $425M IPO, hitting Nasdaq alongside Verve, Molecular Partners (Endpoints)
• A replacement for reading glasses? An RA, Versant-backed startup thinks its eyedrops could solve farsightedness (Endpoints)
• Viral manufacturer Vibalogics plots out expansion at German site as US growth plans are underway (Endpoints)
• In a move to boost its natural killer candidates, Senti Bio will build out its own San Francisco manufacturing facility (Endpoints)
• As it awaits pivotal review of lead drug, FibroGen bolsters its early pipeline with licensing deal for galectin program (Endpoints)
• Bayer closing down San Francisco research hub as attention turns to Berkeley plan (Endpoints)
• Sid Mukherjee's Vor adds clinical manufacturing facility at existing Boston-area site, beefing up for a commercial push (Endpoints)
• Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs; Public Workshop (FDA)
• Premenopausal Women with Breast Cancer: Developing Drugs for Treatment; Guidance for Industry (FDA)

• Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products (KHN)
• MDUFA V: FDA Proposes New Program To Engage External Experts Early – But Industry’s Skeptical (MedtechInsight)
• Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study (MedtechDive)
• A helping hand: Spanish inventor crafts 3D-printed, prosthetic arms (Reuters)
• NHS to pilot artificial pancreas for type 1 diabetes (Pharmafile)
• Medtronic's HeartWare HVAD pump recalls and decision to exit (MedtechDive)
• Regulatory Pathways for an Integral Drug-Device Combination Product Platform based on Quality by Design (Guest Blog) (EFPIA)
• Fractyl Adds $100M Investment To Address Root Causes Of Type 2 Diabetes (MedtechInsight)

• New York Opioid Trial Delayed Again As Jury Selection Lags (Law360)
• Congress Already Preparing For User Fee Bills (Pink Sheet)
• PhRMA Statement on PASTEUR Act Introduction (PhRMA)
• BD Sues Beckman Coulter Over Flow Cytometry Patents (MedtechInsight)
• No GlaxoSmithKline Restitution in Criminal Trade Secrets Case (Bloomberg)
• HHS Drug Discount Push ‘Flawed,’ Court Says in AstraZeneca Suit (Bloomberg)
• Medicaid commission to Congress: Increase rebates for accelerated approval drugs (Endpoints)
• Government Seeks to Dismiss Lawsuit Challenging the Canadian Drug Importation Rule (FDA Law Blog)