Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

• Trump administration submits formal notice of withdrawal from WHO (STAT) (WSJ)
• Pence, Azar reassure governors Trump won't end virus emergency declaration (Politico)
• Drug prices steadily rise amid pandemic, data shows (Politico)
• In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab (Fierce) (Endpoints) (BioPharmaDive)
• Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent? (Endpoints)
• Novartis teams with Civica Rx to ease hospital shortages for high-demand injectables (Fierce)
• Merck hits rare FDA setback for cancer drug Keytruda (BioPharmaDive) (Endpoints)
• Merck dangles up to $425 million to team with Flagship’s Foghorn Therapeutics (Endpoints)
• Gilead axes $445M Precision Biosciences gene therapy hep B pact (Fierce)
• Genentech, Amgen Settle Herceptin, Avastin Biosimilar Disputes (Big Molecule Watch) (Patent Docs)

• ‘Desperation science’ slows the hunt for coronavirus drugs (AP)
• The Dangerous Race for the Covid Vaccine (Politico)
• EU secures potential COVID-19 drugs from Roche, Germany's Merck – source (Reuters)
• EU scrambles to buy intensive care drugs to tackle COVID shortages (Reuters)
• Gilead Sciences to create 140 jobs at Irish operations (RTE)
• EU gives AZ’s Lynparza green light for BRCA-mutated pancreatic cancer (PMLive)
• Did a pharma trade group try to sabotage a Dutch government report on compulsory licensing? (STAT)

• W.H.O. to Review Evidence of Airborne Transmission of Coronavirus (NYTimes)
• SCIENCE & TECH SPOTLIGHT: Herd Immunity For COVID-19 (GAO)
• Analysis: How A COVID-19 Vaccine Could Cost Americans Dearly (KHN)
• Scientists warn of potential wave of COVID-linked brain damage (NBC)
• Trump to launch short-term 'surge' COVID-19 testing in hot spot cities (The Hill)
• Drug controller asks states to enforce maximum retail price for Remdesivir (Economic Times)
• New clinical trial platform launched to accelerate COVID-19 treatments (PharmaTimes)
• Could Amgen test Enbrel or other anti-TNF drugs against COVID-19? CEO Bradway drops a hint (Fierce)
• Coronavirus (COVID-19) Update: Daily Roundup July 7, 2020 (FDA)

• 5 FDA approval decisions to watch in the 3rd quarter (BioPharmaDive)
• Update from WHO and Pew Charitable Trusts: urgent action needed to accelerate antibiotic development (WHO)
• A swift big pharma endorsement for Kiadis (Vantage) (Endpoints)
• Gene-editing discovery could point the way toward a ‘holy grail’: cures for mitochondrial diseases (STAT)
• WHO Drafting Regulatory Convergence White Paper On Cell And Gene Therapies, US FDA's Marks Says (Pink Sheet)
• Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm (Pink Sheet)
• A moment of truth arrives for CytoDyn’s Covid-19 drug. Don’t let spin obscure it (STAT)
• Purdue Pharma Made Political Contributions After Going Bankrupt (The Intercept)
• Expectations Are High For New EMA Boss (Pink Sheet)
• EMA Scientific Advice Demand Up But Not For Orphan Drugs (Pink Sheet)
• ‘Open & Constructive’: Early Feedback Supports Simultaneous Scientific Advice In Europe (Pink Sheet)
• Indian drug companies complain of hefty charges on stuck consignments from China (Economic Times)
• GSK sets the stage for a toe-to-toe market showdown with Gilead's HIV champion Truvada (Endpoints)
• Zai Lab inks China deal with Turning Point with $25M upfront; Xencor, Atreca team up on bispecifics (Endpoints)
• 'Fundamentally different' from Portola, Dutch biotech lands €32M to steer anti-anticoagulant through the clinic (Endpoints)
• Singular focus on ROR1 earns VelosBio $137M to fund PhI ADC and other programs (Endpoints)
• Concert gets BTD for alopecia drug, setting up a late-stage showdown with giant rival Pfizer (Endpoints)

• European Commission Unlikely To Allow Virtual Audits Under MDR/IVDR In The Short Term (MedtechInsight)
• CMS not yet sold on Baxter, Outset tech in kidney care payment proposal (MedtechDive)
• Illumina launches whole-genome analysis software to help identify rare diseases (Fierce)
• Cochlear receives FDA clearance for three new hearing devices (mobihealthnews)
• RapidAI snags FDA clearance for neuroimaging analysis device (mobihealthnews)

• AbbVie draws first blood in trade secrets war between Allergan's Botox and Evolus (Fierce) (Law360)
• More Preemption of Breast Implant Claims (Drug & Device Law)
• Amerisource Tries To Save CEO From Opioid Bellwether Depo (Law360)
• Bias Charge Is 'Dangerous Fiction,' Opioid MDL Judge Says (Law360)
• Pharma Co. Files Ch. 11 Plan Proposing Icahn Acquisition (Law360)
• High Court Allows Employers To Opt Out Of ACA’s Mandate On Birth Control Coverage (KHN)
• TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20 (TGA)