Recon: BMS to buy MyoKardia for $13.1B; EMA’s PRAC reviews possible kidney injury from remdesivir

• Warp Speed's focus on vaccines may have shortchanged antibody treatments (Politico)
• Bristol to Pay $13.1 Billion for Heart-Drug Maker MyoKardia (WSJ) (STAT) (FT) (Press)
• White House Takes Issue With FDA’s Plans for Authorizing a Covid-19 Vaccine (WSJ)
• Biotech Industry Pushes Trump Administration to Release New Vaccine Guidelines (NYTimes)
• Memo details HHS push to upend FDA’s testing oversight (Politico)
• Clinical Trials Hit by Ransomware Attack on Health Tech Firm (NYTimes)
• FDA Approves Drug Combination for Treating Mesothelioma (FDA)
• FDA’s own documents reveal agency’s lax, slow, and secretive oversight of clinical research (Science)
• US appeals court revives GlaxoSmithKline $235.5 mln verdict against Teva (Reuters) (Law360)
• US calls for WHO reforms, timely information on outbreaks (Reuters)

• China rolls out experimental Covid vaccine as it eyes global market (FT)
• One in 10 may have caught COVID, as world heads into 'difficult period': WHO (Reuters)
• With 1 million dead, are we any better at treating Covid-19? (FT)
• EMA committee probes possible kidney injury from Gilead's remdesivir (Reuters) (EMA)
• AstraZeneca restarts another COVID vaccine trial, US delay lingers (BioPharmaDive) (PharmaJapan)
• Less than half UK population to receive coronavirus vaccine, says task force head (FT)
• Discoverers of hepatitis C virus win Nobel medicine prize (FT) (NYTimes)
• Kyowa Kirin’s Crysvita wins EU approval for expanded XLH population (PharmaTimes)

• Severity of Trump's illness unclear four weeks ahead of election (Reuters)
• Trump treated with experimental antibody cocktail for COVID-19 (Reuters) (CNBC)
• Instead of Reassurance, Trump’s Doctor Delivers Confusion, Experts Say (NYTimes)
• Use of Dexamethasone to Treat Trump Suggests Severe Covid-19, Experts Say (NYTimes) (NPR)
• Expert panel recommends US join international vaccine pool, contribute vaccine to low-income nations (STAT)
• In vaccine priority recommendations, U.S. panel touches on race, poverty (NBC)
• As cold weather arrives, US states see record increases in COVID-19 cases (Reuters)
• Azar says HHS reviewing $300M pandemic ad campaign amid scrutiny (Politico)
• Hydroxychloroquine Is Part of the Online Conversation, Again (NYTimes)
• Trump official pressured CDC to change report on Covid and kids (Politico)
• EUA For COVID-19 Vaccine Would Mean Fewer Patient-Years Of Follow-Up But More Pharmacovigilance (Pink Sheet)
• Quidel antigen test to detect COVID-19 and flu gets FDA nod (MedtechDive)
• Reality Check On UK Production Capacity For COVID-19 Treatments (Pink Sheet)
• India and South Africa demand waiver of certain provisions of Intellectual Property for Covid-19 therapeutics (Economic Times)
• Dr Reddy's seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine (Economic Times)

• PDUFA VII Talks Begin With Similar Goals For Industry, US FDA (Pink Sheet)
• April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) (FDA)
• Not Pandemic-Proof: Insulin Copay Caps Fall Short, Fueling Underground Exchanges (KHN)
• Merck research chief Roger Perlmutter to retire, leaving immunotherapy legacy (BioPharmaDive)
• FDA defies advisory panel recommendation, rejecting Mesoblast's Ryoncil in paediatric steroid-refractory acute graft versus host disease (Pharmafile)
• MHLW to Draft Guidelines by Year-End on Use of Patient Registry Data in Drug Filing (PharmaJapan)
• GSK's ViiV, armed with long-term Dovato data, eyes 'tipping point' for 2-drug HIV regimen (Fierce) (Press)
• Opdivo/Yervoy combo flops again in melanoma, but Bristol Myers Squibb also has a new OK to celebrate (Endpoints)
• Neil Kumar bets nearly $1B on what BridgeBio hopes will be their first big drug (Endpoints)
• After weathering failure, rejection and layoffs, ImmunoGen touts a new 'breakthrough' drug in its comeback plan (Endpoints)
• Harvard 'MacArthur genius’ Kevin Eggan steps in to run early-stage research at rare disease specialist BioMarin (Endpoints)
• With Covid-19 mucking the tires, Robert Duggan throws another $50M behind his big antibiotics play (Endpoints)

• 5 ways COVID-19 is reshaping the medtech industry (MedtechDive)
• J&J, Acutus And Boston Scientific Announce Plans For Pulsed Field AF-Ablation Technologies (MedtechInsight)
• Icy HHS/FDA Relations Could Complicate An Already Drawn-Out Quality System Reg Rewrite (MedtechInsight)
• Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program (MedtechInsight)

• Understanding the Short-Term CR (Alliance for a Stronger FDA)
• The Heeding Presumption's Evolving Role In Pharma Suits (Law360)
• Amarin Tells Fed. Circ. Vascepa Patents Didn't Get Fair Shot (Law360)
• Patents A Key Focus As Drug-Pricing Debate Intensifies (Law360)
• J&J Unit Wins Block Against Seller Of Counterfeit Implants (Law360)
• Restitution and Disgorgement Authority Under FTC Act Section 13(b) Rejected – Again (FDA Law Blog)