Recon: Sanofi accelerates COVID-19 vaccine plans; Gilead inks $1.5B buyout deal for Pionyr

• The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy (STAT)
• Lawmakers push Covid-19 bills to prevent price gouging, track federal funds used to discover drugs (STAT)
• As approval decision nears, fate of Intercept’s NASH drug clouded by murky FDA review delays (STAT)
• Gilead pens $1.5B buyout option deal for Pionyr (Fierce) (Endpoints)
• Pandemic Forced Insurers To Pay For In-Home Treatments. Will They Disappear? (KHN)
• Sana Biotechnology, the secretive startup, lays (some) cards on the table (STAT) (Fierce) (Endpoints)
• A Year In, 1st Patient To Get Gene-Editing For Sickle Cell Disease Is Thriving (NPR)

• WHO sets out vaccines allocation plan (Politico)
• Sanofi Targets Speedier Approval of Coronavirus Vaccine (Bloomberg) (Endpoints) (STAT) (PharmaTimes) (Fierce)
• Pig trial of AstraZeneca's COVID-19 vaccine shows promise with two shots (Reuters)
• Boehringer to sell stake in Hikma (PharmaTimes)
• After a bribery scandal in China, GSK found a suspected whistleblower. The real one is still waiting in the shadows (STAT)
• Cancer drug: New treatment halts tumour growth (BBC)

• Remdesivir Races Through EU Review (Pink Sheet)
• Democrats: Trump has yet to spend nearly $14B for COVID tests, contact tracing (The Hill)
• Supplies Sent To Labs By Trump Administration To Boost Testing Are Not Always Helpful (NPR)
• No silver bullet: LabCorp and Quest hawk return-to-work COVID-19 tests but employers not rushing in (MedtechDive)
• 9 hand sanitizers may contain toxic methanol, FDA warns (NBC)
• Coronavirus (COVID-19) Update: Daily Roundup June 22, 2020 (FDA)

• The End Of The FDA Approvals Boom? Fewer Applications Are A COVID-19 Consequence (Pink Sheet)
• Biotech: DIY disaster zone (Financial Times)
• Jazz preps first solid tumor launch with Zepzelca's small cell lung cancer nod (Fierce)
• Mylan, looking to capitalize on Biogen's Tecfidera patent loss, faces fork in the road on generic launch (Fierce)
• Bayer-backed Century buys Empirica to create brain cancer CAR-Ts (Fierce)
• Sarepta tries to fine-tune its gene therapy approach (BioPharmaDive)
• Meet the latest genomic data company — aka WuXi NextCODE without the China operations (Endpoints)
• Myovant readies NDA #3 as relugolix sails to its 5th positive PhIII — this time in endometriosis (Endpoints) (STAT)
• Seven years after licensing BTK inhibitor from Biogen, beleaguered pennystock biotech partner concedes defeat (Endpoints)
• Former Bristol Myers Squibb site marketed as the new home for an 'onshoring' drugmaker (Fierce)
• Oncology Dominant As Japan Maintains Approvals Pace (Pink Sheet)
• Celgene’s CAR-T Therapy Filed in Japan for B-Cell Lymphoma: BMS (PharmaJapan)

• Revised FDA Guidance Says Makers Of Tests, Hospital Beds, More Should Tell Agency Of Shortages (MedtechInsight)
• BARDA backs study of Empatica's COVID-19 early warning platform (MedtechDive)
• Medtronic Evolut TAVR system gets expanded label in Europe (MedtechDive)
• Invitae scoops up ArcherDX in $1.4B precision oncology deal (MedtechDive)
• Dana-Farber researchers detect early kidney cancer with DNA methylation-screening blood test (Fierce)

• White House weighs CDC overhaul (Politico)
• An Analysis of a Failed Biosimilar Antitrust Class Action (Patent Docs)
• Submissions received: Fees and charges proposal 2020-21 (TGA)
• TGA to review complaints of alleged non-compliant advertising of medicinal cannabis products to the public (TGA)
• Investor Says Endo Lied About Role In NY Opioid Crisis (Law360)
• Novartis Seeks To Block Imports Of German-Made Eye Shots (Law360)
• Cook Medical Wants Fraud Claims Tossed From MDL (Law360)
• Shareholders Seek Class Cert. In Teva Price-Fixing Suit (Law360)
• Alere Tells PTAB To Reconsider New Record On SAS Remand (Law360)