Recon: UK approves Pfizer-BioNTech COVID vaccine; Hahn says vaccine approval possible by mid-December

• FDA chief Hahn says mid-December vaccine approval just 'possible': ABC News (Reuters)
• Hahn downplays White House meeting on vaccines (The Hill)
• Trump to FDA: Why is Europe beating us on vaccine? (Politico)
• UK's Pfizer vaccine approval should reassure Americans: US health chief (Reuters)
• Moderna CEO expects emergency use nod for COVID-19 vaccine shortly after FDA's December 17 meet (Reuters)
• The US has spent billions stockpiling ventilators, but many won’t save critically ill COVID-19 patients (Reuters)
• US Department of Transportation is Preparing the Way for Swift COVID-19 Vaccine Transport (DOT)
• Ovid’s treatment for a rare, untreatable disease fails in a key trial (STAT)
• Boston Scientific recoups $800M by selling off BTG's antidote business (Fierce)

• UK approves Pfizer-BioNTech COVID-19 vaccine in world first (Reuters) (NYTimes) (FT) (MHRA 1, 2) (Press)
• EU criticises 'hasty' UK approval of COVID-19 vaccine (Reuters)
• UK regulator says it did not cut any corners to approve Pfizer vaccine (Reuters)
• Pfizer-BioNTech seeks full marketing approval from UK for COVID-19 vaccine (Reuters)
• Interpol warns that COVID-19 vaccines could be targeted by criminals (Reuters)
• Bayer sets up cell and gene platform to foster purchased biotech firms (Reuters) (Endpoints)

• Virus May Have Arrived in US in December, but Didn’t Spread Until Later (NYTimes)
• Rapid Testing for Children Barrels Ahead, Despite a Lack of Data (NYTimes)
• WHO fine-tunes advice on COVID masks for public, health workers (Reuters)
• Philippines gives FDA emergency use powers for COVID-19 drugs, vaccines (Reuters)
• COVID vaccinations in Germany will take over a year - expert panel head (Reuters)
• First doses of AstraZeneca vaccine to arrive in Brazil by February, health minister says (Reuters)
• Poland to wrap coronavirus vaccine strategy by week's end - PM's aide (Reuters)
• Roche nets FDA authorization for quantitative COVID-19 antibody test (Fierce) (Press)
• Dr Reddy's Labs begins phase 2/3 trials for Russia's Sputnik V COVID-19 vaccine (Economic Times)

• Roche turns up the heat on Lilly with another Gavreto approval, elbowing its way into the thyroid cancer space (Endpoints) (Press) (FDA)
• Biosimilars Group Pushes For Medicine Access Measures (Law360)
• US Payers Rate ICER Assessment Updates Using Real World Data As Potentially ‘High Impact’ (Pink Sheet)
• Long after Merck and Bristol Myers created a multibillion-dollar market, the PD-1 leaders are once again duking it out — this time over a $12B-plus pot (Endpoints)
• Regenerative Medicine Comes Of Age – In The Age Of COVID-19 (Pink Sheet)
• CDMO Sterling plots buyout of antibody-drug conjugate specialist in play at next-gen oncology market (Fierce)
• Merck sells off its Moderna stake after making record gains amid the pandemic (Endpoints)
• Genetic reprogramming rejuvenates nerve cells and restores vision in mice (STAT)
• Vectura, Kinaset Therapeutics set to develop inhaled asthma drug (PharmaTimes)
• Chinese biotech Zai Lab nabs Roche cancer veteran as new R&D exec, drug hunter (Fierce)
• Corey Goodman introduces Tallac Therapeutics with a $62M Series A, hoping to fight solid tumors through innate and adaptive immunity (STAT)
• News briefing: Exelixis pays $20M to in-license a preclinical ADC for the pipeline; Another preclinical biotech shoots for a big IPO (Endpoints)
• AbbVie eyes cancer, immunology in latest protein degradation pact, handing Frontier Medicines $55M upfront (Endpoints)
• J&J buys an early-stage gene therapy for the eye — the only known program for an under-the-radar biotech (Endpoints)
• Halozyme scores $190M Horizon deal to develop subQ Tepezza formula (Fierce)
• FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer (FDA)

• On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions (MedtechInsight)
• Zimmer puts up $250M in surgical device deal, Boston Scientific nets $800M in BTG pharma sell-off (MedtechDive)
• Bayer signs AI imaging platform pact with Blackford Analysis (Fierce)
• Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues (FDA)

• Moderna, Pfizer Playing The Long Game With Novel Vaccine IP (Law360)
• In Opioid MDL, Fears Of Allergan Dissolving To Avoid Payout (Law360)
• Biotech Co. Says Rival Stole Trade Secrets In 'Brazen Fraud' (Law360)
• Generic Co. Gets Horizon's Painkiller Patent Partly Axed (Law360)
• Clinics Barred From Gilead HIV Drug Program For Now (Law360)
• Del. Judge Finds Teva Infringed ADHD Drug IP On Remand (Law360)
• DC Circ. Upholds FDA Rule Treating Vaping Like Tobacco (The Hill)
• Explanatory note for safeguarding drug supply interim order (Health Canada)
• Importation and sale of medical devices for COVID-19 guidance document: Background (Health Canada)
• Consultation: Amending the Food and Drug Regulations to provide expedited access to COVID-19 drugs (Health Canada)
• Priority applicant guidelines for medical devices (including IVDs) (TGA)
• Pre-submission meetings with TGA (TGA)