Recon: WHO says three COVID vaccines in final review for EUL; Hahn’s exit interviews

• Outgoing FDA chief: The agency fought 'substantial' pressure under Trump (Politico)
• Trump FDA Chief Was 'Disgusted' by Riots, Stayed to Guide Agency: Q&A (Bloomberg)
• “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science (Vanity Fair)
• Janet Woodcock to Lead FDA on Interim Basis (WSJ)
• Biden to hit reset on nation's fight against COVID-19 after taking office (Reuters) (Politico)
• The 9 biggest challenges Biden will face on Covid-19, from today on (STAT)
• Moderna on Track to Make 100 Million Vaccine Doses by End of March, CEO Says (WSJ)
• Moderna says possible allergic reactions to COVID-19 vaccine under investigation (Reuters)
• After Moderna’s medical miracle, some investors step back (STAT)
• 4,400 Moderna Vaccine Doses Not Kept Cold Enough May Be Unusable (NPR)
• Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots (Washington Post)
• Abbott's COVID-19 antigen test may help with faster detection, isolation – CDC (Reuters)
• Biden will bring US into COVAX vaccine initiative, Blinken says (Axios)

• WHO: Three COVID-19 vaccines under final review for emergency use (Reuters 1, 2)
• COVID-19 shots to cost $3 to $10 under African Union vaccine plan (Reuters)
• EU and BioNTech/Pfizer clash over reduced vaccine deliveries (FT) (Reuters)
• Italy considers legal action over Pfizer vaccine delivery delays (Reuters)
• Russia files Sputnik V vaccine registration in Europe (Reuters)
• Chinese media criticise Pfizer COVID-19 vaccine, tout local shots (Reuters)
• India, 'pharmacy of the world', starts COVID vaccine shipments to neighbors (Reuters)
• Pfizer vaccine appears effective against UK coronavirus variant (Reuters) (STAT) (FT)
• Merck KGaA, GSK suffer lung cancer drug setback (Reuters) (Endpoints)
• China's COVID-19 vaccine makers apply to join COVAX scheme (Reuters)
• Backers of IP waiver for COVID-19 drugs make fresh push at WTO (Reuters)
• TGA grants additional provisional determination for a COVID-19 vaccine (TGA)

• Lower-income countries fall behind in race for vaccines (FT)
• Cheap antiparasitic could cut chance of Covid-19 deaths by up to 75% (FT)
• Senate Democrats call on Biden to immediately invoke Defense Production Act (The Hill)
• New California Variant May Be Driving Virus Surge There, Study Suggests (NYTimes)
• Pandemic could be WHO's Chernobyl moment for reform -review panel (Reuters)
• WHO chief welcomes EU proposal for pandemic preparedness treaty (Reuters)
• Could a Smell Test Screen People for Covid? (NYTimes)
• Japan's vaccine programme chief denies reports of May roll-out (Reuters)
• South Korea in talks to secure 40 million doses of Novavax's COVID-19 vaccine (Reuters)
• Cash-strapped Venezuela cannot join COVAX vaccine program, PAHO says (Reuters)
• Mexico to ramp up distribution of Sputnik V vaccine through March (Reuters)
• Brazil battles Chinese red tape to get active vaccine ingredients (Reuters)
• Brazil does not expect to finish AstraZeneca vaccines locally until March – Fiocruz (Reuters)
• Peru says Sinopharm, Pfizer seek approval for their COVID-19 vaccines (Reuters)
• China steps up COVID-19 vaccine drive ahead of Lunar New Year (Reuters)
• S.African experts urge government to lay out COVID-19 vaccine plan (Reuters)
• Chile regulator greenlights Sinovac COVID-19 vaccine for emergency use (Reuters)

• Biotech’s presence on new social media app Clubhouse is growing (STAT)
• Merck, Bayer win FDA approval for heart failure drug (BioPharmaDive)
• 2020 biotech IPOs shatter all the records (Nature)
• Trump and DeSantis want Florida to import prescription drugs. Does Biden? (TampaBayTimes)
• The IPO flood keeps rising with 4 more biotechs and a SPAC on their way to Nasdaq (Endpoints)
• Focus on Covid-19 does not distract the FDA (Evaluate)
• Enhertu bags EU approval for HER2-positive breast cancer (PharmaTimes)
• Beam, Verve stockpile cash as investors bank on gene editing progress (BioPharmaDive)
• Failure to launch? Half of drugs rolled out since 2004 didn't live up to sales forecasts: report (Fierce)
• ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19 (Pink Sheet)
• Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA (Pink Sheet)
• Covid-19 claims another PDUFA victim as GlaxoSmithKline pushes back planned PD-1 rollout (Endpoints) (Evaluate)
• Beyond 2021: Cell Therapy Manufacturing Trends (GEN)
• Biopharma Manufacturers Shouldn’t Rush When “Going Digital” (GEN)
• Adagene plans $125M IPO to go after cancer niches targeted by BMS and Pfizer (Fierce)
• Fresenius Kabi pulls anti-inflammation drug Ketorolac over particulate fears—again (Fierce)
• Turnstone buys Myst to add tumor-infiltrating lymphocyte assets (Fierce)
• Amryt’s Myalepta scores NICE backing for rare lipid disorder (PharmaTimes)
• Lonza to sell 2 plants to NextPharma as it plows ahead with $93M capsule expansion (Fierce)
• Pieris finally vaults FDA hold on next-gen solid tumor hunter, clearing the path for mid-stage trial (Endpoints)
• FDA hits the brakes on Histogen's knee cartilage therapy, asking for more info on manufacturing process (Endpoints)
• News briefing: Verastem CMO exits two weeks after joining company; Thermo Fisher inks $550M M&A deal (Endpoints)
• BioMed Realty snaps up innovation campus site within earshot of pricey and bustling Boston biotech hub (Endpoints)
• Paul Hudson faces down French unions in fight to restructure Sanofi (Endpoints)
• FDA Grants Priority Review to 2 sBLAs for Nivolumab in the Treatment of Cancers of the Gastrointestinal Tract (Cancer Network)

• Thermo Fisher nets hand-held COVID-19 test maker Mesa Biotech with $550M deal (Fierce)
• Philips to buy medical device integrator Capsule Technologies for $635M (Fierce)
• Forging trust in AI, sustaining the virtual care boom and other CES takeaways (MedtechDive)
• Hillrom makes cardiac monitoring play with $375M Bardy Dx buy (MedtechDive)
• CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others (MedtechDive)
• Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation (MedtechInsight)
• Chinese regulators announce classification adjustments and UDI submission guidelines (Emergo)

• Latest CMS Data Reveal the Truth About U.S. Drug Spending (Drug Channels)
• Exit Interview: C.D.C. Head Redfield Reflects on His Time on the Job (NYTimes)
• Opinion: Azar’s ‘Sunset Rule’ will bring a dangerous new dawn for health regulation (STAT)
• Surgeon general to step down as Biden requested (Politico)
• Longtime Becerra aide and two health policy experts to be tapped for key posts (STAT)
• ALS Patients To Gain Quicker Access To Disability Benefits And Medicare (NPR)
• Bayer Must Face Bulk Of Takeda's Hemophilia Drug IP Suit (Law360)
• PTAB Denies Bid To Review Eye Shot Patent, Citing ITC Case (Law360)
• Mallinckrodt OK'd To Pay Fees In Ch. 11 Despite Outcry (Law360)
• BPCIA Info Exchange Is Failing To Streamline Patent Litigation (Law360)
• FCC Exempts Certain Pharma Calls From TCPA Rules (Law360)
• Mylan Can't Escape EpiPen Distributors' Antitrust Claims (Law360)