Recon: US to buy 8.5M Ellume at-home COVID tests; Bayer to produce CureVac vaccine

• Biden administration readies battle plan as Covid variants reach the U.S. (Politico)
• Moderna asks FDA to OK 5 additional doses per Covid vaccine vial (CNBC) (Reuters)
• US distributes 49.9M doses of COVID-19 vaccines, administers 31.1M shots (Reuters)
• Novavax expects to produce 150 million vaccine doses per month as early as May: CEO (Reuters)
• Trump officials actively lobbied to deny states money for vaccine rollout last fall (STAT)
• Biden administration pumps brakes on signature Trump drug pricing proposal (STAT)
• U.S. Reaches Deal With Australian Company for At-Home Covid-19 Tests (WSJ)
• Top FDA official: Agency working on 'streamlined' process for updating vaccines if needed (The Hill)

• EU reverses course after Irish border curbs for vaccines trigger uproar (FT) (Reuters)
• EU's Von der Leyen says AstraZeneca will deliver 9 million more vaccine doses (Reuters)
• EU’s Push for Vaccine Supplies Gets Help From Bayer Agreement (Bloomberg) (BioPharmaDive)
• UK rules out reducing gap between vaccinations in care homes (FT)
• EU repeats Pfizer/BioNTech to deliver 75 million extra vaccine doses in Q2 (Reuters)
• Oxford kept COVID-19 vaccine trial volunteers in dark about dosing error, letter shows (Reuters)
• Britain raises order to 100 million Valneva COVID-19 vaccine doses (Reuters)
• India eyes global vaccine drive to eclipse rival China (FT)
• China's CanSino says gets green light to continue Phase III trials (Reuters)
• Pregnant Women May Receive Covid Vaccines Safely, W.H.O. Says (NYTimes)
• S.Korea's Seegene develops first COVID-19 test kit that can detect multiple variants (Reuters)

• How the Search for Covid-19 Treatments Faltered While Vaccines Sped Ahead (NYTimes)
• WHO team, on tightly controlled China mission, visits hospital (Reuters)
• WHO team in China's Wuhan visits provincial CDC (Reuters)
• Vietnam approves AstraZeneca vaccine, cuts short Communist Party congress (Reuters)
• CDC issues rule requiring travelers to wear face masks (Politico)
• Biotech partner drops GlaxoSmithKline’s adjuvant as it moves Covid-19 vaccine into PhII/III, citing ‘manufacturing considerations’ (Endpoints)
• Israel says coordinated passage of 1st COVID-19 vaccines shipment to Palestinians (Reuters)
• Germany is already ordering vaccines for 2022, minister says (Reuters)
• Older Adults Without Family or Friends Lag in Race to Get Vaccines (KHN)
• AstraZeneca vaccine to arrive in France by next week (Reuters)
• AstraZeneca COVID-19 vaccine applies for full regulatory approval in Brazil (Reuters)
• COVAX to send AstraZeneca shot to Latin America, some states to get Pfizer too (Reuters)
• Pfizer tells Panama vaccine shipments to resume mid-February, minister says (Reuters)
• Colombia reaches COVID-19 vaccine agreements with Moderna, Sinovac (Reuters)
• Malaysia to receive first batch of Pfizer vaccines on Feb. 26 – report (Reuters)
• Johns Hopkins professor and biotech colleagues tout new tech to test Covid-19 vaccine response (Endpoints)

• Horizon Therapeutics to Purchase Viela Bio for $3.1 Billion (Bloomberg) (Endpoints)
• The FDA delayed its decision on Biogen’s Alzheimer’s drug. Now what? (STAT) (Pink Sheet)
• In pursuit of an HIV cure, Gilead jumps into a T cell-driving vaccine program with a $785M deal that triggers PhI (Endpoints)
• Third Rock's stealthy MOMA Therapeutics taps a longtime Millennium, Takeda vet as CEO (Endpoints)
• Merck pokes Bristol Myers in the eye with Keytruda data showing safety red flags in Yervoy combo trial (Endpoints)
• AstraZeneca's EGFR inhibitor Tagrisso cuts relapse, death risks in patients with and without prior chemotherapy (Endpoints)
• Shifting strategy, Coherus buys rights to experimental cancer drug (BioPharmaDive)
• Concert dumps schizophrenia drug CTP-692 after failing phase 2 (Fierce)
• New Therapeutic Targets & A Rich Year For Approvals: EMA’s PRIME In 2020 (Pink Sheet)
• RTC issues arrests warrants vs three Sanofi Pasteur execs in Dengvaxia vaccine case (Manila Bulletin)
• The packed PD-(L)1 game just got another player — a low-profile biosimilars company looking to branch out with a $150M cash pact (Endpoints)
• Khosla Ventures helps seed a next-gen regenerative medicines startup boasting AI-based stem cell culturing technology (Endpoints)
• Bristol Myers Squibb Application for Zeposia® (ozanimod) for the Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by U.S. Food and Drug Administration (Press)
• Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China (Press)
• Takeda Completes Sale of Select OTC and Non-Core Assets to Hypera Pharma (Press)

• Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30% (MedtechDive)
• CGM, insulin pump players look to 2021 as watershed year for diabetes wearables market (MedtechDive)
• 2021 Forecast Includes Rise In FDA Enforcement Actions (MedtechInsight)
• FDA approves Medtronic's diamond-laden heart ablation catheter (Fierce)
• Perspectum's liver-scanning software scores FDA clearance for planning cancer surgeries (Fierce)
• Complexity And Confusion At The Border As UK Medtech Faces New EU Trading Arrangements (MedtechInsight)

• Biden’s Budget Request for FY 22 and Related Issues (Alliance for a Stronger FDA)
• Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures (MHRA)
• Teva, Mylan and fellow valsartan makers have to face consumer fraud claims: judge (Fierce) (Law360)