Recon: Trump to issue ‘America First’ vaccine order; AstraZeneca publishes interim COVID vaccine data

• Pfizer COVID-19 vaccine data wins backing of FDA staff, authorization nears (Reuters) (STAT) (Politico) (FT)
• Trump to order priority access to US COVID-19 vaccines for Americans (Reuters) (CNBC)
• ‘I literally don’t know’: Operation Warp Speed scientist can’t explain Trump’s vaccine order (Politico)
• Trump Administration Passed on Chance to Secure More of Pfizer Vaccine (NYTimes)
• Gottlieb confirms US turned down Pfizer offer for more vaccine doses (Axios) (CNBC) (The Hill)
• Pfizer, Moderna decline White House's 'Vaccine Summit' invitation (Reuters) (STAT)
• JNJ targets COVID-19 late-stage trial results by January (Reuters)
• Sarepta shares first clinical data on next-generation Duchenne drug (BioPharmaDive)
• Biden to formally unveil health team (Politico)
• The Future of the FDA in a Disruptive Age (Milken Institute)
• FDA finds fault with a Bristol plant, but it may not upset key approval of a cancer drug (STAT) (Endpoints)

• In COVID-19 milestone for West, Britain starts mass vaccination (Reuters) (FT) (MHRA 1, 2)
• 'Go for it,' says grandmother who got world's first Pfizer COVID vaccine in Britain (Reuters) (BBC)
• Britain hopes for regulator's verdict on Oxford vaccine in a couple of weeks (Reuters)
• AstraZeneca publishes interim vaccine data in Lancet, reveals 10 hospitalizations, 1 death in pivotal control arms (Endpoints) (NBC) (STAT) (The Lancet)
• Output of Oxford-AstraZeneca doses held up (FT)
• Japan's AnGes begins phase 2/3 clinical trial of DNA-based COVID-19 vaccine (Reuters)
• Demand for COVID-19 tests to outstrip supply for months, says Roche CEO (Reuters)
• Roche says three antibodies show blood cancer treatment potential (Reuters)
• India could authorise COVID-19 vaccines in weeks, 300 million on priority list (Reuters)
• Serum likely to supply COVID-19 vaccine at over $3 a dose to Indian govt (Reuters)
• Chinese province to give COVID-19 vaccines to vulnerable groups, general public in 2021: local media (Reuters)
• WHO announces development of new guidance on Hepatitis C self-testing (WHO)

• Trump administration has yet to launch promised effort to get Americans to trust Covid-19 vaccines (NBC)
• Operation Warp Speed officials will meet with Biden transition on Thursday (The Hill)
• Switzerland increases order for Moderna's COVID-19 vaccine (Reuters)
• UK's initial AstraZeneca shots will come from Europe, taskforce says (Reuters)
• Brazil in advanced talks with Pfizer to buy 70 million COVID-19 vaccine doses (Reuters)
• Israel to get initial Pfizer coronavirus vaccine shipment on Thursday, minister says (Reuters)
• Poland has bought over 60 million COVID-19 vaccine doses, PM says (Reuters)
• Abu Dhabi seeking volunteers for Russian COVID-19 vaccine trial (Reuters)
• Turkey could start Chinese COVID vaccination this month: Sozcu newspaper (Reuters)
• CorVent Medical wins EUA for multiple patient ventilator (MassDevice)

• Families tell U.N. Vertex is violating human rights with cystic fibrosis drug pricing (STAT)
• Divergent results from Agios, Forma trials for their sickle cell disease drugs (STAT)
• With new data and a storied history, Eli Lilly’s blood cancer pill is looking stronger (STAT)
• CMOs Face Capacity Challenges, Talent Shortages As Pandemic Increases Demand For Their Services (Pink Sheet)
• Driven by Covid-19 fever, Forbion notes investor interest in vaccines and new therapies as part of $557M fund (Endpoints)
• A KRAS drug is likely coming — fast — as the FDA points Amgen’s frontrunner to a looming finish line (Endpoints)
• Non-profits fill gaps in the broken market for antibiotics (FT)
• Jazz Pharma’s SCLC drug fails to meet primary endpoint in combo trial (PMLive)
• NICE backs AZ' Calquence for chronic lymphocytic leukaemia (PharmaTimes)
• Two medicines accepted for use by NHS Scotland (PharmaTimes)
• ASH: Gilead's CAR-T med Yescarta shows promise earlier in lymphoma therapy (Fierce)
• Months of limbo at OpenBiome put fecal matter transplants on hold across the country (STAT)
• Is there room for a new way to drug RNA? ARCH, Foresite join Atlas, The Column Group for $81M bet (Endpoints)
• Ziopharm drama continues with new letter from activist group; Alnylam, Centogene join forces on ATTRv screening program (Endpoints)
• Vigil Neuroscience launches with a $50M Series A and two former Amgen neuroscience candidates (Endpoints)
• Barely two months after unveiling a new breed of radiopharmaceuticals, RayzeBio brings total haul to $150M (Endpoints)
• GlaxoSmithKline R&D vet Min Li nabs $100M to launch a Bob Nelsen-backed startup focused on China’s burgeoning neuro market (Endpoints)
• #ASH20: Out to shake up CML once again, Novartis lays out head-to-head between third-gen Gleevec scion and Pfizer rival (Endpoints)
• Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation (Press)
• FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps (Press)
• ASH: Takeda's Iclusig pads case for new leukemia use with 5-year survival data (Fierce)
• Takeda Announces Approval of TAKHZYRO® (lanadelumab) subcutaneous injection in China for the Treatment of Hereditary Angioedema (Press)

• Pear Therapeutics nabs $80M Series D to commercialize three digital therapeutics (Endpoints) (Fierce)
• Bayer updates Essure birth control device reports of deaths, injuries on social media (MedtechDive)
• Endologix AAA graft to go before FDA panel over potential life-threatening leak risk (MedtechDive)
• Respiratory Health company AireHealth lands 510(k) for connected nebulizer (mobihealthnews)
• Boston Scientific gains FDA nod for SCS (MassDevice)

• In Becerra, an HHS Nominee With Political Skill But No Front-Line Health Experience (KHN)
• Trump’s health nemesis gets a new starring role: Reversing Trump’s policies (Politico)
• Senate Republicans Throw the Brakes on Timing for Becerra Hearings (KHN)
• 3 reasons the drug industry should be worried about Biden’s HHS pick, Xavier Becerra (STAT)
• Big Pharma Slams 'Most-Favored Nation' Rule On Drug Prices (Law360)
• Full Fed. Circ. Urged To Undo Hatch-Waxman Venue Limits (Law360)
• Pfizer Unit Gets 'Put Up' Order In Osteoarthritis IP Fight (Law360)
• OIG Finalizes Safe Harbor Amendments Relating to Rebates, but Benefits to Patients Are Unclear (FDA Law Blog)
• Feds Call Walmart Preemptive Opioid Suit Improper (Law360)
• Another Opioid Bellwether Delayed For COVID-19 (Law360)
• US agency behind Kodak's beefy drug manufacturing loan played by the books, investigation finds: report (Fierce)
• Doctor Selling COVID-19 “Cure” Charged with Lying to U.S. Customs, Stealing Employee’s Identity (FDA)
• Listed medicines that are required to be tested for the presence of Aristolochic acids (TGA)
• Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices (TGA)