Recon: US signs $1.5B deal for Moderna coronavirus vaccine; Mesoblast GVHD therapy faces clinical, manufacturing questions ahead of adcomm

• Moderna Inks $1.5 Billion Coronavirus Vaccine Deal With US (WSJ) (Reuters)
• Vir Biotech to begin mid-to-late stage study of COVID-19 drug candidate in August (Reuters)
• The top-selling drugs in the US in 2019 (Axios)
• Out-of-pocket spending on specialty drugs dropped dramatically after states capped costs (STAT)
• Mesoblast faces FDA pushback over cell therapy manufacturing, clinical data: documents (Fierce) (Pink Sheet) (Sydney Morning Herald)
• Regeneron's Praluent sidekick nabs speedy FDA review, with February PDUFA date (Fierce) (Endpoints)
• Covid-19 Data Reporting System Gets Off to Rocky Start (WSJ)
• Atomwise Raises $123 Million for AI-Based Drug Discovery (WSJ)

• German institute says COVID-19 vaccine could be available in autumn (Reuters)
• Russia says medics to get anti-COVID shots in two weeks, rejects safety concerns (Reuters)
• Experts Worry About Russia’s Rushed Vaccine (NYTimes)
• Philippines talking to Russian vaccine maker on trials, seeks 'complete dossier' (Reuters)
• Israel to examine Russia's COVID-19 vaccine, minister says (Reuters)
• Mexico to trial China, US COVID-19 vaccines, may produce some (Reuters)
• AstraZeneca bumps up vaccine deal with Brazil to $360M with more doses, licensing rights (Fierce)

• Racial Disproportionality in Covid Clinical Trials (NEJM)
• A Vaccine Is Just a Formula Without a Few Medical Essentials (Bloomberg)
• Companies test antibody drugs to treat, prevent COVID-19 (AP)
• Vaping linked to risk of COVID-19 in teens, young adults (Reuters)
• Alphabet’s Verily builds its own lab to speed up coronavirus test results (CNBC)
• Baxter Obtains US FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic (Press)

• Internal US FDA Disagreements Feature In One-Quarter Of Novel Approvals (Pink Sheet)
• The curious story of Kodak’s pivot to pharma (Financial Times)
• Bristol Myers Squibb commits $300 million to combat racial disparities and double number of Black, Latino executives (Endpoints)
• 4 questions for neurology startups as venture investors pour millions into the field (STAT)
• Martin Shkreli's infamous Daraprim falls off top 20 most expensive drugs list (Endpoints)
• FDA/Sponsor Meetings During COVID: How To Overcome The Loss Of ‘Hallway Chitchat’ (Pink Sheet)
• Biosimilars Showing Accelerated Uptick in Japan, Doctor Fee Incentive as Tailwind (PharmaJapan)
• BMS, on a roll, touts 2 Opdivo GI cancer wins—including one earlier in treatment (Fierce)
• F2G raises $61M for late-phase antifungal R&D (Fierce) (Endpoints)
• Life science incubator Paragon Biosciences grabs new CEO for investment arm (Fierce)
• Roche pulls a tumor micro-environment drug out of the freezer, hands it to a UK upstart (Endpoints)
• Advances in oligonucleotide drug delivery (Nature)
• Harmony Biosciences sets terms on $100M IPO; FDA accepts a Protalix BLA for review (Endpoints)
• Expiration date extensions of certain lots of doxycycline hyclate capsules (FDA)

• Coronavirus muddies FDA's trajectory on device warning letters (MedtechDive)
• Medtronic to buy Companion Medical, adding connected insulin pen to diabetes unit (MedtechDive)
• Inari Medical revenue jumps in 1st quarterly report since public debut (MedtechDive)
• Sientra claims market gains as breast implant sales rebound faster than rivals (MedtechDive)
• MagVenture wins FDA clearance for OCD TMS treatment device (MassDevice)

• Humana Sues Teva Over Recalled, Tainted Blood Pressure Drugs (Bloomberg Law)
• Elizabeth Holmes’ Theranos trial set to begin on March 9, 2021 (CNBC)
• Fed. Circ. Urged To Undo Amgen's Win Over Cancer Drug IP (Law360)
• Drugmakers Say Resellers Trying To Duck Bellwether Status (Law360)
• Mylan Asks Fed. Circ. To Undo PTAB Loss In Tecfidera Fight (Law360)
• FDA Pressed To Take E-Cigs Off Market During Pandemic (Law360)
• Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines (MHRA)
• User guide: Evaluation of substances for use in listed medicines and assessed listed medicines (TGA)