Recon: Merck to buy VelosBio for $2.75B; AZ to seek COVID vaccine EUA with ex-US data

• After Rocky Start, FDA’s Hahn Wins Over Skeptics (WSJ)
• AstraZeneca aims to bring non-US vaccine data before the FDA (Reuters)
• Merck to bolster cancer drug portfolio with VelosBio $2.75 billion deal (Reuters) (Endpoints)
• Cardinal Health, AmerisourceBergen book billions in costs related to opioid lawsuits (Reuters)
• Bluebird tanks as FDA's LentiGlobin demands in sickle cell delay filing to late 2022 (Fierce) (Endpoints)
• All-or-Nothing Bet on Bristol Drugs Goes Sour as FDA Reviews Lag (Bloomberg)
• Bristol Myers Squibb Reports Third Quarter 2020 Financial Results (Press)
• What do the top 10 biotech M&A deals of 2020 tell us? Premiums are in, bolt-ons rule and the ADC comeback is on (Endpoints)
• Hims Built a $1.6 Billion Online Empire By Pushing Prescriptions (Bloomberg)

• WHO-led COVID drug scheme doubles down on antibodies, steroids and shuns remdesivir (Reuters)
• Covid-19 vaccine market worth $10bn a year, analysts say (FT)
• Australia orders more COVID-19 vaccines for total of 135 million doses (Reuters)
• Chile, Peru green-light AstraZeneca COVID-19 vaccine trials (Reuters)
• COVID vaccine deliveries on ice as AstraZeneca awaits trial data (Reuters) (FT)
• India-made COVID-19 vaccine could be launched as early as February - government scientist (Reuters)
• Bangladesh signs deal with India for 30 million doses of COVID-19 vaccine (Reuters)
• China’s Fosun Kicks Off Biggest Pharma IPO in India (Bloomberg)
• World Health Assembly charts course for COVID-19 response and global health priorities (WHO)

• Who Should Get a Covid-19 Vaccine First? (NYTimes)
• Poor Countries Fall Behind In Race To Reserve COVID-19 Vaccine (NPR)
• Lack Of Details On J&J COVID Vaccine Trial Safety Pause Raises ACIP Concerns About Transparency (Pink Sheet)

• Americans are spending more on specialty medicines, despite rebates given to payers (STAT)
• Gene therapy for autism-linked condition weakened legs, robbing two people of ability to walk (Science)
• CRISPR, Vertex show CRISPR/Cas9 gene-editing therapy works in more patients (Fierce)
• AZ’s Forxiga wins EU approval for heart failure (PharmaTimes)
• Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma (BioPharmaDive) (Endpoints)
• BioMarin gets its dwarfism drug in the FDA's door — but can they change regulators’ minds about a longer follow up? (Endpoints)
• Latest J&J-partnered Legend Biotech data spotlight continued high response rate but 10 patient deaths (Endpoints)
• UK Early Access For BioCryst’s Hereditary Angioedema Drug (Pink Sheet)
• AI Can Find Many Drugs To Repurpose For COVID-19, But Real-World Results Mixed (Scrip)
• Rigorous Study Backs A Psychedelic Treatment For Major Depression (NPR)
• Amgen and Novartis back Aimovig with new data as migraine competition heats up (Endpoints)
• GW plots path to new drug approvals as Epidiolex tops sales predictions (Fierce)
• Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus (Pink Sheet)
• News briefing: Cosentyx shows early positive signs in psoriatic arthritis; Pfizer's PhIIb for cardio drug triggers $75M milestone (Endpoints)

• Hologic bets on COVID-19 molecular testing boon beyond 2021 (MedtechDive)
• Stryker says Wright deal closing imminent after key antitrust green lights (MedtechDive)
• Turkish Notified Body TSE no longer available for European IVDD (Emergo)
• MDSAP Council updates guidance on conformity assessments and related requirements (Emergo)
• Cardiovascular Systems up on Street-beating Q1 results (MassDevice)
• Cardinal Health rises on Street-beating Q1, raised EPS guidance (MassDevice)
• TransMedics posts Street-beating Q3 results, despite losses (MassDevice)
• BD beats The Street in Q4, posts 2021 guidance (MassDevice)
• Insulet surpasses Q3 earnings estimates, raises guidance (MassDevice)

• HHS Floats Plan To 'Sunset' Unnecessary Regulations (Law360)
• Amgen Biosimilar Rows Reveal Manufacturing Patents' Value (Law360)
• Merck Says Pfizer's Trade Secrets Counterclaims Are Useless (Law360)
• Biomet Orthopedics Can't Duck Defective Hip Implant Suit (Law360)
• Fed. Circ. Urged To Restore Narcan Patents (Law360)