Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early trial

• Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job (BioCentury) (Endpoints) (Bloomberg)
• Biden’s Covid board in the dark on final vaccine plan (Politico)
• Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up (STAT) (Bloomberg) (NEJM)
• J&J vaccine on track for March rollout with target to deliver 1 billion doses this year: exec (Reuters)
• Alexion pauses enrollment for COVID-19 study testing its rare blood-disorder drug (Reuters)
• Drug makers sue HHS over a discount program serving low-income populations (STAT) (Law360)
• Former Merck employee arrested for stealing trade secrets on cancer research (STAT) (Endpoints)
• Mark Cuban wades into the generic drug shark tank with a new company (STAT) (Endpoints)
• Stem Cell Clinic Takes On FDA Regulations In 11th Circ. (Law360)
• Officials: Trump's promised $200 drug-discount cards won't happen (Politico)
• Combination of two drugs can help treat methamphetamine addiction for some, new clinical trial data shows (STAT) (NEJM)

• Lonza awaits licence for Swiss plant making Moderna COVID-19 vaccine ingredients (Reuters)
• Russia to submit Sputnik V vaccine for EU approval, says RDIF chief (Reuters)
• German vaccine institute praises efficacy of Astra-Oxford vaccine (Reuters)
• Two members of WHO delegation to Wuhan held back over health screening (Reuters) (NYTimes)
• Philippines approves Pfizer-BioNTech vaccine for emergency use (Reuters)
• African Union secures 270 million COVID-19 vaccine doses from manufacturers (Reuters)
• Neglected tropical diseases: WHO to formally launch new road map for next decade (WHO)
• UNICEF, WHO, IFRC and MSF announce the establishment of a global Ebola vaccine stockpile (WHO)

• COVID-19 infection gives some immunity, but virus can still be spread, study finds (Reuters) (FT)
• World Bank chief says vaccine rollout critical for poorer countries (Reuters)
• Moderna CEO says the world will have to live with Covid ‘forever’ (CNBC)
• Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19 (NEJM, Editorial)
• Celltrion announces positive top-line results from COVID-19 treatment trial (Pharmafile)
• Chinese COVID-19 vaccine Ad5-Ncov shows high antibody levels at Russian trial (Reuters)
• Moscow says approval of non-Russian COVID-19 vaccines possible: TASS (Reuters)
• Hungary embarks on approval process for Sinopharm COVID vaccine: foreign minister's spokesman (Reuters)

• The Future of Drug-Pricing Transparency (NEJM)
• 5 questions facing the FDA in 2021 (BioPharmaDive)
• Unsupported Price Increase Report (ICER)
• Amgen tops cost watchdog's price gougers list based on 'unfounded' increases for Enbrel without meaningful data (Endpoints)
• Alzheimer’s drugs: trials and tribulations (Financial Times)
• Reform has unleashed Chinese drugs innovation boom, though some pharma firms may not survive under intense price pressure, industry leaders say (SCMP)
• Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold (FDA Law Blog)
• Gilead and Vir unite to find a ‘functional cure’ for hepatitis B (PharmaTimes)
• Novartis gets breakthrough designation for Xolair successor, setting up spotlight for PhIII readout later this year (Endpoints)
• Bayer’s finerenone scores FDA priority review for chronic kidney disease (PMLive)
• BeiGene's tislelizumab gets China approval for non-small cell lung cancer (Pharmafile)
• Fujifilm doubles down on Boston foothold, renting some major legroom to chase cell and gene therapies (Endpoints)
• Chris Garabedian's first Xontogeny company, Landos Biopharma, preps a nine-figure IPO as lead program heads to PhIII (Endpoints)
• As venture funding in oncology flourishes, neuro has seen shallower pockets. A European investor wants to change that (Endpoints)
• UPDATED: A much-hyped CV drug failed, repeatedly. Now, investors are betting nearly $200M on one last PhIII bid (Endpoints)
• News briefing: Precision Medicine Group acquires cell and gene therapy-focused services firm Project Farma; RoosterBio and Sartorius collab on gene therapy manufacturing (Endpoints)
• Covid-19 roundup: Alexion's C5 inhibitor Ultomiris misses the PhIII bar; Lonza in waiting game to use ingredients in Moderna vaccine (Endpoints)
• #JPM21: Avidity CSO Art Levin runs full speed to the clinic with 'dream' antibody oligonucleotide conjugate therapy (Endpoints)

• Novartis trial shows no benefits from Pear's schizophrenia app as CEO cites trial irregularities (mobihealthnews)
• Remote monitoring, wearable companies look to capitalize on virtual care boom: JPM21 (MedtechDive)
• Intuitive, J&J, Medtronic and Zimmer talk robotic surgery ambitions: JPM21 (MedtechDive)
• Philips joins Merck KGaA to develop AI-guided fertility treatments (Fierce)
• Steris inks $4.6B buy of Cantel Medical amid flurry of M&A (MedtechDive)
• India Permits Sale Of Some Devices Beyond Licensing Deadline (MedtechInsight)

• Department of Veterans Affairs Paid About Half as Much as Medicare Part D for Selected Drugs in 2017 (GAO)
• No Prison For Ex-Acclarent Execs In Off-Label Marketing Case (Law360)
• PTAB Mulls Analogous Prior Art In Sanofi, Mylan Injector Case (Law360)