Regulatory Focus™ > News Articles > 2021 > 1 > Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early tr

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

Posted 14 January 2021 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

Tags: US, worldwide

Regulatory Focus newsletters

All the biggest regulatory news and happenings.