Regulatory Focus™ > News Articles > 2021 > 1 > Recon: BioNTech boosts vaccine output for 2021; Sanofi buys Kymab for up to $1.5B

Recon: BioNTech boosts vaccine output for 2021; Sanofi buys Kymab for up to $1.5B

Posted 11 January 2021 | By Michael Mezher 

Recon: BioNTech boosts vaccine output for 2021; Sanofi buys Kymab for up to $1.5B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Novavax bosses cash out for $46 million with COVID-19 vaccine trials still under way (Reuters)
  • Lilly says Alzheimer's drug slows clinical decline in mid-stage trial (Reuters) (STAT)
  • Vertex Pharma taking more aggressive M&A stance, flush with cash from cystic fibrosis drugs (STAT)
  • Bluebird Bio to Spin Off Cancer-Drug Unit (WSJ) (STAT)
  • Biden dresses down his Covid team over plans to speed vaccinations (Politico)
  • Hospitals say syringes supplied by feds waste vaccine doses (Politico)
  • Pressure Grows for States to Open Vaccines to More Groups of People (NYTimes)
  • HHS expands COVID-19 public health emergency until April (Fierce)
  • Pandemic, Democratic Wins Leave Drug Industry at Crossroads (Bloomberg)
In Focus: International
  • Oxford-AZ vaccine can be up to 80% effective with a delay between doses - UK official (Reuters)
  • BioNTech lifts 2021 COVID-19 vaccine output target to 2 billion doses (Reuters)
  • Sanofi buys Kymab for up to $1.5 billion to expand in immunotherapy (Reuters)
  • Russia to try out 'Sputnik-Light' COVID vaccine to make it go further (Reuters)
  • China says WHO team to probe COVID-19 origins will arrive Thursday (Reuters)
  • Relief Therapeutics says Zyesami to be included in COVID-19 clinical trial (Reuters)
  • Roche gets EU green light for influenza treatment Xofluza (Reuters)
  • Health Canada-approved COVID-19 treatment drug rejected by British Columbia (Vancouver Sun)
  • New partnership pledges clear and consistent evidence-based guidance on medicines for pregnant and breastfeeding women (MHRA)
Coronavirus Pandemic
  • Trial of COVID-19 blood plasma finds no benefit in severely ill patients (Reuters)
  • India to continue export of medicines, including vaccines: PM Modi (Reuters)
  • India wants Serum Institute to lower price of AstraZeneca shot – sources (Reuters)
  • India signs purchase order with Serum for AstraZeneca vaccine – source (Reuters)
  • Indonesia approves China's Sinovac vaccine as infections surge (Reuters) (WSJ)
  • Brazil to announce more efficacy data of Sinovac's vaccine (Reuters)
  • Malaysia buys additional 12.2 million doses of Pfizer-BioNTech COVID-19 vaccine (Reuters)
  • Palestinians approve Russian COVID-19 vaccine for use in self-rule areas (Reuters)
  • Philippines signs deal to secure 30 million doses of COVID-19 vaccine Covovax: distributor (Reuters)
  • Philippines books 25 million doses of Sinovac's COVID-19 vaccine (Reuters)
  • Russia's Gamaleya applies for emergency vaccine use in Philippines (Reuters)
  • Seychelles rolls out COVID-19 vaccination using China's Sinopharm, says president's office (Reuters)
  • Gilead CEO expects remdesivir to effectively treat Covid strains found in UK, South Africa (CNBC)
Pharma & Biotech
  • FDA advisory panel meetings became ‘rarer and tougher’ in 2020 (STAT)
  • Company dedicated to cutting drug prices raises lots of money, releases few details (STAT)
  • EU Orphan And Pediatric Proposals Insufficient, Says Industry (Pink Sheet)
  • UK-EU Deal Allows For ‘Significant Divergence’ In Data Protection & SPCs (Pink Sheet)
  • 10 key clinical trials to watch in the first half of 2021 (BioPharmaDive)
  • Some Long-Standing FDA Regs Face Mandatory Review Or Rescission Under New HHS Rule (Pink Sheet)
  • JPM: Biogen bullish on Alzheimer’s drug approval, sees Lilly data as a positive, despite AdComm rejection (Fierce)
  • JPM: Alnylam CEO outlines aggressive plan to catapult into biotech's top 5 (Fierce)
  • JPM: Regeneron has spoken with the FDA about odronextamab hold, hopes to get patients back soon (Fierce)
  • #JPM21: Reshma Kewalramani is on the hunt for 'mid-to late-stage assets,' new tools to replenish Vertex pipeline (Endpoints)
  • Editas Medicine's science head Albright leaves for new job just as biotech gets trial clearance for sickle cell therapy (Endpoints)
  • Hot on the heels of a positive PhIII, Immunocore hauls in $175M as it hunts its first TCR OK (Endpoints)
  • Recall report: Fresenius Kabi yanks inflammatory med Ketorolac after finding particulates in vials (Endpoints)
  • GlaxoSmithKline backs a preclinical acne treatment from Eligo Bioscience that uses CRISPR to kill bacteria (Endpoints)
  • EQRx scores $500M to drive its disruptive drug pricing model and late-stage oncology hopefuls to market (Endpoints)
  • BioMarin tries to get hemophilia gene therapy back on track with positive data (BioPharmaDive)
  • Boehringer Ingelheim announces partnership with Google (PharmaTimes)
  • Biogen advances Spinraza study in SMA patients treated with Novartis’ Zolgensma (PMLive)
  • Biogen, Genentech and F-Prime power new neurodegenerative biotech to $110M unveiling (Fierce)
  • Fujifilm Plans to Invest $40M in New Facility (GEN)
Medtech
  • Wall Street paints rosy 2021 for medtech as electives snap back (MedtechDive)
  • First MDR Notified Body Designated In Finland As Nordic Numbers Nudge Up (MedtechInsight)
  • Outlook 2021: Medtechs Must Look To Late 2021 And 2022 For A Return To Normal Times (MedtechInsight)
Government, Regulatory & Legal
  • Democrats have their best shot yet at letting Medicare negotiate drug prices — but it’s still not a done deal (STAT)
  • Even With Senate Control, Democrats Will Need Buy-In From GOP on Key Health Priorities (KHN)
  • Tennessee to become the first state to run a closed Medicaid drug formulary (STAT)
  • The Purdue Pharma Opioid Settlement — Accountability, or Just the Cost of Doing Business? (NEJM)
  • 5 Major Drug And Medical Device Developments In 2020 (Law360)
  • Drug. Co. Can't Keep Emails Under Wraps In Valsartan MDL (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

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