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Regulatory Focus™ > News Articles > 2021 > 6 > Recon: EMA signs off on two more Pfizer/BioNTech manufacturing sites; EU to extend vaccine export co

Recon: EMA signs off on two more Pfizer/BioNTech manufacturing sites; EU to extend vaccine export controls through September

Posted 22 June 2021 | By Michael Mezher 

Recon: EMA signs off on two more Pfizer/BioNTech manufacturing sites; EU to extend vaccine export controls through September

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • New Drug Could Cost the Government as Much as It Spends on NASA (NYTimes)
  • Biden administration likely to miss Independence Day vaccination target (Politico)
  • Pear Therapeutics to go public in $1.6 billion SPAC merger (STAT) (Endpoints)
  • FDA Approves First Oral Anticoagulant for Children (Medscape) (FDA)
  • Blackstone to invest $250M in cell therapy startup backed by Intellia, Cellex (BioPharmaDive)
  • BMS inks another Revlimid patent settlement—this time with Sun Pharma (Fierce)
  • Senate Finance chair releases principles for lowering prescription drug prices (The Hill) (Huffpost) (Wyden)
In Focus: International
  • Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine (Reuters) (EMA)
  • EU takes up option to buy 150 million more Moderna COVID-19 shots (Reuters)
  • EU to extend vaccine export control mechanism until end of September (Reuters)
  • AI drug discovery start-up Insilico raises more than $255m (FT)
  • US directs millions of COVID-19 shots to Latin America, Africa, Asia (Reuters) (Politico)
  • World Bank, African Union join forces to expand access to COVID-19 vaccines (Reuters)
  • South African consortium establishes mRNA tech transfer hub to get vaccines to a region often overlooked by pharma (Endpoints)
  • Most poorer countries do not have enough COVAX shots to continue vaccinations: WHO (Reuters)
  • Forty New Medicines & 16 New Indications Under Consideration For WHO Essential Medicines List (Health Policy Watch)
Coronavirus Pandemic
  • Study testing Moderna vaccine in transmission prevention to include young adults (Reuters)
  • CDC says US young adults less likely to take COVID-19 vaccine (Reuters)
  • They Relied on Chinese Vaccines. Now They’re Battling Outbreaks. (NYTimes)
  • Sweden to offer COVID vaccine for people aged 16 and up - Health Agency (Reuters)
  • Dual-antibody drugs effective against COVID-19 variants in animal study (Reuters)
  • Tonix Pharmaceuticals to develop TNX-102 for long COVID syndrome (PMLive)
Pharma & Biotech
  • Biogen's new Alzheimer's drug serves as a rallying cry for drug pricing reforms (Endpoints)
  • Biogen isn’t the only drug company that will profit from the new Alzheimer’s drug Aduhelm (STAT)
  • Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited (NYTimes)
  • Merck's Keytruda blazes a path in first-line cervical cancer, making good on drugmaker's push for earlier patients (Endpoints)
  • EMA Doubles Number Of EU Early Access Approval Recommendations (Pink Sheet)
  • J&J cell therapy partner Legend carves out production foothold in Belgium as myeloma drug nears finish line (Fierce)
  • Big Pharma backers jump on board 'Treg' cartographer's lead round with up to six candidates in the pipe (Endpoints)
  • Horizon And Arrowhead To Develop RNAi Therapeutic For Gout (Scrip)
  • EU Review Time Lengthens for BMS’s CAR-T Therapy Liso-Cel (Pink Sheet)
  • On the hunt for the next Moderna, investors have pumped 'platform plays' with cash. Can anything slow the runaway train? (Endpoints)
  • BioMarin's gene therapy lead jumps ship to rival biotech Vedere Bio II (Fierce)
  • The Covid-19 transgenic cow antibody startup goes public in $325M SPAC merger (Endpoints)
  • They went from daily to once every two months. But how much longer acting can HIV meds be? ViiV enlists Halozyme's tech to find out (Endpoints)
  • LAG-3 continues generating heavy buzz as Australia's Immutep locks down new funds (Endpoints)
  • EU green lights AZ, MSD’s rare disease therapy Koselugo (PharmaTimes)
  • NanoCarrier’s Angiosarcoma Med Bags US FDA’s Fast Track Designation (PharmaJapan)
  • MDR Practicalities: Companies Explain Impact Of Notified Body Timings And Questions Process (Medtech Insight)
  • FDA Approves Medtronic’s Arctic Front For ‘First-Line’ Treatment For AFib (Medtech Insight)
  • Software Servicers Can Help Keep Products On Market After Manufacturers Stop Providing Support: US FDA (Medtech Insight)
  • It's Class I For Recall Of Smiths Medical Insulin Syringes, FDA Says (Medtech Insight)
  • Smartphone AI app capable of reading HIV test results in low-resource settings, study finds (Fierce)
  • Duke, HumanFirst launch center to ensure digital health tools are up to snuff for clinical trials (Fierce)
Government, Regulatory & Legal
  • Former FDA Chief Counsel Lands Role as MoFo Practice Co-Lead (Bloomberg Law)
  • High Court Skips Amgen Unit's Arthrex Arguments In IP Case (Law360)
  • Fed. Circ. Won't Eye Amgen Case But Disputes 'Sky Is Falling' (Law360)
  • Arthrex Ruling Leaves Attys Eyeing USPTO For Guidance (Law360)
  • IRS' IP Pricing In Medtronic Case Untenable, Witness Says (Law360)
  • DOL Seeks Employers' Input On Drug Cost Disclosure Policy (Law360)
  • CVS Didn't Need To Report Drug Discounts To PBM, Jury Told (Law360)
  • BIO’s chief on the FDA commissioner rumors, drug pricing, and IP rights (STAT)
  • Medicaid Enrollment Surpassed 80 Million, a Record, During the Pandemic (NYTimes)
  • Cost-effectiveness studies for widely used Medicare Part D drugs are few and far between (STAT)
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.


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