Regulatory Focus™ > News Articles > 2021 > 8 > Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo

Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo

Posted 02 August 2021 | By Michael Mezher 

Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Under Pressure to Grant Full Approval to Covid-19 Vaccines (WSJ) (STAT)
  • US Authorities Seek Documents From Troubled Covid Vaccine Manufacturer (NYTimes)
  • Theranos Patients: The Emerging Wild Card in the Trial of Elizabeth Holmes (WSJ)
  • FDA okays Regeneron COVID-19 antibody as preventive in high-risk settings (Reuters)
  • How the biopharma industry is helping to pay for the bipartisan infrastructure bill (Endpoints)
  • AstraZeneca wins first FDA approval for systemic lupus drug in a decade (BioPharmaDive)
In Focus: International
  • AstraZeneca official ‘hopeful’ to settle EU court case on vaccines contract in ‘weeks’ (Politico)
  • Pfizer and Moderna raise EU Covid vaccine prices (FT) (Reuters)
  • UK Regulator To Lose 20% Of Staff In Post-Brexit Cost-Cutting Plans (Pink Sheet)
  • Takeda still on the hook for €398M tax linked to distant AbbVie-Shire breakup fee (Fierce)
  • J&J says still in talks with Indian govt on COVID-19 vaccine (Reuters)
  • Six-month countdown to go-live for the Clinical Trials Information System (CTIS) (EMA)
Coronavirus Pandemic
  • Hard-won gains at risk as Delta variant spreads- WHO (Reuters)
  • Vaccinated People May Spread the Virus, Though Rarely, C.D.C. Reports (NYTimes)
  • More than 100K vaccine breakthroughs identified in US: report (The Hill)
  • New Rule Raises Question: Who’ll Pay for All the Covid Tests? (NYTimes)
  • Combining AstraZeneca and mRNA COVID-19 vaccines is effective -Danish study (Reuters)
  • Republican report says coronavirus leaked from China lab; scientists still probing origins (Reuters)
  • UAE rolls out Sinopharm COVID-19 vaccine to children aged 3-17 (Reuters)
  • AstraZeneca Vaccine OK’ed for Age 40 and Up under Emergency Program (PharmaJapan)
Pharma & Biotech
  • Ipsen continues its shopping spree with a $1B-plus deal for Exicure's next-gen oligonucleotides (Endpoints)
  • Vancouver pharmaceutical company CytoDyn says it’s under federal investigation over COVID-19 treatment claims (Oregon Live)
  • BioMarin gears up for two 'transformational' launches, Voxzogo and Roctavian: CEO (Fierce)
  • A pharma merger's impact ripples across West Virginia as Viatris plant closes (BioPharmaDive)
  • Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater (Endpoints)
  • A global pandemic fiasco sets the stage for Tillman Gerngross to introduce his biotech unicorn to Wall Street (Endpoints)
  • Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact (Endpoints)
  • AbbVie To Switch Track In Alzheimer’s From Tau To Beta-Amyloid (Scrip)
  • EC approves BMS’ Opdivo as adjuvant treatment for oesophageal or GEJ cancer patients (PharmaTimes)
  • UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis (PharmaTimes)
  • Moderna takes on a low-risk pact with CAR-T player Autolus for mRNA-based cancer drugs (Endpoints)
  • What happens when you give a mouse a human self-antigen? Investors bet $110M to find out (Endpoints)
  • With clinical trials lined up for Zentalis drugs, China's Zentera sets its sights on more dealmaking and an IPO (Endpoints)
  • Tibsovo clears another hurdle for Servier, but can it make Agios' old drug profitable? (Endpoints)
  • Retired neurologist with Alzheimer’s knows firsthand the risks of Aduhelm (STAT)
  • Intercept charts new path to NASH approval for Ocaliva, as long as safety holds (Fierce)
  • AbbVie Reports Second-Quarter 2021 Financial Results (Press)
  • Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech (Patch)
Medtech
  • Digital health, heart disease devices feature in latest FDA breakthrough designations (MedtechDive)
  • FDA ups premarket application user fees by 2.5% for FY 2022 (MedtechDive)
  • Abbott debuts smart monitor that fishes for abnormal heart rhythms in the data stream (Fierce)
  • ‘A mini-engineering feat’: High-tech headphones drown out the scary noises inside an MRI (STAT)
  • FDA clears 3D hologram tech for ‘science-fiction’ surgical planning (Fierce)
Government, Regulatory & Legal
  • Johnson & Johnson not liable for Illinois woman's death in talc case (Reuters)
  • FTC Drops AndroGel Antitrust Case Against AbbVie (Law360)
  • Australian Judge Makes Bold Patent Leap For AI Inventions (Law360)
  • McKesson Wants Prescription Data In Cherokee Opioid Case (Law360)
  • Anthem Sued Over Alleged Refusal To Cover Spinal Device (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.

 

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