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Regulatory Focus™ > News Articles > 2022 > 2 > Recon: GSK sees sales growth in 2022; EMA sets up new real-world data center

Recon: GSK sees sales growth in 2022; EMA sets up new real-world data center

Posted 09 February 2022 | By Michael Mezher 

Recon: GSK sees sales growth in 2022; EMA sets up new real-world data center

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5 (CNBC)
  • Pfizer’s 2022 outlook falls short of Wall Street’s lofty expectations (FT)
  • CVS expects 70%-80% drop in COVID vaccine administration in 2022 (Reuters)
  • CVS inks a deal with Medable to enroll more patients in clinical trials (STAT)
  • Purdue Pharma bankruptcy mediator says Sacklers, US states closer to deal over opioid claims (Reuters)
  • U.S. biotech Sarepta loses bid to challenge rival's muscular dystrophy patents (Reuters)
  • ‘I have a right to change my mind’: A top FDA regulator is unapologetic over his about-face on Chinese cancer drugs (STAT)
  • FDA’s agenda in limbo as Biden’s nominee stalls in Senate (AP)
In Focus: International
  • GSK sees sales growth in 2022 after quarterly beat, prepares for spin-off  (Reuters) (FT)
  • Chinese healthcare stocks sell off after US adds companies to ‘unverified’ list (FT)
  • Qiagen forecasts profit above estimates as non-COVID businesses rebound (Reuters)
  • EU ramps up collection of public health data to improve drug reviews (Reuters) (EMA)
  • Global COVID response program 'running on fumes' amid budget shortfall (Reuters)
  • TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose (TGA)
Coronavirus Pandemic
  • EU wants pandemic treaty to ban wildlife markets, reward virus detection (Reuters)
Pharma & Biotech
  • Axsome’s migraine drug finally slated for FDA inspection, but investors want to know about stalled depression therapy (Fierce)
  • Premature birth drug saga drags on as Covis questions fairness of FDA hearing (Endpoints)
  • Checkmate plucks BMS exec Bash to be new CEO (Fierce)
  • After Q4 sales sink, Amgen CEO Bob Bradway details lofty growth strategy for 2030: Can he pull it off? (Endpoints)
  • SMC approves Biogen’s Vumerity for patients with multiple sclerosis (PMLive)
  • With first human data, long-struggling Silence Therapeutics leaps into next big cardiovascular race (Endpoints)
  • Taking on Big Pharma-sized indications, tiny biotech claims early win in fat loss. Will it translate to diabetes, NASH and beyond? (Endpoints)
  • Novo Nordisk's Wegovy passes NICE checkpoint on course to blockbusterland (Fierce)
  • How PDUFA VII can catalyze ‘lightspeed’ vaccine and drug development (STAT)
Medtech
  • Federal Investigation Into Spine Surgeries Uses Mob Laws to Target Health Care Fraud (KHN)
  • Zimmer gives investors first look at its dental & spine spinoff (MedtechDive)
  • BioCardia, Cook Medical land FDA breakthrough nods in latest designations (MedtechDive)
  • Element Biosciences acquires Loop Genomics to add long-read tech to DNA sequencing platform (Fierce)
  • Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets (FDA)
Government, Regulatory & Legal                                                               
  • FTC Gets More Time To Review Pfizer's $6.7B Arena Deal (Law360)
  • New England Compounding Center's National Sales Director Sentenced (FDA)
  • The fall of Eric Lander and the end of science’s ‘big ego’ era (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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