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Regulatory Focus™ > News Articles > 2022 > 1 > Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spuriou

Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spurious HIV drugs

Posted 18 January 2022 | By Joanne S. Eglovitch 

Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spurious HIV drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US would seek global approach to updating Covid-19 vaccines, official says (STAT)
  • FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi (BioPharmaDive) (Fierce)
  • With few remaining unapproved drugs, researchers tell FDA its Unapproved Drugs Initiative is no longer effective (Endpoints)
  • FDA orders DMD trial halt, raising questions about a whole class of promising drugs (Endpoints)
  • Gilead says counterfeiting network sold $250 mln worth of its HIV drugs (Reuters)
  • Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim (Pink Sheet)
  • Drugmaker Endo signs $65 mln opioid settlement with Florida (Reuters)
In Focus: International
  • EU watchdog urges vaccine developers not to focus only on Omicron (Reuters)
  • EU regulator finds mRNA COVID-19 shots safe during pregnancy (Reuters)
  • Germany's Evotec partners with Lilly to research metabolic diseases (Reuters)
  • GlaxoSmithKline rejects Unilever’s $68B consumer buyout offer, but a bigger bid is brewing (Fierce)
  • UK upstart raises $100M in bid to digitize and standardize cell and gene therapy manufacturing  (Endpoints)
  • Britain preparing for end-June switch to paid COVID tests – document (Reuters)
  • UK Regulator Calls For More Patient Involvement In Trial Design (Pink Sheet)
Coronavirus Pandemic
  • WHO urges manufacturers to provide COVID-19 vaccine data (Reuters)
  • WHO's top scientist says no evidence healthy kids, adolescents need COVID-19 boosters (Reuters)
  • Merck signs supply deal with UNICEF for 3 mln courses of COVID-19 pill (Reuters)
  • At Davos, a ‘good news, bad news’ message emerges about Covid-19 (STAT)
  • ‘Nocebo effect’: two-thirds of Covid jab reactions not caused by vaccine, study suggests (The Guardian)
  • Walensky faces CDC burnout as pandemic enters third year (Politico)
  • Israel sticks with 4th vaccine shot, sees Omicron wave waning next week (Reuters)
  • Britain reports 438 new COVID-19 deaths, highest since February (Reuters)
  • Public health experts say vaccine equity a must to end pandemic (Reuters)
Pharma & Biotech
  • Covid vaccine makers Pfizer, J&J notch high brand marks amid overall still-strong pharma industry rep: Harris Poll (Endpoints)
  • Roche Tries Again With Failed Huntington’s Drug Tominersen (Scrip)
  • CBO: Medicare negotiations will hamper drug development more than previously thought (Endpoints)
  • 5 questions facing gene therapy in 2022 (BioPharmaDive)
  • Ten months after devastating failure, Roche says it sees path forward for Huntington’s drug  (Endpoints)
  • With key FDA decision pending on psoriasis, UCB’s bispecific notches phase 3 win for spinal arthritis condition (Fierce)
  • Tiny biotech hammered as lead drug fails a key PhII study (Endpoints)
Medtech
  • Cybersecurity leads ECRI's list of top medtech hazards for 2022 (MedTech Dive)
  • Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing (MedTech Dive)
  • Cardio Industry Puts Weight Behind UK Call For National CVD Strategy (Medtech Intelligence)
  • Dexcom CEO on G7's global launch, COVID-19 slowing new patient adds, international growth (MedTech Dive)
Government, Regulatory & Legal
  • US faces ‘critical moment’ in pricing reform that ‘won’t come again,’ nonprofit founder says after tallying 554 new hikes (Fierce)
  • Novo Nordisk comes out clean in $1.8B investor lawsuit alleging insulin misdirection (Fierce
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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