Recon: Novartis bags EU authorization for CML drug Scemblix; AZ’s Farxiga cuts death risk for heart failure patients

ReconRecon | 29 August 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna Patent Strike on Pfizer Sets Up Post-Covid Vaccine Feuds (Bloomberg)
  • Moderna sues Pfizer and BioNTech over Covid-19 vaccine (STAT) (Washington Post)  (Endpoints) (Reuters)
  • Moderna’s Suit Against Pfizer/BioNTech Is About More Than Money (Scrip)
  • Incyte secures second FDA approval for bile duct cancer drug in mutated cancer type (Endpoints)
  • ALS Drugs: FDA May Adjust Development Recommendations In Real Time For Ongoing Programs (The Pink Sheet)
  • Drug manufacturers must submit reports on quality problems to FDA. Almost half of sites still don't, new report finds (Endpoints)
  • Coin flip: Top analyst gives Amylyx ALS drug a 50% chance at approval as rare second adcomm approaches (Endpoints)
  • With two new expensive gene therapy approvals, outcomes-based pricing deals grab the spotlight again (Endpoints)
  • Drug Pricing And User Fees: CBER Will Need To Build Up As Gene Therapies Become More Popular (The Pink Sheet)
  • Monkeypox Shot Effort to Get $11 million in US Funding Deal (Bloomberg) (Reuters)
  • Very few in the U.S. getting full monkeypox vaccine series - CDC chief (Reuters)
  • Abbott restarts Similac infant formula production at Michigan facility (Reuters)
In Focus: International
  • US and China reach landmark audit inspection deal (Financial Times) (Endpoints) (CNBC)
  • EU Committee To Discuss Future COVID-19 Vaccine Purchasing Deals (The Pink Sheet)
  • Novartis: Scemblix approved in the EU for adults with chronic myeloid leukemia (Reuters)
  • Britain approves Novavax COVID shot for 12-17 year-olds (Reuters)
  • Swiss drugs regulator approves first bivalent Covid-19 booster (Reuters)
  • Factbox: Vaccines delivered under COVAX sharing scheme for poorer countries (Reuters)
  • Japan panel approves AstraZeneca's Evusheld COVID treatment (Reuters)
Pharma & Biotech
  • Analysis: Novartis CEO may struggle to rally investors to Sandoz spin-off (Reuters)
  • Adderall Shortages Spread to Four Pharmaceutical Companies (Bloomberg)
  • After years of failures, the hunt for a new type of Parkinson’s drug is on (Endpoints)
  • BMS, J&J’s secondary stroke med falls short in phase 2, but companies see enough potential to push forward  (Fierce) (Endpoints)
  • MSD India Chief On The Now, Next For Januvia, Gardasil And Keytruda’s Ascent (Scrip)
  • Lupin Liquidating Japan JV With Yoshindo, Partners I’Rom For Denosumab Biosimilar (Scrip)
  • Bayer's chronic kidney disease drug misses the mark on lowering cardiovascular death (Endpoints)
  • Bayer initiates asundexian Phase III study program (Reuters)
  • AstraZeneca’s Farxiga Becomes First Drug to Lower Fatality for All Forms of Heart Failure (Biospace) (Reuters) (Fierce)
  • Horizon charts massive biologics expansion in Ireland, where it’ll add 350 new jobs (Fierce)
  • Novartis cuts manufacturing jobs, closes North Carolina plant ahead of Sandoz spinoff (Fierce)
  • Invigorating T cells by crippling a gene to improve immunotherapies for blood and solid cancers (Fierce)
  • Expert Panel Opinion Defers EU Market Entry For Tricuspid Valve Replacement System (MedTech Insight)
  • FDA takes N95 respirators off medical device shortage list (MedTech Dive)
  • Medtronic reports six more injuries, one additional death related to HVAD battery problems (MedTech Dive)
  • MDIC Initiative Seeks To Improve Cancer Diagnostics Using Gene Sequencing (MedTech Insight)
  • Investor Eye: What's Changing In Medtech Deal Making As We Approach The End Of 2022? (MedTech Insight)
  • As medical device companies look to snap up Medicare dollars, potential conflicts lurk (STAT)
  • Medtronic’s extravascular ICD meets safety, efficacy endpoints in recent study (MedTech Dive) (Fierce)
  • Abbott’s heart pump boasts improved 5-year life expectancy for heart failure patients (Fierce)
  • Exec Chat: Medtronic Neuromodulation Approaches Inflection Point (MedTech Insight)
  • Olympus inks $3B sale of scientific tools unit to private equity firm Bain Capital (Fierce)
  • Ultrasound AI outperforms human clinicians in randomized, blinded study  (Fierce)
Government, Regulatory & Legal
  • Gilead fights back against BMS Supreme Court petition in patent fight (Endpoints) (Fierce)
  • AbbVie fends off patent claim in unusual whistleblower case (Fierce) (Endpoints)
  • 3M combat earplug lawsuits to proceed, judge rules, despite bankruptcy case (Reuters)
  • Ethicon to Face Trial Over Allegedly Defective Pelvic Mesh (Bloomberg)
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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