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