Recon: Pfizer to seek FDA approval for meningococcal vaccine after phase 3 success; Swiss agency probing Novartis in patent investigation

ReconRecon | 15 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer gears up to submit meningococcal shot for approval this year after phase 3 success (Fierce) (Biospace)
  • U.S. to spend more than $2 billion to launch Biden’s biomanufacturing initiative  (Biospace) (STAT)
  • Crunch time for FDA user fees as reauthorization looks to hitch a ride on short-term spending bill (Endpoints)
  • Government-paid experts helping industry at the table with FDA? Agency spells out guardrails (Endpoints)
  • After FDA rejection, Vanda sues agency over regulatory rebuffs on jet lag med (Fierce) (Bloomberg)
  • FDA, NIH Partner for Rare Neurodegenerative Disease Research (Bloomberg)
  • FDA Staffing, Resource Gaps Makes Applying COVID Learnings To Other Disease Areas Challenging (Pink Sheet)
  • Califf Urges Congressional Patience On Opioid Actions (Pink Sheet)
  • Still leery about animal deaths, FDA lifts a full hold on Friedreich’s ataxia drug — but there’s a big condition (Endpoints)
  • CDC director: U.S. seeing decline in monkeypox new case growth (Reuters)
In Focus: International
  • Delay For Commission’s EU Pharma Reform Proposal (Pink Sheet)
  • EU Gears Up For Compulsory Licensing Reform (Pink Sheet)
  • EU, US & Japan Welcome India In ‘Critical’ Pharmacopeial Harmonization Move (Pink Sheet)
  • Take whatever COVID booster you can get, says head of EU drugs watchdog (Reuters)
  • Brazil dismisses antitrust complaint against Gilead over pricing for a hepatitis C drug (STAT)
  • New WHO Access Platform Could Mean Tiered Pricing In Europe (Pink Sheet)
  • End of COVID pandemic is 'in sight' -WHO chief (Reuters)
  • Moderna open to supplying COVID vaccines to China, CEO says (Reuters)
  • Nigeria to produce vaccines locally with Serum Institute of India (Reuters)
Pharma & Biotech
  • Genentech-partnered Novome lands $43.5M to push gastrointestinal drug through mid-stage study (Endpoints)
  • With Nasdaq delisting threat, IMV drops 3rd of staff in refocus on lead oncology asset  (Fierce)
  • Alnylam, Regeneron hit go on phase 2 trial of genetic NASH therapy after generating signs of efficacy (Fierce)
  • Cardiff drops its lead prostate cancer program, sending shares into a tailspin (Endpoints)
  • Are biotech SPACs back? Cancer-focused Apollomics to take blank-check route (Fierce)
  • Takeda’s manufacturing site in Belgium gets a €300M boost for plasma therapy production (Endpoints)
  • Medtech Insight’s EU Regulation Basics 2: Key Organizations And Documents And Why Risk Matters (Medtech Insight)
  • Annex XVI Manufacturers Send Formal Notice To Tardy European Commission (Medtech Insight)
  • Swissdamed Devices Database Will Mirror Eudamed (Medtech Insight)
  • FBI warns of cyber risks from legacy medical devices (Medtech Dive)
  • Medtronic reports two deaths related to endotracheal tube recall (Medtech Dive)
  • Tasso earns FDA clearance for its home blood collection device for telehealth tests (Fierce)
  • FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19 (Medtech Dive)
  • Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts (Medtech Dive)
  • Baxter reportedly considering shedding dialysis businesses: Bloomberg (Fierce)
  • Class-Action Suit Alleges Medtronic’s Rosy Forecast For MiniMed780G Misled Investors (Medtech Insight)
Government, Regulatory & Legal
  • Novartis headquarters raided in Swiss competition authority’s patent probe (Fierce) (Reuters)
  • Genzyme Again Beats Patients’ Lawsuit Over Fabrzyme Shortage (Bloomberg)
  • Akorn to Pay $7.9 Million to Resolve False Claims Allegations (Bloomberg)
  • Anthem Prosthetic Device Settlement Wins Approval, With Caveat (Bloomberg)
  • Ninth Circuit backs district court, tosses Nexus Pharma appeal in compounding drug suit (Endpoints)
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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