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

• 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)

• 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)

• Genentech-partnered Novome lands $43.5M to push gastrointestinal drug through mid-stage study (Endpoints)
• With Nasdaq delisting threat, IMV drops 3^rd 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)

• 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)