Recon: US to end COVID emergencies on 11 May; Amgen launches first Humira biosimilar in US
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- U.S. to end COVID-19 emergency declarations on May 11 (Reuters) (Bloomberg) (STAT)
- As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions (Pink Sheet)
- FDA Launches Plans for Food Program Revamp After Watchdog Review (Bloomberg)
- End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes (Pink Sheet)
- FDA may not always require post-approval trials to be enrolled before accelerated approvals (STAT)
- U.S. seeks to expand birth control coverage under Obamacare (Reuters)
- A watershed year for biosimilars — if regulators and policymakers step up (STAT)
- FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire (Pink Sheet)
- FDA names former Oracle executive as new digital health leader (STAT)
In Focus: International
- CTIS: EU Industry Welcomes ‘Landmark Moment’ But Says Issues Still Need Addressing (Pink Sheet)
- ‘Quick Guide’ To Help EU Clinical Trial Sponsors As CTIS Hits 31 January Milestone (Pink Sheet)
- U.K. lawmakers urge Pfizer not to raise the price of its Covid-19 vaccine (STAT)
- China Approves Two More Home-Grown COVID-19 Antivirals (Pink Sheet)
- Korean Industry Demands Bold Support Amid US Policy Moves (Pink Sheet)
- AbbVie’s Humira gets a U.S. rival, but costs could stay high (Reuters) (STAT)
- Pfizer’s 2023 Projections Reflect End to Emergency COVID-19 Measures (BioSpace)
- Bayer under investor pressure to speed up CEO changeover (Reuters)
- Pfizer punts pair of orphan drugs amid rare disease R&D rethink (Fierce)
- Sanofi offers retirement scheme to hundreds of staffers at 2 Indian vaccine plants (Fierce)
- India’s Sun Pharma beats Q3 profit view on higher sales of specialty drugs (Reuters)
- Gilead nixes Matinas oral COVID-19 antiviral to focus on late-phase internal program (Fierce)
- Pfizer-backed decentralized cooperative raises $4.1M to fund longevity research (Endpoints)
- 10 top M&A targets in biotech for 2023 (Fierce)
- Charles River secures $50M acquisition of drug discovery tech company (Endpoints)
- Inovio orders 2nd round of layoffs in 6 months after vaccine flops (Fierce)
- Quince lays off 47% of staff, stakes sale sign for asset days after separate pipeline deal (Fierce)
- New York City invests $20M into biotech 'innovation space' at the Brooklyn Navy Yard (Endpoints)
Medtech
- MDR Amendment Proposal Likely To Be Adopted In Two Weeks’ Time (MedTech Insight)
- FDA device center’s 2022 report reveals 37% drop in annual breakthrough designation (MedTech Dive) (MedTech Insight)
- EU Borderline Product Court Ruling Puts Tricky “Negative Burden Of Proof” On Manufacturers (MedTech Insight)
- Medtronic recalls 22,000 hemodialysis catheters for potential hub defect (MedTech Dive)
- GE HealthCare plots 2023 growth in first solo earnings report (Fierce) (MedTech Dive)
Government, Regulatory and Legal
- Appeals court tosses J&J's controversial 'Texas two-step' bankruptcy case (Endpoints) (Bloomberg)
- Court rules for drugmakers in 340B fight over contract pharmacies (BioPharmaDive)
- Shielding Lethal Injection Contractors’ Identities Not Justified (Bloomberg)
- Investors Say Biopharma Execs Hid New Migraine Drug Issues (Law360)
- Covid Testing Lab’s Dispute With Blue Cross Minnesota Gets Trim (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.
