Recon: US to end COVID emergencies on 11 May; Amgen launches first Humira biosimilar in 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)

• 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 2^nd 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)

• 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)

• 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)