Recon: FDA staff raise concerns over Spectrum’s cancer drug ahead of adcomm; EMA calls for biosimilar interchangeability in EU

• US drug regulator resumes surprise inspections in India (Economic Times)
• Merck to start studying lower dose of HIV drug after FDA hold (Reuters)
• Adderall Shortages in US Spread to Two More Drug Suppliers (Bloomberg)
• Negotiations over legislation to reauthorize the FDA’s user fee programs continue into this week (Politico)
• House Democrat presses bill to encourage more diversity in clinical trials run by NIH (STAT)
• Biden’s claim that ‘pandemic is over’ complicates efforts to secure funding (Washington Post)
• Is the Covid-19 pandemic over? The answer is more art than science (STAT)
• Ahead of FDA filing, Sage and Biogen tout more data in hopes of alleviating durability concerns (Endpoints)
• IV bag maker Baxter says Puerto Rico facilities are in good shape after Hurricane Fiona (Politico)
• FDA Opioid Review Will Be Led by Team at Ohio State, Califf Says (Bloomberg)
• Moderna Covid Booster Supply Is Limited in US, Pharmacies Say (Bloomberg)
• FDA slams Spectrum and Oncopeptides cancer drugs over efficacy concerns ahead of ODAC meeting (Endpoints) (Reuters)

• EMA calls for biosimilar interchangeability across the EU (BioWorld)
• EU health regulator says COVID pandemic not over (Reuters)
• Pharma Firms Lament Inconsistencies In EU Blood, Tissues & Cells Proposal (Pink Sheet)
• Swissmedic updates nitrosamine impurity evaluation requirements (Politico)
• US-China Decoupling Gets On Biotech's Nerves (Scrip)
• BeiGene keeps its Brukinsa momentum going by winning NICE nod for rare lymphoma (Fierce)
• Pharma Readies For Price Caps On Glargine, Teneligliptin, Lenalidomide In India (Pink Sheet)
• GAVI financing to allow for immediate funds for next pandemic (Reuters)
• Slovakia Eases Market Access For Innovative Medicines (Pink Sheet)
• Uganda declares Ebola outbreak after Sudan strain found (Reuters)

• Seagen secures a speedy FDA review on Tukysa as Merck buyout talks reportedly stall (Endpoints)
• Medicare Part D Price Inflation Rebates Won’t Mean As Much In Inflationary Times (Pink Sheet)
• Thought COVID was bad? DOD taps Evotec to bolster its defenses against bubonic plague (Fierce)
• Phlow looks to raise $50M as US aims to boost domestic manufacturing (Endpoints)
• Merck Joins Accumulus Synergy as a Sponsor to Transform the Global Drug Regulatory Submission Process (Biospace)
• Clover touts phase 3 omicron data as wait for COVID-19 vaccine approvals drags on (Fierce)
• GSK puts supplies on the hook as it amps up sustainability pause (Fierce)
• Wave Presents Promising Biomarker Data in Huntington’s Disease (Biospace)
• Slow Start? Vesalius Axes 43% of Staff 6 Months After Launch (Biospace) (Biopharma Reporter)
• New CRISPR startup, drawing big-name backers, seeks to fix diseases caused by large DNA errors (STAT)
• Rocket Fuels AAV Cardia Portfolio with Renovacor Buy (Biospace)
• From clinical fail to raising cash? Virios goes for public offering as shares reach all-time low (Endpoints)

• Notified Body Spare Capacity Is A Moving Target And Difficult To Pinpoint (MedTech Insight)
• Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts (MedTech Dive)
• Minute Insight: FDA Clears Zimmer Biomet’s Identity Shoulder, ZB Calls It ‘Biggest Shoulder Launch In the Last Five Years’ (MedTech Insight) (MedTech Dive)
• Insulet locks down EU approval for Omnipod 5 automated insulin pump (Fierce)
• Abbott’s FreeStyle Libre CGM reduces Type 2 diabetes hospitalizations by 67%: study (Fierce)

• Jury rules against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff (MedTech Dive) (Medical Design & Outsourcing)
• Novartis Lawsuit Over Macular Degeneration Treatment Proceeds (Bloomberg)
• Boston Scientific Ignored Complaints, Suit Against Clinics Says (Bloomberg)
• Vanda inks $11.5M deal to settle off-label drug promotion accusations (Endpoints)