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

ReconRecon | 20 September 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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