Recon: FDA halts use of two monoclonal antibodies ineffective against Omicron; J&J expects 46% jump in COVID vaccine sales in 2022
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Halts Use of Two Treatments Ineffective Against Omicron (Bloomberg) (FDA) (Endpoints) (Reuters)
- As Pfizer and BioNTech begin clinical trial of Omicron-based vaccine, timeline to authorization is unclear (STAT) (BioPharma Dive)
- Fauci says 'prudent' to have Omicron vaccine, but may not be needed (Reuters)
- J&J expects COVID vaccine sales to jump as much as 46% in 2022 (Reuters)
- Siemens to Supply 50 Million Rapid Covid Tests for US (Bloomberg)
- How much? Pfizer leads top pharma companies' ramped up lobby spending on Congress (Endpoints)
- Insulin giants Eli Lilly and Novo Nordisk boosted their lobbying spending as Democrats eyed pricing reform (STAT)
- Rhode Island, in reversal, to settle opioid claims against US drug distributors (Reuters)
- Bayer Pulls Aliqopa Combo-Filings In EU, US & Other-Markets--But-May-Resubmit (Pink Sheet)
- BioNTech: watchdogs' requirements may defer planned launch of Omicron shot (Reuters)
- China Aims To Synchronize With Global Drug Approvals By 2025 (Pink Sheet)
- Saudi Arabia agrees deal with GSK to develop healthcare sector (Reuters)
- UK Imposes New Limits On Deferring Registration Of Clinical Trials (Pink Sheet)
- US funding to WHO fell by 25% during pandemic (Reuters)
- Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched (EMA)
- COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges (Pink Sheet)
- Learning from Covid-19 requires a modeling renaissance (STAT)
- Omicron’s Radical Evolution (NYT)
- Cannabis compound CBD stops coronavirus in test tube, but can it treat COVID? (Reuters)
- Hospitals Ask Congress for $25 Billion Amid Omicron’s Onslaught (Bloomberg)
- US COVID peak may be over but not the pain as deaths rise (Reuters)
- Israel mulls offering 4th COVID vaccine dose to all adults (Reuters)
- GSK looks to stand out in the severe asthma space with at-home injections for kids 6 to 11 years old (Endpoints)
- J&J 'constantly looking' at biotech M&A, but focused on small, mid-sized deals (BioPharma Dive)
- Onward Ho: Biocon Signals Glargine Build Up, US Biosimilars Pricing ‘Sanity’ (Scrip)
- Could Faricimab Data Help Roche Maintain Ophthalmic Market Foothold? (Scrip)
- Mirati Spies ‘First-In-Class’ Chance For KRAS Inhibitor In Pancreatic Cancer (Scrip)
- Pivotal study shows Sierra Oncology drug improves anemia and other symptoms of myelofibrosis (STAT)
- Sanofi Pairs Up With Non-Profit Protas In Quest To Cut Clinical Trial Costs (Scrip)
- Backed by Bayer's Leaps, Boston-based Cellino lands $80M for cell therapy-in-box (Endpoints)
- Gene editing startup Metagenomi raises $175M to advance research pipeline (BioPharma Dive)
- Gen 2: Berkeley spinout lands $175M megaround to keep it on the cutting edge of the booming gene-editing field (Endpoints)
- A new cancer immunotherapy brings cautious hope for a field long awaiting the next big breakthrough (Endpoints)
- Nasal sprays to stave off viruses days at a time? J&J’s newest biotech partner draws $140M for 'proactive' approach (Endpoints)
- Providers Asked To Use Fewer Blood Collection Tubes In Face Of Shortage (MedTech Intelligence)
- Nevro And Medtronic Announce FDA Approval Of Spinal Cord Stimulation Label Expansions (MedTech Intelligence)
- Medtronic gets earlier-than-expected FDA approval for pain device; Nevro stock falls on first-advantage concerns (MedTech Dive)
- COVID-19 Delays CMS Final CLIA Rule On Analyte Proficiency Testing (MedTech Intelligence)
- GE Healthcare's Q4 revenue hit by continued supply chain challenges (MedTech Dive)
- J&J's Q4 device recovery slowed by omicron surge; impact expected in H1 (MedTech Dive)
- Why Virtual Manufacturing Is Likely To Be Less Popular Under EU’s New Device Regulations (MedTech Intelligence)
- Top Senator ‘Disappointed’ With Missing MDUFA Package (MedTech Intelligence)
- J&J, DePuy Win Fees From Whistleblowers in Hip Implant Case (Bloomberg)
- Lawmakers Ask FTC To Investigate Price Gouging Of COVID-19 Tests (MedTech Intelligence)
- ‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation (Pink Sheet)
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