Recon: US Supreme Court to take up Amgen patent case; Monoclonal antibody for RSV gets EMA approval
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- U.S. Supreme Court gives Amgen a boost by agreeing to review a closely watched patent case (STAT) (Reuters)
- FDA Requirements For Next Round Of COVID Vaccines Unclear (Pink Sheet)
- Pfizer, BioNTech data support new Covid booster’s advantage over original vaccine (BioPharma Dive)
- What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Proposed Initiatives (Pink Sheet)
- Eli Lilly says some staff want to leave Indiana because of abortion ban, Financial Times reports (Reuters)
- A ‘blank check’: Bill to boost antibiotic development blasted as a ‘flawed’ giveaway to pharma (STAT)
- Amgen on IRA's drug price negotiations: 'Material adverse effect' on sales, business and operations (Endpoints)
- FDA still not ready to go back to actual in-person meetings with biopharma sponsors (Endpoints)
In Focus: International
- RSV Market Shake Up Starts As Sanofi And AZ’s Beyfortus Wins First Approval (Scrip) (Fierce)
- Germany’s Digital Health Fast-Track Scheme: What Manufacturers Need To Know (Medtech Insight)
- Keytruda: NICE Rejects English Funding For Endometrial Cancer But Says Yes For Renal Cancer (Pink Sheet)
- A leaked version of a U.K.-India free trade deal sparks alarm over access to medicines (Pink Sheet) (STAT)
- Change Management Tool From Global CRO Body Seeks To Address Hesitation Around Decentralized Trials (Pink Sheet)
- German expats in China will have access to BioNTech vaccine, says Scholz (Reuters)
- Novel solution to biotech’s market valuation woes: Just give the cash back (STAT)
Pharma & Biotech
- Bispecific cancer drugs and gene therapy advances: What to watch at next month’s ASH meeting (BioPharma Dive)
- GSK's blood cancer drug fails main goal of trial, shares fall (Reuters)
- Building a biotech in a downturn: 3 lessons from VCs and startup CEOs (BioPharma Dive)
- China Suspends GSK Tender Qualification Under Dutasteride Ban (Pink Sheet)
- Amgen Does Not Expect Big Enbrel Price Impact From US Humira Biosimilar Launches (Scrip)
- US FDA’s New Acting Generics Chief Relearning System After 24 Years Of Experience (Pink Sheet)
- Teva Lowers Forecast As Q3 Revenues Decline Amid Growing Generic Competition (Scrip)
- GSK Hails Success For Novel Antibiotic – But Reaching $1bn Sales Will Be A Challenge (Scrip)
- BioNTech lifts lower end of vaccine sales target range (Reuters)
- Lilly, Boehringer say Jardiance slows kidney disease progression in trial (Reuters)
- A turnaround for Editas Medicine, a CRISPR laggard, hinges on updates on key treatments (STAT)
- FDA approval decision for Apellis Pharma’s eye disease drug delayed to review more clinical data (STAT)
- Biopharma companies to FDA: Internationally harmonize plans to standardize safety data and analysis (Endpoints)
Medtech
- FDA Clears First At-Home Diagnostic To Assess Risks Of Liver Or Lung Disease, Including COPD (Medtech Insight)
- iRhythm narrowed loss in Q3 on higher sales of cardiac wearables (MedTech Dive)
- Medtech Challenged To Build On 2021 Amid Threats Of Recession: Views From Industry Leaders (Medtech Insight)
- Biotech company seeks to overcome hurdles to develop flu vaccine skin patch (STAT)
Government, Regulatory & Legal
- CMS Extends Telehealth Coverage For 2023 (Medtech Insight)
- BSI Receives Expert Panel Opinion For Non-Novel Device (Medtech Insight)
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