Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA's RWE pilot cites challenges in emulating RCTs - Regulatory Focus

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Posted 16 May 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

• FDA approves Eli Lilly's treatment for type 2 diabetes (Reuters) (Endpoints) (STAT)
• FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE (The Pink Sheet) (Endpoints)
• Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs (The Pink Sheet)
• Unpersuaded by the data, FDA rejects cheap, generic SSRI as a Covid-19 drug (Endpoints)
• FDA tags Editas’ thalassemia cell therapy an orphan drug as it rounds final bend in race to clinic (Fierce)
• UCB Psoriasis Drug Will Need to Wait for US Approval (Biospace) (Endpoints)
• FDA to address baby formula imports as soon as Monday (Reuters)
• Allure Labs Cited for Suspected Underreporting of Problematic OTC Drug Events (FDAnews)

In Focus: International

• EMA Proposes Extending Remote QP Batch Certification Post-Pandemic (The Pink Sheet)
• Digital Data Deluge Can Affect Oversight Of Patient Safety In Trials (The Pink Sheet)
• EU says no final decision taken on ending Valneva COVID vaccine contract (Reuters)
• Scotland Okays Funding For Keytruda and Opdivo For Esophageal Cancer, Among Other Drugs (The Pink Sheet)
• Japan Passes New Economic Security Bill – What's The Pharma Impact? (The Pink Sheet)
• Lacking vaccines, North Korea battles COVID with antibiotics, home remedies (Reuters)
• North Korea's Kim orders military to stabilise supply of COVID drugs (Reuters)
• Japan to offer up to $100 mln in aid to help Indo-Pacific nations fight COVID (Reuters)

Pharma & Biotech

• Staying in the back seat to Keytruda, Bristol Myers reports another pivotal setback in urothelial cancer (Endpoints)
• BMS, Synairgen Regroup After Trials Miss Primary Endpoints (Biospace)
• To TIGIT or not to TIGIT? Roche’s latest trial flop casts shadow on Big Pharma’s $6B bet (Fierce)
• From Redditors to creditors: Orphazyme’s wild ride ends with $13M sale to satisfy bankruptcy court (Fierce) (Endpoints)
• UK generics maker shutters, eliminating 1,000 jobs (Endpoints)
• Scientists are finally learning how to design proteins from scratch. Drug development may never be the same (Endpoints)

Medtech

• Risk Management Standard Update Published Within Days For EU MDR Use (MedTech Insight)
• FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests (MedTech Dive)
• FDA finalizes guidance on clinical feasibility studies of diabetic glycemic control devices (MedTech Dive)

Government, Regulatory & Legal

• French court rules against Sanofi in landmark Depakine case (Endpoints)
• Justices Pass on Otsuka Judgment in Abilify Warning Case (Bloomberg)
• Greece plans to go to court to seek compensation from Novartis over a bribery scandal (STAT)
• Walgreen’s Deal Spurred Quick Theranos Investment, Jury Told (Law360)

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.

© 2022 Regulatory Affairs Professionals Society.

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Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA's RWE pilot cites challenges in emulating RCTs - Regulatory Focus
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