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

• 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)

• 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)

• 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)

• 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)

• 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)