Recon: Lilly receives subpoena over COVID drug manufacturing site; FDA grants EUA for GSK-Vir antibody drug

• Eli Lilly receives DoJ subpoena over COVID-19 drug manufacturing plant (Reuters) (Endpoints)
• US FDA gives emergency use approval for GSK-Vir COVID-19 antibody drug (Reuters) (FDA)
• US pauses use of Eli Lilly Covid-19 mAb combo in six more states due to variants from Brazil, India (Endpoints)
• FDA adds new 'do not use' note to Intercept's Ocaliva label after a slew of side effect reports in cirrhosis patients (Endpoints)
• FDA approves new imaging tool to find advanced prostate cancer, drugmaker says (NBC)
• Drug makers argue an HHS rule would penalize them for offering co-pay coupons (STAT)
• Opioid Trial In West Virginia Comes Amid A National Reckoning For Big Pharma (NPR)
• Judge Clears Purdue Pharma’s Restructuring Plan for Vote by Thousands of Claimants (NYTimes)
• Broad Coalition of Democrats Presses Biden to Expand Medicare (NYTimes)

• German researchers tie cold viruses used to deliver COVID-19 vaccine to rare blood clot risk (Reuters)
• India’s Zydus Cadila seeks human trial approval for COVID-19 antibody cocktail (Reuters)
• India scraps local trials for COVID shots, says Pfizer vaccine could arrive by July (Reuters)
• Sinopharm's two COVID-19 shots effective, study says (Reuters)
• Sanofi, GSK kick off Phase III trial for COVID-19 shot (Reuters) (Press)
• Not enough data to back use of inhaled steroids for COVID-19 -EU regulator (Reuters) (EMA)
• Russian court rejects U.S firm's lawsuit over COVID-19 drug remdesivir (Reuters)
• WHO: Africa in 'urgent need' of 20 million second vaccine doses within six weeks (The Hill)

• WHO reboots IP sharing scheme for Covid shots, drugs and tests (FT)
• Dems back growing calls for Congress to probe Covid lab leak theory (Politico)
• Covid: Russia starts vaccinating animals (BBC)
• Germany aims to offer adolescents COVID-19 vaccine by end August – document (Reuters)
• Israel to rule on adolescent vaccinations, link to heart inflammation next week (Reuters)
• Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19 (Press)
• Bharat Biotech submits new request to Brazilian regulator on GMP issues for Covaxin (Economic Times)

• 'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA (BioPharmaDive)
• UniQure moves Huntington's gene therapy to next phase of key trial (BioPharmaDive)
• Esco raises $200M to set up Boston cell and gene therapy hub (Fierce)
• Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs (BioPharmaDive)
• AbbVie, building out its post-Humira future, posts 5 late-stage trial wins for Skyrizi and Rinvoq (Fierce)
• Xtandi raise, Padcev lift and a women's health surprise: Astellas outlines $17B 5-year plan (Fierce)
• FDA, FTC warn 5 companies over supplements sold to treat infertility, reproductive disorders (The Hill)
• ICER Study On Coverage 'Fairness' Could Inform Manufacturer Pricing vs Benefit Design Debate (Pink Sheet)
• Five analytics firms launch RWE lobbying group to press Congress, FDA on guidance, Cures 2.0 (Endpoints)
• Merck KGaA draws the curtain on newest lipid nanoparticle for mRNA vaccines, turbocharging its annual capacity (Endpoints)
• A UK antifungal player with a Big Pharma pedigree bags fresh round of cash as it races toward late-stage trial (Endpoints)
• Viatris telegraphs closure of decades-old West Virginia plant, where more than 1,400 will lose jobs: report (Fierce)
• Looking to build new smart cells, BlueRock teams with Tim Lu's Senti Bio in 'second-order' engineering alliance (Endpoints)
• Astellas outlines another five-year plan; Bayer's VC arm leaps into digital health (Endpoints)
• FDA steers J&J/Legend CAR-T to a quick decision as partners prep a looming showdown with Bristol Myers, bluebird (Endpoints)
• Novo Holdings, Vivo lead a record $200M raise for a Singapore-based tools player with plans for a Boston hub, new deals (Endpoints)
• As FDA clears relugolix for uterine fibroids, Myovant, Pfizer gear up to take on AbbVie in commercial rivalry (Endpoints)

• GenapSys rakes in $70M for tabletop genomic sequencing platform (Fierce)
• FDA draft guidances lay out postmarket medical device data requirements (MedtechDive)
• Ada Health reels in $90M in Bayer-led series B for AI-powered symptom checker (Fierce)
• Prescription video game developer Akili snags $160M to launch ADHD treatment (Fierce)
• Ibex wins European approval for breast cancer-spotting AI pathology tool (Fierce)
• Quest partners with Paige to create AI-enabled cancer pathology products (MedtechDive)
• MDR challenges remain as regulation goes into effect: MedTech Europe (MedtechDive)
• Swiss Break Off High Level EU Talks But Say Medtech MRA Should Be Updated (MedtechInsight)
• MDR is live. Here are 5 things to know on where the rule stands. (MedtechDive)
• Happy MDR DoA and Swixit / noTurkxit day! (medicaldeviceslegal)
• Digital chatbot Woebot lands FDA breakthrough designation to tackle postpartum depression (mobihealthnews)
• With An Eye On Diversity, FDA Recognizes MedTech Color Collaborative Community (MedtechInsight)
• China Releases Its 2025 Vision For The Medtech Sector – May 2021 Update (MedtechInsight)

• Insurance Ruling Clarifies Excess Coverage For Opioid Suits (Law360)