Recon: FDA approves Jazz’s Rylaze for most common childhood cancer; Novartis eyes entry to mRNA field

• Patient Drug Prices Can Vary by $50 a Pill Among US Hospitals (Bloomberg)
• Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug (STAT)
• Johnson & Johnson to initiate its first vaccine study for adolescents in fall (The Hill)
• FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer (FDA) (Fierce)
• As the Pace of Vaccinations Slows, Biden Makes a Personal Appeal (NYTimes)
• Inside the Biden Administration’s Scramble to Share Vaccine With the World (NYTimes)
• Surgeon General says Johnson & Johnson Covid vaccine may protect people against delta variant (CNBC)

• Novartis weighs entry into mRNA technology, chairman tells paper (Reuters)
• Elliott ratchets up pressure on GSK chief with call for change (FT)
• CureVac says speaking to EU about ideal region to use vaccine (Reuters) (CNBC)
• German vaccine body says a vaccine double dose protects well against Delta variant (Reuters)
• EU-approved COVID-19 vaccines protect against Delta variant, says official (Reuters)
• Roche to cut 300-400 product development jobs – Blick (Reuters) (Endpoints)
• WHO calls for lower prices on Gilead drug for Covid-linked black fungus (FT)

• FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide (FDA)
• NIH study suggests rapid antigen and PCR tests for COVID-19 are equally reliable when used frequently (Fierce)
• COVID-19 IP Waiver Supporters Splinter On What To Cover (Law360)
• Dr Reddy's Labs denied approval for final trial of Russian-made Sputnik Light (Economic Times)
• Serum Institute confident of European drug regulator nod for Covishield in a month (Economic Times)
• India's Zydus Cadila applies for emergency use nod for COVID-19 vaccine (Economic Times)
• Another repurposed drug bites the dust in Covid-19 as Angion bails on organ damage drug effort (Endpoints)

• The biotech scorecard for the third quarter: 12 stock-moving events to watch (STAT)
• Gene therapy to regenerate cardiac muscle after a heart attack passes a key test in pigs (STAT)
• Mallinckrodt cleared to sell a rare disease drug to a startup, but parents worried over ongoing access (STAT)
• Sakigake Tag Revoked for Eisai’s E7090 after Pemazyre Approval (PharmaJapan)
• MHRA approves Paion’s ‘ultra-short-acting’ anaesthetic Byfavo (PharmaTimes)
• Catalyst, Zogenix, Rigel and Pfizer kick off pharma's July price hikes: report (Fierce)
• FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency (Pink Sheet)
• US FDA Considers Incorporating Patient Input In Generic Drug Assessments (Pink Sheet)
• Catalent bags a German stem cell developer to build its next-gen therapeutics wing (Endpoints)
• GSK Shingrix Shingles Vaccine Could Get CDC Panel Nod For Use In Immunocompromised Adults (Pink Sheet)
• A viral vector player is expanding its footprint in Basque Country amid heightened demand (Endpoints)
• Pfizer bets on Spero candidate, wading deeper alongside GSK and Roche into abandoned antibiotic market (Endpoints)
• From basement lab to Wall Street: AbSci looks to bring its 'protein printing' platform public (Endpoints)
• Nestlé is betting $525M on a bid to pioneer world's first microbiome drug (Endpoints)
• Apellis, Beam team up to test base editing against the broad field of complement disorders (Endpoints)
• Former Viela CEO Bing Yao finds his next gig — bringing Chinese R&D innovation stateside (Endpoints)
• Horizon takes the leap into manufacturing, buying out an Irish plant with around 40 employees in tow (Endpoints)
• Fujifilm outlays whopping $850M for its Diosynth CMDO wing, looking to rapidly scale cell culture production (Endpoints)
• Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter (FDA)

• Australian conformity assessment bodies (TGA)
• FDA clears miniature surgical robot for needle-based procedures (Fierce)
• FDA wants to require timely updates, patches for legacy devices: cyber chief (MedtechDive)
• Auto-Injector Issues Get Cross-Center Investigation From US FDA (MedtechInsight)
• Viz.ai sets its sights across the pond with CE mark for stroke-detecting AI (Fierce)
• Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (FDA)
• US News hospital rankings to add back surgery, hip fracture and overuse (MedtechDive)

• Teva Says Intas Unit Seeks Cancer Drug Generic Far Too Soon (Law360)
• US Supreme Court Limits Estoppel Rule In Blow To PhRMA (Pink Sheet) (MedtechDive)
• Cancer Patients Can't Use Psilocybin Therapy, DEA Argues (Law360)
• Okla. Judge Won't Certify Midcase Appeal In Opioid Bellwether (Law360)