Recon: FDA approves Jazz’s Rylaze for most common childhood cancer; Novartis eyes entry to mRNA field
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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