Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

ReconRecon | 27 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug (STAT)
  • AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push (Fierce)
  • Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder (STAT)
  • CDC to reverse indoor mask policy, saying fully vaccinated people should wear them indoors in Covid hot spots (NYT) (CNBC) (STAT)
  • Federal law doesn't prohibit Covid-19 vaccine requirements, Justice Department says (CNN)
  • Vaccine mandate calls fueled by COVID-19's latest spike (The Hill) (Reuters)
  • What you need to know about the new COVID-19 surge (The Hill)
In Focus: International
  • Takeda fleshes out CNS pact with peptide drugmaker, setting aside $3.5B in future milestones (Endpoints)
  • Russian government takes additional measures for localization of API production (Pharmaletter)
  • EU says it is on track for 70% vaccination target by end of summer (Reuters)
  • Moderna says COVID-19 vaccine supply outside United States to slow down (Reuters)
  • With All Eyes On Tokyo, The City Has Just Hit A New High In COVID-19 Cases (NPR)
Coronavirus Pandemic
  • Many Say Mandating Vaccines For Health Care Workers Is Critical To Pandemic's End (NPR)
  • Antibodies from Sinovac's COVID-19 shot fade after about 6 months, booster helps – study (Reuters)
  • Canada has enough COVID-19 vaccines to inoculate everyone eligible – Trudeau (Reuters)
  • Ireland lowers COVID-19 vaccine age to 12 to boost strong takeup (Reuters)
Pharma & Biotech
  • Cytiva and Pall to spend $1.5bn on manufacturing capacity expansion, new hires (Biopharma Reporter)
  • AstraZeneca teams up with Regeneron for obesity-busting drug pact focused on genetics (Fierce)
  • Seeking deals from all areas of U.S. and Canada, Lumira raises $220M fourth fund (Biocentury)
  • Candel gets busy IPO week moving with downsized raise as Rajiv Shukla's third SPAC goes public (Endpoints)
  • Artios raises $153M to fund DNA damage repair clinical trials (Fierce)
  • Canadian biotech Absci sees shares soar in IPO debut (Biopharma Reporter)
  • BMS, BridgeBio partner to study drug combo for lung cancer (Outsourcing Pharma)
  • Merck women's health spinout Organon bags preterm labor drug ahead of phase 3 (Fierce)
  • Encouraging early results in Alzheimer’s for Prothena (Pharmaletter)
  • Alzheimer's conference surveys progress, setbacks (Bioworld)
  • Discovering biomarkers to find new ways to treat diseases of unmet need (MedCity News)
  • Zantac Chronicles V – Medical Monitoring and the Wheels Coming Off (Drug & Device Law)
  • Despite JAK 'anxiety,' ICER experts overwhelmingly back Incyte's ruxolitinib cream in atopic dermatitis (Fierce)
  • Amazon And Google Are Finally Tackling One Of Healthcare’s Biggest Problems: Unstructured Health Data (Forbes)
  • BioNTech spearheading malaria mRNA vaccine development program, with tech transfer planned for Africa (Endpoints)
  • How one startup foretold the neuroscience renaissance (Endpoints)
  • Opinion: On compounding, the FDA marches to the beat of its own biases (STAT)
  • ANDA Approval Decline Continues, But Why? (Pink Sheet)
  • Pharma industry, CROs adapting to COVID-19 impacts: survey (Outsourcing Pharma)
  • The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route (Scrip)
  • FDA inspection delays a worry for the future (Bioworld)
  • Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery (MedTech Dive)
  • Medtronic ‘Prevails’ in Europe with Launch of New DCB (MD+DI)
  • Quidel to transfer heart failure assay to Beckman Coulter to end litigation (MedTech Dive)
Government, Regulatory & Legal
  • Purdue Pharma’s Creditors Vote Yes To Bankruptcy Deal Shielding Billionaire Owners From Future Opioid Lawsuits (Forbes)
  • Closing Arguments To Begin In West Virginia's Opioid Crisis (NPR)
  • Amyris Can't Arbitrate $881M Cannabinoid IP Fight (Law360)
  • Is This the WTO Waiver End Game? (Patent Docs)
  • Tainted Weight Loss Products (FDA)
  • Takeda Beats Antitrust Claims In Heartburn Drug Patent Fight (Law360)
  • Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling (Bill of Health)
  • DEA Should Allow Psychedelic Therapy, 9th Circ. 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.


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