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