Recon: Pfizer, Moderna raise EU vaccine prices; FDA approves AZ’s lupus drug Saphnelo
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Under Pressure to Grant Full Approval to Covid-19 Vaccines (WSJ) (STAT)
- US Authorities Seek Documents From Troubled Covid Vaccine Manufacturer (NYTimes)
- Theranos Patients: The Emerging Wild Card in the Trial of Elizabeth Holmes (WSJ)
- FDA okays Regeneron COVID-19 antibody as preventive in high-risk settings (Reuters)
- How the biopharma industry is helping to pay for the bipartisan infrastructure bill (Endpoints)
- AstraZeneca wins first FDA approval for systemic lupus drug in a decade (BioPharmaDive)
- AstraZeneca official ‘hopeful’ to settle EU court case on vaccines contract in ‘weeks’ (Politico)
- Pfizer and Moderna raise EU Covid vaccine prices (FT) (Reuters)
- UK Regulator To Lose 20% Of Staff In Post-Brexit Cost-Cutting Plans (Pink Sheet)
- Takeda still on the hook for €398M tax linked to distant AbbVie-Shire breakup fee (Fierce)
- J&J says still in talks with Indian govt on COVID-19 vaccine (Reuters)
- Six-month countdown to go-live for the Clinical Trials Information System (CTIS) (EMA)
- Hard-won gains at risk as Delta variant spreads- WHO (Reuters)
- Vaccinated People May Spread the Virus, Though Rarely, C.D.C. Reports (NYTimes)
- More than 100K vaccine breakthroughs identified in US: report (The Hill)
- New Rule Raises Question: Who’ll Pay for All the Covid Tests? (NYTimes)
- Combining AstraZeneca and mRNA COVID-19 vaccines is effective -Danish study (Reuters)
- Republican report says coronavirus leaked from China lab; scientists still probing origins (Reuters)
- UAE rolls out Sinopharm COVID-19 vaccine to children aged 3-17 (Reuters)
- AstraZeneca Vaccine OK’ed for Age 40 and Up under Emergency Program (PharmaJapan)
- Ipsen continues its shopping spree with a $1B-plus deal for Exicure's next-gen oligonucleotides (Endpoints)
- Vancouver pharmaceutical company CytoDyn says it’s under federal investigation over COVID-19 treatment claims (Oregon Live)
- BioMarin gears up for two 'transformational' launches, Voxzogo and Roctavian: CEO (Fierce)
- A pharma merger's impact ripples across West Virginia as Viatris plant closes (BioPharmaDive)
- Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater (Endpoints)
- A global pandemic fiasco sets the stage for Tillman Gerngross to introduce his biotech unicorn to Wall Street (Endpoints)
- Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact (Endpoints)
- AbbVie To Switch Track In Alzheimer’s From Tau To Beta-Amyloid (Scrip)
- EC approves BMS’ Opdivo as adjuvant treatment for oesophageal or GEJ cancer patients (PharmaTimes)
- UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis (PharmaTimes)
- Moderna takes on a low-risk pact with CAR-T player Autolus for mRNA-based cancer drugs (Endpoints)
- What happens when you give a mouse a human self-antigen? Investors bet $110M to find out (Endpoints)
- With clinical trials lined up for Zentalis drugs, China's Zentera sets its sights on more dealmaking and an IPO (Endpoints)
- Tibsovo clears another hurdle for Servier, but can it make Agios' old drug profitable? (Endpoints)
- Retired neurologist with Alzheimer’s knows firsthand the risks of Aduhelm (STAT)
- Intercept charts new path to NASH approval for Ocaliva, as long as safety holds (Fierce)
- AbbVie Reports Second-Quarter 2021 Financial Results (Press)
- Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech (Patch)
- Digital health, heart disease devices feature in latest FDA breakthrough designations (MedtechDive)
- FDA ups premarket application user fees by 2.5% for FY 2022 (MedtechDive)
- Abbott debuts smart monitor that fishes for abnormal heart rhythms in the data stream (Fierce)
- ‘A mini-engineering feat’: High-tech headphones drown out the scary noises inside an MRI (STAT)
- FDA clears 3D hologram tech for ‘science-fiction’ surgical planning (Fierce)
- Johnson & Johnson not liable for Illinois woman's death in talc case (Reuters)
- FTC Drops AndroGel Antitrust Case Against AbbVie (Law360)
- Australian Judge Makes Bold Patent Leap For AI Inventions (Law360)
- McKesson Wants Prescription Data In Cherokee Opioid Case (Law360)
- Anthem Sued Over Alleged Refusal To Cover Spinal Device (Law360)
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