Regulatory Focus™ > News Articles > 2021 > 4 > Recon: US puts J&J in charge of Emergent facility; FDA extends review of AbbVie’s Rinvoq for atopic

Posted 05 April 2021 | By Michael Mezher 

Recon: US puts J&J in charge of Emergent facility; FDA extends review of AbbVie’s Rinvoq for atopic dermatitis

2736 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca (Reuters) (CNN) (NYTimes)
  • US searches for new AstraZeneca vaccine producer after Emergent mix-up (Politico)
  • Emergent gets $23 million additional order for vaccine production (Reuters)
  • Acadia preps for battle as the FDA rejects a potential blockbuster application (Endpoints) (STAT)
  • 2,400 people remain without rare disease drug as Takeda manufacturing woes continue (Endpoints)
  • Shortages of Key Drugs for Children Spur New Hospital Coalition (Bloomberg)
  • Pharmacies score customer data in vaccine effort. Some are crying foul. (Politico)
  • Another day, another delay: FDA pushes back a second review for AbbVie's Rinvoq, this time in atopic dermatitis (Endpoints) (Fierce) (Press)
In Focus: International
  • UK regulator found total of 30 cases of blood clot events after AstraZeneca vaccine use (Reuters)
  • Australia to continue AstraZeneca vaccination despite blood clotting case (Reuters)
  • India's Panacea Biotec to produce 100 million Sputnik V doses annually: RDIF (Reuters)
  • Cadila seeks nod to repurpose Hepatitis C drug for COVID-19 in India (Reuters)
  • Ukraine approves Chinese vaccine as COVID-19 cases hit new record high (Reuters)
  • Piramal Pharma to acquire 100% stake in Hemmo Pharma for ₹775 crore (Livemint)
Coronavirus Pandemic
  • Researchers Are Hatching a Low-Cost Coronavirus Vaccine (NYTimes)
  • Former Biden, Trump advisers renew push to delay second Covid vaccine (STAT)
  • Pfizer says working on new COVID-19 vaccine supply deal to Israel (Reuters)
  • Johnson & Johnson applies for emergency COVID-19 vaccine use in the Philippines (Reuters)
  • Study: COVID-19 Vaccine Is Safe During Pregnancy And May Protect Baby, Too (NPR)
  • Opinion: ‘Authorization’ status is a red herring when it comes to mandating Covid-19 vaccination (STAT)
  • HHS launches mask design improvement contest (The Hill)
Pharma & Biotech
  • Takeda, CSL Behring fold big plasma alliance after PhIII flop — joining a slew of antibodies that failed to help hospitalized patients (Endpoints)
  • CDMO Ajinomoto to bring AstraZeneca fill-finish work to San Diego plant (Fierce)
  • Legal Limitations on Appointment of New FDA Commissioner (Alliance for a Stronger FDA)
  • Watchdog calls for probe into 'inappropriate' FDA-Biogen aducanumab collaboration (Fierce)
  • Supernus battles back from CRL, scoring the FDA's approval for non-stimulant ADHD med Qelbree (Endpoints)
  • Peter Thiel jumps aboard Alloy's latest $75M round, adding some heft to the antibody discovery outfit's nascent platform (Endpoints)
  • Sanofi Inks Agreement to Build Influenza Vaccine Manufacturing Facility in Canada (GEN)
  • Rain Therapeutics headlines newest slate of IPO-bound biotechs with $100M penciled in for lead oncology program (Endpoints)
  • Legend Biotech, J&J finish off rolling submission for CAR-T hopeful, approach finish line (Fierce)
  • Watch out, Bristol Myers — J&J is right behind you; Blake Byers leaps out from GV to do his own thing (Endpoints)
  • Having shipped its first benchtop gene editing devices, Inscripta draws another $150M from deep investor well (Endpoints)
  • Taiho’s Cholangiocarcinoma Drug Gets Breakthrough Therapy Tag from FDA (PharmaJapan)
  • A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling (Press)
  • Liquid biopsies dominate FDA's latest breakthrough device nods (MedtechDive)
  • Nanox Announces FDA Clearance of 510(k) for Single Source Nanox.ARC Digital X-Ray (Press)
  • Class 1 Device Recall Tenacore serviced Alaris Pump Bezel Assembly (FDA)
Government, Regulatory & Legal
  • Martin Shkreli pushes back on lifetime public company ban from prison cell in bid to get back to business (Endpoints) (Law360)
  • AndroGel Makers, Buyers Clash Over FTC Getting Discovery (Law360)
  • Pharmacies Take Swipe At Judge Amid Tightening Opioid MDL (Law360)
  • State sues drug companies over opioids (Juneau Empire)
  • Broad Files Motion in Opposition to CVC Priority Motion (Patent Docs)
  • GAO Won't Revisit Ruling Backing VA Nuclear Medicine Deal (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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Tags: US, worldwide

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