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

• 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)

• 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)

• 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)

• 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)

• 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)