Recon: FDA approves Regeneron antibody for rare cholesterol disorder; EMA says kidney problems not related to remdesivir

• FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial (NYTimes)
• As Millions Get Shots, FDA Struggles to Get Safety Monitoring System Running (NYTimes)
• Biden administration finalizes purchase of 200M additional vaccine doses (Politico) (NPR) (NYTimes)
• Biden says there will not be enough COVID vaccines by end of summer to vaccinate all Americans (Reuters)
• FDA commissioner race could test pharmaceutical industry’s sway (Roll Call)
• Biden’s delay on naming FDA chief perturbs some experts (Washington Post)
• Covid relief becomes a vehicle for drug reform (Politico)
• Regeneron's Evkeeza wins FDA approval in ultra-rare cholesterol disease (Fierce) (Endpoints) (FDA)
• Amgen loses bid to revive patents for cholesterol drug Repatha (Reuters) (Fierce) (Law360)
• Becton Dickinson's combination test for COVID-19 gets FDA authorization (Reuters)

• Kidney problems in COVID-19 patients unrelated to remdesivir: EU drugs regulator (Reuters) (EMA)
• EU approves all requests for COVID-19 vaccine export to UK, U.S., Japan, China (Reuters)
• French authority recommends single COVID-19 shot for those previously infected (Reuters)
• Japan panel recommends approval of Pfizer COVID-19 vaccine after morning arrival (Reuters)
• India, pharmacy of the world, falls behind on vaccinations at home (Reuters)

• Trump Was Sicker Than Acknowledged With Covid-19 (NYTimes)
• China refuses to give WHO raw data on early COVID-19 cases: WSJ (Reuters)
• Manitoba buys COVID-19 vaccine candidate, first province to bypass Ottawa (Reuters)
• EU, WHO team up to help with COVID-19 vaccinations in Armenia, Azerbaijan, Ukraine (Reuters)
• Pakistan to allow private firms to import COVID shots, exempt from price caps (Reuters)
• Pakistan approves Chinese CanSinoBIO COVID vaccine for emergency use (Reuters)
• Chhattisgarh rejects Bharat Biotech vaccine approved without efficacy data (Reuters)
• Montenegro and St. Vincent approve Russia's Sputnik V vaccine – RDIF (Reuters)

• Mallinckrodt faces regulatory delay as COVID-19 restrictions continue to upend FDA's inspection schedule (Fierce)
• Amicus drug for Pompe disease falls short in key clinical trial, but company will push for approval (STAT)
• A pair of biotechs prepares to hit Nasdaq, as total 2021 IPO raise quickly approaches $3B (Endpoints)
• FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues (Endpoints)
• NICE recommends Bristol Myers Squibb's skin cancer drug Opdivo for NHS use (Pharmafile)
• MHLW Orders Pref. Govts to Strengthen Snap Inspections against Drug Makers after Kobayashi Kako Fiasco (PharmaJapan)
• Gyroscope posts early win with gene therapy for AMD, giving hope for its immune complement system target (Endpoints)
• Roche touts less onerous schedule for its in-the-eye injection faricimab, hoping to sweeten the sales pitch over Eylea (Endpoints)
• NASH Drug Development Questions? US FDA Has Many Of The Answers (Pink Sheet)
• Takeda Files Its 1st Cell Therapy, Darvadstrocel, in Japan (PharmaJapan)
• GlaxoSmithKline to shut down antibiotics production, cut 300 jobs in wake of Novartis buyout (Fierce)
• Bristol Myers Squibb pens $1.3B biobucks pact with Molecular Templates, axes Celgene CAR-T asset (Fierce)
• Takeda's maribavir clears cytomegalovirus infections in phase 3 (Fierce)
• Denali's small sneak peek shows up positives for its Hunter syndrome asset (Fierce)
• Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection (NEJM)
• JCR Pharma’s JR-141 Gets FDA’s Fast-Track Status (PharmaJapan)

• Chiesi launches pilot inhaler recycling scheme in the UK (PharmaTimes)
• 3 Q4 takeaways: COVID-19 testing strong (for now), electives hit, and M&A (MedtechDive)
• Abbott, Medtronic could benefit as spinal cord stim seen rebounding (MedtechDive)

• Opinion: By looking the other way, pharma money helped fuel a toxic political atmosphere in the US (STAT)
• Commission publishes study on Assessment of the EU Member States’ rules on health data in the light of GDPR (European Commission)
• Counterfeit N95 Scam Widens as Senator Demands FTC Investigation (KHN)
• As Drug Prices Keep Rising, State Lawmakers Propose Tough New Bills to Curb Them (KHN)
• Drug companies seek billion-dollar tax deductions from opioid settlement (Washington Post)
• With a legislative vote, Maryland’s prescription drug affordability board moves forward (STAT)
• Blue Cross Units, CVS Want Drug Pricing Suits Combined (Law360)
• GAO Says Drug Test Deal Debrief Can't Extend Protest Period (Law360)
• Merck Sues To Block Inventia's Generic Diabetes Drug (Law360)
• Calif. Biotech Firm Settles SEC's COVID-19 Blood Test Claims (Law360)
• PTAB Grills Mylan And Merck In Diabetes Drug IP Battle (Law360)