Recon: US looking into Pfizer’s China operations; Novartis’ Ilaris fails to help COVID patients in Phase 3 trial

• Controversial Alzheimer’s Drug Faces Critical Test Before FDA Panel (NYTimes) (Reuters) (STAT 1, 2) (In the Pipeline) (Endpoints)
• Humanigen inks COVID-19 drug development agreement with US defense department (Reuters)
• Humanigen touts analysis of Covid drug, but statisticians say disclosure is inappropriate (STAT)
• US government looking into Pfizer's operations in China (Reuters)
• Regeneron hopes US will authorize coronavirus antibody drug soon (Reuters) (FT)
• First COVID-19 Vaccine Doses To Go To Health Workers, Say CDC Advisers (NPR)
• CDC Report: Officials Knew Coronavirus Test Was Flawed But Released It Anyway (NPR)
• $26 Billion Settlement Offer in Opioid Lawsuits Gains Wide Support (NYTimes)

• WHO looks at mink farm biosecurity globally after Danish coronavirus cases (Reuters) (NPR)
• AstraZeneca's COVID-19 vaccine to begin clinical trials in China – executive (Reuters)
• Aspirin to be tested as potential COVID-19 drug in UK study (Reuters)
• Novartis arthritis drug fails to help COVID-19 patients (Reuters)
• Celltrion's COVID-19 antibody drug cut recovery time-early study (Reuters)
• Japan's Takeda eyes new focus on vaccines after OTC asset sales (Reuters)
• Novo Nordisk lays out $1.8B for Emisphere and its oral delivery tech (Fierce) (Endpoints)
• Time is running out to enact any trade deal with UK - EU lawmakers (Reuters)
• WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines (WHO) (EMA)

• Clots, Strokes And Rashes. Is COVID-19 A Disease Of The Blood Vessels? (NPR)
• AstraZeneca targets severe COVID-19 patients for antibody therapy despite Regeneron, Lilly setbacks (Fierce)
• VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials (KHN)
• Nasal Spray Prevents Covid Infection in Ferrets, Study Finds (NYTimes)
• Children Produce Weaker Coronavirus Antibodies, Study Finds (NYTimes)
• The Next COVID Vaccine Race: Comparative Efficacy In Post-Market (Pink Sheet)
• Pressure Group Undaunted By EU Refusal To Disclose COVID-19 Vaccine Contracts (Pink Sheet)
• FDA Reissues EUA for PerkinElmer COVID-19 RT-PCR Test, Enabling Sample Pooling (GEN)

• ‘I don’t think it goes away’: Pharma experts weigh in on the next 4 years of drug pricing reform (STAT)
• Sanofi hits the brakes on a top pivotal program following “new adverse events” (Endpoints)
• FDA gene therapy holdups suggest closer scrutiny by agency (BioPharmaDive)
• Citing pandemic, Sarepta defers much-anticipated DMD gene therapy PhIII, will head to regulators after 10-person study (Endpoints) (BioPharmaDive)
• AstraZeneca gets a much-needed boost for blood thinner Brilinta with an OK on stroke (Endpoints)
• FDA's Inaction On Issuing Licensing Rules For Wholesalers and 3PLs Creating Confusion (Pink Sheet)
• Global Benchmarking Data Offer Path To Improved Drug Manufacturing Quality (Pink Sheet)
• Endo to cut 560 staffers, shutter drug plants to save cash for spring cellulite launch (Fierce)
• NICE backs AbbVie’s Rinvoq for severe active rheumatoid arthritis (PharmaTimes)
• Assembly Bio's hepatitis B program flops as a potential cure in PhII, sending shares spiraling (Endpoints)
• A First For England's NICE - Interim Review Of Spinraza Access Agreement Gets Under Way (Pink Sheet)
• Vertex’s Kalydeco scores another label extension in EU (PharmaTimes)
• China approves Astellas' Xtandi in non-metastatic castration-resistant prostate cancer (Pharmafile)
• China Cell Therapy Party On: $500m+ Raised In JW IPO, Other Rounds (Scrip)
• UNICEF and WHO call for emergency action to avert major measles and polio epidemics (WHO)
• Neglected tropical diseases and One Health: gearing up against antimicrobial resistance to secure the safety of future generations (WHO)

• MHLW Won’t Exclude Software Programs from Conditional Approval Coverage: Official (PharmaTimes)
• ICER says more data is needed on digital app treatments for opioid use disorder (Fierce)
• Guardant beats expectations but warns COVID-19 surges will hurt Q4 growth (MedtechDive)
• Zimmer reports record robot installs, ASC-inspired M&A (MedtechDive)

• 4 Things To Know About China's Revised Patent Law (Law360)
• Fed. Circ. Restricts Venue Options For Hatch-Waxman Suits (Law360)
• FDA Must Study Enviro Risks Of Genetically Engineered Fish (Law360)
• Merck Plows Ahead With Another Suit Over Diabetes Drug (Law360)
• Servier Loses Bid To Enforce EU Pay-For-Delay Ruling In UK (Law360)
• European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab) (Big Molecule Watch)
• Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme (TGA)