Reconnaissance: US examines Pfizer operations in China; Novartis’ Ilaris fails to help COVID patients in P.

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Featured: United States

• Controversial Alzheimer’s drug faces critical testing before FDA panel (NYTimes) (Reuters) (STAT 1, 2) (in the pipeline) (endpoint)
• Humanigen signs COVID-19 drug development agreement with US Department of Defense (Reuters)
• Humanigen urges Covid drug analysis, but statisticians say disclosure is inappropriate (STAT)
• US government examines Pfizer operations in China (Reuters)
• Regeneron hopes US will soon clear coronavirus antibody drug (Reuters) (FT)
• First doses of COVID-19 vaccine to be sent to healthcare professionals, CDC (NPR) consultants say
• CDC Report: Officials Knew Coronavirus Test Was Faulty But Released Anyway (NPR)
• $ 26 Billion Settlement Offer in Opioid Lawsuits Gets Broad Support (NYTimes)

In the foreground: international

• WHO examines biosecurity of mink farms 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 a potential COVID-19 drug in a UK study (Reuters)
• Novartis arthritis drug does not help COVID-19 patients (Reuters)
• Celltrion’s anti-COVID-19 antibody drug reduced early recovery time (Reuters)
• Japanese Takeda aims for new focus on vaccines after OTC asset sale (Reuters)
• Novo Nordisk Rolls Out $ 1.8 Billion For Emisphere And Its Oral Delivery Technology (Fierce) (Endpoint)
• Time is running out to put any trade deal with UK lawmakers in place – EU (Reuters)
• Joint WHO-ICMRA Statement on the Need for Better Global Regulatory Alignment on COVID-19 Drugs and Vaccines (WHO) (EMA)

Coronavirus pandemic

• Clots, strokes and rashes. Is COVID-19 a blood vessel disease? (NPR)
• AstraZeneca targets severe COVID-19 patients for antibody therapy despite setbacks by Regeneron and Lilly (Fierce)
• VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials (KHN)
• Nasal spray prevents Covid infection in ferrets, study results (NYTimes)
• Children produce weaker coronavirus antibodies, study results (NYTimes)
• The next race for COVID vaccines: comparative efficacy in post-marketing (pink sheet)
• Pressure group undaunted by EU refusal to disclose COVID-19 vaccine contracts (pink sheet)
• FDA reissue EUA for PerkinElmer COVID-19 RT-PCR test, enabling sample pool (GEN)

Pharma & Biotech

• ‘I don’t think he’s going away’: pharmaceutical experts speak out on next 4 years of drug price reform (STAT)
• Sanofi presses the brake on a key program following “new adverse events” (endpoint)
• Delays in FDA gene therapy suggest closer scrutiny by the agency (BioPharmaDive)
• Citing a Pandemic, Sarepta Postpones Long-Awaited DMD PhIII Gene Therapy, Will Head to Regulators After 10-Person Study (Endpoints) (BioPharmaDive)
• AstraZeneca Gets Much-needed Boost to Brilinta Blood Thinner with an OK to Stroke (Endpoints)
• FDA inaction on issuing licensing rules for wholesalers and 3PLs creates confusion (pink sheet)
• Global benchmarking data offers a path to improved drug manufacturing quality (pink sheet)
• Endo will cut 560 employees, drug shutters to save money for spring cellulite launch (Fierce)
• NICE supports AbbVie’s Rinvoq for severe active rheumatoid arthritis (PharmaTimes)
• Assembly Bio’s hepatitis B program fails as a potential cure in PhII, sending the shares spiral (Endpoint)
• A first time for England’s NICE – Provisional revision of the Spinraza access agreement begins (pink sheet)
• Vertex’s Kalydeco gets another label extension in the EU (PharmaTimes)
• China approves Xtandi of Astellas in castration-resistant non-metastatic prostate cancer (Pharmafile)
• China Cell Therapy Party on: $ 500 million + raised in JW IPO, other rounds (Scrip)
• UNICEF and WHO call for emergency action to avert major measles and polio (WHO) outbreaks
• Neglected Tropical Diseases and One Health: Prepare for Antimicrobial Resistance to Ensure the Safety of Future Generations (WHO)

Medtech

• MHLW will not exclude software programs from conditional approval coverage: official (PharmaTimes)
• ICER Says More Data On Digital App Treatments Is Needed For Opioid Use Disorder (Fierce)
• Guardant Exceeds Expectations But Warns COVID-19 Spikes Will Hurt Fourth Quarter Growth (MedtechDive)
• Zimmer reports record-breaking robot installations, M&A (MedtechDive) inspired by the ASC

Government, regulation and legal

• 4 things to know about Chinese patent law (law 360)
• Powered. Circ. Limit seat options for Hatch-Waxman suits (Law360)
• FDA Must Study Enviro Risks of Genetically Modified Fish (Law360)
• Merck moves forward with another lawsuit for diabetes drug (Law360)
• Servier loses candidacy to enforce European late payment rule in the UK (law360)
• European Patent Office Regulation in favor of Sanofi and Regeneron regarding Praluent® (alirocumab) (Big Molecule Watch)
• Clinical Trial Exemption Scheme (CTX) renamed Clinical Trial Approval Scheme (CTA) (TGA)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the leading regulatory, biopharmaceutical and medical technology news from around the world.

Inclusion of a story in Regulatory Recon does not imply approval by Regulatory Focus or RAPS.