Recon: HHS asserts rulemaking authority over FDA; AstraZeneca releases COVID vaccine trial blueprints

• In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over FDA (NYTimes) (Endpoints) (HHS)
• Democratic chairman says White House blocked FDA commissioner from testifying (The Hill)
• A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards’ (NYTimes)
• Top US Health Officials Tiptoe Around Trump’s Vaccine Timeline (NYTimes)
• Emails Detail Effort to Silence CDC and Question Its Science (NYTimes)
• Trump suggests Pfizer could win US COVID-19 vaccine approval, JNJ to come later (Reuters)
• Immunomedics drug Trodelvy extends survival in breast cancer patients (Reuters) (STAT)
• Sequencing Firm Illumina to Pay $7.1 Billion for Liquid-Biopsy Firm Grail (WSJ) (FT)
• Mask skeptic lawmaker takes on side gig overseeing drug company trial (Politico)
• #ESMO20: Not just Keytruda anymore: Merck spotlights 3 top early-stage cancer drugs (Endpoints)
• Bristol Myers' Opdivo with Exelixis drug cuts kidney cancer death risk: study (Reuters) (STAT)
• Amgen drug shrinks tumors in lung cancer patients with KRAS gene mutation – study (Reuters) (Endpoints)

• Russia Is Slow to Administer Virus Vaccine Despite Kremlin’s Approval (NYTimes)
• EU in early talks with Italy's ReiThera over potential vaccine supply deal (Reuters)
• AstraZeneca Releases Blueprints for Virus Vaccine Trial Amid Safety Scrutiny (NYTimes)
• AstraZeneca says Tagrisso shown to slow lung cancer spreading to brain (Reuters)
• EU agency recommends AstraZeneca-Merck drug Lynparza for two cancers (Reuters)
• VBI Vaccines signs agreement with Canada to develop COVID-19 vaccine by 2022 (Reuters)
• More than 150 nations join WHO-led global plan for COVID vaccines (Reuters)
• EU Politicians: 'Bring Pharma Manufacturing Back To Europe' (Pink Sheet)

• Fewer Americans say they would take a COVID-19 vaccine compared to four months ago (The Hill)
• You Can Trust the FDA’s Vaccine Process (WSJ Opinion)
• US CDC says coronavirus could spread through air (Reuters) (Politico)
• CDC Reverses Testing Guidelines for People Without Covid-19 Symptoms (NYTimes)
• How to Ship a Vaccine at –80°C, and Other Obstacles in the Covid Fight (NYTimes)
• Experimental Medicines For COVID-19 Could Help Someday, But Home Runs Not Guaranteed (NPR)
• Advances In ICU Care Are Saving More Patients Who Have COVID-19 (NPR)
• As US COVID-19 deaths near 200,000, a nation grapples with grief (Reuters)
• Study suggests dengue may provide some immunity against COVID-19 (Reuters)
• US sets record with over one million coronavirus tests in a day (Reuters)
• COVID-19 data scandal prompts tweaks to elite journal’s review process (Science)
• Not trusting the FDA, Black doctors’ group creates panel to vet Covid-19 vaccines (STAT)
• State treasurers urge Gilead to lower the price of remdesivir and not pursue “unreasonable profits” (STAT)
• Foreign Masks, Fear and a Fake Certification: Staff at CSL Plasma Say Conditions at Donation Centers Aren’t Safe (ProPublica)
• PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower (MedtechDive)
• Post-market review of face masks - Non compliance notices (TGA)

• US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline (Pink Sheet)
• Seattle Genetics stays step ahead of rivals with bladder cancer data (BioPharmaDive)
• Roche looks to genetic modifiers for new drug targets, teaming up with Dutch biotech in $375M deal (Endpoints)
• Roche vaults to the front of the NLRP3 clinical race, paying $448M upfront to bag Inflazome (Endpoints)
• Three more biotechs look to jump onto Nasdaq amid IPO boom, including Norbert Bischofberger's Kronos (Endpoints)
• #ESMO20: 'As good as any PD-1 out there': Regeneron flashes PD-(L)1 lung cancer data to rival Merck (Endpoints)
• Immune Regulation, taking two clinical programs to 'reset' the immune system, nets $53M+ Series B (Endpoints)
• ESMO: Pfizer, Merck KGaA's Bavencio comes up short against placebo in risky head and neck cancer trial (Fierce)
• ESMO: Roche's mixed results put Tecentriq's triple-negative breast cancer use into question (Fierce)
• #ESMO20: Autolus provides glimpse of next-generation CAR-T program, showing early positive safety data (Endpoints)
• UPDATED: #ESMO20: Eli Lilly shows off the data for its Verzenio success. Was it worth $18 billion? (Endpoints)
• UPDATED: #ESMO20: Eli Lilly shows off the data for its Verzenio success. Was it worth $18 billion? (Endpoints)
• ESMO: Novartis posts data from failed spartalizumab phase 3, reaffirms commitment to PD-1 combos (Fierce)
• ESMO: Novartis parses long-awaited survival data for breast cancer blockbuster hopeful Piqray (Fierce)
• #ESMO20: Out to beat Tagrisso, J&J touts 100% ORR for EGFR bispecific/TKI combo — fueling a quick leap to PhIII (Endpoints)
• ESMO: Chi-Med's surufatinib gears up to challenge Novartis, Pfizer with placebo-topping phase 3 (Fierce)
• Biogen stands to lose billions in Tecfidera sales next year, analyst says after new court ruling (Fierce)
• Takeda Pharmaceuticals USA consolidation includes elimination of 170 Chester County jobs (Philadelphia Business Journal)
• Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency (FDA)

• Qiagen completes takeover of PCR automation player NeuMoDx for $248M (MedtechDive)
• Takeda taps Foundation Medicine for lung cancer companion diagnostics (Fierce)
• Abbott scores CE Mark for its first glucose sport biosensor (MobiHealthNews)
• ANVISA eliminates Cadastro pathway for Class II medical devices (Emergo)
• House Forwards Bill On Counterfeit Medical Devices (Law360)
• Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management (FDA)

• Pandemic supercharges campaign battles over Obamacare (Politico)
• Safety-critical alerts are changing at the MHRA (MHRA)
• Testing of medicinal cannabis products being supplied via SAS in Australia (TGA)
• Notice to Stakeholders – Clarification of Requirements Under the Food and Drug Regulations When Conducting Clinical Research With Cannabis (Health Canada)
• 3rd Circ. Backs Allergan's Win In ERISA Suit Over Drug Prices (Law360)
• Lawmakers Say Akin Gump Report Doesn't Clarify Kodak Loan (Law360)
• Derivative Suit Says Biotech Co. Lied About COVID-19 Vaccine (Law360)
• How Pharma Cos. Can Evaluate Alliance Agreements' Validity (Law360)
• Gilead Accused Of Paying To Stave Off HIV Drug Competition (Law360)