Recon: Early Readout Shows Promise for AZ, Daiichi Breast Cancer Drug; FDA Panel Votes Against Correvio Heart Drug

• Correvio suffers fresh blow as heart drug fails to win FDA panel backing (Reuters) (Endpoints)
• Correvio Pharma to explore sale after FDA panel setback, shares plunge (Reuters)
• Blood Tests Show Exposure to Ethylene Oxide (WebMD)
• Pelosi brokers deal with liberals on drug pricing bill (Politico) (STAT)
• Pelosi drug pricing plan would save $456 billion over 10 years: analysis (The Hill)
• Investors fear Pelosi’s drug price plan will kill small biotech firms (CNBC)
• How contaminants from prescription-drug factories pollute waterways (STAT)
• Johnson & Johnson appeals Oklahoma judge's opioid ruling (AP)
• FDA staff spotlight issue with one of Horizon's endpoints but notes efficacy for lead drug (Endpoints)
• Supreme Court justices lean toward insurers on $12 billion Obamacare claims (Reuters)

• China’s Curing Cancer Faster and Cheaper Than Anywhere Else (Bloomberg)
• AstraZeneca-Daiichi drug halts cancer for months in first readout (Reuters) (STAT) (Press)
• EU expands scope of Vertex’ Kalydeco (PharmaTimes)
• Singapore And Malaysia Test Joint Evaluation Of Generics (Pink Sheet-$)
• Novartis still hasn't solved its CAR-T manufacturing issues (BioPharmaDive) (Outsourcing Pharma)
• The Commission and the Council on the MDR state of affairs (MedicalDevicesLegal)
• USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal (Focus)

• In its largest fundraising effort to date, Omega Funds pulls in over $400 million (STAT) (Endpoints)
• In tight Massachusetts job market, it’s relo for biotech and remote for tech hires (STAT)
• 2019 biotech IPOs: party on (Nature)
• Arguments on Drug Pricing (In the Pipeline)
• Foreign Drug Inspections Decline as FDA Hiring Struggles Continue (Focus)
• Sanofi’s sutimlimab set for filing in rare autoimmune anaemia next year (PMLive)
• Amneal buying AvKare, drugmaker to the feds (Fierce) (Press)
• The growing role of connected tech in medical research (Harvard Business School)
• Flagship’s Cellarity Aims to Advance Cell Behavior-Based Therapeutics (Xconomy)
• FDA Warns Two US Drugmakers Over GMP Deficiencies (Focus)
• Afib Drug Gets a Chance to Exit Regulatory Limbo (Medpage)
• Oral immunotherapy can be a game changer for many with food allergies (STAT)
• Immunotherapy drug improves outcomes for some children with relapsed leukemia (NIH)
• Fresh red blood cell transfusions do not help critically ill children more than older cells (NIH)
• The (Possible) “Dark Side” of Gene Editing Technologies (Harvard Bill of Health)
• Antibiotics manufacturing components can trigger adverse reactions. Standards help restore quality and trust. (USP)
• US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest' (Pink Sheet-$)
• UniQure, Pfizer updates hint at gene therapy potential in hemophilia B (BioPharmaDive)
• Immune agonist antibodies face critical test (Nature)
• Battered, cash hungry Intec feels the burn of Novartis rejection (Endpoints)

• GenSight Biologics reports findings from REALITY study and REVERSE-RESCUE analysis highlighting positive benefits from LUMEVOQ™ (GS010) compared to LHON natural history (Press)
• Novartis announces FDA filing acceptance of Xolair® (omalizumab) for treatment of nasal polyps (Press)
• Arrowhead Pharmaceuticals Files IND for Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma (Press)
• APHINITY six-year results strengthen evidence of clinical benefit with Roche’s Perjeta-based regimen (Press)
• KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test (Xconomy)
• SABCS: MacroGenics' margetuximab posts OS gains in specific metastatic breast cancer patients (Fierce)
• Little Leo Pharma enters the prize-fight ring with positive PhIII atopic dermatitis data. Now they just have to beat Dupixent (Endpoints) (Press)
• Exicure Reports Activity of AST-008 in Patients with Merkel Cell Carcinoma and Will Enroll Patients in Phase 2 Study (Press)
• BlackThorn Therapeutics Reports Data Supporting Phase 2 Development of KOR Antagonist, BTRX-335140, in Depression and Other CNS Disorders (Press)
• With looming superbug crisis, Iterum misses in a key antibiotic trial — and its shares tumble (Endpoints)
• CStone announces enrollment target reached in the global Phase III VOYAGER trial of avapritinib in Chinese patients with third-line GIST (Press)
• Xeris Pharmaceuticals Announces Positive Topline Results From the In-clinic Stage of the Phase 2 Study of Its Developmental Ready-to-use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery (Press)
• Bristol-Myers shows off a low-profile AML contender it gained from Celgene buyout — and they’re taking it straight to the FDA (Endpoints)
• Oncternal Therapeutics Announces Opening of Phase 1b Expansion Cohort of Clinical Trial of TK216, Targeted ETS Inhibitor, in Patients with Ewing Sarcoma (Press)
• Seattle Genetics details positive OS and PFS data for tucatinib in breast cancer (Endpoints)

• Google snaps up chief medical officer of health device maker AliveCor, weeks after buying Fitbit (CNBC)
• What Sanofi’s withdrawal from diabetes tech tells us about digital health (STAT) (MedtechDive)
• FDA names Beta Bionics' pancreas tech a breakthrough device (MedtechDive)
• Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant (MassDevice)
• FDA clears Cochlear piezoelectric hearing implant (MassDevice)
• Biolase lands 510(k) for dental hygiene laser (MassDevice)
• STAAR Surgical Announces FDA IDE Clinical Study Approval (Press)

• MDL Judge Calls out Plaintiffs’ Counsel − Not Acting in Clients’ Best Interests (Drug & Device Law)
• Justice Department Will Reportedly Review Google’s $2.1 Billion Fitbit Acquisition (Forbes)
• White House Summons Feuding Health Officials for Counseling Session (NYTimes)
• The IRS Sent a Letter to 3.9 Million People. It Saved Some of Their Lives. (NYTimes)
• FDA's E-Cigarette Regulations Upheld By DC Circ. (Law360-$)
• 3 Strategies To Manage Case Scope In ANDA Patent Litigation (Law360-$)
• GLAAD Urges Facebook To Drop Law Firms' HIV Drug Ads (Law360-$)
• Ex-Kite CEO Undermines Testimony Of Pharma Co.'s Founder (Law360-$)
• States Demand Purdue Fight Opioid Crisis With 9-Point Plan (Law360-$)
• Clinical Biopharma Sienna OK'd To Sell IP In Ch. 11 (Law360-$)

• FDA Advisory Committee Calendar

• Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043) (MHRA)

• Asia Regulatory Roundup: Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch (Focus)

• Update to listed medicine ingredients in December 2019 (TGA)