Recon: AZ Backs $1B China Biotech Fund; Confirmation Hearing for FDA Commissioner set for 20 November

• Senate HELP Committee to Hold Confirmation Hearing for Nominee Hahn on 20 November (HELP)
• CRISPR Takes Its First Steps in Editing Genes to Fight Cancer (NYTimes) (AP) (NPR)
• White House and Pelosi part ways on relief for drug prices (AP)
• ASH preview: Celgene, Bluebird, and J&J out with early but telling data in blood cancer (STAT)
• Mallinckrodt receives SEC subpoena over Acthar gel lawsuit (Reuters)
• Gilead touts new data for fast-growing Biktarvy as older HIV meds show some cracks (Fierce) (Press)
• Regeneron is buying back $1 billion in stock, but hell has not yet frozen over (STAT)
• Regenxbio hit with FDA clinical hold, pushes back gene therapy timelines (BioPharmaDive)
• Roche escapes lawsuit claiming it illegally quashed Biocad's biosimilar hopes (Fierce) (Law360-$)
• CVS quarterly results lifted by higher prices for brand name drugs (Financial Times)
• Walgreens Boots Alliance explores $70bn buyout (Financial Times) (CNBC)

• AstraZeneca backs $1bn China biotech fund for smaller ventures (Financial Times) (Reuters) (Press)
• Britain's AstraZeneca to distribute Sun Pharma cancer drugs in China (Reuters)
• Top execs from AstraZeneca, Roche, Sanofi and GSK tout China investments at import expo (Fierce)
• Biogen Adds Two More Biosimilars in $100M Samsung Bioepis Deal (Xconomy) (Endpoints) (Press)
• Trial backs Inovio/Sanofi combo in hard-to-treat brain cancer (PMLive)
• Alzheimer's breakthrough? Not so fast — experts poke holes in data underlying China's surprise approval (Endpoints)
• New Amplitude fund looks to bet over $100m on incipient Canadian biotech market (Endpoints)
• WHO scales up cholera vigilance in Khartoum, Sudan (WHO)
• BSI’s Dutch Notified Body is Latest to be Designated Under MDR (Focus)

• FDA Renames and Restructures Oncology Office (Focus)
• FDA Raises Concerns With API Manufacturers (Focus)
• Naltrexone May Help Stop Meth Cravings, Research Indicates (NPR)
• Alvotech and STADA Agree on Strategic Biosimilar Partnership (Press)
• UPS drone makes first home prescription deliveries for CVS (Reuters)
• Regeneron defends bid to challenge Merck in lung cancer (BioPharmaDive)
• Tardy marketing application filing, trial failure trouble Supernus investors (Endpoints)
• Early data on NextCure's immuno-oncology drug in lung cancer patients delights investors (Endpoints)
• US FDA Tried, But Failed, To Take Compounding Issue Off The Table At Makena AdComm (Pink Sheet-$)
• Recro Pharma Appeal of CRL for Non-Opioid Pain Product Granted (FDA News-$)
• Aquestive Petitions FDA to Halt Approval of NDA for Emergency Seizure Spray (FDA News-$)
• Health technology assessment methodology in metastatic renal cell carcinoma (Nature)
• Endo CEO's departure another C-suite hit at generic industry's biggest players (Fierce)
• Vifor commits €25M to nephrology R&D joint venture with Evotec (Fierce) (Endpoints)
• After being bumped by BMS, ex-CSO Lynch lands as chair of Kleo Pharma (Fierce)
• Radius plans to cut loose oncology assets (Fierce)
• Using Clinical Decision Support Tools To Facilitate Decision-Making In Precision Medicine (Forbes)

• New data to be presented at ASH 2019 highlight Sanofi's commitment to treat challenging blood cancers and rare blood disorders (Press)
• BioLineRx Announces BL-8040 in Combination With KEYTRUDA Shows Clinical Activity in Heavily Pretreated Metastatic Pancreatic Cancer Patients (Press)
• New data for isatuximab in multiple myeloma to be presented at ASH 2019 (Press)
• ExCellThera launches trial of drug to expand umbilical cord blood for stem-cell transplants in cancer (Fierce)
• Ark Biosciences Reports Successful Completion of Phase II Proof-of-Concept Clinical Trial of Ziresovir for Treatment of Infants Hospitalized with Respiratory Syncytial Virus (RSV) Infection (Press)
• Alzheon Publication Defines New Path for 2nd Generation Anti-Amyloid Drugs for Alzheimer’s Disease, Supporting Launch of Phase 3 Study with ALZ-801 Oral Tablet (Press)
• Trovagene Announces Data from Acute Myeloid Leukemia (AML) Phase 1b/2 Trial of Onvansertib Chosen for Oral Presentation at ASH 2019 Annual Meeting (Press)
• ArQule Announces Release of American Society of Hematology Abstract Detailing Results of the Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies (Press)
• bluebird bio to Present New Data from Gene and Cell Therapy Programs at 61st American Society of Hematology Annual Meeting and Exposition (Press)
• Verastem Oncology to Present Phase 2 PRIMO Study Data Evaluating Duvelisib in Relapsed or Refractory Peripheral T-Cell Lymphoma at the American Society of Hematology 2019 Annual Meeting (Press)
• GlycoMimetics to Present Further Analysis of Data From Phase 1/2 AML Trial of Uproleselan at 61st ASH Meeting (Press)
• Xencor to Present Initial Data from the Phase 1 Study of XmAb®13676 in B-Cell Malignancies at the American Society of Hematology Annual Meeting (Press)
• Updated Results from Phase 2 SPiReL Study Evaluating IMV’s DPX-Survivac as Combination Therapy in Patients with r/r DLBCL to be Presented at 61st American Society of Hematology (ASH) Annual Meeting (Press)
• Rocket Pharmaceuticals to Present Preliminary Phase 1 Data of RP-L102 “Process B” for Fanconi Anemia at the 61st American Society of Hematology Annual Meeting (Press)

• Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks (FDA)
• FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations (FDA) (Press)
• The FDA Warns that Biotin May Interfere with Lab Tests (FDA)
• EU MDCG weighs in on medical device certification issues (MassDevice)
• Insulet Q3 earnings beat The Street despite bottom-line slide (MassDevice)
• Vyaire Medical receives FDA clearance for bellavista 1000e ventilator system (MassDevice)
• Edwards SAPIEN 3 TAVI Receives Expanded Approval In Europe (Press)
• Proven bellavista™ 1000e Ventilator System Receives FDA Clearance (Press)

• Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices (Focus)
• Democrat Beshear poised to eke out victory in Kentucky governor race (Politico)
• Vape Shops Likely to Be Exempted in Planned FDA E-Cig Curbs (Bloomberg)
• New Calif. Pay-For-Delay Law May Hurt Those It Aims To Help (Law360-$)
• Fed. Circ. Offers Obviousness-Type Double Patenting Cure (Law360-$)
• Seema Verma: CMS’s ‘expanded pathway’ for new antibiotics can help fight antimicrobial resistance (STAT)
• Apple opens up its health records service to veterans with iPhones (CNBC)
• FDA Law Alert – November 2019 (FDA Law Blog)
• New Jersey Product Liability Act Knocks out Design Defect, Manufacturing, Warning, Warranty, and Fraud Claims Against IVC Filter (Drug & Device Law)

• FDA Advisory Committee Calendar

• Joint Action on Market Surveillance of Medical Devices Featured in EU Health Programme High Level Conference (CAMD)
• Thermo Fisher invests $24 million in biologics site in Scotland (PharmaManufacturing)
• Good manufacturing practice inspection deficiencies (MHRA)

• FindGene Noninvasive Prenatal Screening Kit Gets Approval from Chinese Regulators (GenomeWeb)
• Puma Biotechnology Licensing Partner CANbridge Pharmaceuticals Receives Registration Approval in Hong Kong for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive HER2-Positive Breast Cancer (Press)

• Chinese delegation visits Gujarat to explore bulk drug industry in India (Pharmabiz)
• Pharmexcil to give a further boost to domestic cos for pharma exports currently at US$ 21 billion (Pharmabiz)
• Antibiotics not included under the current industrial pollution monitoring standards in India: Dr. Swetha Suresh (Pharmabiz)

• Medical device cyber security – Consumer information (TGA)

• Humans Shipped an Awful Cargo Across the Seas: Cancer (NYTimes)