Recon: GSK, AZ Ovarian Cancer Drugs Reduce Risk of Ovarian Cancer Returning; Sobi to Buy Dova for up to $915M

• Chemo Packs New Punch Outside High-Tech Cancer Fight’s Spotlight (Bloomberg)
• FDA Approves Genentech's Rituxan In Children With Two Rare Blood Vessel Disorders (Reuters) (Press) (FDA)
• Flu vaccine selections may be an ominous sign for this winter (STAT)
• Sobi to buy Dova Pharmaceuticals to broaden portfolio, boost US presence (Reuters) (Endpoints)
• Pfizer's Read to step down as chairman, handing role to CEO Bourla (BioPharmaDive) (Press)
• US agents raid genetic testing labs, charge 35 in Medicare fraud probe (Reuters)
• Targeted Amgen drug has low response rate in colon cancer in study (Reuters) (Endpoints) (STAT)
• Bristol-Myers immunotherapy combo outperforms chemo in lung cancer survival: study (Reuters)
• CVS suspends sales of Zantac brand and generic heartburn drug during safety review (Reuters)
• Cancer immunotherapy boom showing no sign of slowdown (BioPharmaDive)
• Pelosi’s drug pricing plan could wipe out some key funding for low-income hospitals (STAT)

• Results of GSK and AstraZeneca trials may widen ovarian cancer drug use (Reuters) (STAT) (PMLive) (Press)
• GlaxoSmithKline's cancer therapy cuts risk of disease progression or death by 38% (Reuters)
• Novartis says Kisqali boosts survival in breast cancer patients (Reuters)
• Roche’s Polivy Reverts To Standard Review In EU (Pink Sheet-$)
• Charging at blockbuster Advair, Novartis boasts topline victories for asthma drugs in twin PhIII studies (Endpoints)
• Govt considering to let US companies make medical devices in India (Economic Times)
• US travel warning adds to pressure on Tanzania over suspected Ebola cases (Reuters)
• Bangladesh bans heartburn drug ranitidine over cancer fears (Reuters)
• Mylan to invest $1 billion in India on capex in 6 years (Economic Times)

• Deerfield puts up $635M to create New York City biotech campus (Fierce)
• CRISPR pioneer Feng Zhang's upstart biotech seeks $100M-plus IPO for preclinical base editing work (Endpoints)
• CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies (IPQ)
• New RA drugs offer 'marginal' benefits at prices that are too high, ICER says (Fierce)
• GSK announces positive real world data for Nucala (PharmaTimes)
• Watch: In a quest for more precise cancer care, hospitals invest in new tools — and new training, too (STAT)
• Roche and Spark Therapeutics, Inc. announce extension of tender offer for shares of Spark Therapeutics, Inc. (Press)
• As Celgene becomes BMS, its I&I lead lands CEO job at Takeda spinoff (Fierce)
• ESMO: G1 shares data on significant increase in breast cancer survival (Fierce)
• ESMO: AbbVie’s PARP veliparib finally gets a win, but can it compete? (Fierce)
• Beam Therapeutics Preps IPO and Sheds Light on Its Gene-Editing Drugs (Xconomy)
• Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Draft Guidance for Industry; Availability (FDA)
• Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured From Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Draft Guidance for Industry; Availability (FDA)

• Roche’s Tecentriq in combination with Avastin shows encouraging results in Phase Ib study of people with unresectable hepatocellular carcinoma (Press)
• Roche's Tecentriq improves overall survival as a first-line monotherapy in certain people with advanced non-small cell lung cancer (Press)
• Roche to present new and updated data at ESMO 2019 reinforcing the use of Alecensa in the first-line setting for advanced ALK-positive non-small cell lung cancer (Press)
• Roche to present results of first prospective trial using blood-based next generation sequencing which successfully identifies people for treatment with Alecensa (Press)
• Pfizer Announces Positive Top-Line Results from Second Pivotal Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib, in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis (Press)
• GSK presents new data showing promising anti-tumour activity with GSK3359609, an ICOS receptor agonist, in combination with pembrolizumab in head and neck squamous cell carcinoma (HNSCC) (Press)
• Novartis, Eli Lilly marquee positive survival data for CDK 4/6 franchises — but can they actually beat Pfizer's blockbuster? (Endpoints)
• #ESMO19: AstraZeneca heralds Tagrisso's OS lead over old TKIs in lung cancer niche (Endpoints) (Press)
• GRAIL to Present New Data in Late-Breaking Oral Presentation at the European Society for Medical Oncology (ESMO) 2019 Congress (Press)
• Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint (Press)
• #ESMO19: Bristol-Myers Squibb boasts impressive 5-year melanoma OS data on Opdivo/Yervoy combo, though it still can't pinpoint who should take it (Endpoints) (Press)
• Adjuvant Treatment with Opdivo (nivolumab) Continues to Demonstrate Extended Recurrence-Free Survival at Three Years in Resected High-Risk Melanoma Patients (Press)
• BMS plugs on with Opdivo plus Yervoy in first-line NSCLC (PMLive) (Press)
• Seattle Genetics' armed antibody scores high in frontline bladder cancer, taking center stage at ESMO (Endpoints) (Press)
• Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (Press)
• MSD’s Keytruda meets primary endpoint in triple-negative breast cancer (Pharmafile) (Endpoints)
• ESMO 2019: CStone presents pooled safety data from the Phase 1b trial of CS1001, demonstrating promising overall safety and tolerability (Press)
• Positive Study Results of Phase IIa Clinical Trial Using Intravenous Administration of Mesenchymal Stem Cells for Ischemic Stroke Published in Peer-Reviewed Stroke Journal (Press)
• Intact Vascular Announces Positive One-Year Data from TOBA III Clinical Trial (Press)
• Five Prime Therapeutics Presents Updated Data From the Phase 1a/1b Trial of FPA150 at the European Society for Medical Oncology 2019 Congress (Press)
• Bicycle Therapeutics Announces Presentation of Updated Data from Phase I/IIa Trial Evaluating BT1718 in Patients with Advanced Solid Tumors at ESMO 2019 Annual Congress (Press)
• ImmunoGen Presents Full Data from Phase 3 FORWARD I Study of Mirvetuximab Soravtansine in Ovarian Cancer at ESMO (Press)
• ImmunoGen Presents Initial Data from Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination with Carboplatin and Avastin® at ESMO (Press)
• NOXXON Presents Latest Clinical Data From Phase 1/2 NOX-A12 / Keytruda® Combination Trial at the ESMO Congress (Press)
• Preliminary Results From IMV’s Phase 2 Basket Trial Evaluating DPX-Survivac as a Combination Therapy in Patients With Advanced and Metastatic Solid Tumors to Be Presented at ESMO Congress 2019 (Press)
• X4 Pharmaceuticals Reports Positive Data from Phase 2a Trial of Mavorixafor in Combination with Axitinib in Advanced Clear Cell Renal Cell Carcinoma Patients (Press)
• Adlai Nortye Presents Encouraging Phase 1b Study Data of AN0025 (an Oral EP4 Antagonist) for Locally Advanced Rectal Cancer at ESMO 2019 (Press)
• Sunovion and PsychoGenics Initiate DIAMOND Phase 3 Clinical Studies for SEP-363856 in the Treatment of Adults and Adolescents with Schizophrenia (Press)
• Bridge Biotherapeutics Presents Positive Results from Phase 1 Clinical Study of BBT-877 for Idiopathic Pulmonary Fibrosis (IPF) Treatments at the ERS International Congress 2019 (Press)
• Isofol Announces Presentation on the Global Phase 3 Study of Arfolitixorin in Metastatic Colorectal Cancer at 2019 ESMO Congress (Press)
• Tolero Pharmaceuticals Presents Preliminary Findings from Phase 1 Study Evaluating Investigational Agent TP-0903 in Patients with Advanced Solid Tumors at ESMO 2019 (Press)
• Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma (Press)
• ESMO 2019: Forbius Demonstrates Target Engagement in Phase 1 Immuno-Oncology Clinical Trial with AVID200, First-in-Class TGF-beta 1 & 3 Inhibitor (Press)
• MiNA Therapeutics Presents Clinical and Pre-Clinical Data at ESMO Supporting MTL-CEBPA as Immunological Combination Treatment (Press)
• Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in China for Malignant Ascites (Press)
• Iksuda Therapeutics Presents First Data on Lead Antibody Drug Conjugate, Demonstrating Effective Tumour Regression (Press)

• CDRH Issues Draft Guidance on Safer Technologies Program (FDA Law Blog)
• Emergo Group launches new RAMS digital medical device RA/QA management system (MassDevice)
• More reimbursement wins for Inspire Medical Systems (MassDevice)

• New leader looms at CMS innovation center (Politico)
• Dank Vapes, TKO and Other THC Vaping Brands Are Linked to Illnesses, CDC Says (NYTimes)
• Mylan forks over $30M to settle SEC's EpiPen accounting probe (Fierce) (STAT)
• Another big biopharma merger runs into another snag at the FTC. What now? (Endpoints)
• J&J appeals 'unprecedented' $572M opioid verdict to Oklahoma Supreme Court (Fierce)
• Avanir to pay $116 million to settle bribery charges, while two docs and former sales reps are indicted (STAT)
• Stupid Expert Tricks (Drug & Device Law)
• Federal Oversight For Plaintiff Lawyer Advertising (Drug & Device Law)
• Antitrust Case Against IQVIA Will Join Larger Fight In NJ (Law360-$)
• Ex-BD engineer accused of stealing trade secrets (MassDevice)

• FDA Advisory Committee Calendar

• EFPIA Wants Continued And More Inclusive Japan Policy Dialog (Pink Sheet-$)
• Hancock says UK will consider mandatory vaccinations (PMLive)
• Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) (MDA2019/031) (MHRA)

• Cellular Biomedicine Group's ReJoin® Therapy Receives Stem Cell Drug Application Acceptance For Phase II Clinical Trials by China NMPA (Press)

• Enforceable undertaking guidelines (TGA)