Recon: Aurobindo to Buy Sandoz Assets for $900M; FDA Extends Review of Roche's Tecentriq Combo by Three Months

• FDA extends review of Roche's Tecentriq by three months (Reuters) (PharmaTimes)
• GSK to axe 650 positions across US workforce (Pharmafile)
• The reinvention of Bob Hugin: Amid anger over drug prices, a former pharma CEO makes a run for the Senate (STAT)
• Sangamo team rushes to defend first human gene editing data as MPS II therapy offers a hit — and a miss (Endpoints) (STAT)
• CAR-T pioneer on riding the NIH roller coaster, speaking up for science, and his funder Sean Parker   (STAT)
• How a tech startup wants to connect cancer patients to treatments (Axios) (STAT)
• 23andMe is gauging interest in a $749 'premium' service that would offer deeper health data (CNBC)
• Hospitals band together to make drugs to combat shortages and high prices (CNBC) (Washington Post)
• FDA launches pilot payer program to help mitigate coverage woes for medtech startups (MedCity) (FDA Voice)
• As Theranos Dissolves, Healthcare Startup Funding Hits Record High (Forbes)
• Anti-aging medicine is so hot even this controversial idea has investors (MIT Technology Review)
• Walgreens to supply Kaleo's allergy shots as EpiPen shortage drags (Reuters)

• WHO Regulatory Agency Benchmarking System Set For Early 2019 Launch (Pink Sheet-$)
• Novartis to sell Sandoz assets to Aurobindo for $900m (PharmaTimes) (Economic Times) (Reuters)
• UN negotiators near agreement on TB declaration (Politico Pro)
• For the first time, researchers will release genetically engineered mosquitoes in Africa (STAT)
• Government talks to drug companies about Brexit stockpiling (The Guardian)
• ProQR soars as childhood blindness drug succeeds in early trial (Reuters)
• Israeli radiation therapy firm Alpha Tau raises $29 million (Reuters)
• NICE u-turn approves funding for rare disease therapy Crysvita (PharmaTimes)
• Italian CDMO buys India API plant that supplies Novartis (Fierce)
• China Expands Essential Drugs List (BioCentury)
• Teva finally dumps laquinimod, ending failure-riddled saga (Fierce)
• Congo records first Ebola death in major eastern trade hub (Reuters)

• FDA turns to real-world evidence to improve regulatory process (Pharmafile)
• JAMA Forum: Extending the User Fee Approach to Pharmaceuticals (JAMA)
• Westlake Bio Unveils $320M Fund to Put Los Angeles on the Biotech Map (Xconomy) (Fierce)
• On Cusp of Gene Therapy Clinical Trial, 4D Molecular Reels in $90M (Xconomy) (Fierce)
• Here’s a Cheap Way to Fight Drug Misuse: Send Doctors a Sharp Letter (NYTimes)
• REMS Abuse Website: All Sizzle, No Steak? (Pink Sheet-$)
• A new CAR-T is credited with a ‘surprising’ impact in tiny study of advanced liver cancer — raising hopes on solid tumors (Endpoints)
• ITF Pharma Announces FDA Approval Of TIGLUTIK™ (Riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) (Press)
• Roche to present new data from its extensive lung cancer programme at the 2018 World Conference on Lung Cancer (WCLC) (Press)
• Startup Gossamer Bio poaches Bristol-Myers Squibb executive as CSO (Fierce)
• Generics group says branded drugmakers blocking $13B in annual savings (BioPharmaDive)
• NIH study broadens understanding of High Impact Chronic Pain in the U.S. (NIH)
• Clinical trial testing topical cream plus influenza vaccine in progress (NIH)
• FDA Approves Clinical Trial of Novel Treatment for Fibromyalgia (Press)
• HPV Vaccine May Reduce Risk Of Transmitting Devastating Throat Disease To Children (Forbes)
• No sweat? Dermira snags reps, sets price and plots branded ads for Qbrexza launch (Fierce)
• Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period (FDA)
• Novo Nordisk's Ozempic spends big on TV in August but still trails AbbVie, Pfizer big guns (Fierce)

• Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata (Press)
• Gilead, Galapagos clear another PhII hurdle for filgotinib, but can they hope to catch up with Novartis’ Cosentyx? (Endpoints) (Press)
• With 12 more patients dosed, Bluebird reinforces strong profile for Lenti-D (BioPharmaDive) (Press)
• Baloxavir Marboxil Phase II and III Studies for the Treatment of Influenza Published in the New England Journal of Medicine (Press)
• Ra Pharma Announces Completion of End-of-Phase 2 Interactions with FDA and Design of Phase 3 PNH Program (Press)
• MabSpace Biosciences Doses First Patient in China Phase 1 Trial for MSB2311 and Submitted IND for MSB0254 to NMPA (Press)
• Lilly Announces Positive Phase 3 Results in Study of Flortaucipir PET Imaging Agent (Press)
• Licensing AstraZeneca castoff, Biohaven preps PhIII effort in new neurodegenerative indication (Endpoints) (Fierce)
• FDA waves Loxo through for second ‘breakthrough’ in tissue-agnostic cancer therapy (Endpoints) (PMLive)
• Horizon completes enrollment in TED trial early (PharmaTimes)
• Advicenne Announces FDA Clearance of IND to Commence Pivotal Phase 3 Trial of ADV7103 for Distal Renal Tubular Acidosis (Press)
• Antidote Therapeutics Receives Orphan Drug Designation for ATI-1013 for the Treatment of Buerger’s Disease (Press)
• ARMGO Pharma Receives FDA Orphan Drug Designation for ARM210/S48168 for the Treatment of Ryanodine Receptor Type 1 Related Myopathies (Press)
• Thrombolytic Science Initiates Phase 2 Clinical Trial of its Novel Treatment Regimen for Ischemic Stroke (Press)

• Medical Device Security Improvements Coming - But Not Anytime Soon (Forbes)
• FDA: Labeling requirements to add 2m hours to medtech industry’s regulatory burden (MassDevice)
• Ellipse Buy Reheats M&A Activity for Aesthetics Market (MDDI)
• Syneron Candela acquires Denmark’s Ellipse (MassDevice)
• Embolx wins CE Mark approval for next-gen Sniper balloon occlusion microcaths (MassDevice)
• Histogenics plunges on missed endpoint in NeoCart trial (MassDevice)
• Livongo adds compatibility with Abbott’s FreeStyle Libre Pro (Drug Delivery)
• Asuragen Gets CE Mark for QuantideX NGS Oncology Panel (GenomeWeb)
• Vascular Dynamics launches pivotal trial for MobiusHD hypertension device (MassDevice)

• States Looking To Tax Opioids Pin Hopes On November Elections (KHN)
• Senate Bill Would Legalize Medical Marijuana For Military Veterans (Forbes)
• Cell Phones, Immigration and Why Wyeth v. Levine Was Wrongly Decided on ‘Purposes and Objectives’ Obstacle Preemption (Drug & Device Law)
• PhRMA’s Complaint Against Enforcement of California Drug Pricing Transparency Bill SB 17 Dismissed (FDA Law Blog)
• Juno investors eke out $24M settlement in lawsuit over CAR-T trial deaths (Fierce)
• J&J, Janssen Win Mass. Risperdal Suit On Teen's Weight Gain (Law360-$)
• Tribes Can't Have Opioid Suits Sent To State Court From MDL (Law360-$)

• FDA Advisory Committee Calendar

• New chair put forward for NHS England (PharmaTimes)
• Celltrion calls for wider NHS use of biologics in RA (PharmaTimes)

• Re-election of Dr Poonam Khetrapal Singh as Regional Director for South-East Asia (WHO)
• Seventy-first session of the WHO Regional Committee for South-East Asia (WHO)

• Lax regulatory environment, not lack of laws, to be blamed for J&J hip implant imbroglio (PharmaBiz)

• WHO ship 500 tons of medicine to Yemen (Pharmafile)

• Assisted Reproductive Technologies May Pose Heart Risks for Babies (NYTimes)
• Eleven aboard flight from Dubai hospitalized in apparent flu outbreak (Reuters)
• Cancer in parents may affect kids' academic, professional development (Reuters)