Recon: Pfizer, Novartis Team up to Test NASH Combos

• Novartis, Pfizer join forces on potentially lucrative fatty liver disease (Reuters) (Fierce) (STAT) (Endpoints) (Press)
• US FDA Blows Past Novel Approvals Record On Way To Unprecedented Year For New Drugs (Pink Sheet-$)
• Abbott, AbbVie settle TriCor marketing case for $25 million (Reuters) (STAT) (Law360-$)
• US court overturns J&J's Zytiga patent in combination with prednisone (Pharmafile)
• Days after Alexion deal, Dicerna pens $100M upfront RNAi research pact with Lilly (Fierce) (Xconomy) (Endpoints)
• 'Supporting greed over needs': the group taking on big pharma in the midterms (The Guardian)
• Don't lock them up: Opioid policy shakes up Ohio governor race (Politico)
• HHS secretary warns Big Pharma: Lower prices, or 'you'll get whatever comes at you' (CNBC)
• FDA approves TherapeuticsMD's menopause drug (Reuters) (Endpoints)
• Shionogi aims to double flu-drug market with FDA-approved treatment (Reuters)
• Trump's plan to bring down U.S. drug prices misses root causes (Axios)
• Republicans and the pharmaceutical industry grow apart (Axios)
• That’s A Lot Of Scratch: The $48,329 Allergy Test (KHN)
•  Why Private Equity Is Furious Over a Paper in a Dermatology Journal (NYTimes)

• Takeda proposes sale of Shire drug to gain European approval (Reuters) (Endpoints)
• Desperate Measures: How To Soften The Impact Of No-Deal Brexit (Pink Sheet-$)
• Drugmakers tout new medicines as eye disease battle intensifies (Reuters)
• Not so crystal clear: The EU’s clinical reporting problem (Pharmafile)
• NICE says no to AZ and Vifor’s rival hyperkalaemia drugs (PMLive) (PharmaTimes)
• China Essential Drug List Includes Newly Approved HCV Therapy (BioCentury)
• How A Small Scottish Biotech Firm Could Win A Decisive Battle Against Cancer? (Forbes)
• EMA experts awarded for excellence in standards development (EMA)
• Why Are Drugs Cheaper in Europe? (WSJ)
• Rapid shift from global to national purchase of TB drugs increases risk of stockouts and use of drugs of unknown quality (MSF)

• Celgene to launch five new products through to 2020 (PMLive)
• Should Failure to Disclose Significant Financial Conflicts of Interest Be Considered Research Misconduct? (JAMA)
• Common Blood Pressure Medication Linked To Increased Risk Of Lung Cancer (Forbes)
• Esperion’s cholesterol drug clears the last big safety hurdle, turning the corner to the FDA — now the big challenge looms (Endpoints) (STAT)
• Julian Adams manages to complete his $50M IPO at Gamida Cell — at a heavy cost (Endpoints)
• Novartis CEO Vas Narasimhan on gene therapy, innovation, and the company pivot (STAT)
• FDA Grants First Qualification Of A Clinical Safety Biomarker (BioCentury)
• Regulatory Lessons For Advanced Therapy Makers: A Case Study (Pink Sheet-$)
• How FDA’s LPAD Pathway Tipped The Scales For Insmed’s Arikayce Amikacin (BioCentury)
• Seattle Genetics Sags As Adcetris Sales Miss Target (BioCentury)
• New 'peptoids' show promise in resistant prostate cancer (Fierce)
• New data back Ovid’s Angelman drug, say analysts (Fierce)
• Scientists And Parents Band Together To Research Cures For Rare Childhood Cancer (NPR)
• Novartis, Gilead, Celgene/Agios blood cancer treatments sweep Prix Galien awards (MedCity)
• What R&D Leadership Swapping Means For Pharma Companies (BioCentury)
• Repeat flu vaccinations don't hurt kids and might help boost immunity, study finds (NBC) (Forbes)
• Seniors In The Deep South And Rural Western States Prescribed Most Benzodiazepines And Opioids (Forbes)
• Amgen, Regeneron appear most at risk from Trump's latest pricing plan (BioPharmaDive)
• Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications (FDA)

• Roche's eye drug beats Lucentis at Phase 2 in wet age-related macular degeneration (Pharmafile) (Press)
• Roche expands its PhIII program for Eylea rival as long-acting data back its blockbuster contender faricimab (Endpoints)
• Takeda Comments on Ongoing Phase 1 Review by the European Commission of the Proposed Acquisition of Shire plc (Press)
• REGENXBIO Announces Additional Positive Interim Phase I Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2018 Annual Meeting (Press)
• ActoBio Therapeutics™ Doses First Patient in Phase Ib/IIa Clinical Study of AG019 for the Treatment of Type 1 Diabetes (Press)
• Generex Biotechnology Announces IND Filing for a Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for the Treatment of Triple-Negative Breast Cancer (Press)
• TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause (Press)

• CDRH Introduces Third 510(k) Pilot in Less than Two Months – This Time on OCT Devices (FDA Law Blog)
• karius’ blood test diagnoses blood, deep tissue infections using cell-free DNA (BioCentury)
• Slow Medicine: The Apple Watch and Overdiagnosis (Medpage)
• Should Stryker Worry About Zimmer's New Robotics Offering? (MDDI)
• Zimmer Has to Reduce the Size of Its Portfolio, CEO Says (MDDI)
• Bringing Precision Diagnostics Home (MDDI)
• Fresenius Medical touts Crit-Line hemodialysis fluid management studies (MassDevice)
• Genentech touts data for refillable eye implant in wet-AMD trial (Drug Delivery)
• GenSight Biologics launches trial for gene therapy, eye device combo (Drug Delivery)
• Philips board backs reappointment of CEO van Houten, CFO Bhattacharya | Personnel Moves – October 29, 2018 (MassDevice)
• Bio-Rad Receives U.S. FDA Clearance for the IH-Reader 24, Expanding the Company’s Offering for the Blood Typing Market (Press)

• J&J Can't Arbitrate Distributor's Claims In Remicade Row (Law360-$)
• These Doctors Are Illegally Prescribing Addiction Medications. But Should They Be Prosecuted? (BuzzFeed)
• 2 Moves By Trump This Past Week Could Reshape U.S. Health Insurance In Big Ways (NPR)
• Shopping for Insurance? Don’t Expect Much Help Navigating Plans (NYTimes)
• Patent Dance Developments: A Tale Of 2 Antibodies (Law360-$)
• On Prevention of Federal Fraud on the FDA Claims That Avoid Buckman (Drug & Device Law)

• FDA Advisory Committee Calendar
• Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 4-5 December 2018

• Strength and Opportunity 2017 supplemental report: Trends in the UK life sciences, 2009 – 2017 (Gov.UK)
• Gwyneth Paltrow's lifestyle firm Goop reported to UK watchdogs over 'potentially dangerous' health advice (CNBC)

• Indian pharma companies top in biosimilars globally (Times of India)
• Banned ingredients in diet pills putting Indians at risk (Times of India)
• Local pharma formulators to benefit from new USFDA generic guidance: Report (Economic Times)
• Industry urges Centre to change definition of manufacturers in Guidance Document for Medical Devices (PharmaBiz)
• Granules' US unit gets two USFDA observations (Economic Times)
• Cipla gets USFDA nod for hypertension, cardiac drug (Economic Times)

• Therapeutic goods advertising: Update 29 October 2018 (TGA)
• Education priorities 2018-19 (TGA)
• Australia to list new lung cancer and cholesterol drugs on PBS (PharmaLetter-$)

• Ninth child dies in deadly viral outbreak in New Jersey (Reuters)
• Why Is CBD Everywhere? (NYTimes)
• The Plant People Are Buying Online For A 'Legal High': It's Not Cannabis. (Forbes)