Recon: Sandoz Recalls One Lot of Losartan; NICE Rejects Wider Use of Lynparza for Ovarian Cancer

• Cardiac devices can cost six times more in US than in Europe (Reuters)
• Azar says new mandatory oncology pay model is coming (Modern Healthcare)
• Novartis division Sandoz recalls one lot of blood pressure drug (Reuters) (FDA)
• Stryker closes $1.4B K2M buy (MassDevice)
• Rep. Peter Welch on drug prices, the potential for bipartisan action, and a ‘broken market’ (STAT)
• Elijah Cummings sparred with Martin Shkreli and Mylan’s CEO. Now he’s got a gavel to take on pharma (STAT)
• As Novartis' other cancer launches struggle, Lutathera gets off to flying start (Fierce)
• Sarepta shares sink on the back of a monster $500M raise (Endpoints)
• FDA Extends Review of Samsung Bioepis' Trastuzumab Biosimilar (BioCentury)
• Coherus prices biosimilar to Amgen's Neulasta at 33 percent discount (Reuters) (Fierce)
• US regulators snip red tape for medical devices to curb opioid crisis (Reuters)
• Google has hired Geisinger's David Feinberg to lead its health strategy (CNBC)
• FDA authorizes emergency use of first Ebola fingerstick test with portable reader (FDA)
• FDA plans curbs on e-cigarette sales over concerns about surge in teen vaping (Washington Post) (Reuters) (NYTimes) (Politico)

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• Jazz Pharma files for EMA approval of solriamfetol (PharmaLetter-$) (Press)
• AstraZeneca: back from the abyss (Financial Times)
• AstraZeneca chief says Europe should pay more for drugs—and the U.S. should pay less (Fierce)
• NHS diabetes prescriptions top £1 billion a year (Pharmafile)
• NICE says no to expanding use of AZ’ Lynparza (PharmaTimes) (Pharmafile)
• NICE nod for Jazz’ AML chemo (PharmaTimes)
• Lenvima backed for NHS use to treat liver cancer (PharmaTimes)
• ‘Drastic’ Japan Price Reforms Hitting R&D Incentives, Plans – EFPIA (SCRIP-$)
• The rise and rise of medtech in Asia (McKinsey)
• How one small not-for-profit company hopes to build a model for tackling needed drugs (STAT)
• Mexico and Argentina To Cut Burden for Pharma By Swapping GMP Reports (Pink Sheet-$)
• China’s BeiGene delays US filing for rival to Imbruvica (PharmaPhorum) (PharmaLetter)
• Innovent, Eli Lilly cite a new success for their PD-1 in lung cancer, with a likely pioneering approval in China looming (Endpoints)
• WuXi Biologics breaks ground on $240m manufacturing site near Beijing (BioPharmaReporter)
• Chinese Regulators Revamp Innovative Medical Device Review Process (Emergo)
• US concerned about Ebola outbreak in Congo conflict zone: official (Reuters)

• What’s in a p value? (Evaluate)
• Animal rights group urges drug makers to discontinue a test that ‘traumatizes’ rodents (STAT)
• AmerisourceBergen's compounding site still on ice despite beefed-up oversight (BioPharmaDive)
• Soon-Shiong presents first data on cancer memory vaccine at SITC (PMLive)
• Alabama's biggest insurer will no longer cover OxyContin prescriptions (Pharmafile)
• Sage May Be Forced To Simplify Brexanolone Dosing Regimen (Pink Sheet-$)
• GPCR drug discovery: integrating solution NMR data with crystal and cryo-EM structures (Nature)
• How can Ironwood fix slowing Linzess sales? Ditch partner Allergan, analyst suggests (Fierce)
• Penn spinout preps for human studies of a new-model CAAR, aiming at a one-time cure for autoimmune diseases (Endpoints)
• Opinion: Drug prices on ads: as ‘relevant’ as percent daily value on food labels (STAT)
• Why veterans make good hires in biotech: We’re out to save lives, not sell widgets (STAT)
• Themis pulls out of IPO, looks into 'strategic options' to fund phase 3 vaccine trial (Fierce)
• NOCDURNA® (desmopressin acetate) Sublingual Tablets Now Available by Prescription in US for Treatment of Nocturia Due to Nocturnal Polyuria (Press)

• Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018 (Press)
• Mirati Presents Preliminary Biomarker Data From Ongoing Phase 2 Clinical Trial Of Sitravatinib In Combination With Nivolumab At The SITC 33rd Annual Meeting (Press)
• Arcus Biosciences Presents Initial Data from the Phase 1 Dose-Escalation Study of AB122, its anti-PD-1 antibody, at the SITC 2018 Annual Meeting (Press)
• Alnylam Presents Updated Phase 1/2 Open-Label Extension (OLE) Results for Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyria (Press)
• MedDay Pharmaceuticals Announces Full Patient Enrollment for MD1003 Phase III Clinical Trial (SPI2) in Progressive Multiple Sclerosis (Press)

• FDA approves Medtronic renal denervation trial in on-med patients (MassDevice)
• Medtronic to Announce Financial Results for Its Second Quarter of Fiscal Year 2019 (Press)
• Medtronic Delivers Significant Progress on Global Corporate Citizenship Efforts (Press)
• US FDA Updates UDI Policy for Direct Marking of Medical Devices (Emergo)
• Premier buys clinical decision support tools provider Stanson Health for $51.5M (MedCity)
• Second Sight Medical wins final CMS reimbursement nod for Argus II (MassDevice)
• MaxQ AI wins FDA 510(k) clearance for acute intracranial hemorrhage triage algorithm (mobihealthnews)
• Titan Spine closes undisclosed Series B round (MassDevice)
• Could AI be the next big thing for medical device manufacturing? (Medical Design & Outsourcing)
• TransEnterix posts Street-beating Q3 (MassDevice)
• Globus Medical Q3 beats The Street (MassDevice)
• ICU Medical posts mixed bag Q3 (MassDevice)
• Senseonics reports mixed Q3 results (MassDevice)

• Blood-Pressure Drug Cos. Hit With Suit Over Contamination (Law360-$)
• Del. Jury Finds Flexus Took Incyte Secrets, Nixes Damages (Law360-$)
• HHS recommended that the DEA make kratom a Schedule I drug, like LSD or heroin (STAT)
• Trump's latest move to crack down on abortion (Politico)
• A Glimmer of an Idea on an Experimental Use Exemption (Patent Docs)
• Final Curtain for Plaintiffs’ Experts in the Mirena IIH MDL (Drug & Device Law)
• Through International Support, U.S. Has Opportunity to Align Own Agencies on Precision Biotech (BIO)

• FDA Advisory Committee Calendar

• Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (EMA)
• Human Medicines Highlights November 2018 (EMA)
• Liverpool Uni leads EU kidney research project (PharmaTimes)

• GE Healthcare strengthens single-use manufacturing in China (BioPharmaReporter)
• China issues clinical guidance for CNS drugs (PharmaLetter)
• FiercePharmaAsia—Big Pharma's China Q3; Genentech trade secret suit; Janssen-Yuhan EGFR pact (Fierce)

• Health ministry to discuss quantum of compensation related to serious adverse event due to faulty medical devices (PharmaBiz)
• Indian pharma sees Bangladesh emerging as the pharma market of future (PharmaBiz)

• Medical Devices Safety Update, Volume 6, Number 6, November 2018 (TGA)
• TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018 (TGA)
• ACM meeting statement, Meeting 11, 4 October 2018 (TGA)