Regulatory Focus™ > News Articles > 11 > Recon: Sandoz Recalls One Lot of Losartan; NICE Rejects Wider Use of Lynparza for Ovarian Cancer

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

Posted 09 November 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $500M raise (Endpoints)
  • FDA Extends Review of Samsung Bioepis' Trastuzumab Biosimilar (BioCentury)
  • Coherus prices biosimilar to Amgen's Neulasta at 33 percent discount (Reuters) (Fierce)
  • US regulators snip red tape for medical devices to curb opioid crisis (Reuters)
  • Google has hired Geisinger's David Feinberg to lead its health strategy (CNBC)
  • FDA authorizes emergency use of first Ebola fingerstick test with portable reader (FDA)
  • FDA plans curbs on e-cigarette sales over concerns about surge in teen vaping (Washington Post) (Reuters) (NYTimes) (Politico)
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In Focus: International
  • Jazz Pharma files for EMA approval of solriamfetol (PharmaLetter-$) (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 $240m manufacturing site near Beijing (BioPharmaReporter)
  • Chinese Regulators Revamp Innovative Medical Device Review Process (Emergo)
  • US concerned about Ebola outbreak in Congo conflict zone: official (Reuters)
Pharmaceuticals & Biotechnology
  • What’s in a p value? (Evaluate)
  • Animal rights group urges drug makers to discontinue a test that ‘traumatizes’ rodents (STAT)
  • AmerisourceBergen's compounding site still on ice despite beefed-up oversight (BioPharmaDive)
  • Soon-Shiong presents first data on cancer memory vaccine at SITC (PMLive)
  • Alabama's biggest insurer will no longer cover OxyContin prescriptions (Pharmafile)
  • Sage May Be Forced To Simplify Brexanolone Dosing Regimen (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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 $51.5M (MedCity)
  • Second Sight Medical wins final CMS reimbursement nod for Argus II (MassDevice)
  • MaxQ AI wins FDA 510(k) clearance for acute intracranial hemorrhage triage algorithm (mobihealthnews)
  • Titan Spine closes undisclosed Series B round (MassDevice)
  • Could AI be the next big thing for medical device manufacturing? (Medical Design & Outsourcing)
  • TransEnterix posts Street-beating Q3 (MassDevice)
  • Globus Medical Q3 beats The Street (MassDevice)
  • ICU Medical posts mixed bag Q3 (MassDevice)
  • Senseonics reports mixed Q3 results (MassDevice)
US: Assorted & Government
  • Blood-Pressure Drug Cos. Hit With Suit Over Contamination (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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