Regulatory Focus™ > News Articles > Regulatory Recon: Merck Releases Data From Alzheimer's Trials; NICE Approves First Breast Cancer Dru

Regulatory Recon: Merck Releases Data From Alzheimer's Trials NICE Approves First Breast Cancer Drug in a Decade (3 November 2016)

Posted 03 November 2016 | By Michael Mezher 

Regulatory Recon: Merck Releases Data From Alzheimer's Trials NICE Approves First Breast Cancer Drug in a Decade (3 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Adverse events in trial dent hopes for Roche hemophilia drug (Reuters) (Fierce)
  • Merck posts package of BACE1 data from Alzheimer's trials (Fierce) (Merck) (Scientific American) (Science Translational Medicine)
  • Antibiotics Are Hard, Continued (In the Pipeline) (Pink Sheet-$)
  • Multifaceted approach to multidrug resistance (Nature)
  • Lifesaving Cancer Drugs May in Rare Cases Threaten the Heart (NYTimes)
  • The Impact Of ABSORB II: Down The Slippery Slope (CardioBrief)
  • Worse Than the Disease (Undark)
  • Director's Update: Meeting GDUFA Commitments (Slides)
  • New Data Show Power, Limits of Bluebird's Gene Therapy For Blood Diseases (Xconomy)
  • The backlash over high drug prices is hitting pharma where it hurts (STAT)
  • Genetic test costs taxpayers $500 million a year, with little to show for it (STAT)
  • West Virginia AG blasts 'irresponsible, sweetheart' EpiPen settlement with Mylan (CNBC) (STAT)
  • Lead MDUFA Negotiator Details Changes in MDUFA IV Financing (Focus)
  • Device Lets Cancer Patients Assist in their Own Breast Reconstruction, at Home (MIT Technology Review)
  • FDA Builds Quality Dashboard To Focus CMC Reviews And Inspections On Greatest Risks (Pink Sheet-$)
  • Gilead quietly drops drugs from line up alongide Q3 results (Pharmafile)
  • AveXis gains after revealing SMA study details (BioCentury)
  • Allergan misses revenue forecasts as sales of older drugs slump (Financial Times)
  • Valeant Hit With Chancery Suit Over Libido Drug Marketing (Law360-$) (Fierce)

In Focus: International

  • There's a Blood Battle Raging Between Europe's Drug Giants (Bloomberg)
  • NICE approves first new drug for breast cancer in a decade (Pharmafile) (Reuters)
  • Parallel EMA-FDA Pediatric Advice On The Cards For Companies (Pink Sheet-$)
  • Drug Giant Faced a Reckoning as China Took Aim at Bribery (NYTimes)
  • Japan's Takeda Pharmaceutical Seeks to Expand Overseas (WSJ) (BioCentury)
  • Engineering Viruses To Kill Cancer Cells, Canada-Based Turnstone Raises $41.4M (Forbes)
  • Government may disband National Pharmaceutical Pricing Authority (Economic Times)
  • Singapore Medical Device Regulators Target Telehealth (Emergo)
  • Where Is The Reward? New Drug Developers See Red In China (SCRIP-$)
  • Genmab revenues more than double year to date (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Insys Therapeutics Pops On Earnings Beat, But Revenues Plunge (Forbes)
  • How The Battle Against Opiods Could Put Older Adults At Risk (Forbes)
  • Clinical trials and their patients: The rising costs and how to stem the loss (Pharmafile)
  • Making It Digital: What Is Pharma Doing? (SCRIP-$)
  • Palliative care should be standard in cancer treatment: guideline (Reuters)
  • Will Palatin's Phase III Female Sex Endpoint Swap Pass With FDA? (Pink Sheet-$)
  • Keeping Up with ..... FDA's Drug Compounding Lists: Todays PCAC Meeting (FDA Law Blog)
  • Wockhardt data may delay US solithromycin review says Cempra after asking Uquifa for CMC info (In-PharmaTechnologist)
  • Catalent breaks ground on WI expansion to support commercial biomanufacturing (BioPharma-Reporter)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • First hearing-disorder drugs stumble (Nature)
  • Momenta and Mylan initiate Phase I clinical trial for Orencia (abatacept) biosimilar (BiosimilarNews)
  • FDA Accepts Genentech's Biologics License Application For Subcutaneous Formulation Of Rituximab (Press)
  • ACADIA Pharmaceuticals Initiates Phase III Trial of Pimavanserin for Adjunctive Treatment in Patients with Schizophrenia (Press)
  • New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo (Press)
  • Midstage Vitae drug flops in PhII, leaving Allergan's $640M buyout in question (Fierce)
  • Bellicum Announces Data Presentations on Lead Product Candidate BPX-501 and CAR-T and TCR Programs at the 58th American Society of Hematology Annual Meeting (Press)
  • Omeros Files Orphan Drug Application for OMS721 in Immunoglobulin A Nephropathy (Press)
  • Bristol-Myers Squibb to Present New Data at the 58th Annual Meeting & Exposition of the American Society of Hematology Demonstrating Research Advancements in Immuno-Oncology and Across Multiple Blood Cancers (Press)
  • Juno Therapeutics to Highlight CAR T Advances in B-cell Malignancies at ASH 2016 (Press)
  • Santalis Pharmaceuticals Obtains FDA Allowance To Start A Phase 2 Clinical Study For The Treatment Of Mild To Moderate Atopic Dermatitis (AD) (Press)
  • Revance Announces Initiation of Phase 2 Trial of RT002 Injectable to Treat Plantar Fasciitis (Press)
  • Researchers to Present New Phase 1/2 Data on ALXN1210 in Patients with PNH at ASH 2016 Annual Meeting (Press)
  • One year data from Kiadis Pharma's ongoing Phase II trial with ATIR101™ will be presented at the American Society of Hematology 2016 Annual Meeting (Press)
  • Aurinia Announces Plans for Single Phase III Clinical Trial for Voclosporin in the Treatment of Lupus Nephritis Following Successful Completion of End of Phase II Meeting With FDA (Press)

US: Medical Devices

  • St. Jude shipped old versions of heart device 17 months after key design change (Star Tribune)
  • Inside the largest medical device acquisition in history (Medical Design & Outsourcing)
  • Prioritizing patient preference & risk in device trials (MassDevice)
  • 2016 Readers' Choice Medtech Company of the Year (MDDI)
  • What it's like to be a woman in the corner office: A DeviceTalks podcast (MassDevice)
  • TCT 2016: Claret's pivotal data far from a masterstroke (EP Vantage)
  • TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3 (MassDevice)
  • E-Qure wins FDA nod for bio-electrical signal wound therapy (MassDevice)
  • Baxter launches pivotal trial for citrate anticoagulant-renal replacement solution combo (MassDevice)
  • Apollo Endosurgery Announces Successful Completion of LAP-BAND® FDA Post-Approval Study (Press)
  • Arterys Receives 510(k) Clearance for Arterys Software for Cloud-Based Medical Image Visualization and Quantification (Press)

US: Assorted & Government

  • Emergency Funding For Ebola Response: Some USAID Reimbursements Did Not Comply with Legislative Requirements and Need to Be Reversed (GAO)
  • State Interest In 1332 Waivers Gaining Steam (Health Affairs Blog)
  • Comparing Medicare Prescription Drug Plans (NYTimes)
  • Bad Experiences and Serious Injury Do Not Make a Drug and Device Law Claim (Drug and Device Law)

Upcoming Meetings & Events

Europe

Asia

  • Japan approves St. Jude Medical's EnSite, TactiCath (MassDevice)
  • CALL FOR COMMENTS on the PROPOSED document "Guidelines for adverse event reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative" (AHWP)
  • Japanese firm invests $11.4 mn in TB and malaria research (BioSpectrum)

India

  • Aurobindo Pharma may buy Portugal's Generis, deal likely to be valued at $200 million (Economic Times)

Australia

  • TGA presentation: University of Technology, Sydney, 19 October 2016 (TGA)

Canada

  • Regulatory decision summary for ZEPATIER (Health Canada)
  • Summary Basis of Decision Daklinza (Health Canada)
  • Regulatory decision summary for CORTIMENT (Health Canada)
  • Summary Safety Review - Interferon beta products - Assessing the Potential Risk of Pulmonary Arterial Hypertension (Health Canada)

Zika

  • Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability (FDA)
  • Accurate Facebook posts about Zika virus were plentiful, not popular (Reuters)

General Health & Other Interesting Articles

  • Start-Ups for the End of Life (NYTimes)
  • Science Rewards Eureka Moments, Except When It Doesn't (NPR)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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