Regulatory Focus™ > News Articles > 2 > Recon: Vertex Picks Two Drugs to Advance for CF Triple Combinations; NICE Backs Roche's Perjeta for

Recon: Vertex Picks Two Drugs to Advance for CF Triple Combinations; NICE Backs Roche's Perjeta for Breast Cancer

Posted 01 February 2018 | By Michael Mezher 

Recon: Vertex Picks Two Drugs to Advance for CF Triple Combinations; NICE Backs Roche's Perjeta for Breast Cancer

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Vertex chooses two drugs to advance in cystic fibrosis triple combinations (CNCB) (Reuters)  (Endpoints) (Forbes) (Press)
  • Top product sales forecasts for 2018 (Nature)
  • Pharma's latest defense against drug pricing criticism: Drugs lower health-care costs (CNBC)
  • The Viagra effect: Sales of Lilly's ED drug Cialis slide after little blue pill goes generic (Fierce)
  • Eli Lilly CEO rebuffs Trump's attack on drug prices (CNBC)
  • Why Brenda Fitzgerald had to resign (Politico)
  • Attorney General Sessions Announces DEA Surge to Combat Prescription Drug Diversion (DoJ)
  • As States Target High Drug Prices, Pharma Targets State Lawmakers (KHN)
  • Heart group warns of cardiovascular risks after treatment for breast cancer (STAT)
  • Puma touts its latest advances in a basket trial for Nerlynx, as Europeans appear ready to reject the drug (Endpoints) (Press)
  • Show me the data: Docs remain squeamish about Merck lung cancer drug as first-line treatment (STAT)
  • FDA and Opioids: Too Much Regulation or Not Enough? (Medpage)
  • A town of 3,200 was flooded with nearly 21 million pain pills as addiction crisis worsened, lawmakers say (Washington Post)
  • Baxter Reports 2017 Fourth-Quarter and Full-Year Results (Press)
  • North Korea threats spur US search for new radiation therapies (Reuters)
  • Pharmacist tied to U.S. meningitis outbreak gets eight years in prison (Reuters)

In Focus: International

  • NICE backs Roche's Perjeta for breast cancer (PharmaTimes) (The Guardian)
  • Drugmaker Roche sees slow growth as copycats take toll (Financial Times) (Press)
  • Roche silently scraps two one-time blockbuster hopefuls as $725M Seragon deal craters (Endpoints)
  • Amazon Wants to Disrupt Health Care in America. In China, Tech Giants Already Have. (NYTimes)
  • Australia To Identify High-Risk Companies Ahead Of First Pharmacovigilance Inspections (Pink Sheet-$)
  • Danish drug maker Novo Nordisk's profit edges higher as chair departs (Financial Times)
  • European Union moves toward a formal policy for reviewing new medicines (STAT) (Pink Sheet-$)
  • How China Regulatory Reforms Ring In International Biotechs' New Year (Pink Sheet-$)
  • Korea To Examine Companies' R&D-Related Accounting For Transparency (SCRIP-$)
  • India Wants to Give Half a Billion People Free Health Care (NYTimes)
  • Namibia reports first cholera case after deadly outbreak in Zambia (Reuters)
  • Are we missing the real opioid drug crisis? (BBC)

Pharmaceuticals & Biotechnology

  • China might be winning the CRISPR race, but we have the FDA (Popular Science)
  • Flu vaccine provided dismal protection against this winter's virus, early data suggest (STAT)
  • Botox injections may relieve migraine pain in children, adolescents (NBC)
  • Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia (NEJM)
  • Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia (NEJM)
  • Nuclear scare to fuel anti-radiation drug sales? PTx buys ex-Sanofi drug just in case (Endpoints) (Xconomy)
  • Avrobio Raises $60M for Fabry Disease Gene Therapy, Rest of Pipeline (Xconomy) (Endpoints)
  • Is too much money being invested in oncology? (MedCityNews)
  • Think your odds of R&D success are miserable? MIT's Andrew Lo might have a surprise for you (Endpoints)
  • Even obese breast cancer survivors may cut heart disease risk with exercise (Reuters)
  • Voyager founder and CEO to step down, no replacement yet (Fierce)
  • AstraZeneca, Syndax ally to test PD-L1 drug and CSF1R inhibitor in solid tumor patients (Fierce)
  • Trump needs to pressure drugmakers, not Congress, to let terminally ill patients use experimental treatments, experts say (CNBC)
  • Can Vending Machines That Dispense Prescription Opioids Help Addicts Survive The Opiate Crisis? (Forbes)
  • Zealand, underwhelmed by Sanofi's Soliqua sales, plans to ride solo on future launches (Fierce)
  • Tumor 'vaccine' clears several cancer types in mice (Fierce)
  • Lilly/BI's Basaglar: A Rosier Outlook For US Biosimilars? (SCRIP-$)
  • Gene therapy: Reprogramming α-cells reverses diabetes (Nature)
  • Immunotherapy: Oncolytic virotherapy enables checkpoint blockade (Nature)
  • Pharmacogenomics: Know your GPCR mutations (and target them right) (Nature)
  • Engine Biosciences Nabs $10M to Develop AI-Based Drug Discovery Tech (Xconomy)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Transdermal patch for treatment of schizophrenia hits Phase III goals (PharmaLetter-$)
  • MeiraGTx Receives Rare Pediatric Disease Designation for A002 for the Treatment of Achromatopsia Due to Mutations in the CNGB3 Gene (Press)
  • Vaxart Announces Its Oral Flu Vaccine Significantly Reduced Rate of Influenza Infection in Phase 2 Challenge Study (Press)
  • Panacea Pharmaceuticals Completes Enrollment in Phase 1 Study of First-in-Class Cancer Vaccine Therapy in Patients with Persistent Prostate Cancer (Press)
  • Imago BioSciences Receives FDA Approval of IND Application for the Treatment of Myeloid Malignancies (Press)

Medical Devices

  • Potential blood test for Alzheimer's shows early promise (Reuters)
  • The Countdown to Implementing ISO 13485:2016 (MDDI)
  • Will Zimmer Be Medtech's Comeback Kid of 2018? (MDDI)
  • Boston Scientific slides to Q4 red on $861m tax charge (MassDevice)
  • Grünenthal Group Receives FDA's Expedited Access Pathway Designation for VIVO (Press)

US: Assorted & Government

  • GAO Blocks Big Biz Protest On FDA Small Biz Software Deal (Law360-$)
  • Indiana's Brand Of Medicaid Drops 25,000 People For Failure To Pay Premiums (NPR)
  • Democrats Ask GAO to Review White House Action on Opioids Since Emergency Declaration (FDANews-$)
  • Judge that nixed Juxtapid's DOJ settlement prompts Aegerion to admit its off-label sins (Fierce)
  • Proposed Legislation to Reform the OTC Drug Monograph System (FDA Law Blog)
  • Missouri Federal Court Rejects Effort to Limit the Effect of BMS (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • EMA recommended 35 new drugs in 2017 (Nature)
  • Danish Watchdog Says CD Pharma Abused Its Dominance (Law360-$)
  • EudraVigilance system v.1.5 release notes  (EMA)
  • Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population (EMA)
  • Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance (EMA) (Comments)
  • Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance (EMA)
  • Paracetamol oral use immediate release formulations product-specific bioequivalence guidance (EMA) (Comments)
  • Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance  (EMA)
  • Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2017 – 2018 (MHRA)
  • Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2016 – 2017 (MHRA)

Asia

  • Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region (Press)

India

  • Daiichi Wins Enforcement Of $550M Ranbaxy Award In India (Law360-$)

Australia

  • Prescription medicines: registration of new generic medicines and biosimilar medicines (TGA)
  • Australian Court Restrains Apotex Challenge To Cipla-Meda's Dymista (SCRIP-$)
  • A future of better pain management without codeine awaits Australia (The Guardian)

Other International

  • New Zealand's Medsafe regulatory body removes pelvic mesh products from market (MassDevice)

General Health & Other Interesting Articles

  • After a Cancer Diagnosis, Playing the Odds (NYTimes)
  • A Doctor's Painful Struggle With an Opioid-Addicted Patient (NYTimes)
  • Omega-3 Supplements Don't Protect Against Heart Disease (NYTimes)

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.


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