Recon: US Prescription Drug Spending to Increase 6.6 Percent in 2018; Merck KGaA, Pfizer's Bavencio Fails in Ph. III Lung Cancer Trial

Posted 15 February 2018 | By Michael Mezher

Recon: US Prescription Drug Spending to Increase 6.6 Percent in 2018; Merck KGaA, Pfizer's Bavencio Fails in Ph. III Lung Cancer Trial

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

In Focus: US

  • FTC nominees open to tech probes, concerned about high drug prices (Reuters)
  • Spending growth on prescription drugs will double this year (STAT) (Reuters) (Health Affairs)
  • New York Will Investigate Reports of Gay Men Denied Insurance (NYTimes)
  • A biotech goes quiet on pivotal trial of a cancer vaccine, as doctors, investors, patients are left to wonder (STAT)
  • Merck KGaA, Pfizer's immunotherapy fails in lung cancer trial (Reuters)
  • Gottlieb Outlines FY 2019 Budget Goals (Focus)
  • Vertex's big week continues as nonopioid pain drug clears second Ph2 test (Fierce)
  • Trump presses key Republican to move on 'right to try' (STAT)
  • Irish drugmaker Horizon Pharma raises painkiller price to $3,000 in US (Financial Times)
  • FDA Approves First Treatment for Non-Metastatic, Castration-Resistant Prostate Cancer (Focus) (Reuters) (Endpoints)
  • FDA Clears First Blood Test to Aid Concussion Evaluations (Focus) (NYTimes)
  • Biogen shares tumble after key exec notes a changeup to pivotal aducanumab study due to 'variability' (Endpoints)
  • Minnesota renews push for tax on prescription opioids (Reuters)
  • Medical Records May Finally Be Coming To Your Apple Smartphone (NPR)

In Focus: International

  • Oxford BioMedica wins second $100 million gene therapy contract (Reuters)
  • EMA Drops 130 US Manufacturing Site Inspections Under Landmark MRA (Pink Sheet-$)
  • Vertex Cancels CF Trials In France (BioCentury) (Endpoints)
  • Celltrion receives EU approval for trastuzumab biosimilar Herzuma (Biosimilar News)
  • Santhera, reeling from DMD blow, lands cystic fibrosis drug (Fierce)
  • An Interview With Cuba's Top Regulator (Focus)
  • Indivior bets on $1 billion anti-addiction shot as legal bill weighs (Reuters) (Financial Times)
  • Teva shares jump after Berkshire Hathaway reveals $358m stake (Financial Times)
  • Shire warns on competition from generic drugs (Financial Times)
  • UDI for Medical Devices Going Global (Emergo)
  • Evidence from the field: Fractional doses of yellow fever vaccine provided protection, study finds (STAT)
  • Government to bring major changes in Drug Pricing Control Order (Economic Times)
  • China reports first human case of H7N4 bird flu (Reuters)
  • Nokia starts review of digital health business, cuts jobs in Finland (Reuters)
  • Saudi FDA Wants Drug & Device Firms To Report Payments To Doctors, Health Institutions (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Why Do So Few Docs Have Buprenorphine Waivers? (Medpage)
  • Charleston's Anti-Emetic/Opioid Combo Flops At US FDA Panel Over Postmarketing, Dosage Concerns (Pink Sheet-$)
  • Pharmaceutical Co-Crystals: FDA Finalizes Guidance (Focus)
  • White House Targets Generic Exclusivity to Lower Drug Prices (Bloomberg)
  • FDA Wants Generic Sponsors To Know If Anything Missing Before Submitting ANDA (Pink Sheet-$)
  • FDA's No. 2 Official Sounds Off on Right to Try, Opioid Crisis (BIO)
  • Digital divide persists with online portals for cancer patients (Reuters)
  • Exclusive Express Scripts Data: Most People Have Very Low Out-Of-Pocket Prescription Costs (Drug Channels)
  • Stratatech Begins Test of Engineered Skin for Diabetic Foot Ulcers (Xconomy)
  • 3 ways the U.S. should prepare for the next flu pandemic (STAT)
  • Fecal transplants move into the mainstream to treat difficult infection (STAT)
  • Company Seeks to Combat Aging And Disease With AI And Deep Learning (Forbes)
  • Asthma Linked To Infertility In Women Who Only Take Short-Term Medication (Forbes)
  • Woeful Axovant starts axing staff, but departing CEO David Hung gets a $2.6M exit package/bonus (Endpoints)
  • Building confidence in biosimilars (GaBI)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Selumetinib Granted Orphan Drug Designation by the U.S. FDA for Neurofibromatosis Type 1 (Press)
  • Shire's SHP647 bags another orphan badge (PharmaTimes)
  • Paratek submits new drug application to FDA for omadacycline  (Press)
  • The New England Journal of Medicine Publishes SPINRAZA® (nusinersen) Phase 3 Study Results in Individuals with Later-Onset Spinal Muscular Atrophy (Press)
  • OTEZLA® (Apremilast) Phase II Data Showed Clinically Meaningful Improvements in Patients with Active Ulcerative Colitis (Press)
  • Cinacalcet versus Placebo for secondary hyperparathyroidism in chronic kidney disease patients: a meta-analysis of randomized controlled trials and trial sequential analysis (Nature)
  • ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer (Press)
  • Evofem Biosciences Completes Enrollment of Phase 3 Contraceptive Trial of Amphora Ahead of Schedule (Press)
  • Arrowhead Receives Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV for Treatment of Hepatitis B (Press)
  • Aravive Biologics Initiates Phase 1 Study of Novel GAS6-AXL Pathway Inhibitor, AVB-S6-500 (Press)

Medical Devices

  • LivaNova Pumps Up its Heart Portfolio with TandemLife Deal (MDDI)
  • Top Medtech Companies of 2017: Notable Newcomers (MDDI)
  • FDA approves AI stroke application, signaling a shift in triage software oversight (Fierce)
  • Mazor Robotics shares down despite Street-beating Q4, FY2017 earnings (MassDevice) (MDDI)
  • Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI (MassDevice)
  • Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use (FDA)

US: Assorted & Government

  • Pfizer Says Insurers Owe $30M For Off-Label Marketing Suit (Law360-$)
  • Who won and who lost in tax reform? AbbVie, of course, but Regeneron, Roche, AstraZeneca and more (Fierce)
  • Impact Of Rebates On Drug Pricing Will Diminish -- CMS Experts (Pink Sheet-$)

Upcoming Meetings & Events

Europe

  • Draft Report on a European One Health Action Plan against Antimicrobial Resistance (EP)
  • Publication of final project plan of the assessment on "Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard cataract surgery" (EUnetHTA)
  • Edwards Lifesciences wins CE Mark for Centera TAVR (MassDevice)
  • DreaMed Diabetes wins CE Mark for insulin therapy management platform (Drug Delivery)

Australia

  • Opdivo gains approval in Australia for advanced bladder cancer (PharmaLetter)

General Health & Other Interesting Articles

  • A Cancer Researcher Takes Cancer Personally (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.


Categories: Recon

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe