Regulatory Focus™ > News Articles > 2019 > 7 > Recon: FDA Approves Merck’s Antibiotic Recarbrio to Treat Complicated Infections

Recon: FDA Approves Merck’s Antibiotic Recarbrio to Treat Complicated Infections

Posted 17 July 2019 | By Michael Mezher 

Recon: FDA Approves Merck’s Antibiotic Recarbrio to Treat Complicated Infections

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Merck's treatment for urinary, abdominal infections gets FDA approval (Reuters) (Endpoints) (FDA) (Press)
  • Merck urges caution on use of its newly approved antibacterial (BioPharmaDive)
  • Pharma deploys its top guns to Capitol Hill as senators mull drug pricing package (STAT)
  • States Are Making Progress on Opioids. Now the Money That’s Helping Them May Dry Up (NYTimes)
  • Calls Grow For Medicare To Cover Anti-Rejection Drugs After Kidney Transplant (KHN)
  • CVS enters home dialysis care with clinical trial of new system (Reuters)
  • Elon Musk wants to test brain-reading implants in paralyzed patients next year (STAT)
  • 3 Gilead execs, including R&D head, to leave as leadership shake-up continues (BioPharmaDive) (Endpoints) (Fierce)
  • Mallinckrodt forced to shutter ALS study testing its controversial Acthar gel (Endpoints) (Press)
  • Drug makers flooded US with billions of opioid pills as epidemic surged, data shows (The Guardian) (NPR)
  • Who’s the toughest on drug prices? A game of political one-upmanship is driving the policy debate in Washington (Endpoints)
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In Focus: International
  • Frequency signs $80 million deal with Astellas Pharma (STAT) (BioCentury) (Endpoints) (Press)
  • Merck’s Keytruda is First to Add Indications Under TGA’s Provisional Approval Pathway (Focus)
  • FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection (Focus)
  • Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA (Focus)
  • Congolese cross-border trader's Ebola death fuels Uganda outbreak fears (Reuters)
  • Debate over whether to test a second Ebola vaccine turns acrimonious (STAT)
  • Kisqali combination follows Verzenio onto Cancer Drugs Fund (PMLive)
  • Following footsteps of chart-topping Chinese counterparts, Alphamab Oncology files IPO at HKEX (Endpoints)
  • AstraZeneca to pay millions of pounds to former staff (Financial Times)
Pharmaceuticals & Biotechnology
  • FDA Warns Strides Pharma for Uncontrolled Document Shredding (Focus)
  • What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains (Focus)
  • Seer entices ex FDA commissioner McClellan to its board; Vanda tests tradipitant in motion sickness study (Endpoints)
  • Bayer, Longwood back star researcher's deep dive into the tumor microenvironment for new I/O targets (Endpoints)
  • Seattle Genetics investors breathe a sigh of relief as Adcetris posts 30% sales growth (Fierce)
  • Illumina sets up first ex-US accelerator site in Cambridge (PMLive)
  • Inovio cuts staff, research to buy time (BioPharmaDive) (Fierce) (Endpoints)
  • Immusoft names former Amgen biologics chief as chief scientific officer (Fierce)
  • PureTech acquires LYT-100 to treat lymphedema (PharmaTimes)
  • JAMA: Withdraw This Flawed and Inaccurate Article About the 340B Program and Drug Prices (Drug Channels) (JAMA)
  • AstraZeneca to switch entire fleet to electric vehicles by 2030 (Pharmafile)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer (Press)
  • U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension (Press)
  • Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-ANG3 (Press)
  • Elios Therapeutics Announces Positive Top-Line Data from Phase IIb Study Evaluating TLPLDC, a Personalized Therapeutic Cancer Vaccine, in Patients with High-Risk Melanoma (Press)
  • Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products (FDA)
  • Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold by OCuSOFT (FDA)
Medical Devices
  • The Sad Truth About Sleep-Tracking Devices and Apps (NYTimes)
  • FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions (Focus)
  • Abbott gains on Q2 earnings beat, raised outlook (MassDevice)
  • CDRH Instructs on Magnetic Field Interference with Shunt Systems (Focus) (MassDevice)
  • Teleflex recalls neonatal breathing devices (MassDevice)
  • Paragon Biosciences Launches Qlarity Imaging to Advance the First FDA-Cleared Artificial Intelligence Breast Cancer Diagnosis System (Press)
  • Class 1 Device Recall Alaris System with Guardrails Suite MX (FDA)
US: Assorted & Government
  • Alexander: CBO Says Lower Health Care Costs Act Will Reduce Health Insurance Premiums, Lower Prescription Drug Costs (Alexander)
  • CBO Finds Major Savings in FDA Provisions of Senate Health Bill (Focus)
  • Justice Department Announces Results in Fight Against the Opioid Crisis At One Year Mark of Operation S.O.S. (DoJ)
  • The House is about to back repealing Obamacare’s unpopular ‘Cadillac tax’ in rare bipartisan vote (CNBC)
  • E&C Committee approves bill requiring companies to justify drug price increases (BioCentury)
  • Pharmacy Benefit Cos. Improved Opioid Policies, Judge Says (Law360-$)
  • What High Court's Kisor Ruling Means For FDA Decisions (Law360-$)
  • Study confirms heart benefit of soy as FDA reviews this claim (Reuters)
  • UCB, Inc. v. Watson Laboratories Inc. (Fed. Cir. 2019) (Patent Docs)
  • Judicial Involvement in the Settlement Process (Drug & Device Law)
  • Former Insys Execs Want Sentencing Delayed Until 2020 (Law360-$)
Upcoming Meetings & Events Europe
  • EC Revises Drug Safety Features Q&A (Focus)
  • Advertising investigations: June 2019 (MHRA)
  • Medical Device Alerts issued in June 2019 (MHRA)
  • Letters and drug alerts sent to healthcare professionals in June 2019 (MHRA)
  • Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease (MHRA)
  • Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation (MHRA)
  • Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food (MHRA)
Asia
  • Abbisko builds combination strategy with China rights to X4's mavorixafor (BioCentury)
  • Korea’s Orum stays local with $30M round to build out cell-penetrating platform (BioCentury) (Endpoints)
  • Eisai’s Halaven cleared for breast cancer in China (PharmaLetter-$)
India
  • New Drugs and Clinical Trial Rules to promote local trials in India to develop new drugs & vaccines. Dr Naresh Sharma (PharmaBiz)
  • Growth in imports of devices is being purposely exaggerated by domestic cos to seek hike in customs duty: MTaI (PharmaBiz)
Australia
  • Disinfectant Claim Guide - specific claims and non-specific claims (TGA)
  • Guidance on the regulation of exempt disinfectants in Australia (TGA)
General Health & Other Interesting Articles
  • New Clues on Why Women's Alzheimer's Risk Differs From Men's (AP)
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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