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

• 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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• 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)

• 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)

• 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)

• 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)

• 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-$)

• FDA Advisory Committee Calendar

• 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)

• Abbisko builds combination strategy with China rights to X4's mavorixafor (BioCentury)
• Korea’s Orum stays local with $30M round to build out cell-penetrating platform (BioCentury) (Endpoints)
• Eisai’s Halaven cleared for breast cancer in China (PharmaLetter-$)

• 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)

• Disinfectant Claim Guide - specific claims and non-specific claims (TGA)
• Guidance on the regulation of exempt disinfectants in Australia (TGA)

• New Clues on Why Women's Alzheimer's Risk Differs From Men's (AP)