Regulatory Recon: Grassley Pushes for Drug Pricing Measures in CHIP Reauthorization; US Presses India on Device Price Caps (4 October 2017)

Posted 04 October 2017 By Michael Mezher

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

In Focus: US

  • Grassley Presses for Drug Pricing Measures in CHIP Reauthorization (Morning Consult)
  • CMS Puts Brakes on Part B Drug Payment Demo (Medpage)
  • Mylan says FDA approves its generic multiple sclerosis treatment (Reuters 1, 2) (Endpoints) (Financial Times) (WSJ) (Press)
  • Copaxone Generics: Who Will Win First Filer Exclusivity? (Focus)
  • FDA Rolls Out Zero-Tolerance Policy On ANDA Typos (Pink Sheet-$)
  • ACLU sues over FDA restrictions on abortion pill access (Reuters) (Law360-$)
  • FDA: Blindness Risk From Compounded Vancomycin Eye Injections (MedScape) (FDA)
  • The Hepatitis Drug Market Is Worse Than Wall Street Realizes (Bloomberg)
  • CytomX scores deal with Amgen worth potential $1.5B (Pharmafile) (Endpoints)
  • US House committee launches probe of Allergan patent deal (Reuters)
  • FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing (Focus)
  • FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions (Focus)
  • What failure? Catabasis shares soar after execs tout open-label data, PhIII plans (Endpoints) (Fierce) (BioCentury) (Press)
  • Can Janssen Revive Its Key Remicade Patent? Federal Circuit Hears Pitch (Pink Sheet-$) (Big Molecule Watch)

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In Focus: International

  • South Africa watchdog drops over-charging probe into Aspen, Equity (Reuters)
  • US pressing India to avoid capping medical device prices, allow withdrawals (Reuters)
  • Pharma leaders fail in attempt to secure judicial review of UK bill curbs policy (Financial Times)
  • EMA publishes comments on Member States' hosting bids (EMA)
  • Merck ups investment in its Italian biotech manufacturing site (PharmaLetter-$) (InPharmaTechnologist)
  • AbbVie adds biologic production capability to Singapore facility (Pharmafile)
  • Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (Focus)
  • Fosun Pharma acquires 74% stake in Gland Pharma for $1.09 billion (Economic Times)
  • Brexit Won't Alter EU Agency Heads' Ambitious Work Plan – For Now (Pink Sheet-$)
  • New Patent Database To Help Drug Procurement Agencies Worldwide (Pink Sheet-$)
  • Partners commit to reduce cholera deaths by 90% by 2030 (WHO)
  • Refugees' health problems in Greece mostly unmet: medical charity (Reuters)
  • Three biophysicists win 2017 Nobel Prize in chemistry for imaging molecules of life (Washington Post)

Pharmaceuticals & Biotechnology

  • Top-Selling, Top-Prescribed Drugs for 2016 (MedScape)
  • Drilling Down on Generic vs Brand Risk (Medpage)
  • Immunotherapy: Tisagenlecleucel — the first approved CAR-T-cell therapy: implications for payers and policy makers (Nature)
  • Lonza buys US clinical manufacturing site from Shire (Reuters) (BioPharmaReporter)
  • Another slow quarter for biopharma takeovers (EP Vantage)
  • FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products (FDA)
  • Commissioner Gottlieb's Statement: "We Want You"... Seeking Able-Bodied Compounders to Register as Outsourcing Facilities Pursuant to FDCA Section 503B (FDA Law Blog)
  • The Emergent Microbiome: A Revolution for the Life Sciences -- Part XIII: The Microbiome and Antibiotic Resistance (Patent Docs)
  • Walgreens Expands Medication Disposal To 1,500 Stores In Opioid Battle (Forbes)
  • As Eli Lilly moves some marketing in-house, should ad agencies brace for fallout? (Fierce)
  • Failure to vaccinate is likely driver of U.S. measles outbreaks, report says (Washington Post)
  • PPD hires FDA, Novartis and Genentech veteran in new dual role (Fierce)
  • Gabapentin, opioids, and the risk of opioid-related death: A population-based nested case–control study (PLOS)
  • Gene-Edited Skin Could Be Its Own Blood-Sugar Sensor (MIT Technology Review)
  • Amgen-partnered Immatics bags a $58M round to fund its first clinical steps on new T-cell tech for cancer (Endpoints)
  • Biotech says its vaccines target and kill cancer cells, with fewer side effects (BioPharmaReporter)
  • Backed by Big Pharma VCs, Palleon ramps up a new approach to immuno-oncology with a $48M startup round (Endpoints)
  • Juno opens HQ & cancer research site (BioPharmaReporter)
  • Elligo Receives FDA Award to Evaluate Harmonized Data Model for Safety Assessment of New Oncology Therapies (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Takeda Paves The Way For Myovant With Phase III Fibroid Success (SCRIP-$)
  • Following FDA debacle in '09, Motif lines up a new shot at approval for antibiotic iclaprim (Endpoints)
  • Amicus' latest positive update on Pompe drug hints at accelerated approval pitch (Endpoints) (Xconomy)
  • Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens (Press)

Medical Devices

  • CLIA Waiver Decisions: FDA Begins Posting Summaries (Focus)
  • The FDA just approved the first mobile device and app to help you quit smoking (CNBC)
  • Too Little, Too Late: MedTech Startups Struggle to Find Early Funding (MDDI)
  • Teleflex closes $1B NeoTract buy (MassDevice)
  • It's official: Abbott closes $5B Alere buy (MassDevice)
  • After Blowing The Whistle On Theranos, Tyler Shultz Is Going Back Into Medical Testing (Forbes)
  • IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions (Emergo)
  • Baxter launches 2 studies of HDx hemodialysis using Theranova dialyzer (MassDevice)
  • US FDA Approves New Continued Access Protocol for the ReCell Device for Treatment of Burn Injuries (Press)
  • Solta Medical Receives FDA 510(k) Clearance for Thermage FLX System, Newest Generation Skin Smoothing Technology (Press)
  • Nexxt Spine Announces FDA Clearance for the NEXXT MATRIXX System (Press)

US: Assorted & Government

  • FDA Warns Bakery Company 'Love' Is Not an Ingredient in Granola (Bloomberg) (Law360-$)
  • Congress moves toward funding lapsed federal children's health insurance program, House eyes Medicare hike for higher earners (CNBC)
  • Lapse In Federal Funding Imperils Children's Health Coverage (NPR)
  • With Affordable Care Act's Future Cloudy, Costs for Many Seem Sure to Soar (NYTimes)
  • Pfizer Loses Suit Against Texas Agency Over Sharing Medicaid Data With Lawmakers (FDANews-$)
  • Supreme Court won't review $3m pelvic mesh loss for J&J's Ethicon (MassDevice)
  • Gilead To Take 9th Circ. Escobar Ruling To High Court (Law360-$)
  • Novartis, Genentech Want 'Hopeless' Kickback Suit Tossed (Law360-$)
  • Report: Mylan to pony up $20m to Massachusetts in EpiPen settlement (Drug Delivery)
  • The Third Circuit Fosamax Preemption Error Has Got To Go, Part 2 (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Information on changes to the guidance document (formerly Information sheet) on the Fast-track authorisation procedure (Swissmedic)
  • HiberGene Meningitis Test Gets CE Mark (GenomeWeb)

Asia

  • PMDA Updates - September, 2017
  • FDA Warns Korean Drugmaker Over Testing, GMP Issues (Focus)

India

  • India CEO Pay: Local Firms Still Way Ahead Of Foreign Peers (SCRIP-$)
  • Health ministry issues draft rules to facilitate sales of drugs online (PharmaBiz)
  • Health ministry releases pharmacovigilance guidelines to ensure ease of doing PV practices (PharmaBiz)

General Health & Other Interesting Articles

  • Infant Sleep Positioners: FDA Warning - Risk of Suffocation (FDA)
  • Obesity-related cancers rising, threatening gains in US cancer rates (Reuters)
  • Breast-cancer death rate drops almost 40 percent, saving 322,000 lives, study says (Washington Post)

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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