Regulatory Focus™ > News Articles > Regulatory Recon: Senate Committee to Look Into Rising Off-Patent Drug Costs & Clinical Trial Result

Regulatory Recon: Senate Committee to Look Into Rising Off-Patent Drug Costs & Clinical Trial Results from ASH (7 December 2015)

Posted 07 December 2015 | By

Regulatory Recon: Senate Committee to Look Into Rising Off-Patent Drug Costs & Clinical Trial Results from ASH (7 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Why the US Should Pay Irish Drug Prices if Pfizer Wants to Pay Irish Tax Rates (Washington Post)
  • Rising Drug Costs to Be in Focus at Congressional Hearing (WSJ) (Senate Committee on Aging)
  • For Hepatitis C Drugs, US Prices are Cheaper Than in Europe (Forbes)
  • Diagnosing Theranos (Forbes)
  • Cheap Drugs Create Quality Temptations, FDA Official Says (Pink Sheet-$)
  • PDUFA VI: FDA Wary of Industry Proposals With More Metrics (Tan Sheet-$)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA adds warnings to SGLT2 inhibitors' labels (BioCentury) (FDA 1, 2)
  • Production begins at uniQure MA plant to support gene therapy pipeline (BioPharma-Reporter)
  • FDA delay in safety rule leaves US patients at risk, says Public Citizen (PharmaLetter-$) (Public Citizen)
  • KaloBios Buys Chagas Drug With Eye On Priority Review Voucher (SCRIP-$)
  • Defining 'Substantial Efficacy': Post Hoc Analysis OK (When FDA Does It) (Pink Sheet-$)
  • Eight Themes From The Corner Of Interoperability And Precision Medicine (Forbes)
  • Heart Drug Safety Concerns Prompt Shutdown at Laguna Pharmaceuticals (Exome)
  • JMCP Validates the Ability to Quantify the Safety Risk of Drugs (Advera)
  • How industry should improve beyond-the-pill-programmes (PharmaPhorum)
  • The Future Looks Bright For Orphan Drugs (SCRIP-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Merck KGaA, Threshold drug fails in late-stage cancer trials (Reuters) (Press)
  • AbbVie, J&J leukemia drug cuts death risk vs chemo in new patients (Reuters)
  • FDA Grants Fast Track Designation To Luspatercept For Treating Lower-risk MDS (Press)
  • Novartis trial shows drug improves survival for AML patients (Reuters)
  • Novartis: Lymphoma study shows CART on track for 2017 US submission (Reuters)
  • Celgene in Collaboration with Astrazeneca Announce Initiation of Fusion Clinical Development Program in Immuno-Oncology (Press)
  • bluebird bio reports new data from HGB-205 and HGB-206 studies of LentiGlobin at ASH (PharmaLetter-$)
  • Adaptive Biotechnologies' clonoSEQ MRD Test Can Be Used to Guide Post-Transplant Treatment Decisions in Multiple Myeloma Patients (Press)
  • New Longer-Term Data for Empliciti (elotuzumab) Showed a Continued Progression-Free Survival Benefit in Patients with Relapsed or Refractory Multiple Myeloma (Press)
  • Two Phase 3 Studies Reinforce Sustained Benefits of Treatment with Jakafi (ruxolitinib) in Patients with Myeloproliferative Neoplasms (MPNs) (Press)
  • Takeda Reports Five-Year Overall Survival Data for ADCETRIS (Brentuximab Vedotin) Demonstrate Durable Remissions in Relapsed/Refractory Hodgkin Lymphoma (Press)
  • Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for NINLARO (ixazomib), First and Only Once-Weekly Oral Proteasome Inhibitor Recently Approved for Multiple Myeloma (Press)
  • Pivotal Phase II Study Showed Nearly 80 Percent of People with Hard-to-Treat Type of Chronic Lymphocytic Leukemia Responded to Investigational Medicine Venetoclax (Press)
  • ARIAD Announces Initiation of OPTIC-2L Randomized Phase 3 Trial of ponatinib vs. nilotinib in Second-Line Patients with Chronic-Phase Chronic Myeloid Leukemia (Press)
  • Acetylon Presents Data from Three Phase 1b Studies of Ricolinostat (ACY-1215) for the Treatment of Lymphoma and Multiple Myeloma (Press)
  • Epizyme Presents Updated Data from Ongoing Phase 1 Study of Tazemetostat Showing Objective, Durable Responses in Relapsed or Refractory Non-Hodgkin Lymphoma (Press)
  • Spectrum Pharmaceuticals and Onxeo Announce Complete Response in 67% of Patients with Peripheral T-Cell Lymphoma in Combination of Belinostat (Beleodaq®) and Standard CHOP (Press)
  • New data from pivotal study showed Roche's Gazyva/Gazyvaro induced deep remissions and provided meaningful quality of life improvements in people with difficult-to-treat indolent non-Hodgkin lymphoma (Press)
  • New results from CLL11 study show Gazyva/Gazyvaro provided people with previously untreated chronic lymphocytic leukaemia a treatment-free period of nearly four years (Press)
  • Novartis announces new CTL019 study data demonstrating overall response in adult patients with certain types of lymphoma (Press)
  • Clearside Biomedical, Inc. Enrolls First Patient in Phase 3 Clinical Trial of CLS-TA Using Suprachoroidal Drug Administration (Press)
  • ADC Therapeutics Receives FDA Clearance to Begin Clinical Studies for Its Second Novel Antibody Drug Conjugate ADCT-402 against Lymphomas and Leukemia (Press)

US: Medical Devices

  • Why Are Investors Running Away From Medical Devices? (Forbes)
  • FDA Emphasizes Timesavers In New eCopy Guidance (Gray Sheet-$)
  • Why medical devices are so hard to secure (mHealthNews)
  • Should Doctors Also Act as Device Sellers? (MedpageToday)
  • Google Life Sciences edges into Theranos terrain with needle-free, micro blood draw patent filing (FierceMedicalDevices)
  • Qfix Receives 510(k) Clearance for Encompass SRS Immobilization System (Press)
  • Troubled Insulet recalling additional 18 lots of wearable insulin pump due to needle failure (FierceMedicalDevices)
  • Cepheid Receives FDA CLIA Waiver for Xpert Flu+RSV Xpress Test (Press)
  • Solid-State Batteries Make for Smaller Medical Devices and Fewer Procedures (MDDI)
  • Novocure touts preliminary data on tumor treating fields (MassDevice)

US: Assorted and Government

  • The Senate votes to get rid of the medical device tax (MedCityNews)
  • Time To Get Aggressive Against Trade Secret Bandits (SCRIP-$)
  • Arkansas Supreme Court halts decision on disclosure of execution drugs (Reuters)
  • Senate drops Canadian drug import amendment (DSN)
  • Scientists use breakthrough DNA technology to diagnose cases of tuberculosis faster (MNT)
  • The Third Circuit Does an About-Face on RICO Claims (Drug and Device Law)
  • Merck Statement Regarding CUBICIN (daptomycin for injection) Patent Litigation (Press)
  • Health and Human Services Drug Pricing Forum (Policy and Medicine)
  • Lipo Escultura Corp. Issues Nationwide Recall of Lipo Escultura Due to Undeclared Sibutramine and Diclofenac (FDA)
  • Ariosa v. Sequenom: In Search of Yes After a Decade of (National Law Review)
  • Pfizer Seeks To Toss Zoloft Birth Defects MDL (Law360-$)
  • Medtronic finally escapes Lenox MacLaren bone mill suit (MassDevice)
  • Gore wins round in stent graft bout with Bard (MassDevice)
  • AbbVie, Endo Deceived Men About Testosterone Gel, Suit Says (Law360-$)

Upcoming Meetings and Events              

Europe

  • EMA Reinforces GCP By Ruling Out Data Replacement (SCRIP-$)
  • EU Medical Device/IVD Trilogue Will Probably Not Finish in 2015 (MedicalDevicesLegal)
  • European Red Tape Adjusted To Help Biotech Raise Money (SCRIP-$)
  • Novartis' Cosentyx Has Comparative Benefit After All, Says German HTA (SCRIP-$)
  • Amgen files application in Europe to expand indication of Kyprolis to treat multiple myeloma (PharmaLetter-$)
  • GSK set to kickstart asthma mAb sector after EU Nucala approval (BioPharma-Reporter)
  • Charity calls on NICE to reverse rejection of Amgen's PCSK9 inhibitor (PharmaTimes)
  • Novo Nordisk submits MAA for faster-acting insulin aspart (EPR)
  • Mynosys wins CE Mark for Zepto capsulotomy device (MassDevice)
  • EU OKs add'l delivery cath for InspireMD's CGuard stent (MassDevice)

India

  • Centre to amend D&C Rules to bring all notified medical devices under Schedule M III (PharmaBiz)
  • Commerce ministry to consider issue related to policy circular no 9 soon (PharmaBiz)

China

  • CFDA adds comment period for rule changes (BioCentury)
  • China FDA gives manufacturing nod for EV71 hand, foot and mouth vaccine (FiercePharmaAsia)

Japan

  • Novartis' Alcon recalling more intraocular lenses in Japan (BioSpectrum)

Canada

  • Development Safety Update Report - International Conference on Harmonisation (ICH) Topic E2F (Health Canada)
  • Health Canada Issues Notice of Compliance for Gilead's Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection (Press)

Australia

  • Classification of IVD medical devices (TGA)

Other International

  • Three types of marijuana to hit Uruguayan pharmacies in 2016 (Reuters)
  • South Korea Debates Regenerative Meds Law (SCRIP-$)
  • Malaysia won't lose access to generics due to TPP, PwC says (FiercePharmaAsia)

General Health & Interesting Articles

  • Harnessing The Immune System To Fight Cancer: 'Now We Can Offer Hope' (Forbes)
  • Research making progress on why young non-smokers get lung cancer (Washington Post)
  • HPV Vaccine is Recommended for Boys (ICT)
  • Annual HIV diagnoses down 19 percent over the past decade (Washington Post)
  • Ending the HIV–AIDS Pandemic — Follow the Science (NEJM)

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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