Regulatory Recon: Olympus Raised Scope Prices

Regulatory Recon: Olympus Raised Scope Prices Following Superbug Outbreak, Gilead to Pay Merck $200m in Damages Over Hep C Patents

Headlines: US:

•  Use social media to assess the health of the Afar (Scientific American)

• Make betrixaban Portola pass the exam data with the FDA? (Detailed information $ Pink) (BioCentury)

• FDA: Generic abuse deterrent opioid should be "not less than Trademarks Versions (Focus) (FDA Law Blog) (STAT)

• New system works best track defective medical devices (Baltimore Sun)

• Device Maker for Olympus Scopes price come as propagated superbug infections (KHN)

• Gilead took a lot of success lately. This is what we really have to fear (STAT)

• Gilead Merck to pay $ 200 million in damages in patent medicines hepatitis C (WSJ- $) (Reuters)

Headlines: International:

• Health Canada and public review of the joint FDA ICH guidelines (Health Canada)

• EU Summary: PRAC recommended for Zydelig antibiotics offset the risk of infection, changes in monitoring service medical literature (Focus)

• The discussion of EU rules Medtech future waits until the regulations ($ scriptures) adopted vaccine scandal China reveals the fault system, more than 130 arrested ($ WSJ-) (BBC) (Economic Times) (Time)

• Summer 2016 date set for the execution of medical equipment of the Rules of Chinese clinical trials (Emergo)
• Sanofi goes to the Supreme Court on the Prohibition of India in diabetes fixed dose combination drugs (A-PharmaTechnologist)

• Canada will not appeal ruling allowing patients to grow their own pot (Reuters)

 USA .: Pharmacy and Biotechnology

•  Bayer and Regeneron to develop a new combination treatment of the eye (PharmaPhorum)

• Race to comply with FDA guidelines (ESG Focus-members)

• Researchers call transparency When warnings Black (Focus) box removed

• Consent and consistency in the NPRM (Bill of Health from Harvard)

• 'Moonshot' Cancer Research won the enthusiastic support of the STAT-Harvard survey (STAT)

• Many patients at high risk for stroke do not receive the necessary anticoagulants (Reuters)

• DUNS Number NDC against registration of OTC medicines (FDA Atty)

• Crafts for the restructuring of the Forum as key Neuro Drug clinical trial does not exceed (Xconomy) (Press)

• New ground to reduce the misuse of antibiotics: Ambulatory Care (Health Affairs blog)

• USP Reference: 5 Tools You Should Know About (USP)

• Thinking outside the box in Rx Price: from vaccines Part D Grouping ($ RPM Report)

USA .: Pharmacy and Biotechnology: results of clinical studies, documents and Designations 

• Phase III pivotal study in metastatic hormone sensitive Begun ENZALUTAMIDE prostate cancer (press)

Medical devices in the US:

• Taking cybersecurity Bullseye back (Pharmaceutical verification of conformity)

• An introduction to manufacturing execution systems for the medical device industry (MedDeviceOnline)
• Quality management has evolved! (GxP Lifeline)

• Ackman Pershing Square Gets Senate investigation into drug prices (Bloomberg)
• Sanuwave test lacks efficacy end point, but showed superiority over 24 weeks (MassDevice)

• Bioabsorbable Xeltis congenital heart valve pulmonary obstruction Green The FDA (Medgadget)
• Fortimedix surgical Announces 510 (k) Submission of FMX314 innovative surgical platform (release)

• TransEnterix, Inc. reported SurgiBot FDA 510 (k) Submission Process (release)
• Carestream seeking FDA approval for training purposes cone-beam CT images to 3D view (MassDevice)

United States: Assortment and government

• Genzyme hits Sun with the game on generic drugs Leukemia ($ Law360-)
• Indivior says the FDA's request soon generic Suboxone ($ Law360-)

• Sequenom launches diagnostic method patents of Mercy of the Supreme Court (National Law Journal)
• Last of five defendants guilty in multimillion-dollar Medicare fraud scheme associated Detroit area Home Companies Health (Department of Justice) are declared
• V Zubik. Burwell oral argument (Health Letter Harvard)

• Paying only pay more if the risks of the drug is not disclosed? GSK seeks Supreme Court Response (Pink detailed $)
• Fed. Circ. Supports Depomed drug patent validity ($ Law360-)

• US regulators finalize new limits silica for construction, other industries (Reuters) 

Upcoming Meetings and Events 

• Advisory Committee RAPS 'Tracker FDA meeting
• Context Analysis: FDA Advisers of the United States Committees to examine the sustained-release opioid abuse projects Teva with properties disuasión-- June 7, 2016 (AADPAC-DSRM) (Tario)

• Background analysis: FDA Advisory US Committee to examine Novo Nordisk insulin Degludec and liraglutide (Xultophy) type 2 diabetes - May 24, 2016 (EMDAC) (Tario)

Europe

• The key to the harmonization of GCP inspections future of the EU, said the industry ($ scriptures)
• With the departure of Andrew Witty, GlaxoSmithKline bid farewell to fraud? (Forbes)

• Poland to prohibit emergency contraception without a prescription (Reuters)
• EC approves the application switch market Elocta consent to Biogen SOBI ($ PharmaLetter-) 

Asia

• China, the FDA promises to guarantee the supply of "holes" of the vaccine in a speech at the Boao Forum (fierce)
• Japan seeks new releases Lilly as Zyprexa challenge Crafts ($ PharmAsiaNews-)

India

• India does not stop controversial policy-Drug Licenses (Law360- $)

• NPPA to resolve disputes with manufacturers of drugs for the drug shipment (Economic Times) 

Canada

• LumiThera wins Health Canada approval for the trial of photobiomodulation (MassDevice) 

Zika

• A traveler Zika brought to America in 2013 (New York Times) (Reuters)
• General health and other interesting items

• TB cases are increasing in the United States for the first time in 23 years (Washington Post)
  Discovery genome holds key for creative agencies (MIT Technology Review) (Forbes)