Regulatory Recon: FDA Approves UCB Seizure Drug Briviact

Regulatory Recon: FDA Approves UCB Seizure Drug Briviact, IQWiG Denies Added Benefit of Praluent (2016)

In USA:

• Novartis gains FDA very important therapy for AML treatment (Reuters)
• The FDA approves Briviact for treatment of partial seizures (FDA)
• Hit-Zika  Puerto Rico is prepared to import the entire blood supply (Reuters)
• FDA Panel recommends monitoring depth, long-term leadless pacemakers (MassDevice) (Press)
• PDUFA negotiations: First Communications Breakthrough Even in the register (Pink information- $)
• Dear FDA: The Daraprim site lacks important safety information! (Pharma Marketing Blog)
• Offers free courses Edu FDA continues to help healthcare providers understand "biosimilars" (FDA Voice)
• In the first test of human, medical optogenetics aim to restore sight to the blind (MIT Technology Review)

In Focus: International

• Praluent added advantage of not proven, says IQWiG (Pharma Letter $) (IQWiG)
• South Korea remains the engine of the Biopharma industry, squeezing the review process (Thomson Reuters)
• Divergent views persist into three bands of thorny issues in the EU regulation ($ clinically)
• Unnecessary prescriptions of antibiotics reduced to a retrial (MHRA) (study)
• The differences between the reference and biosimilars (Jamie)

US: Pharmaceuticals & Biotechnology

• How ad narrators take the medication fear about side effects (STAT)
• Chinese FDA banned chemotherapy signature allows the ship to us as the threat shortages (Focus) looms
• FDA finalizes guidance on the collection of safety data for advanced and post-approval trials (Focus)
• Guidance for Industry immunogenicity of the related low molecular weight heparin considerations (FDA)
• When cancer treatment offers hope rather than cure (New York Times)
• Evolution of strategies to improve preclinical cardiac safety testing ($ NEJM-)
• FDA meeting with companies using clinical decision to treat difficult cases (information- rose $)
• Labeled drug levels observed set staggered as evidence for off-label promotion (details rose $) (Duke-Margolis)
• The FDA should focus on the safety and efficacy of drugs, not the results of life of patients (Hill)
• Guidance 'side of genes "to fight tumors difficult to treat (Boston Globe)
• A new drug for severe form of MS generates light of hope - and tempered expectations (STAT)
• Editorial: Call the address Pharma ($ scriptures)
• Generic cut in bipolar disorder market at $ 4.2 billion by 2024, the report ($ PharmaLetter-)
• Common antibiotics can cause delirium, confusion and hallucinations (Forbes)
• The blood of Ebola survivor gives clues to new vaccines and antibody drugs (Forbes) (BioWorld)
• Overdose deaths related benzodiazepines, Study Suggests (Forbes) soar
• 2016 The year of the implementation of Pharmacy (Policy and Practice)
• Overcome major obstacles in the development of a drug against cystic fibrosis (MNT)
• Wall Street Horizon Partners Informa BioMedTracker to provide dates FDA approval of drugs and pharmaceuticals intelligence to investment professionals (press)
• Issues Baxter nationally on a voluntary recall of a batch of sodium chloride 0.9% for irrigation due to the presence of particles (FDA)
• Extension of the Science of patient feedback: Construction of patient records smarter (cures faster)
• Eliminates 771 FDA drug basic facilities data recording (Registrar Corp)

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

• Nivalis Therapeutics Announces FDA Fast Track Designation for N91115 in patients with cystic fibrosis (press)
• Strategia Therapeutics Initiates a Phase I clinical trial of the "FF-10502" Law for FUJIFILM anti-cancer agent in patients with advanced cancer (press)
• Spectrum Pharmaceuticals Announces Acceptance by the FDA for NDA Submission of EOquin (apaziquone for intravesical instillation) (Press)
• Shifter nanoparticles to deliver anticancer drugs to tumors (press)

US: Medical Devices

• Genomics course Gets FDA letter (GenomeWeb)
• Fix the non-trade objectives in the distribution of medical devices Agreements (Emergo)
• Bayer refuted allegations congressman about the safety of Essure (Focus)
• ISO-80369 is going to be ready? (MDDI)
• Subsequent studies for approval: similarities and differences in fundamental studies of Medical Devices (CRO __gVirt_NP_NN_NNPS <__ blog)
• If the quality: work with stakeholders to improve the safety of medical devices for patients (GxP Lifeline)
• Plasmonic interferometer cheap Prickless could activate glucose meter (IEEE Spectrum)
• AdvaMed confirms former COO BIO Whitaker is the new CEO (MassDevice)
• ScandiDos Gets FDA 510 (k) to Delta4 Discover America (press)

US: Assorted & Government

• Amarin, Look FDA for another month Crumble out off-label promotion Regulation (Focus) ($ scriptures)
• Objectives of the Congress of the FDA premarket review, clinical trials of medical devices (Emergo)
• NuVasive not infringe the patent of Medtronic, judge says ($ Law360-)
• Sandoz asked the Supreme Court to reverse the decision biosimilar (National Law Journal)
• Message visits - reduce the scope of what constitutes off-label promotion (legal drugs and instruments)
• Something Fishy in the Appropriation Act: With GE salmon, one side of smoke and mirrors (FDA Law Blog)
• More than 51 hospitals Join the federal regulation of CIM (detailed $ Gray)
• Takes SEC blow to Kaye Scholer Atty In the civil case Shkreli ($ Law360-)
• Johnson & Johnson loses another suit pelvic mesh (MassDevice)
• Regulatory levels of US securities new charges in the case of press release piracy (MassDevice)
• Rosetta received conditional approval from thyroid test in New York (GenomeWeb)

Upcoming Meetings & Events

• FOOD "FDA Advisory Committee Meeting Tracker

Europe

• EU regulations Summary: VMA Looks reduce the risk of PML in patients taking Tysabri MS drugs (18 February 2016) (Focus)
• Teva made concessions in considering offering for Allergan unit (Bloomberg) (Reuters)
• Praxbind Boehringer paid in England, Ireland and Wales (Pharma Letter $)
• CE approved Brilinta AstraZeneca a new dose of 60 mg (EPR)
• generics and biosimilars European politicians adopt disclosure rules (Gabi)
• Measures to increase the use of generic drugs in Greece (Gabi)

Asia

• Regulatory Roundup Asia: drug safety, traceability to the forefront of the reform of China's health plan (February 16, 2016) (Focus)
• China is testing the system authorization holder Boehringer marketing and gets the first contract ($ PharmaLetter-)
• Korea Accelerating efforts to develop, implement orphan drugs ($ News- PharmAsia)
• New Rules Singapore has an approval impact of drugs, testing, checking ($ News- PharmAsia)

India

• AP govt create SPV to develop medical devices Park, near Vizag (Pharmabiz)
• Indian pharmaceutical corrective and preventive measures to fit practical effective medication reminders (Pharmabiz)
• DFDA Myanmar Gujarat FDCA willing to adopt the model of e-government to improve the regulatory mechanism (Pharmabiz)
• IPC adds 8 new standards and reference substances impurities 10 New Indian Pharmacopoeia (Pharmabiz)
• Institute of Biotechnology in Cuba concessions negative patents although India and the EU (24 Insight)
• Zydus Cadila gets FDA approval for the capsules of doxycycline (Economic Times)
• Divis Laboratories Visakhapatnam 7. Unit-2 has passed FDA inspection (Economic Times)

Canada

• Paragraph health professional directors on special access and Medical Devices-Custom Made (Health Canada)
• Provinces of Canada closed the door Alexion on the price of medicines for rare diseases (STAT)
• Consultation: Draft Guidance for Industry - Preparation and Presentation of Goods reported health summary - The updated Annual Summary and Issues Related Summary reported (Health Canada)

Australia

• Prepare to date more than 300 names of ingredients: Australia Shows Pharma ($ scriptures)

Zika Virus

• What is a Brazilian city mosquitos tackle (MIT Technology Review)
• Keep Zika outbreak perspective (Forbes)
• Obama Administration pushes steps using Puerto Rico with Zika virus ($ WSJ-)
• Zika outbreak could be a harbinger of the threat of global warming (New York Times)
• World Bank provides $ 150 million in financing to countries affected Zika (Reuters)
• Experts matter hypothesis that Zika sick only 1 in 5 (Reuters)
• Brazil's Rousseff guaranteed resources for vaccine Zika (Reuters)
• Vatican Zika crisis pressures to soften position contraception (Reuters)
• Zika may increase the risk of mental illness, the researchers said (New York Times)
• American researchers, Brazil team up to fight Zika (Reuters)
• WHO recommends contraception in countries where Zika virus (New York Times)
• CDC adds two destinations through travel guide related to the Zika virus (CDC)

Other International

• Patients left in lurch as Bayer pulls free anti-coagulant (RadioNZ)
• Transition Successfully to ISO 9001:2015 (Quality Digest)
• Ex-NAFDAC DG hands over to Director of Administration (PulseNG)

General Health & Other Interesting Articles

• New HIV diagnoses decreased, but not for black gay and bisexual men (Health Affairs blog)
• 1-3 adults do not get enough sleep (CDC)
• Increases hospice long bills Medicare ($ WSJ-)
• Drink more coffee can undo the liver damage from alcohol (Reuters)
• Wounded American soldier soon receive the first penis transplant (Reuters)