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23:52 EDT 3rd September 2015 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 6,200+

Wednesday 2nd September 2015

Sacramento Metropolitan AQMD Receives Federal Grant to Study Toxic Pollutants From Wood Smoke in Sacramento

The U.S. Environmental Protection Agency has awarded the Sacramento Metropolitan Air Quality Management District (SMAQMD) a $360,000 grant to study toxic pollutants from wood smoke in Sacramento. Residential wood smoke is Sacramento’s main source of wintertime air pollution and it is suspected to be the main source of some hazardous air pollutan...

Broad Changes Needed To Spur Indian Device Sector

India has promised to change import duties seen as discouraging the local manufacture of medical devices, as a report forecasts that industry sales could increase nearly eight-fold to $50bn in a decade with the right tariffs, regulatory structure, qu...

Amicus buys private dermatology start-up Scioderm for $229mm up front plus earn-outs

Amicus Therapeutics Inc. bought privately dermatology start-up Scioderm Inc. for $229mm up front--$125mm in cash and 7mm Amicus shares worth $104mm. Scioderm may also receive $361mm in cash or stock earn-outs for reaching clinical and regulatory mile...

A large-scale functional screen identifies Nova1 and Ncoa3 as regulators of neuronal miRNA function

MicroRNAs (miRNAs) are important regulators of neuronal development, network connectivity, and synaptic plasticity. While many neuronal miRNAs were previously shown to modulate neuronal morphogenesis, little is known regarding the regulation of miRNA...

mTOR activates the VPS34-UVRAG complex to regulate autolysosomal tubulation and cell survival

Lysosomes are essential organelles that function to degrade and recycle unwanted, damaged and toxic biological components. Lysosomes also act as signalling platforms in activating the nutrient-sensing kinase mTOR. mTOR regulates cellular growth, but ...

Triggered Ca2+ influx is required for extended synaptotagmin 1-induced ER-plasma membrane tethering

The extended synaptotagmins (E-Syts) are ER proteins that act as Ca2+-regulated tethers between the ER and the plasma membrane (PM) and have a putative role in lipid transport between the two membranes. Ca2+ regulation of their tethering function, as...

Incyte licenses Hengrui's anti-PD-1 mAb

Incyte Corp. (NASDAQ:INCY) acquired exclusive, worldwide rights outside of Greater China to SHR-1210, a mAb against PD-1 from Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:3600276).Hengrui will receive $25 million up front and is eligible for $90 milli...

NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC

Combined expertise will help medical device sector increase manufacturing efficiency while reducing risk and ensuring regulatory and quality compliance ANN ARBOR, Mich. and LIBERTYVILLE, Ill. (PRWEB) September 02, 2015 NSF International, a leading provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has acquired A...

India's Former Agriculture Minister Pitches for GM Crop Field Trials

Mr. Sharad Pawar, India's former Union Minister of Agriculture pitches for field trials of GM crops and has called on Prime Minister Narendra Modi to intervene in clearing the policy paralysis and regulatory uncertainty for GM crops. Mr. Pawar said that in India, GM crops, including Bt brinjal and corn are ready for release, while field trials of o...

Lannett To Acquire Kremers Urban Pharmaceuticals For $1.23 Billion

PHILADELPHIA, Pa., Sept. 2, 2015 /PRNewswire/ -- Transaction Highlights: Substantially increases, diversifies revenue base with highly profitable specialty products Expands pipeline with exciting products Near-term growth potential with 11 product applications pending at the FDA, of which five include Paragraph IV certifications  Provides medium and longer term growth potential with 17 ...

Axovant Sciences To Present At Upcoming Investor Conferences

HAMILTON, Bermuda, Sept. 2, 2015 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced upcoming presentations at three investor conferences: Wednesday, September 9 at 4:55 PM at the Baird 2015 Healthcare Conference in New York at the New York Palace hotel Thursday, September 10 at 2:00 PM...

Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency

THOUSAND OAKS, Calif., Sept. 2, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy. If appr...

Letter to Orexo shareholders from CEO Nikolaj Sørensen

UPPSALA, Sweden–(BUSINESS WIRE)–Regulatory News: Orexo AB (publ) (STO:ORX) informs that the CEO of Orexo, Nikolaj Sørensen, today has sent a letter to all shareholders of the company. The letter provides an update on the commercialization of Zubsolv® and the sales … Continue reading → Cet article Letter to Orexo shareholders from CEO Nikolaj Sørensen est apparu e...

Healtec® Announces Executive Leadership Change

Wound Care Device and Product Company Welcomes Stanley H. Salot Jr. as President and CEO Covington, LA (PRWEB) September 02, 2015 Healtec® LLC hired Stanley H. Salot Jr. as new President/CEO and Regulatory Affairs Officer following the departure of Kristen Dietz, former Chief Operations Officer. Shaun Carpenter MD, FAPWCA, CWSP, co-founder and Chief Medical Officer of Healtec® released ...

Gene–Stress–Epigenetic Regulation of FKBP5: Clinical and Translational Implications

Mannatech’s Executive Promotions to Fuel Company Momentum

Mannatech, Incorporated (NASDAQ: MTEX), the founder of the

Pharma Legal and Compliance Summit 2015 - an insight into the Indian pharma industry

The pharmaceutical industry has been one of India's most vibrant and forward moving sectors of the economy. At the same time, it has come up against roadblocks in terms of the stringent legal and regulatory environs of the country

Gilead's Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study

- F/TAF Currently Under Review for Marketing Approval by U.S. and European Regulatory Agencies - Gilead Sciences, Inc. (NASDAQ:GILD) today announced that a Phase 3 study evaluating its investigati...

HYD Pharma Receives GMP Certification for Deuterium-Depleted Water (DDW) Production Facility

Company will soon apply for ethical approval to start Phase 2 clinical trial in chronic lymphocytic leukemiaBudapest, Hungary, September 2, 2015 / B3C newswire / -- Following a successful audition by the Hungarian National Institute of Pharmacy and Nutrition in May, 2015, Trigon Biotechnology Inc., strategic partner of HYD Pharma Inc., has received new GMP compliance certificates for the deute

Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study

– F/TAF Currently Under Review for Marketing Approval by U.S. and European Regulatory Agencies – Gilead Sciences, Inc. (NASDAQ:GILD) today announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection met its prim...

pSivida Corp Announces Fourth Quarter and Fiscal Year 2015 Financial Results Release Date and Conference Call Information

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced that its financial results for the fourth quarter and fiscal year 2015 will be released after the market close on Wednesday, September 9, 2015, followed the same day by a conference call and live webcast ...

Theorem's Webinar Offers Strategies to Improve Clinical Endpoint Adjudication

Theorem, a leading global contract research organization (CRO) that optimizes trial conduct, will explore the clinical endpoint committee (CEC) process in the webinar, “

FDA Approves Pediatric Indication for EMEND® (aprepitant) Capsules in Combination with Other Antiemetic Agents

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for EMEND® (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, EMEND capsules are now approved for use in combi...

Novartis bags EU approvals for three ex-GSK drugs

Revolade, Tafinlar and Mekinist all receive regulatory approval

Navidea Biopharmaceuticals Announces Dual Listing on Tel Aviv Stock Exchange

- Common shares already listed on NYSE MKT will also list on the Tel Aviv Stock Exchange (TASE) beginning September 8, 2015 under ticker symbol NAVB - - Company anticipates joining TASE's TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed indexes - Navidea Biopharmaceuticals Inc., (NYSE MKT: NAVB), a biopharmaceutical company focus...



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