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20:28 EDT 29th May 2015 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 6,400+

Thursday 28th May 2015

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment

– If Approved, Would Provide Potential New Backbone for Future HIV Therapy Combinations – Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company’s Marketing Authorization Application (MAA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been ...

BRIEF-Beijing Leadman Biochemistry gets regulatory approval for assets restructuring

* Says gets securities regulator's approval for assets restructuring, shares to resume trade on May 29

Vital Options International Presents Two Programs During the ASCO Cancer Conference Working to Improve Patients’ Access to the Latest Cancer Treatments

-- Accelerating Innovation: Living Longer and Stronger, Why Innovation Is Critical for Patients - Friday, May 29th, 7 to 9 pm CDT— --Right Patient. Right Treatment. Right Now! Fighting to Remove Reimbursement Barriers and Expedite Regulatory Approvals - Sunday, May 31st, 11am to 1pm CDT— --Both Programs to be Webcast Live and A...

Tokai Pharmaceuticals to Present at Upcoming Investor Conferences

Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases, today announced that it will present at two upcoming investor conferences: Lee Kalowski, Chief Financial Officer, will present at the Jefferies 2015 Healthcare Conf...

Corbus Will Interview Twice as Many Candidates in 2015 as Its Ranks Grow

View the original article on BioSpace Yuval Cohen is the chief executive officer of Corbus Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focusing on rare, life-threatening, chronic inflammatory diseases. BioSpace chatted with Cohen about hiring trends and where the company will be hiring in 2015. Based in Norwood, Mass., Cohen said Corbus is growing by leaps and bounds and this...

Sarah Cannon Research Institute Names Dawn Sauro to Executive Team

Sarah Cannon Research Institute (SCRI), the research arm of HCA’s global cancer enterprise, Sarah Cannon, today announced it has named Dawn Sauro as the new president of the company’s full service contract research organization (CRO), Development Innovations. In her role, Sauro will provide executive oversight for Sarah Cannon’s line of business that...

Medical analytics firm bought back by founders, given new name

Mansoor Khan and Dr. Fauzia Khan have bought Alere Analytics and rebranded it Persivia.  -More- Four Key Strategies to Manage Cardio Device Trials Make your cardiovascular device trials more effective by understanding four essential best pr...

Plant breeding: UK bioscientists push for crop policy

In assessing the next generation of plant-breeding techniques such as gene editing (Nature520, 131–132;10.1038/520131b2015), the European Union (EU) should take into account criticisms of its current regulatory system for new crop varieties.Last ye...

Ibrutinib (IMBRUVICA®) in Combination with Anti-PD-L1 Antibody (MEDI4736) Study Commences for Patients with Two Relapsed/Refractory Blood Cancers

SUNNYVALE, Calif., May 28, 2015 /PRNewswire/ -- Pharmacyclics, Inc. today announced the initiation of PCYC-1136-CA, a multi-center study that will investigate the use of ibrutinib (IMBRUVICA®) in combination with MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca. The Phase Ib/II study will examine the safety, tolerability and effectiveness...

Cipher Pharmaceuticals to Present at Jefferies 2015 Global Healthcare Conference

MISSISSAUGA, ON, May 28, 2015 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) today announced that Shawn Patrick O'Brien, President and Chief Executive Officer, will present at the Jefferies 2015 Global Healthcare Conference in New York on Tuesday, June 2, 2015. Cipher is scheduled to present at 2:00 PM ET, followed immediately by a Q&A breakout session. Cipher's presentatio...

Challenges ahead for European clinical trials

The European Society for Medical Oncology (ESMO), in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), expressed their views on the EU Clinical Trials Regulation in an official position paper recently publis...

A Clorox Employee's Journey to Promote Hand Hygiene in Guatemala with Clean the World and ACI

By Mary-Ann Warmerdam SOURCE: The Clorox Company DESCRIPTION:As part of its commitment to social engagement, the American Cleaning Institute (ACI) supports the nonprofit Clean the World (CTW) in its effort to improve personal hygiene standards while recycling hotel amenities like soap. Lack of basic hygiene is a leading cause of mortality in children worldwide; CTW's approach is an effectiv...

Cannabics Pharmaceuticals Inc. Files Patent Application Which Covers Novel Personalized Anti-Cancer Treatment

BETHESDA, Md., May 28, 2015 /PRNewswire/ -- Cannabics Pharmaceuticals Inc. (CNBX) announced today that it has filed an exclusive patent application with the US Patent & Trademark Office (USPTO) on a System and Method for High Throughput Screening of Cancer Cells. Cannabics' team of scientists has developed a high throughput screening system which is specifically designed to give personalized ...

IGI Laboratories, Inc. Announces Third ANDA Submission Of 2015

BUENA, N.J., May 28, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-five. Jason Grenfel...

Johnson & Johnson Announces Acceptance of Binding Offer From Cardinal Health To Acquire Cordis

NEW BRUNSWICK, N.J., May 28, 2015 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the acceptance of the March 1, 2015 binding offer from Cardinal Health to acquire its Cordis business for an approximate value of $2 billion. The offer was accepted after consultations with relevant works councils and trade unions. The company expects the transaction to close towards the e...

Cardinal Health Binding Offer To Acquire Cordis Accepted

Cordis Is A Worldwide Leader In Cardiac And Endovascular Medical Products DUBLIN, Ohio, May 28, 2015 /PRNewswire/ -- Cardinal Health today announced that its March 1, 2015 binding offer to acquire Johnson & Johnson's Cordis business for $1.944 billion in cash was formally accepted.  The offer was accepted after consultations with relevant works councils and trade unions. The trans...

Merus Labs to Present at Jefferies 2015 Healthcare Conference in New York

TORONTO, May 28, 2015 /PRNewswire/ - Merus Labs International Inc. ("Merus" or the "Company") [TSX: MSL, NASDAQ: MSLI], a specialty pharmaceutical company, announced today that Barry Fishman, Chief Executive Officer is scheduled to present at the Jefferies 2015 Healthcare Conference as follows: Date: Monday, June 1, 2015Time: 4:30 p.m. EDT The presentation will be available on the Company's...

Symphogen’s Antibody Mixtures Highlighted in Three Peer-Reviewed Journals

Pioneering and Novel Approach to Anti-EGFR and Pan-HER Antibodies Validated in Clinical and Pre-clinical Research Papers Symphogen, a private biopharmaceutical company developing recombinant antibody mixtures, announced today the publication in May 2015 of two papers with new clinical data for its lead anti-EGFR antibody mixture, Sym004, in the journal...

Whitehouse Labs Renews & Enhances Partnership with PTI Inspection Systems

Working together to provide clients with state of the art leak testing method development and validation programs. New York, NY (PRWEB) May 28, 2015 Whitehouse Laboratories is excited to announce that it has renewed and enhanced its long term partnership with PTI Inspection Systems. Whitehouse Labs and PTI will continue to work together to provide clients with custom-tailored method development ...

Former CEO and Chair of the Council of Experts at the USP, Roger L. Williams, MD, Joins NDA Partners as a Premier Expert Consultant

NDA Partners announced today that Roger L. Williams, MD, an expert in clinical pharmacology and internal medicine and former Chief Executive Officer and Chair of the Council of Experts at the US Pharmacopeial Convention (USP), has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants who design and implement critical solutions to help clients success...

OSE Pharma and Simbec-Orion to participate in the 51st annual Meeting of the American Society of Clinical Oncology, May 29th to June 2nd 2015, Chicago

Regulatory News: OSE Pharma SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company based in France, developing T specific immunotherapy treatments against invasive and metastatic...

Wednesday 27th May 2015

McBrideCQ @ Avicenna

McBrideCQ is looking forward to attending the Avicenna projects 5th and final meeting, held in Barcelona on 4th-5th June. We are please to be associated with the Avicenna project.  The event will present the proposed Roadmap to a large group of ...

An IL-27/Lag3 axis enhances Foxp3+ regulatory T cell–suppressive function and therapeutic efficacy

Pediatric OTC Cough/Cold Rulemaking Absent From FDA Regulatory Agenda

The Spring 2015 unified agenda lists June for a final rule on deeming electronic cigarettes and other alternatives to traditional cigarettes and smokeless tobacco products subject to FDA regulation. FDA adds an item to create a single set of regulati...

Amarin Granted Summary Judgment Motion in Suit Against FDA Seeking New Chemical Entity Market Exclusivity for Vascepa(R) (Icosapent Ethyl) Capsules

BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - May 28, 2015) - Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, N...


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