Clinical - Approvals News: Breaking Clinical - Approvals News, Comments and Articles. - Page: 2

Vical Has A Deep Bench And Near-Term Catalysts

ByGregory Stuckey:Vical Has A Deep Bench And Near Term CatalystsIn my previous Biotechnology industry article, A Journey To Add Biotech To The Portfolio, I investigated the Biotechnology industry to find some companies that might be worth investing in. Without repeating the entire article I created a stock screener and did some additional number crunching to develop a list of companies with a mark...

Actavis Confirms Appeals Court Issues Injunction Related to Generic Pulmicort RESPULES® Distribution

PARSIPPANY, N.J., May 24, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has granted a motion by AstraZeneca to enjoin Actavis from further distribution of its generic version of AstraZeneca's Pulmicort RESPULES® (budesonide inhalation suspension) 0.25, 0.5 mg products, pending resolution of AstraZeneca's app...

Patients suffering from orphan diseases can look forward to a wider range of drug options in the future

The new report* shows that the relatively unsatisfied market for orphan disease drugs could prove to be a big hit for pharmaceutical companies able to improve upon the limited options currently available to patients. GBI Research’s analysis of industry trends suggests that the orphan disease therapeutics market is likely to see a steady increase in value over the forecast period. There a...

Disease-modifying treatments are becoming a reality for Cystic Fibrosis (CF) sufferers, potentially transforming this life-threatening condition into a manageable one

The new report* highlights Vertex Pharmaceuticals’ Kalydeco (ivacaftor), which received Marketing Authorization Approvals (MAA) in the US and EU last year, and represents a milestone in the CF therapeutics market, as we begin to enter an era of personalized medicine. CF is caused by a genetic mutation which leads to the production of thickened sticky secretions in organs with epithelial...

Astellas and Medivation file for approval of enzalutamide in Japan

Japanese drug major Astellas Pharma (TYO: 4503) has submitted an application for marketing approval of enzalutamide to the Ministry of Health, Labor and Welfare in Japan for the treatment of prostate cancer.

Dr. Andrew Bronin is recognized among Castle Connolly's Top Doctors® for Rye Brook, NY region in 2013

RYE BROOK, N.Y., May 24, 2013 /PRNewswire-USNewswire/ -- Castle Connolly Medical Ltd., America's trusted source for identifying Top Doctors, has selected Rye Brook's Dermatology specialist Dr. Andrew Bronin for inclusion in its highly selective list of Regional Top Doctors this year. (Photo: http://photos.prnewswire.com/prnh/20130524/DC20635 ) Castle Connolly Medical Ltd. publishes its lis...

Proposal to list Roche's Neulastim and Actemra in New Zealand

New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of a proposal to list pegfilgrastim (Neulastim) for prevention of neutropenia in patients undergoing cancer chemotherapy and tocilizumab (Actemra) for systemic juvenile...

PIPELINE WATCH – two failures, two filings and two approvals

This week’s Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

Successful Capital Raise, Data For Lead Candidate, And Small Float Are Opportunitites For Stemline

ByPropThink:By Ivan DeryuginStemline Therapeutics (STML) completed its IPO in January of this year, (the company was founded in 2003), and as its name implies, the company develops cancer therapies that specifically target cancer stem cells (referred to as CSC). The company's two clinical-stage assets, SL-401 and SL-701, are in development across seven oncology indications in Phase I/II trials; th...

All Amarin Eyes On Sunday's Prescription Data

ByQuoth the Raven:There is a war on between bulls and bears for the fate of biotech startup Amarin (AMRN). The next piece of the puzzle will fill itself in on Sunday this weekend, and it's going to be extremely important to investors. Bulls want to shut bears up; shorts are hoping for a second unimpressive week in a row. Amarin, right now, seems to have three very simple factors that are going to...

Tensions, Threats Emerge In Ariz. Medicaid Expansion Debate

In addition, the legislative debate continues in Texas while in Florida there's speculation about what's to become of the state's uninsured population now that the legislature didn't take action. Arizona Republic: Threat, Vetoes Fly As Tensions Rise Over Medicaid Expansion Gov. Jan Brewer sent five bills to the scrap heap Thursday in a pointed gesture intended to prod lawmakers into a deal on the...

Sangamo Biosciences (SGMO) gets $6.4 M from CIRM – BUY

    Strategic Partnership Award from California Institute for Regenerative Medicine   SGMO receives $6.4 Million Strategic Partnership Award From California Institute for Regenerative Medicine (CIRM) to develop ZFP Therapeutic® for Beta-thala...

Xarelto Approved for ACS Secondary Prevention in Europe

The European Commission has approved a 2.5-mg twice-daily dosage based on the ATLAS ACS 2 TIMI 51 trial. International Approvals

Edison Investment - Innate Pharma - New preclinical candidate - New anti-inflammatory and anti-cancer progress

A preclinical anti-TLR3 candidate in IPH33 (anti-inflammatory) has been selected for preclinical studies, which is now ready for partnering. Meanwhile, an IPH41 (anti-cancer) anti-KIR3DL2 candidate should be selected by the end of 2013. Lead product, anti-KIR antibody lirilumab (IPH2102), is in a Phase II trial for acute myeloid leukaemia (AML) and in two Phase I trials for solid cancers. One tr...

Edison Investment - CytRx - Focus on aldoxorubicin

CytRx is now focused on fully exploiting the potential of aldoxorubicin in advanced soft tissue sarcoma (STS) following the failure of tamibarotene. The aldoxorubicin clinical programme has delivered important data points in recent weeks, which increase our confidence in the first- and second-line STS indications. Aldoxorubicin appears safe in front-line STS… A recent Data Safety Monit...

Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial

Danish insulin giant Novo Nordisk (NOV: N) has released headline results from a 56-week double-blind Phase IIIa clinical trial investigating the potential of liraglutide, the active ingredient of its type 2 diabetes agent Victoza, to induce and maint...

Biosimilars and US exclusivity

Currently, the legal pathway in the US for the approval of biosimilars is the Biologics Price Competition and Innovation Act (BPCI Act) of 2009.

Thomson Reuters Quarterly Report on U.S. Generic Drug Industry

24th May 2013: Thomson Reuters Movers and Shakers quarterly report, focusing on the U.S. generic drug industry.  Movers and Shakers is the best source of information on generic approvals and challenges, notable mergers and acquisitions, and emerging industry trends. Interested in learning more about the latest developments in generics?  Click here to download the latest edition of...

Sandoz to start phase III etanercept trial

Sandoz, the generic drug division of Swiss drug giant Novartis, is to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register.

Antares Pharma to Present at the Deutsche Bank Securities, Inc. 38th Annual Health Care Conference

Antares Pharma, Inc. (NASDAQ: ATRS) today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at the Deutsche Bank Securities, Inc. 38th Annual Health Care Conference on Thursday May 30, 2013 at 10:40 am Eastern Time. A live webcast of the presentation will be available via the “Investor Relations” page of...

Elixir Medical Corporation Announces Outstanding Two-Year Results from the EXCELLA BD Randomized Clinical Trial for the CE Mark-Approved DESyne® BD System with Biodegradable Polymer Coating

Results Set a High Standard in Sustained Long Term Clinical Outcomes Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today excellent long-term results of its CE Mark-approved DESyne® BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating c...

Renal Tubular Acidosis Type IV in Hyperkalemic Patients

This condition may cause hyperkalemia in patients with moderately impaired renal function. Clinical Endocrinology

Zensun Announces Positive Data from Phase II Trials of Neucardin

Zensun Sci & Tech, Ltd., a Shanghai-San Diego biopharma, reported positive results from four Phase II trials of its lead drug candidate, Neucardin™, a treatment for heart failure. Because of the successful tests, Zensun has filed with the C...

St. Jude, Boston Scientific Release Encouraging Renal Denervation Data At EuroPCR

New clinical data from St. Jude Medical’s and Boston Scientific’s trials of renal denervation devices to treat hypertension show both companies are making progress in their development of these novel blood pressure therapies, but they both remain...

Steven Carr to Deliver Pittcon 2014 Wallace H. Coulter Plenary Lecture

The Pittcon Program Committee is pleased to announce that Steven Carr, director of proteomics at the Broad Institute of MIT and Harvard, will deliver the Wallace H. Coulter Plenary Lecture at PIttcon 2014. Dr. Carr is internationally recognized as a leader in the development of novel proteomics methods and in their application in biology and medicine. Dr. Carr and his group collaborate with s...