Pharmaceuticals News and Research

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Incline acquires IONSYS, announces $43 million Series A financing

Incline Therapeutics, Inc., a privately-held, hospital-focused specialty pharmaceutical company, announced today that it has entered into an agreement to acquire the rights to IONSYS™ (fentanyl iontophoretic transdermal system) from ALZA Corporation and completed a $43 million Series A financing.

22 Jun 2010

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA.

22 Jun 2010

Cadence Pharmaceuticals to acquire Incline Therapeutics

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.

22 Jun 2010

Also in Global Health News: WHO scraps drug development group; Access to medication in Philippines; Yellow fever vaccine shortage; HIV-positive employee protection

Lancet World Report examines how "[d]isappointment over a long-awaited report on improving drug research and development for neglected diseases" led the WHO to form a new Consultative Expert Working Group (CEWG) to strategize around drug research and development. The formation of the new group comes after the report from the previous working group (EWG) was questioned due to "what some perceived to be a missed opportunity, unclear methods, a lack of transparency and signs of industry interference" and after "suspicions of impropriety" surfaced.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante Pharmaceuticals, Inc., today announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study's unblinded safety data. The review was based on data from almost 1,500 women-years of exposure.

21 Jun 2010

BioSante announces $15 million registered direct offering

BioSante Pharmaceuticals, Inc. today announced that it has received commitments from several institutional investors to purchase $15 million of securities in a registered direct offering. The investors are Deerfield Management Company and other institutional investors. BioSante expects to receive net proceeds of approximately $14.2 million after deducting placement agent fees and other offering expenses.

21 Jun 2010

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Saladax Biomedical, Inc. announced today that it has entered into a multi-year development and commercialization agreement with Bristol-Myers Squibb Company for the development of certain clinical diagnostic tests to be used in conjunction with the development of certain therapeutic compounds in the Bristol-Myers Squibb pipeline.

21 Jun 2010

Simulations Plus third-quarter consolidated preliminary revenues up 14.9% to $3.1M

Simulations Plus, Inc., a leading provider of software for pharmaceutical discovery and development, today released preliminary revenues for its third fiscal quarter ended May 31, 2010.

21 Jun 2010

Essen BioScience, Nycomed partner to develop modulators of voltage-gated ion channels

Essen BioScience Inc. - a specialty provider of cell-based assay solutions and contract research services - and Nycomed - a privately owned global pharmaceutical company headquartered in Zurich, Switzerland - are pleased to announce a joint discovery agreement to identify novel small molecule ion channel modulators as pain therapeutics.

From Sartorius 21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

Inovio Pharmaceuticals set to be added to Russell 3000 Index

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the company is set to be added to the broad-market Russell 3000® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 25, according to a preliminary list of additions updated on June 18 on www.russell.com.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

Results of two clinical proof-of-concept studies for CER-627 program to be presented at EAS Congress 2010

Cerenis Therapeutics SA, a privately held biopharmaceutical company developing HDL-related compounds for the treatment of cardiovascular and metabolic diseases, today announced it will present the results of two clinical proof-of-concept studies for its CER-627 program (niacin/aspirin combinations) at the 78th European Atherosclerosis Society Congress on June 20-23 in Hamburg, Germany.

21 Jun 2010

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

OncoGenex Pharmaceuticals, Inc. announced today the initiation of a Phase 3 registration trial of custirsen sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC). This trial, referred to as the Prostate Cancer SATURN Trial, is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries to develop and commercialize OGX-011/ TV-1011.

21 Jun 2010

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Affymax, Inc. and Takeda Global Research & Development Center, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced preliminary top-line results from the Phase 3 clinical program for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients.

21 Jun 2010

Sosei reaches agreement to acquire 100% of Activus

Sosei Group Corporation, announced today that it has reached an agreement to acquire 100% of Activus Pharma Ltd., a privately-held biopharmaceutical company based in Chiba, Japan.

21 Jun 2010

EIN News expands health news-monitoring coverage

With impending lawsuits from states, an uprising from the Tea Party sect and an outpouring of rhetoric from both major parties, the healthcare debate is far from over.

21 Jun 2010

Medco Health Solutions, Celesio join to help relieve financial burden on healthcare payors across Europe

Medco Health Solutions, Inc. and Celesio AG, two of the world's leading pharmacy-driven healthcare companies, today announced a joint venture with a long-term goal of improving patient health and helping to relieve the crushing financial burden on healthcare payors across Europe.

21 Jun 2010

Incidental findings in brain imaging can be managed ethically and cost-effectively: UBC researchers

The increasing number of incidental findings in brain imaging can be managed ethically and cost-effectively by screening study participants based on gender, age and family history, according to University of British Columbia researchers.

21 Jun 2010

Pharmaceuticals News and Research

Incline acquires IONSYS, announces $43 million Series A financing

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Cadence Pharmaceuticals to acquire Incline Therapeutics

Also in Global Health News: WHO scraps drug development group; Access to medication in Philippines; Yellow fever vaccine shortage; HIV-positive employee protection

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante announces $15 million registered direct offering

Saladax Biomedical, Bristol-Myers Squibb collaborate to develop clinical diagnostics

Simulations Plus third-quarter consolidated preliminary revenues up 14.9% to $3.1M

Essen BioScience, Nycomed partner to develop modulators of voltage-gated ion channels

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Inovio Pharmaceuticals set to be added to Russell 3000 Index

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Results of two clinical proof-of-concept studies for CER-627 program to be presented at EAS Congress 2010

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Sosei reaches agreement to acquire 100% of Activus

EIN News expands health news-monitoring coverage

Medco Health Solutions, Celesio join to help relieve financial burden on healthcare payors across Europe

Incidental findings in brain imaging can be managed ethically and cost-effectively: UBC researchers

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