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Jazz Pharmaceuticals Announces FDA Approval of Defitelio® (defibrotide sodium) for the Treatment of Hepatic Veno-Occlusive Disease (VOD) with Renal or Pulmonary Dysfunction Following Hematopoietic Stem-Cell Transplantation (HSCT)

Commentspr newswire2016-04-01 10:02 Read   383

azz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) granted marketing approval for Defitelio® (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.

GENFIT TO BEGIN ELAFIBRANOR CLINICAL PROGRAM IN PBC

TrendGENFIT2016-04-01 09:52 Read   108

GENFIT today announced at the GENFIT R&D Event in New York City, that the Company plans to begin a second Elafibranor clinical program in 2016, targeting unmet need in the liver disease Primary Biliary Cholangitis (PBC)

Lilly's new arthritis drug beats placebo in latest successful trial

TrendFierce biotech2016-04-01 09:38 Read   125

Eli Lilly ($LLY) and research partner Incyte ($INCY) released positive new data from the RA-BEACON Phase III trial showing its investigational rheumatoid arthritis pill baricitinib met its primary endpoint of improved ACR 20 response when compared with placebo at week 12.

Genital Herpes Immunotherapy GEN-003 Shows Sustained Reduction of Viral Shedding Rate, Durable Impact on Clinical Disease 12 Months Post-Dosing

TrendGenocea Biosciences2016-04-01 09:29 Read   285

Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

Commense Advances Microbiome Platform Targeting Early Childhood Health

R&Dpure tech health2016-04-01 09:20 Read   89

Commense, focused on preventing and treating disease through microbiome-based interventions in infancy and early childhood, advances its discovery and development platform, names its founding scientists and advisors and executes an exclusive license in the microbiome field. 

Health Tip: Watch for Mental Health 'Red Flags' in Kids

Healthdrugs2016-03-31 13:19 Read   202

Children and teens aren't immune to stress and mental health issues, and parents should be aware of potential warning signs.

Sanofi Genzyme helps cancer biotech ImmuneXcite close $8.6M financing round

EVENTSFierce biotech2016-03-31 13:12 Read   167

ImmuneXcite has raised $8.6 million in a Series A financing round as the immuno-oncology biotech announced the addition of Glaxo ($GSK) and Sanofi Genzyme ($SNY) veterans to its executive crew.

SEC: Biotech Company Misled Investors About New Drug's Status With FDA

RegulatorSEC2016-03-31 12:58 Read   87

The Securities and Exchange Commission today announced fraud charges against a Massachusetts-based biotech company and three former executives for misleading investors about the company’s efforts to obtain Food and Drug Administration (FDA) approval for its flagship developmental drug to treat kidney cancer.

Newron Receives Complete Response Letter from US FDA for Xadago® (safinamide)

TrendBUSINESS WIRE2016-03-31 12:37 Read   134

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced today that a complete response letter from the FDA has been received for safinamide.

ARIAD Announces Reduction in Workforce as Part of Ongoing Company-Wide Strategic Review

R&DBUSINESS WIRE2016-03-31 11:24 Read   146

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it is reducing approximately 25 percent of its headquarter positions.

SEC: Biotech Venture Capitalist Stole Investor Funds for Personal Use

RegulatorSEC2016-03-31 11:16 Read   79

The Securities and Exchange Commission today announced that a San Francisco-based biotech venture capitalist has agreed to settle charges that he siphoned money from a fund managed by his firm in order to prop up other struggling businesses he owned and finance his lavish lifestyle.

Keryx Biopharmaceuticals Announces Positive Top-line Results from Pivotal Phase 3 Study of Ferric Citrate for the Treatment of Iron Deficiency Anemia in Adults with Non-Dialysis Dependent Chronic Kidney Disease

TrendYAHOO2016-03-31 10:54 Read   78

Keryx Biopharmaceuticals, Inc. (KERX), a biopharmaceutical company focused on bringing innovative medicines to market for people with renal disease, today announced positive top-line results for its pivotal 24-week Phase 3 study of ferric citrate, an oral, iron-based medicine in development for the treatment of iron deficiency anemia (IDA) in adults with stage 3-5 non-dialysis dependent chronic kidney disease (NDD CKD).