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Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

Watson receives FDA approval for Androderm lower-dose formulations

Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved its Androderm (testosterone transdermal system) 2 mg and 4 mg formulation.

21 Oct 2011

Pfizer releases Phase III study results comparing VFEND-ERAXIS combination to VFEND for IA

Pfizer Inc. today reported the top-line results of an international Phase III clinical trial which compared the combination of VFEND (voriconazole) and ERAXISTM (anidulafungin) to VFEND monotherapy for primary therapy of invasive aspergillosis, a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems.

1 Oct 2011

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Merck issues statement on GARDASIL human papillomavirus vaccine

Merck, known as MSD outside the United States and Canada, issued the following statement on GARDASIL, Merck's vaccine to protect against certain diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

14 Sep 2011

Incyte announces FDA acceptance of NDA filing for ruxolitinib to treat myelofibrosis

Incyte Corporation announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte's lead investigational compound, ruxolitinib, as a potential treatment for patients with myelofibrosis.

3 Aug 2011

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.

30 Jul 2011

Cadence confirms FDA dosing recommendations for OFIRMEV

Cadence Pharmaceuticals, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) approved dosing recommendations for OFIRMEV (acetaminophen) injection remains 4,000 mg per day for adults and adolescents weighing at least 50 kg.

29 Jul 2011

Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

Yaupon Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its propriety gel formulation of mechlorethamine hydrochloride (mechlorethamine).

28 Jul 2011

Baxter GAMMAGARD LIQUID for PI receives FDA approval for subcutaneous administration

Baxter International Inc. announced today that the U.S. Food and Drug Administration has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency.

From Baxter International Inc. 25 Jul 2011

AMAG enters definitive merger agreement with Allos Therapeutics

AMAG Pharmaceuticals, Inc. and Allos Therapeutics, Inc. today announced that they have entered into a definitive merger agreement under which the companies will combine in an all-stock merger with a total equity value of approximately $686 million.

21 Jul 2011

PENNSAID Viscous Solution Phase 2 clinical trial for osteoarthritis pain meets primary endpoint

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the treatment of pain, today announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of top-line results from a Phase 2 study conducted by Covidien, of twice-daily administration of PENNSAID Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel.

30 Jun 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Endo Pharmaceuticals announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted.

24 Jun 2011

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene International Sàrl announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

18 Jun 2011

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

Groupe d'Etude des Lymphomes de l'Adulte (GELA) and Celgene International Sarl today announced a collaboration to conduct an international randomized study to evaluate the therapeutic potential of the REVLIMID/rituximab combination regimen (R2) in patients with newly diagnosed follicular lymphoma.

17 Jun 2011

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

Celgene International Sàrl announced that clinical data from two studies evaluating the use of REVLIMID® (lenalidomide) with standard R-CHOP chemotherapy in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

17 Jun 2011

GE Healthcare announces results of Optison heart ultrasound contrast agent presented at ASE

Today, GE Healthcare Medical Diagnostics announced results of a study that evaluated the cardiopulmonary safety of Optison- (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in improving suboptimal echocardiograms.

14 Jun 2011

Incyte announces additional results from ruxolitinib Phase III trial on myelofibrosis

Incyte Corporation announced today additional symptom improvement and quality of life (QoL) results from COMFORT-I, a randomized, double-blinded, placebo-controlled Phase III trial of Incyte's JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis (MF).

13 Jun 2011