Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

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

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

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

The first data to show that Neupro® (rotigotine transdermal system) significantly improved wellbeing and daily activities that are often impaired by pain related to Restless Legs Syndrome (RLS) were presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

18 Jun 2010

Roche implements risk mitigation plan in taspoglutide Phase III programme

Ipsen, a global biopharmaceutical group, today announced that its partner Roche today announced the implementation of a risk mitigation plan in the taspoglutide Phase III programme. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Lantheus Medical Imaging reports new Phase 4 data from DEFINITY study

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced new data from a Phase 4, open-label safety study evaluating the effect of DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, an echocardiography contrast agent, on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure.

14 Jun 2010

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Celgene International Sàrl announced that data from the planned second interim analysis (median follow-up of 21 months) of a phase III, randomized, double-blind study of continuous REVLIMID (lenalidomide) for the treatment of elderly patients with newly diagnosed multiple myeloma show improvement in progression-free survival, the primary endpoint of the study.

14 Jun 2010

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

11 Jun 2010

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

Abraxis BioScience, Inc. presented trial design information from its ongoing phase 3 registration trial of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year.

11 Jun 2010

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

CoLucid Pharmaceuticals, Inc.,, an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study.

10 Jun 2010

Helsinn Healthcare S.A., Eisai announce signing of licensing agreement

Helsinn Healthcare S.A. and Eisai Inc. today announce the signing of a licensing agreement granting Eisai Inc. commercialization rights for a new product for potential use in the prevention of chemotherapy-induced nausea and vomiting in the United States.

9 Jun 2010

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Regeneron Pharmaceuticals, Inc. announced that a Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that ARCALYST (rilonacept), also known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

9 Jun 2010

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

Biogen, Elan launch My MS Health, a web-based PRO research program

Biogen Idec and Elan Corporation, plc, in collaboration with EPI-Q, Inc. and Avatar International, LLC, today announced the launch of My MS Health, a first-of-its-kind, web-based, patient-reported outcomes research program. My MS Health is designed to track and provide instant reports on patient function and quality of life using validated measures over time.

9 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Hypersensitivity News and Research

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

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

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

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

Roche implements risk mitigation plan in taspoglutide Phase III programme

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

UCB announces availability of Vimpat oral solution formulation

Lantheus Medical Imaging reports new Phase 4 data from DEFINITY study

Phase III study of REVLIMID for treating patients with multiple myeloma shows improvement in PFS

Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Abraxis BioScience presents phase 3 trial data on metastatic malignant melanoma

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

Helsinn Healthcare S.A., Eisai announce signing of licensing agreement

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Biogen, Elan launch My MS Health, a web-based PRO research program

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

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