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Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. [More]
Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. [More]
Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII. [More]
New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025 – early detection and management are key

New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025 – early detection and management are key

The International Society of Nephrology (ISN) will present the findings of a new global study on Acute Kidney Injury (AKI), seen by experts as a key step forward in their efforts to eliminate preventable deaths from the condition by 2025 (0by25). [More]
Egalet announces net revenues of $1.9 million for 2014

Egalet announces net revenues of $1.9 million for 2014

Egalet Corporation today reported financial results for the year ended December 31, 2014. [More]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. [More]
FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

FDA approves Astellas' CRESEMBA for treatment of invasive aspergillosis, invasive mucormycosis

Astellas today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for the use of CRESEMBA (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). [More]
Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals plc announced today that researchers will present data on the use of defibrotide, an investigational medicine being studied in the United States (U.S.) for the treatment of hepatic veno-occlusive disease (VOD), a rare, potentially life-threatening, early complication in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy. [More]
Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, a privately-held pharmaceutical company, today announced a national strategic partnership with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, that will help support its goal of cutting prescription drug-related deaths in half, saving approximately 10,000 lives over five years. [More]
FDA approves RYTARY for Parkinson's disease treatment

FDA approves RYTARY for Parkinson's disease treatment

Impax Pharmaceuticals, a division of Impax Laboratories, Inc., today announced that the U.S. Food and Drug Administration approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. [More]
Lilly receives FDA approval for CYRAMZA (ramucirumab)

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). [More]
Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen today announced that new data from a pivotal Phase 2 study evaluating BLINCYTO (blinatumomab) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) was presented at the 56th American Society of Hematology Annual Meeting and Exposition. [More]
Prodromal symptoms precede PD by up to a decade

Prodromal symptoms precede PD by up to a decade

Many prodromal symptoms of Parkinson’s disease appear long before a clinical diagnosis is made, shows a large study of patients in primary care. [More]
Many pediatric chest X-rays unnecessary, offer no clinical benefit

Many pediatric chest X-rays unnecessary, offer no clinical benefit

Researchers at Mayo Clinic found that some children are receiving chest X-rays that may be unnecessary and offer no clinical benefit to the patient, according to a study presented today at the annual meeting of the Radiological Society of North America. [More]
Janssen announces submission of NDA for three-month paliperidone palmitate

Janssen announces submission of NDA for three-month paliperidone palmitate

Janssen Research & Development, LLC today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. [More]
FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. [More]
Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Astellas' isavuconazole gets FDA orphan drug designation for treatment of invasive candidiasis

Astellas announced today that the U.S. Food and Drug Administration has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis. [More]
Bariatric surgery may be risk factor for condition that causes severe headaches

Bariatric surgery may be risk factor for condition that causes severe headaches

Bariatric surgery may be a risk factor for a condition that causes severe headaches, according to a study published in the October 22, 2014, online issue of Neurology®, the medical journal of the American Academy of Neurology. [More]
Nonmotor predictors of Parkinson’s dementia revealed

Nonmotor predictors of Parkinson’s dementia revealed

Researchers have identified nonmotor and nondopaminergic motor features that predict incident dementia in patients with Parkinson’s disease. [More]
Fecal microbiota transplantation officially recommended for effective treatment of C. difficile infection

Fecal microbiota transplantation officially recommended for effective treatment of C. difficile infection

The transplantation of faecal microbiota from a healthy donor has been shown in recent clinical studies to be a safe and highly effective treatment for recurrent Clostridium difficile (C. difficile) infection and is now recommended in European treatment guidelines. [More]
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