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Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

New drug patiromer could improve potassium levels of patients with diabetic kidney disease

Among patients with diabetic kidney disease and hyperkalemia (elevated potassium levels in the blood), a potentially life-threatening condition, those who received the new drug patiromer, twice daily for four weeks, had significant decreases in potassium levels which lasted through one year, according to a study in the July 14 issue of JAMA.

15 Jul 2015

$Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC$

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone.

19 Jun 2015

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib.

1 Jun 2015

Eisai Phase 3 trial of eribulin meets primary endpoint in patients with advanced soft tissue sarcoma

Eisai Inc. announced today the results of its Phase 3 trial (Study 309), which showed that eribulin met the study's primary endpoint evaluating overall survival in patients who had advanced leiomyosarcoma (LMS) or adipocytic sarcoma (ADI), two types of advanced soft tissue sarcoma.

30 May 2015

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

29 May 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015.

28 May 2015

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC).

6 Apr 2015

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.

10 Mar 2015

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).

8 Mar 2015

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.

9 Dec 2014

ZS Pharma reports positive ZS-9 Phase 3 clinical trial for treatment of hyperkalemia

ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today presented detailed results from HARMONIZE (ZS004) at the late-breaking Clinical Science Special Reports Session of the American Heart Association Scientific Sessions.

18 Nov 2014

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.

3 Nov 2014

Promising results for low-dose insulin in paediatric diabetic ketoacidosis

Results of a randomised trial suggest that low-dose insulin may be at least as good as standard-dose insulin for the treatment of children with diabetic ketoacidosis.

30 Oct 2014

Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim today announced that Striverdi Respimat (olodaterol) Inhalation Spray 5 mcg is now available by prescription in pharmacies across the United States.

8 Oct 2014

Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

A final analysis of the Phase 3 COU-AA-302 trial presented today at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain showed that ZYTIGA® (abiraterone acetate) plus prednisone significantly prolonged overall survival (OS), compared to an active control of placebo plus prednisone, in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).

30 Sep 2014

Mylan launches Potassium Chloride Extended-release Tablets

Mylan Inc. today announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con.

22 Aug 2014

Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi and MannKind Corporation announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.

11 Aug 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014.

28 Jun 2014