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LYNPARZA Phase III SOLO-1 results show improved outcome for patients with advanced BRCA-mutated ovarian cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., today announced detailed results from the Phase III SOLO-1 trial testing LYNPARZA (olaparib) 300 mg tablets twice-daily as a maintenance treatment for patients with newly diagnosed advanced BRCA-mutated ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy.

22 Oct 2018

Takeda announces positive Phase 3 ALTA-1L data in first-line therapy for advanced ALK+ NSCLC

Takeda Pharmaceutical Company Limited today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients.

22 Oct 2018

Pfizer announces FDA approval of VIZIMPRO for first-line treatment of EGFR-mutated metastatic NSCLC

Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved VIZIMPRO [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

28 Sep 2018

CHMP adopts positive opinion of Takeda’s ALUNBRIG for treatment of ALK+ non-small cell lung cancer

Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the full approval of ALUNBRIG® as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib.

24 Sep 2018

Avoidable sepsis infections send thousands of seniors to gruesome deaths

Shana Dorsey first caught sight of the purplish wound on her father's lower back as he lay in a suburban Chicago hospital bed a few weeks before his death.

6 Sep 2018

FDA accepts Bristol-Myers Squibb’s application for Sprycel for treating pediatric leukemia

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

30 Aug 2018

FDA expands approval of Vertex' cystic fibrosis medicine to treat children aged 12 to <24 months

Vertex Pharmaceuticals Incorporated today announced the U.S. Food and Drug Administration approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.

16 Aug 2018

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for the treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.

20 Jul 2018

PMDA approves use of LYNPARZA in patients with BRCA-mutated breast cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that Japan's Pharmaceuticals and Medical Devices Agency has approved LYNPARZA tablets for use in patients with unresectable or recurrent BRCA-mutated, human epidermal growth factor receptor 2 -negative breast cancer who have received prior chemotherapy.

2 Jul 2018

U.S. FDA approves first drug for patients with germline BRCA-mutated metastatic breast cancer

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LYNPARZA (olaparib) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

12 Jan 2018

Sunovion announces results from Phase 3 clinical study of new drug in children, adolescents with bipolar depression

Sunovion Pharmaceuticals Inc. today announced post-hoc analysis results of a positive Phase 3 placebo-controlled clinical study, as well as interim data from a long-term open-label extension study evaluating Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression).

28 Oct 2017

FDA approves expanded use of Zykadia for first-line treatment of ALK-positive metastatic NSCLC

Novartis today announced the US Food and Drug Administration approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

27 May 2017

Takeda announces accelerated approval from FDA for new lung cancer treatment

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that ALUNBRIG (brigatinib) has received Accelerated Approval from the U.S. Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.

28 Apr 2017

Study: Women, mostly minorities lack pre-pregnancy nutrition

Black, Hispanic and less-educated women consume a less nutritious diet than their well-educated, white counterparts in the weeks leading up to their first pregnancy, according to the only large-scale analysis of preconception adherence to national dietary guidelines.

17 Mar 2017

Loyola offers gastric balloon as new option to treat obesity

Loyola Medicine's comprehensive weight loss center is offering a new option to treat obesity - a grapefruit-size gastric balloon that takes up as much as half the volume of the stomach.

23 Feb 2017

Scientists find novel way for earlier detection of deadly Merkel cell carcinoma

Scientists have found a way to detect earlier if a deadly cancer, Merkel cell carcinoma (MCC), is recurring in patients, according to a paper to be published 11 a.m. Eastern time, Dec. 7, in the journal Cancer.

7 Dec 2016

Rare germ cell tumor creates unique bond between two young women

Morgan Ellison and Madison McDaniel were diagnosed with a rare germ cell tumor of the ovary earlier this year. The two strangers would soon form a unique bond during their treatment in Birmingham, Alabama.

30 Apr 2016

Genetically engineered mexican lime contains anthocyanins that has several potential benefits

Anthocyanins, pigments that give plants their red, blue, or purple hues, are not typically produced in citrus fruits grown under tropical or subtropical conditions. Now, scientists have genetically engineered a lime that contains anthocyanins, which they say has several potential benefits.

9 Mar 2016

Father-daughter duo co-author research paper on new grapefruit cybrids

When Jude Grosser's daughter, Melinda, was in elementary school, he would often take her to his laboratory at the University of Florida's Citrus Research and Education Center, where he works as a researcher on citrus diseases and creating new varieties.

26 Dec 2015

UC San Diego Health offers safe weight loss option for patients

Patients seeking rapid but safe weight loss have a new option at the Bariatric Metabolic Institute at UC San Diego Health. During an outpatient procedure, surgeons place an adjustable saline balloon in the stomach. The volume and shape of the balloon take up space in the stomach, which encourages food portion control. The device, called Orbera, has been shown to reduce total body weight by 10 percent.

11 Dec 2015