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Updated: 9 hours 20 min ago

Vitamin D may not help your heart

Wed, 06/19/2019 - 10:00
While previous research has suggested a link between low levels of vitamin D in the blood and an increased risk of cardiovascular disease, a new Michigan State University study has found that taking vitamin D supplements did not reduce that risk. The large-scale study, published in the Journal of the American Medical Association Cardiology, found that vitamin D supplements did not decrease the incidence of heart attacks, strokes or other major adverse cardiovascular events.

Japan becomes the first country to approve Roche's personalised medicine Rozlytrek

Tue, 06/18/2019 - 12:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.

Researchers identify enzyme that suppresses immune system in breast cancer

Tue, 06/18/2019 - 10:00
Immunotherapies have transformed cancer care, but their successes have been limited for reasons that are both complex and perplexing. In breast cancer especially, only a small number of patients are even eligible to undergo treatment with immunotherapies, and most see little benefit.

FDA approves Amgen and Allergan's KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab)

Mon, 06/17/2019 - 10:00
Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTITM (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Making it personal: How genetic technologies are changing the face of medicine

Fri, 06/14/2019 - 10:00
The age of one-size-fits-all medicine is fading. Taking its place is an era of personalized medicine - the practice of tailoring disease prevention, diagnosis, and treatment to patients as individuals. Many cancers, for example, are resistant to conventional therapies but respond to medications that target specific cancer-causing genetic mutations.

FDA grants Roche's Polivy accelerated approval for people with previously treated aggressive lymphoma

Thu, 06/13/2019 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies.

Weighing risks and benefits of drug treatment for major depression

Wed, 06/12/2019 - 10:00
Depression is a common and serious problem for older adults. Some 15 to 20 percent of people aged 65 and older who live independently deal with symptoms of major depressive disorder. For residents of nursing homes, the rates of depression may be as high as 50 percent. For some people, medication is an effective part of treatment for depression.

Full data from CAROLINA® outcome trial support long-term cardiovascular safety profile of Trajenta®

Tue, 06/11/2019 - 10:00
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA® trial demonstrating that Trajenta® (linagliptin) did not increase cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk.(1) The findings were reported today at the American Diabetes Association's 79th Scientific Sessions in San Francisco.

Ophthalmic Drugs Conference 2019

Tue, 06/11/2019 - 10:00
19 - 20 November 2019, London, UK.
The global ophthalmic drug market size is expected to reach a value of $30 billion USD by 2023 with growing focus on alternative delivery approaches to replace intravitreal drug delivery and novel drug development being the key factors driving the market.

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Mon, 06/10/2019 - 12:00
Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.

Study finds FDA dermatology advisors receive payments following drug approvals

Mon, 06/10/2019 - 10:00
A team of researchers led by a member of the University of Colorado School of Medicine faculty at the Anschutz Medical Campus examined post-advisory financial relationships between U.S. physicians who advised FDA committees during dermatological drug approval processes. Critics of these industry-physician relationships claim these types of payments could incentivize advisors to alter their voting habits.

Nucala (mepolizumab) gains FDA approval for two new self-administration options

Fri, 06/07/2019 - 12:00
GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.

Jeff Settleman, Ph.D., joins Pfizer to lead Oncology Research & Development

Fri, 06/07/2019 - 10:00
Pfizer Inc. (NYSE: PFE) announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to

Cleveland researchers test novel gene therapy for glioblastoma

Thu, 06/06/2019 - 12:00
A novel gene therapy clinical trial at University Hospitals Seidman Cancer Center and the Case Comprehensive Cancer Center is showing promising results, garnering funding with a prestigious U01 Grant from the National Cancer Institute. The trial focuses on turning patients with a poor prognosis into those with a good prognosis.

Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist®

Thu, 06/06/2019 - 10:00
Novartis announced results from the landmark COMBI-d and COMBI-v clinical trials, concluding that first-line treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) offers both overall and progression-free long-term survival benefits to patients with unresectable or metastatic BRAF-mutation positive melanoma.

Prescription drug costs steadily soar, yet price transparency is lacking

Wed, 06/05/2019 - 12:00
After reviewing tens of millions of insurance claims for the country’s 49 most popular brand-name prescription drugs, a team from Scripps Research Translational Institute found that net prices rose by a median of 76 percent from January 2012 through December 2017 - with most products going up once or twice per year. The substantial price increases were not limited to drugs that recently entered the marketplace, as one might expect, or to those lacking generic equivalents.

Bristol-Myers Squibb announces post-closing leadership team

Wed, 06/05/2019 - 10:00
Bristol-Myers Squibb Company (NYSE:BMY) today announced the future leadership team of the combined company effective upon completion of the company’s pending merger with Celgene Corporation (NASDAQ:CELG). The company is evolving key aspects of its R&D and Commercialization structure to drive the continued growth of a highly successful marketed portfolio, maximize the six near-term launch opportunities and deliver the value of the combined pipeline,

Cholesterol in eggs tied to cardiac disease, death

Tue, 06/04/2019 - 10:00
Research that tracked the diets, health and lifestyle habits of nearly 30,000 adults across the country for as long as 31 years has found that cholesterol in eggs, when consumed in large quantities, is associated with ill health effects, according to Katherine Tucker, a biomedical and nutritional sciences professor in UMass Lowell's Zuckerberg College of Health Sciences, who co-authored the analysis. The study was published in the Journal of the American Medical Association.

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

Mon, 06/03/2019 - 12:00
Today, the U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. A new call center called Project Facilitate will be a single point of contact where FDA oncology staff will help physicians treating patients with cancer through the process to submit an Expanded Access request for an individual patient, including follow-up of patient outcomes.

Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial

Mon, 06/03/2019 - 10:00
Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer[1].