Medical Tidbits,Longest surviving heart transplant recipient says it’s time to change the way we do organ donation.

J&J blog, https://www.medcareernews.com

Thirty years after receiving a new heart, retired professional soccer player Simon Keith returns to his donor’s home town to raise awareness and advocate for reforms across North America.

(April is National Organ Donor Awareness month) 

Thirty years ago retired professional soccer player Simon Keith received a new heart, and as one of the world’s longest surviving heart transplant recipients, he is returning to his donor’s hometown of Newport, Wales, U.K. to support organ donor awareness and the need for reforms in his two home countries of US and Canada read more

How the Janssen Disease Interception Accelerator Can Help Us Shift From Disease Care to Health Care

Our approach to treating disease will change dramatically in the future. In fact, it has already started.

Medical innovation in the last decade has immeasurably improved the lives of millions through diagnostic advances and life-saving medicines. And the biopharmaceutical community has made unequivocal contributions to some of the most challenging diseases of our time.

But despite this progress, we can do more. New avenues and novel insights enable and empower us to go further and make disease—and the idea of “treating it”—a historical artifact. read more

ASTRAZENECA REPORTS TOP-LINE RESULTS FROM THE BRILINTA SOCRATES TRIAL IN STROKE

Missed primary efficacy endpoint; fewer events observed in the Brilinta arm but trend did not reach statistical significance

AstraZeneca today announced the top-line results of the SOCRATES trial, assessing the efficacy of Brilinta/Brilique (ticagrelor) 90mg tablets twice daily, when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient ischaemic attack (TIA). The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart attack) and death was not met. Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population but the trend did not reach statistical significance.

Based on preliminary analyses, safety data is consistent with the known safety profile of Brilinta/Brilique.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We will present the full analysis of the trial results, including  subgroups, at a forthcoming stroke congress and will engage with regulatory agencies on the interpretation of the data. The SOCRATES trial enrolled a patient population that differs from the currently-approved indications for Brilinta/Brilique.”

The SOCRATES trial evaluated the efficacy and safety of 90-day treatment with Brilinta/Brilique versus aspirin for the prevention of major vascular events in patients > 40 years of age with an acute ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) < 5) or TIA (ABCD² score ≥4). Patients randomised into the trial needed to have symptom onset within 24 hours.

In the second half of 2016, data are expected from the ongoing EUCLID trial in peripheral arterial disease (PAD). EUCLID is the fourth trial to read-out from the PARTHENON programme, assessing the potential of Brilinta/Brilique in additional high-risk patient populations.

Lilly’s Taltz(R) (ixekizumab) Receives U.S. FDA Approval for the Treatment of Moderate-to-Severe Plaque Psoriasis

In pivotal studies, most patients treated with Taltz achieved significant skin clearance (PASI 75, sPGA 0 or 1) with many achieving virtually clear (PASI 90) or completely clear (PASI 100, sPGA 0) skin at week 12 –

INDIANAPOLIS, March 22, 2016 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.1read more

New Android App Launched to Protect Cell Phone Users from the Health Hazards of Smartphones Including Cancer Causing Radiation

Modern cell phones commonly known as smartphones emit radiation in the 450–2100 MHz microwave range, which is considered to be possibly carcinogenic. 

Safe Phone is a first of its kind activity tracking smartphone app developed by Dr. Madhukar Dama. He says, “According to the World Health Organization Smartphones have the potential to cause cancer. Users of this new app needn’t worry though; Safe Phone helps owners to use their smartphones wisely, keeping the hazards and radiation in check and making sure app users stay healthy.” read more

Diamyd® in combination with etanercept and vitamin D shows safety in a first preliminary interim report

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that a first six-month interim report comprising five patients in EDCR IIa, a pilot researcher-initiated clinical study in which the diabetes vaccine Diamyd® is combined with two other already approved agents, the immunosuppressive drug etanercept and vitamin D, preliminary shows the treatment is safe and tolerable. No serious side effects have been reported. This is the first time that this combination of agents is tested against the complex autoimmune process that causes type 1 diabetes.

read more

EISAI WITHDRAWS NEW DRUG APPLICATION FOR MECOBALAMIN ULTRA-HIGH DOSE PREPARATION AS TREATMENT FOR AMYOTROPHIC LATERAL SCLEROSIS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has withdrawn its new drug application for ultra-high dose mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan. read more

Pfizer Joins The Human Vaccines Project To Help Decode The Immune System

Pfizer Inc. (NYSE:PFE) today announced it will join the Human Vaccines Project (the Project), a public-private consortium focused on cross-sector collaboration to identify human immune responses associated with optimal vaccine protection. Insights gained will guide the development of potentially improved vaccines against diseases such as influenza, dengue, HIV and other infectious illnesses as well as cancer. read more

Evenamide (NW-3509): Evidence of Anti-Psychotic Efficacy as an Add-On to Antipsychotics in Ongoing Phase 2 Study May Suggest an Alternative Approach to the Treatment of Schizophrenia

MILAN–(BUSINESS WIRE)–Newron Pharmaceuticals S.p.A. (“Newron”), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, announced today that it will present at the 5th Biennial Schizophrenia International Research Society Conference the abstract “Evenamide (NW-3509), a Putative Antipsychotic, Targets Abnormal Electrical Activity and Glutamatergic Abnormalities in Improving Psychotic Symptoms in Patients with Schizophrenia in a Phase II, Placebo-controlled Trial.”  read more

Cerulean Announces Publication Showing CRLX101 Localizes Selectively in Human Tumors, Sparing Adjacent Healthy Tissu)–Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced the publication of clinical data for its lead compound, CRLX101, in the journal Proceedings of the National Academy of Sciences (PNAS). The publication highlights results from an investigator-sponsored clinical trial, in which pre- and post- treatment tumor biopsies from patients with gastric cancer treated with CRLX101 show the presence of CRLX101 and its payload, camptothecin, in tumors, and their absence in surrounding normal tissue. Importantly, inhibition of the molecular targets of CRLX101 was demonstrated in post-treatment biopsies. The article was published online. Initial results from the trial were presented at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 7, 2015. e  read more

Bristol-Myers Squibb to Acquire Padlock Therapeutics, Inc.

.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and Padlock Therapeutics, Inc. announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of Padlock, a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases. The acquisition will give Bristol-Myers Squibb full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis (RA). Padlock’s PAD discovery program may have additional utility in treating systemic lupus erythematosus (SLE) and other autoimmune diseases read more

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