Medical Tidbits, An Important Milestone in the Search for an Ebola Vaccine

medical device sales

It seems there is always a new story in the media about an emerging health threat. Right now, understandably, there is significant public concern about the spread of the Zika virus.

But just over a year ago, it was the Ebola virus and its devastating impact in West Africa that dominated the headlines.

The Ebola epidemic in West Africa may have subsided, but not after leaving a huge human cost—over 11,300 lives were lost, tragically, in the outbreak. Far too many families and communities in the countries of Sierra Leone, Guinea and Liberia were devastated. read more

FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign’s target audience. read more

Nplate® (Romiplostim) Study In The Lancet Shows Significant Increase In Durable Platelet Response Among Children With Immune Thrombocytopenia

Nplate Reduced Rates of Bleeding by More Than 30 Percent in Children Affected by Blood Disorder

THOUSAND OAKS, Calif., April 19, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that The Lancet published results from a Phase 3 randomized, double-blind, placebo-controlled study of Nplate® (romiplostim) in children with symptomatic immune thrombocytopenia (ITP). The study showed that 52 percent of Nplate patients achieved a durable platelet response, compared with 10 percent of placebo-treated patients (p=0.002, odds ratio 9.1, 95 percent CI: 1.9, 43.2). read more

Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures. If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death.

Baxter Announces U.S. Launch of Premix Drug VANCOMYCIN Injection in Sodium Chloride

DEERFIELD, Ill., April 19, 2016 – Advancing Baxter’s longstanding commitment to provide hospitals with convenient presentations of medications that drive efficiency during drug preparation and enhance patient safety in administration, Baxter International Inc. (NYSE: BAX) today announced the launch of a ready-to-use VANCOMYCIN injection in 0.9% Sodium Chloride (Normal Saline) in 500 mg, 750 mg and 1 gram presentations. VANCOMYCIN injection is an antibiotic used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci bacteria. read more

American Medical Association Testifies at House Panel on Pending Medicare Changes

New MACRA Regulations Provide Federal Government Opportunity to Improve Medicare for Physicians and Patients

WASHINGTON – Dr. Barbara McAneny, immediate past chair of the American Medical Association (AMA), told a House panel today that the soon-to-be released regulations to implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) represent a critical opportunity to improve flexibility and innovation in health care that can lead to improved care and better outcomes for patients. Appearing before the House Energy and Commerce Health Subcommittee, she noted the widespread support for transforming the Medicare program to improve payment, streamline quality reporting, and promote better health care delivery. This shared goal was evident last year when Congress, with overwhelming bipartisan support, passed MACRA. read more

Saniona initiates Phase 2a study for Tesomet in type 2 diabetes

Saniona, a leading biotech company in the field of ion channels, today announces that it has initiated recruitment of patients in the Phase 2a clinical studies for Tesomet in type 2 diabetes. The trial comprises a total of 60 patients.  Saniona expects to report the results from the trial within one year.

“We are very excited about the initiation of this important Phase 2a study, which represents a new treatment paradigm in type 2 diabetes. I would like to thank our team and Profil for their professional and effective planning leading to the timely initiation of this clinical study. Four patients have received either Tesomet or placebo and additional three patients may potentially be randomized this week,” says Jørgen Drejer, CEO of Saniona read more

Nuevolution Announces Further Technology Access Fee Payment from Its Drug Discovery Collaboration with Johnson & Johnson Innovation

Stockholm, 20 April, 2016 . Nuevolution AB (publ) today announced that Janssen Biotech, Inc. (Janssen), one of the Pharmaceutical Companies of Johnson & Johnson, has used its option to expand the collaboration with Nuevolution, thereby providing Nuevolution with a further payment of 600,000 USD.

Nuevolution A/S and Janssen Biotech entered into collaboration on 19 October, 2015 for application of Nuevolution’s proprietary Chemetics® drug discovery platform against biological disease targets of interest to Janssen Biotech.  The collaboration was facilitated by Johnson & Johnson Innovation, in partnership with Janssen Discovery Sciences. read more

Two young researchers will share the Assar Gabrielsson Award for their research into leukaemia and screening for prostate cancer

For the first time, the Assar Gabrielsson Foundation is dividing its award between two medical researchers. The winners, Anna Staffas and Rebecka Arnsrud Godtman, have carried out research into cancer which has aroused a great deal of interest. Each of them will receive SEK 100,000. read more

CMS Determines that Existing J-Code J9033 Adequately Describes BENDEKA (bendamustine hydrochloride) Injection

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) (“Eagle” or the “Company”) announced today that the Centers for Medicare & Medicaid Services (CMS) indicated that the Level II HCPCS code J9033 adequately describes BENDEKA® (bendamustine hydrochloride) Injection, a liquid, low-volume (50 mL) and short-time (10-minute) infusion formulation of bendamustine hydrochloride. BENDEKA was approved by the U.S. Food and Drug Administration (FDA) in December 2015 for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.  read more

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