Medical Tidbits,Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for Yervoy (ipilimumab) as Adjuvant Treatment for Fully Resected Stage III Melanoma

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PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% CI: 19, 39) for Yervoy vs. 17 months (95% CI: 13, 22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm). read more

New Heartwarming Campaign Aims to Save Lives of People with Oft-Misdiagnosed Deadly Disease

The Pulmonary Hypertension Association (PHA) is launching Heart2CurePH (#Heart2CurePH), a TV, radio, place-based and print public service campaign. Developed in partnership with leading national cause communications firm, The CauseWay Agency, the PSAs will begin running in donated media, including buses in Los Angeles and New York and transit shelters in Chicago, Philadelphia and San Francisco. The campaign has already received donated time and space throughout November on one of the big screens in Times Square. In addition, PHA is working with its partner PH organizations in 40 countries so that Heart2CurePH (#Heart2CurePH) ads will appear around the world.

Novo Nordisk increased operating profit by 51% in the first nine months of 2015 to DKK 38.3 billion

16% local currency operating profit growth adjusted for the NNIT divestment

Sales increased by 23% in Danish kroner and by 9% in local currencies to DKK 79.1 billion.

  •   Sales of Victoza® increased by 39% (21% in local currencies).
  •   Sales of Levemir® increased by 27% (10% in local currencies).
  •   Sales in North America increased by 33% (10% in local currencies).
  •   Sales in International Operations increased by 23% (17% in local currencies).
  •   Sales in Region China increased by 26% (5% in local currencies).

Gross margin improved by 1.8 percentage points in Danish kroner to 85.4% driven by a positive currency impact.

Operating profit increased by 51% in Danish kroner and by 26% in local currencies to DKK 38.3 billion. Adjusted for the DKK 2.4 billion non-recurring income related to the partial divestment of NNIT, operating profit in local currencies increased by 16%.

Net profit increased by 33% to DKK 26.6 billion. Diluted earnings per share increased by 36% to DKK 10.28. Adjusted for the partial divestment of NNIT, net profit and diluted earnings per share increased by 22% and 24% respectively.

In September, Novo Nordisk announced the US FDA approval of Tresiba® and Ryzodeg® 70/30 after the review of the class II resubmission of the New Drug Applications. 

CryoXtract Instruments Introduces the New CXT 353 Frozen Sample Aliquotter

WOBURN, Mass.–(EON: Enhanced Online News)–CryoXtract Instruments LLC, a provider of automated frozen aliquotting systems for high-value frozen biosamples, is pleased to introduce the CXT 353 Frozen Sample Aliquotter, the next generation semi-automated benchtop instrument for frozen aliquotting of a wide range of sample types including tissue, feces, plasma, whole blood, urine and other biofluids. read more

Frazier Healthcare Partners Closes Oversubscribed $262 Million Life Sciences Fund

MENLO PARK, Calif.–(BUSINESS WIRE)–Frazier Healthcare Partners, a leading healthcare-focused investment firm founded in 1991, has announced the closing of Frazier Life Sciences VIII, L.P., a fund with $262 million in capital commitments that will invest exclusively in companies developing novel therapeutics. Frazier Life Sciences VIII is the firm’s first sector-specific fund and brings the firm’s total committed capital under management to more than $2.4 billion. read more

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis read more

Cleveland Clinic Names Stent Retriever Technology One of the Top Medical Innovations for 2016

Medtronic Pioneered the First Stent Retriever in 2007 with the Introduction of the SolitaireTM Stent Retriever Device

DUBLIN – October 28, 2015 – The Cleveland Clinic has named stent retriever technology, which includes Medtronic plc‘s (NYSE: MDT) SolitaireTM stent retriever device, to a list of the top medical innovations for 2016. The top medical innovations list was revealed today at the Cleveland Clinic’s 2015 Medical Innovation Summit. read more

OncoSec Enrolls First Patient in Biomarker-Focused Pilot Study in Triple Negative Breast Cancer

SAN DIEGO, Oct. 29, 2015 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that the Company has enrolled the first patient into a pilot biomarker trial of ImmunoPulse™ IL-12 in patients with triple negative breast cancer (TNBC). ImmunoPulse™ IL-12, which employs intratumoral electroporation to enhance delivery of DNA-based interleukin-12 (IL-12), is designed to enhance tumor immunogenicity, leading to increased tumor infiltrating lymphocytes (TILs) and pro-inflammatory cytokines.

HSRx Group Completes Influenza Prevention Phase in Study of Novel Combination Drug for Flu Prevention & Treatment

TUCSON, Ariz., Oct. 28, 2015 /PRNewswire/ — HSRx Group, an Arizona-based biopharmaceutical company that is a leader in the development of next generation combination drugs for chronic and infectious diseases, has completed the influenza prevention segment of a  prevention and treatment study begun in November 2014. The phase II-sized study is designed to demonstrate the clinical significance of the HSRx 351 combination drug compared to the leading oral treatment, Tamiflu® (oseltamivir). A proprietary HSRx food-based compound, HSRx 351 is combined with generic oseltamivir to create a new oral flu treatment with a potential long patent life that deploys multiple flu virus-fighting mechanisms to safely achieve a higher level of effectiveness.

 

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