Medical Tidbits,.S. Food and Drug Administration approved cobimetinib (COTELLIC Tablets, Genentech, Inc.) for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib

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U.S. Food and Drug Administration approved cobimetinib (COTELLIC Tablets, Genentech, Inc.) for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.  Cobimetinib is not indicated for treatment of patients with wild-type BRAF melanoma.

The approval was based on the demonstration of improved progression-free survival (PFS) and overall survival (OS) in a multicenter, double-blind, randomized, active-controlled trial conducted in 495 patients with previously untreated, BRAF V600 mutation-positive, unresectable or metastatic melanoma as detected using the cobas 4800 BRAF V600 mutation test.  All patients received vemurafenib 960 mg orally twice daily and were randomized (1:1) to receive cobimetinib 60 mg (n=247) or matching placebo (n=248) orally once daily on days 1-21 of an every 28-day cycle.  The median age of the study population was 55 years (range 23 to 88 years), 58% of patients were male, 93% were White and 5% had no race reported, 60% had stage M1c disease, 72% had a baseline ECOG performance status of 0, 45% had an elevated baseline serum lactate dehydrogenase (LDH), 10% had received prior adjuvant therapy, and less than 1% had previously treated brain metastases. read more

Egalet Announces Issuance of U.S. Patent Covering Guardian™ Technology and Its Abuse-Deterrent Product Candidates

WAYNE, Pa., Nov. 12, 2015 /PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced the issuance of a patent by the U.S. Patent and Trademark Office (USPTO) covering products employing Egalet’s Guardian Technology. U.S. patent number U.S. 9,168,228 titled “Pharmaceutical Compositions Resistant to Abuse” was issued October 27, 2015.

“This patent expands our intellectual property portfolio protecting products using our proprietary abuse-deterrent Guardian Technology,” said Bob Radie, president and chief executive officer of Egalet. “We will continue to strengthen our patent position covering our products which in some cases extends to 2033 to support our organic growth.”

Egalet currently has been granted 14 U.S. patents and 69 patents outside of the United States that cover Guardian Technology and its product candidates.

U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Nov. 12, 2015– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. read more

New Analyses Further Add to the Efficacy and Safety Profile of OFEV® (nintedanib) in Idiopathic Pulmonary Fibrosis (IPF)  

RIDGEFIELD, Conn. and WASHINGTON, Nov. 13, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the presentation of new analyses of OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) at the Pulmonary Fibrosis Foundation’s PFF Summit 2015 in Washington, D.C. In 2014, OFEV became one of the first FDA-approved drug treatments for IPF, a rare and serious lung disease that causes permanent scarring of the lungs. read more

Latest Peer-Reviewed Clinical Study Confirming The Efficacy And Healing Rates Of MiMedx Allografts Is Published In The Journal Of Wound Care

MARIETTA, Ga., Nov. 12, 2015 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and the Dental sectors of healthcare, announced today that the latest peer-reviewed clinical study on MiMedx allografts, “Dehydrated Human Amnion/Chorion Membrane Treatment of Venous Leg Ulcers: Correlation Between 4-week and 24-week Outcomes,” was published in print in the Journal of Wound Care, Vol 24. No 11. November 2015. read more

Thermo Fisher Scientific Authorizes $1 Billion of Share Repurchases and Declares Quarterly Dividend

WALTHAM, Mass.–(EON: Enhanced Online News)–Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that its board of directors has authorized the repurchase of $1 billion of shares of its common stock in the open market or in negotiated transactions. The new share repurchase authorization replaces the existing authorization, in which there was approximately $410 million remaining. The company intends to resume share repurchases in 2016.

BlueWind Medical Announces Successful Completion of Patients’ Follow-Up for its Peripheral Neuropathic Pain (PNP) Study Toward a CE Mark  

BlueWind Medical, developer of the “Reprieve” wireless neuro-stimulation device to treat multiple clinical indications, such as pain management, incontinence (OAB), epilepsy, sleep-apnea and more, announced today the completion of patient follow up for a peripheral neuropathic pain (PNP) study for its CE submission.

 

Alnylam Pharmaceuticals and The Medicines Company Announce that New ALN-PCSsc Results from Late-Breaking Presentation at American Heart Association Meeting Confirm Potential for Bi-Annual Hypercholesterolemia Dose Regimen

CAMBRIDGE, Mass. & PARSIPPANY, N.J.–(EON: Enhanced Online News)–Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and The Medicines Company (Nasdaq:MDCO), a leading biopharmaceutical development and cardiovascular product company, today reported positive results from their ongoing Phase 1 clinical trial with ALN-PCSsc in a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions 2015. read more

FDA granted accelerated approval to osimertinib (TAGRISSO)  once daily tablets, AstraZeneca Pharmaceuticals LP, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.  November 13, 2015.  More Information:

 

 

 

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