Top 10 Cystic Fibrosis Articles of 2015 Highlights from the past year’s work in disease treatments, therapies and some personal stories

http://cysticfibrosisnewstoday.com/2015/12/28/top-10-cystic-fibrosis-news-stories-of-2015/

Originally from Cystic Fibrosis News Today, online

Cystic Fibrosis News Today has covered news of the latest treatments, events, clinical trials, and research updates in cystic fibrosis on a daily basis throughout the past year. As 2015 comes Continue reading Top 10 Cystic Fibrosis Articles of 2015 Highlights from the past year’s work in disease treatments, therapies and some personal stories

Vertex Pharma receives subpoena from Department of Justice

(Reuters) – Vertex Pharmaceuticals Inc said it received a subpoena from the U.S. Department of Justice in the third quarter related to its marketed medicines, seeking documents related primarily to its “good laboratory practices” in a bioanalytical lab.

Good laboratory practices are rules that govern non-clinical safety studies, ensuring quality, integrity and reliability of data. Bioanalytical labs measures drug levels in biological samples, specifically in blood and urine.

“We are in the process of responding to the subpoena and intend to cooperate,” Vertex said in a securities filing.

The subpoena will not impact the safety, effectiveness and commercialization of the company’s existing drugs or those in development, Vertex spokesman Zach Barber told Reuters.

Shares of the cystic fibrosis drugmaker were marginally down after-hours.

Separately, drugmaker Mylan NV and drugstore chain CVS Health Corp said in their quarterly filings that they had received subpoenas from federal agencies.

CVS said the Drug Enforcement Administration (DEA) in September sought documents related to controlled substance policies, procedures and practices at eight pharmacy locations since May 2012.

Last May the company agreed to a fine of $22 million in a settlement with the U.S. Attorney’s Office for the Middle District of Florida, resolving alleged violations of the Controlled Substances Act.

CVS, in its filing, said it is undergoing several audits by the DEA and is in discussions with the agency and the U.S. Attorney’s office in several locations concerning allegations that it has violated certain requirements of the CSA.

Mylan said the U.S. Securities and Exchange Commission was seeking documents with regard to certain “related party matters.”

CVS and Mylan’s shares were little changed after the bell. Neither company was immediately available for comment.

Vertex Pharmaceuticals Incorporated: Profit on the Horizon

Vertex Pharmaceuticals (NASDAQ:VRTX) released outstanding third-quarter earnings on Wednesday with sales of both cystic fibrosis drugs, Orkambi and Kalydeco, selling like hotcakes. Continue reading Vertex Pharmaceuticals Incorporated: Profit on the Horizon

Vertex Turns Up the Heat on Cystic Fibrosis Challengers

Back in 2012, Vertex Pharmaceuticals (NASDAQ:VRTX) changed thousands of lives when it won approval to market Kalydeco to treat cystic fibrosis patients in the U.S. and EU. Cystic fibrosis, or CF, can be caused by one of many mutations Continue reading Vertex Turns Up the Heat on Cystic Fibrosis Challengers

The High Cost—and Difficult Ethics—of Personalized Medicine

Spending on pharmaceuticals is surging again, up 13% in 2014. Surveys show the public is increasingly concerned about the affordability of drugs. Part of the reason for their high costs is the advent of precision (or personalized) medicine, Continue reading The High Cost—and Difficult Ethics—of Personalized Medicine

KPBS Article: $259,000 Drug Hard to Swallow

$259,000 Drug Hard To Swallow For Some Patients
Re-posted here from KPBS website
https://mylifematters508.wordpress.com/2015/08/10/kpbs-article-259000-drug-hard-to-swallow/

or watch link: https://mylifematters508.wordpress.com/2015/08/11/the-kpbs-tv-show/ Continue reading KPBS Article: $259,000 Drug Hard to Swallow

CF Foundation Launches Fully Redesigned Website to Meet the Evolving Needs of People with CF and their Families

Cystic Fibrosis Foundation
Posted on: 21 Jul 15
Today, the Cystic Fibrosis Foundation announced the launch of its fully redesigned website, www.cff.org. The new site reflects the Foundation’s ongoing commitment to provide people with CF the support, tools and information they need to live long and Continue reading CF Foundation Launches Fully Redesigned Website to Meet the Evolving Needs of People with CF and their Families

Doctors challenge Vertex over high price of cystic fibrosis drug

Originally published in the Boston Globe: https://www.bostonglobe.com/business/2015/07/20/researcher-and-group-doctors-challenge-vertex-price-new-cystic-fibrosis-drug/d5PZMlj6T6uzq0usm2xLEL/story.html#

By Globe Staff 

California scientist Paul M. Quinton learned that he has cystic fibrosis at age 19 and has spent his long career in his lab working on ways to cure it. Continue reading Doctors challenge Vertex over high price of cystic fibrosis drug

Vertex Should Expect Approvals For Its Cystic Fibrosis Medications

Summary
• The FDA should see a favorable benefit-to-risk ratio for KALYDECO in children of ages 2-5.
• Positive Phase 3 trials in patients with the most common CF mutation should also be enough for approval. This will triple the current addressable CF market. Continue reading Vertex Should Expect Approvals For Its Cystic Fibrosis Medications

Clinical Trial Alert Vertex Pharmaceuticals

Phase 3 Trial with VX-661 and VX-770 in CF Patients Homozygous DeltaF508 Now Enrolling!

CFF info about this study: http://www.cff.org/Display/dsp_ClinicalResearchHTML.cfm?id=402&CTSubId=79 Continue reading Clinical Trial Alert Vertex Pharmaceuticals