Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (“CF”), today announced the U.S. Food and Drug Administration Continue reading Nivalis Therapeutics Announces FDA Fast Track Designation for N91115 in Patients With Cystic Fibrosis
Nivalis Therapeutics, Inc. announced that the FDA has granted orphan drug designation to its lead candidate, N91115, for the treatment of patients suffering from cystic fibrosis. The stock surged 15.5% on the news. Continue reading Nivalis’ N91115 Gets Orphan Drug Status for Cystic Fibrosis
- Initiation of Phase 1 study with corrector GLPG2222, earning Galapagos a $10 million milestone payment from AbbVie
- Expansion of CF portfolio with three novel candidate drugs, with aim to create the most effective combo
Mechelen, Belgium; 19 January 2016: Galapagos NV (Euronext & NASDAQ: GLPG) provides an update on progress made in the cystic fibrosis (CF) programs. Galapagos and AbbVie (NYSE: ABBV) aim to develop a triple CFTR combination therapy to address 90% of patients with CF. In order to bring a more effective therapy to patients, the companies plan to develop multiple candidates and backups for each of the three components (1st generation correctors, next generation correctors, and potentiators) with the goal of identifying a potential triple combination. In addition to our potentiator and corrector that are being tested in the clinic, a total of four additional compounds have the potential to reach clinical development in the CF program this year. Continue reading Galapagos advances CF clinical development
-Approximately 25,000 people with cystic fibrosis worldwide currently eligible for treatment with ORKAMBI® (lumacaftor/ivacaftor) or KALYDECO® (ivacaftor); Vertex Continue reading Vertex Outlines 2016 Business Priorities to Support the Discovery and Development of New Transformative Medicines for the Treatment of Cystic Fibrosis and Other Serious Diseases
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
(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 (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
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
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
$259,000 Drug Hard To Swallow For Some Patients
Re-posted here from KPBS website