Glaxo Seeks FDA Approval for Experimental Shingles Vaccine

Zostavax is not indicated for the treatment of shingles or postherpetic neuralgia, or for the prevention of chickenpox. GlaxoSmithKline’s Shingrix is a non-live vaccine that had positive results during its Phase III clinical trials. Zostavax is the only shingles vaccine licensed for use in the United States. Since then the plant has undergone a series of expansions, culminating in the FDA licensing the facility to manufacture the bulk ingredient used in Zostavax and Merck’s chickenpox vaccine, Varivax, this week. The vaccine is only for adults who previously have had chickenpox. The Shingles Prevention Study (SPS) is a clinical trial of a live-attenuated vaccine prepared from the Oka/Merck strain of varicella zoster virus. An FDA review of the Zostavax clinical data concluded that the vaccine was effective at curbing shingles pain but did not significantly reduce either shingles-related hospitalizations or death.

Cholera is a disease spread by the fecal-oral route – commonly caused by ingesting water or food contaminated with Vibrio cholerae bacteria. Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017. It can be so severe in some people that it disrupts their lives. to begin shipping the vaccine called Zostavax. For Agenus, the deal is a means of leveraging the long-term value of a late-stage asset in order to invest in some potentially more lucrative early-stage ones, particularly in the fast-growing field of immuno-oncology. Nearly a decade ago, Merck began an extensive overhaul of its vaccine manufacturing that has included its operations in West Point and Elkton, VA, as well as Durham, where 1,100 people now work. LABAs may be used in combination with ICs in the stepping up of treatment for the long-term management of only such asthma that is uncontrolled by controller medications.

Since there’s no guarantee any individual drug will make it through the FDA gauntlet, it takes a reasonably large number of shots on goal to replace revenue lost to generic competition. Martha Rosenberg points out that the FDA has failed over the years in its stated mission to insure the safety of our food and drugs. The integrity of the agency is already badly compromised by industry insiders who move back and forth through the revolving door from Big Pharma employment to executive positions in the FDA, insiders like revolving door poster boy Michael Taylor; but the appointment of Califf represents a new low for the FDA. The rest of us will get to eat cake, but we’ll have to pay for it first. Who Wants to Lower Drug Prices (NYTimes)Inside big pharma’s fight to block recreational marijuana (The Guardian)The trials of Juno  (The Economist)Califf: Nothing Prohibits FDA From Using Real-World Evidence In Decisions (IHP)Congressman calls for probe into Valeant’s pricing of lead poisoning drug (STAT)National Cancer Institute Says Researchers Didn’t Quickly Tell FDA After Two Deaths in a Lymphoma Study (WSJ) (Washington Post)ICER council votes on effectiveness, value of NSCLC therapies (Healio)Taking the initiative in healthcare: Will California voters cap drug prices? Any resulting health benefits, or detriments; in and by the acceptance or rejection of the information on this site, is and comes under the sole responsibility of the reader, as to any decisions that are made, and in regard to any positive or negative resultant outcome that you may realize to be the case. Olaratumab is the first new therapy approved for the initial treatment of STS since doxorubicin’s approval more than 40 years ago.

During an epileptic attacks, the person is not responsive or aware of what is going on around them. The company claimed an effectiveness rate of 80 percent. The warning letter reveals that the IVC blood clot filter maker concealed bad outcomes. It commences with malaise, lethargy, anorexia, nausea, vomiting, and upper abdominal pain. She found out firsthand why the Ethicon mesh package warned synthetic Prolene mesh “can potentiate an infection.” At the time, she didn’t even know she’d been implanted with mesh. “The experimental squalene encephaloneuropathy in the rat.” Exp Toxicol Pathol. Studies by respected medical institutions worldwide link aluminum to autoimmune diseases, particularly degenerative brain diseases such as Alzheimer’s and Parkinson’s diseases.

The precursor material for most meshes is heavyweight plastic hernia mesh first used in the 1970’s. Those who experience a severe allergic reaction, which may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue, should stop using Picato and seek immediate medical attention. 1. A friend had recently called him out on it. According to Reuters, the FDA sent the GSK plant in Canada a warning letter, dated June 12, stating that the company had to rectify various violations found in a facility that manufactures the Flulaval vaccine. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers. To view content sources and attributions, please refer to our editorial policy.