A multiple sclerosis treatment drug can also slow down ALS (Amyotrophic Lateral Sclerosis in mice, recent trials have shown.
Now, it's planned for Gilenya - the drug in question - to be put through phased human-based clinical trials and, potentially, it could then be given to patients with ALS, better-known as Lou Gehrig's disease.
These trials are necessary to establish that Gilenya is suitable for human use but they wouldn't necessarily be as rigorous as those involving brand new drugs, given it's already been approved by drug regulators, once before, to treat MS.
ALS Drug Treatment
However, it's possible that patients with ALS - for which there's only one drug treatment presently available - aren't prepared to wait and want to go ahead regardless, since ALS' progress is swift and life expectancy, once it takes hold, is around two-to-three years in most instances.
Gilenya is the trade name used by Novartis for fingolimod - an oral medication recently rejected by the UK's NICE (National Institute for Health and Clinical Excellence body for
UK-based MS patients.
ALS affects approximately one in every 20,000 people and is typified by weakened muscles, eventually leading to breathing and swallowing problems and the need for mechanical help with respiration and eating.
ALS Treatment Trials
"For ALS patients, yesterday is not fast enough", the ALS Therapy Development Institute's President, Steven Perrin, told the Wall Street Journal. However, he said: "We want to make sure we are not doing any harm. We want to do the [ALS treatment] trials correctly and quickly".
"Novartis encourages research via controlled clinical trials rather than experimental off-label clinical use to assess risks and benefits", a Novartis representative explained, in a statement. "Clinical trials provide more robust information about the efficacy of the drug in a new disease area, and allow for more rigorous safety monitoring."
Pharma News will revisit this topic in future News coverage. Previously, we looked at a
new ALS drug being put through Phase II clinical trials, with extremely positive results then-recorded. The same drug - Cytokinetics' CK-2017357 - entered a new round of trials last November.
Image copyright US Navy - used solely for illustrative purposes
Mo'Nique
after a strong career in comedy — the upn series the parkers and numerous stand-up gigs — this actress showed her range as an artist with her dramatic acting chops in precious, for which she won an academy award for best supporting actress.
Michelle Obama
our first lady is making history not only as an african-american woman but through her dedication to much-needed campaigns (such as her initiative to end childhood obesity , her involvement in raising daughters sasha and malia and her down-to-earth fashion choices.
Nicki Minaj
outspoken about her troubled childhood, as well as in her uber-popular songs, this rapper skyrocketed to stardom after lending her voice to a number of chart-topping rap artists' hits. but her music isn't the only way she put herself on the map: nicki's often-outrageous style has us—and fashion critics—captivated.
Shonda Rhimes
as the creator, head writer and producer of grey's anatomy (and its spin-off, private practice , this woman broke down barriers in the entertainment industry and earned a spot in time magazine's time 100 list of people who helped shape the world in 2007.
Amber Riley
this sag-award winning glee cast member is an example of what amazing things can happen when you refuse to give up your dreams. who would have thought that, after being rejected by american idol, she would be starring in one of the most popular shows on television?
Oprah Winfrey
frequently referred to as the most influential woman in the world, oprah ended her decades-long-running talk show and launched her own cable network, own, last year. as a philanthropist, entertainer and all-around business maven, she is one of the most successful and important women living today.
Cicely Tyson
this guiding light actress and former model is part of the award-winning ensemble cast of the help, which garnered a slew of oscar nominations this year. she's known for her award-winning roles in a number of films that portrayed black history and literature, including sounder, king and the autobiography of miss jane pittman.
Queen Latifah
in terms of career range, this woman is continually reinventing herself. from rapper to academy award-nominated actress, the queen has received top recognition for her talents in film and music. as a spokesperson for brands like jenny craig and covergirl, she's continually inspired women to reinvent themselves as well.
Joan Smalls
this puerto rican-born model has walked in runway shows all over the word and lent her talents to vogue magazine's editorials numerous times. in 2010, she was named the new face of beauty brand estee lauder.
Kamala Harris
the current attorney general of california is the first female, first african-american and first asian-american to ever hold the post. she's also the first person of indian decent to be a u.s. attorney general.
Beyonce
this fierce fashionista and songstress is characterized by her fearless attitude and strong work ethic. her often-empowering songs and dedication to various charities have made her a role model to young girls and women alike. and now, she'll get to share her inspirational spirit with her newborn daughter, blue ivy.
Wendy Williams
this radio-turned-tv talk show host is known not only for her fabulous wigs but her frank talk about her own past, namely her history with weight issues and drugs. often as emotional as the guests on her show, wendy has established a special connection with her audiences, and her show is number one in the super-competitive new york area.
Thelma J. Golden
now the head curator of the studio museum of harlem, thelma was fascinated by museums as a young girl and began grooming herself for her current post during adolescence, becoming an apprentice at the met in new york city right out of high school. she's an example of tenacity and hard work in how she not only followed her dream but took the necessary steps to make it a reality.
Whitney Houston
while she was best known for her unmatchable voice—becoming the only artist (ever to have seven consecutive no. 1 hits on the billboard hot 100, not to mention the best-selling single by a female artist in history with "i will always love you"—houston's legacy runs deeper than her unforgettable pipes. she was the first woman of color to land the cover of seventeen magazine, and the first african-american female artist to get consistent play on mtv with her video for "how will i know."
The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.During that period, the company also continued to sell in this country a related model, which earlier went on the market using a regulatory loophole that did not require a similar safety review.
It is not known how many people overseas received the replacement hip after the agency decided in 2009 not to approve it, nor the number who received the closely linked implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.
The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an articular surface replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.
But in a confidential letter, the F.D.A. told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times.
The agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.
A spokeswoman for DePuy confirmed that the company had received the agency’s so-called nonapproval letter. But the spokeswoman, Mindy Tinsley, declined to release the letter or to respond to questions about when, or if, DePuy disclosed the ruling to doctors, patients, investors or regulators abroad.
A principal researcher on the clinical studies submitted by the company to the F.D.A. said he was not informed of the agency’s decision. Also, a review of publicly available information indicates that the company did not discuss the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.
There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.
However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.
William Vodra, a lawyer who specializes in F.D.A. regulation, said that, in general, drug and medical device makers typically disclose nonapproval letters if they might have a material impact on a company’s finances. Mr. Vodra added that apart from that financial calculation, there was no hard-and-fast rule about making such rulings public.
Mr. Vodra said that if a company decided to withhold a nonapproval letter that contained important safety information about a device used by doctors, it could face damage to its brand. “They have to think long and hard of the reputational impact,” he said.
The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients. An agency spokesman, Morgan Liscinsky, declined to disclose the letter on the ASR, saying the agency had a policy of not releasing such notices because they might contain confidential business information.
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recently tested the top 400 lipsticks and found that all of them contain trace amounts of lead. Among the top 10 contaminated brands five are Maybelline and L’Oreal, owned by L’Oreal USA, two Cover Girl, two NARS lipsticks, and one from Stargazer, according to the FDA’s data. The lipstick with the highest concentration of lead was Maybelline’s Color Sensational “Pink Petal” with a concentration of 7.19 parts per million. But the average concentration out of the 400 lipsticks tested was 1.11 parts per million, well below the proposed limit of 10 parts per million. The Campaign for Safe Cosmetics raised concerns to the FDA urging them to set limits to the amount of lead allowable in cosmetic products. In 2007 the campaign tested 33 lipsticks and found two-thirds of them contained lead and one-third surpassed the FDA’s lead limit for candy, according to TheSpec.com. But the FDA finds no comparison to candy and lipstick saying, “It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and ingested in much smaller quantities than candy.” According to the Halyna Breslawec the chief scientist for the Personal Care Products Council, the trade group representing cosmetics manufacturers, lead is not added to the lipstick but is contained in trace amounts due to the minerals used for the colors. The lead is naturally found in the soil, water and air. Regulation of lead in lipsticks has proven to be difficult. In California, they have laws requiring companies to report chemicals known to cause cancer or cause reproductive harm, But the trace amounts of lead in the products are not high enough to trigger the warnings. The warnings are only triggered when the concentration reaches 5 parts per million. Only two lipsticks exceeded the limit for the warning out of the 400 tested, Maybelline’s “Pink Petal” and L’Oreals’s Colour Riche “Volcanic” lipstick. --- On the Net:
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