Results tagged “FDA approval” from Drugs & Medicaments

Jan. 4 (Bloomberg) -- U.S. regulators approved 18 new drugs in 2006, close to an eight-year low, as drugmakers struggled to develop products for hard-to-treat disorders.

The number of medicines recommended for sale in 2006 and 2005 dropped from the annual average of 26 drugs recorded in the previous six years, according to U.S. data. Last year's approvals include Pfizer Inc.'s cancer treatment Sutent and Merck & Co.'s diabetes drug Januvia.

Drugmakers are spending more on research and developing fewer drugs, the U.S. reported last month. The failure rate of compounds in testing has increased as companies target intractable diseases, a government study said. London-based AstraZeneca Plc, for example, scuttled three experimental drugs last year, including treatments for diabetes and stroke.

U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

Not all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to four companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.

These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.

New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.

The president of Alliance for Human Research Protection’s explains the importance of informing the public.

Just as Vera Sharav sits down to talk about the lack of government oversight of the drug industry, the phone rings. She jumps up to answer it, and after listening patiently for a few minutes, she starts talking about Prozac, warning the caller that U.S. consumers don’t always get the same detailed health warnings about pharmaceuticals as residents of some other countries. After hanging up, Sharav, president of the advocacy group Alliance for Human Research Protection, gets right to the point.

“We’ve got a major crisis in America now,” Sharav says. “There is carnage going on. There are thousands of preventable deaths every year.” Approval of a drug by the U.S. Food and Drug Administration implies that a drug is safe to market to consumers, but Sharav asserts that the FDA’s assurances are not based on good science.

NEW BRUNSWICK, New Jersey (Reuters) - Bristol-Myers Squibb <BMY.N> said on Thursday it could seek approval for as many as three new cancer drugs by next year, including treatments for melanoma and cancers of the breast and bladder.

The company said it plans to seek approval next year for breast cancer drug ixabepilone and to seek approvals by late 2007 or 2008 for bladder cancer treatment vinflunine and melanoma drug ipilimumab.

Memory Pharmaceuticals Announces Release of Clinical Hold on MEM 3454

MONTVALE, N.J., Dec. 11 -- Memory Pharmaceuticals Corp. today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the Company that the clinical hold on the development of this drug candidate has been released. The Company now plans to commence its previously-announced Phase 2a clinical trial for MEM 3454 in Alzheimer's disease during the first quarter of 2007.

"Memory has worked diligently with the FDA since this trial was placed on clinical hold in October, and we are pleased that we will now be able to move forward with the proof-of-concept trial for this important drug candidate," stated Jim Sulat, President and Chief Executive Officer of Memory Pharmaceuticals.

MUMBAI, Dec 7 (Reuters) - Indian drug maker Dabur Pharma Ltd. (DABR.BO) has received approval from the U.S. Food and Drug Administration for oncology drug paclitaxel injections, the regulatory agency's Web site showed.

Paclitaxel is the generic equivalent of Bristol-Myers Squibb Co.'s (BMY.N) Taxol, used in treating ovarian and breast cancer.

 © Reuters 2006.

Health Canada is warning Canadian women that use of a birth control patch may increase their risk of developing blood clots in the legs and lungs.

The department, along with drug maker Janssen-Ortho Inc., issued the statement based on research that showed a U.S. formulation of the company's patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills.

"We're taking the precaution of giving people an additional heads up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

The US Food and Drug Administration (FDA) and the pharmaceutical industry are in strong negotiations to decide how much drug companies will pay the agency to review new drugs from the end of next year, when the current law expires.

Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.

The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.

Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.

by Dennis T. Mangano, Ph.D., M.D.

I was troubled by the recent, near-unanimous decision of the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee publicly advocating the safety of aprotinin¹ — despite considerable evidence to the contrary,^2,3,4 including our recent study² and the FDA's own initial 1993 warning regarding "kidney toxicity."⁵ We learned after the Advisory Committee's meeting of newly disclosed records of 67,000 patients, yielding data that were consistent with our warnings (renal failure, stroke, and heart failure)² and that were inconsistent with the positions of the committee and Bayer.^1,6

In defending the committee's decision, Dr. Hiatt makes allegations in this issue of the Journal regarding our "transparency" (FDA access to our data).⁷ In fact, there is no question that our independent, nonprofit research groups (the Ischemia Research and Education Foundation [IREF] and the Multicenter Study of Perioperative Ischemia [McSPI] reseasrch group) made every effort to have the FDA review in detail all of the source and derivative data from our study² and all associated documentation and operating procedures.

Covance has invested in mass spectrometer technology that it hopes will give it the edge over other contract research organisations (CROs) in the safety testing of new drug candidates.

The company said it was the first CRO to acquire the technology, which “is fast becoming a new standard for qualitative mass spectrometry that enables faster, more sensitive and more reliable detection and identification of compounds in complex mixtures than existing hybrid time-of-flight systems.”

The Thermo LTQ OrbitrapT is said to produce accurate mass data on drugs and metabolites in almost half the time of other mass spectrometers as well as facilitating metabolism evaluation of a drug candidate at a much earlier stage of the development process.

New research at Wake Forest University School of Medicine suggests that certain inhaled asthma medications – as well as similar chemicals our bodies produce during times of high stress – may worsen diseases such as asthma , heart failure and lupus that involve inflammation.

The scientific team led by Raymond Penn, Ph.D., and Matthew Loza, Ph.D, found that beta-agonists, such as those used in the treatment of asthma, increase the accumulation of type 2 T cells, a type of white blood cell that participates in immune system defense mechanisms. In certain diseases such as asthma and lupus, an over-reactive type 2 T cell response occurs and is believed to contribute to the disease.

“Inhaled beta-agonists are very effective in opening up airways and allowing asthmatics to breathe, but their ability to address the underlying inflammation that causes most asthma has been debated for years,” said Penn, an associate professor in the Department of Internal Medicine and the Center for Human Genomics.

The asthma drug AstraZeneca Plc. plans to bring to the United States next year could be just what the doctor ordered for the pharmaceutical giant as it works to rebuild a drug development pipeline hamstrung by the termination of several once-promising prospects.

In mid-2007, AstraZeneca, whose U.S. headquarters is in Fairfax and which employs about 5,000 statewide, plans to roll out Symbicort.

Symbicort is an asthma inhaler that combines two drugs to treat both the swelling of the airways and constriction of the muscles around the airways.

The hardest thing to do for any biopharmaceutical company is obviously just bringing a drug to market. Drug makers though, can make this process easier or harder on themselves by trying to get their drugs approved with a broader label for more indications or to be used sooner in a disease's progression. Because of the conservative nature of the U.S. Food and Drug Administration (FDA) it's usually a smart idea just to bring a drug to market with one label, and then if additional clinical studies suggest it will be useful in other indications, then patient demand and awareness will drive off-label usage of the drug until it receives a broader label.

Drug developer Genentech has pursued this strategy for most of its top drugs, and it has paid off greatly for it. Today, Genentech finally received formal approval to market its breast cancer therapy Herceptin for the early stages of breast cancer before the disease has spread to other parts of the body in the 30% or so of sufferers of the disease that the drug is effective in.

While this formal approval to use Herceptin earlier in the disease's progression will most likely spur higher sales, sales of the drug have been gaining rapidly since the interim results of the trial that brought about this label expansion were announced in April of last year.

HealthDay News -- Despite decades of controversy over the dangers of silicone breast implants, the U.S. Food and Drug Administration on Friday lifted a 14-year ban on their commercial use.

The FDA gave approval to two companies, Allergan Inc., of Irvine Calif., and Mentor Corp, of Santa Barbara, Calif., to market the implants to all women aged 22 and older. Until now, women have only been allowed access to the implants as part of research studies.

"In 1992 the FDA required manufacturers to stop selling silicone gel-filled breast implants because of lack of data to support marketing approval," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said during a late afternoon news conference.

An asthma diagnostic from Sydney biotech Pharmaxis is expected to gain marketing approval in the US, despite poorer-than-expected results in a trial with an existing product.

Investors pushed Pharmaxis down 45¢, or more than 13 per cent, after it announced that its product, Aridol, was only marginally better than the existing methacholine.

The US Food and Drug Administration-approved test of more than 500 patients with "predominantly very mild symptoms" showed Aridol detected asthma in 58 per cent of the cases, compared with methacholine's 54 per cent. Analysts said the results would not affect chances of FDA approval because the tests showed the product was safe and at least as efficient as the existing diagnostic.

Pharmaxis shares recovered from an earlier plunge to close 4¢ lower at $3.22.

source -  The Age

Unlike the Lipitor case where Ranbaxy Laboratories Ltd has been facing severe legal hurdles, a US Court of Appeal has upheld a district court's ruling granting Ranbaxy a 180-day exclusivity on the 80 mg strength of the anti-cholesterol drug, Simvastatin (the generic form of Merck's blockbuster drug, Zocor).

"We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical companies who expend significant effort and finances to introduce affordable generic medicines to the US healthcare system,'' said Jay Deshmukh, Senior Vice-President of Global Intellectual Property, Ranbaxy.

Data on Veridex LLC's lab test to quickly detect breast cancer that has spread to lymph nodes lacks long-term information on survival, U.S. regulatory staff said in documents released on Wednesday.

Veridex, a Johnson & Johnson company, is seeking Food and Drug Administration approval of its GeneSearch Breast Lymph Node Assay to find cancerous growths in lymph node tissue that has been removed from breast cancer patients.

An FDA advisory panel is scheduled to review the test on Thursday and make a recommendation on whether it is safe and effective enough to be marketed. The agency usually follows the recommendations of its outside advisers.

GlaxoSmithKline Plc's new breast cancer pill Tykerb will receive a priority review from U.S. regulators in a move that should speed its path onto the world's biggest drugs market next year, it said on Thursday.

Priority review designation requires the U.S. Food and Drug Administration to decide on a drug application six months after submission. Tykerb was filed for U.S. approval on Sept. 18.

The oral cancer treatment is a potential rival to the blockbuster Herceptin, which is given by injection, and is a key new medicine for Europe's biggest drugmaker. Glaxo hopes it will confirm its arrival as a major force in oncology.

Pharmion Corp. on Wednesday said it acquired Cabrellis Pharmaceuticals for an initial cash payment of $59 million to expand its portfolio with a cancer drug candidate currently in mid-stage trials.

Pharmion said it will make two additional payments of $12.5 million each if the small cell lung cancer drug, amrubicin, gets U.S. and EU approval.

The deal will result in a $55 million charge in Pharmion's fourth quarter, the biotechnology company said. Cabrellis has $4 million in net cash.