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Leonardo Biosystems (tochter) Receives Second $1.25 Million Investment from the Texas Emerging Technology Fund
Leonardo Biosystems (tochter) Receives Second $1.25 Million Investment from the Texas Emerging Technology Fund
Emisphere Technologies crashes with Failed Phase 3 Attempt
BioSante Pharmaceuticals Announces Positive LibiGel(R) Pharmacokinetic Study Results
Transcept Intermezzo Approved by FDA
QuoteNovember 23, 2011 1:05 PM ESTDisplay More
The U.S. Food and Drug Administration today approved Transcept's (Nasdaq: TSPT) Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.
Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.
Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.
“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”
Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.
Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.
Intermezzo is a federally controlled substance because it can be abused or lead to dependence.
Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.
Inhibitex läuft wie das Energizer Bunny :idea:
ja unsere ersten INHX einträge hier waren ziemlich genau vor einem jahr, also unter 2 bucks..
Quoteja unsere ersten INHX einträge hier waren ziemlich genau vor einem jahr, also unter 2 bucks..
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der 2te anstieg ist ja wegen VRUS...
QuoteBio-pharmaceutical company Inhibitex, Inc.'s (NASDAQ: INHX ) shares advanced 20.18% to close at $13.70 after the company announced it plans to expand studies of its experimental hepatitis C treatment
Read more: http://community.nasdaq.com/Ne…ryid=105851#ixzz1fJ9smOrJ
Protalix Announces Successful European GMP Audit
QuoteCARMIEL, Israel, Dec. 1, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE:PLX), announced today that the Irish Medicines Board (IMB) has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel, and has issued a Certificate of GMP Compliance of a Manufacturer for the facility. The IMB Certificate is accepted by all health authorities in the European Union (EU) under the EU's centralized marketing authorization procedure, and by authorities of several other countries that recognize EU Certification. The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for taliglucerase alfa for the treatment of Gaucher disease.
In addition to the EMA, the U.S. Food and Drug Administration (FDA), Israeli Ministry of Health and Brazilian National Health Surveillance Agency have completed audits of the Company's manufacturing facility and deemed the facility acceptable.
"We are pleased to accomplish this major regulatory milestone," said Dr. Michal Kahana, Protalix's Vice President of Quality Affairs. "This important achievement helps demonstrate the viability of our proprietary plant-cell based technology platform, which is the engine behind all our pipeline candidates."
To date, marketing applications for taliglucerase alfa have been submitted in the United States, European Union, Brazil, Israel and Australia. The Prescription Drug User Fee Act (PDUFA) target date for taliglucerase alfa in the United States is February 1, 2012.
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was geht da?
Quotewas geht da?
Peregrine's Bavituximab Shows 50% Improvement in Overall Tumor Response Rate in Randomized Phase II Lung Cancer Trial
200dma @ 1.70$ aktuell
gap offen bei 0.99$
low 4.85$ High 5.95$
FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012
Alexza Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review Finds
QuoteAlexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale.Display More
While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in people with conditions such as asthma, Food and Drug Administration staff said today in a report. Outside advisers to the agency plan to meet Dec. 12 to evaluate the findings.
Adasuve would be the first product for Mountain View, California-based Alexza. The therapy uses an inhalation device developed by the company to deliver a vaporized form of the antipsychotic medication loxapine to the lungs for rapid absorption into the bloodstream. The FDA aims to decide on the product by Feb. 4.
“It is likely that, even with adequate screening for pulmonary risk factors, some patients will require respiratory support post-dose, and some patients will be at risk for respiratory failure and death,” FDA staff said.
The drug, if approved, should only be administered by professionals who have intubation tubes and ventilators “readily available,” according to the report.
Adasuve failed to win FDA approval in October 2010, because the agency was concerned about risks of pulmonary toxicity, particularly in patients with asthma or chronic obstructive pulmonary disorder.
Risk Mitigation Plan
Alexza resubmitted its application in August with a proposed risk-mitigation strategy that includes screening patients to identify those at risk for lung problems and monitoring people who take Adasuve for an hour after treatment.
Those proposals didn’t resolve FDA reviewers’ concerns because it may be difficult for health-care providers to monitor psychiatric patients for early signs of bronchial spasms, the report said.
“Psychotic and agitated patients who develop respiratory symptoms may not be able to notify health-care personnel in a timely manner, and respiratory distress may be confused with acute agitation to the casual observer,” agency staff said. The drug’s sedating effect “may also mask respiratory signs and symptoms while causing further respiratory suppression.”
The FDA asked its Psychopharmacologic Drugs Advisory Committee to weigh in on Adasuve’s effectiveness and safety, and on whether Alexza’s risk-mitigation proposal is sufficient to ensure the benefits of the drug justify its risks.
A company-funded study published in January in the British Journal of Psychiatry found that Adasuve started to work within 10 minutes of inhalation and was more effective than a placebo in cutting agitation levels within two hours.
There haven’t been any studies directly comparing Adasuve with other drugs approved to treat agitation in patients with schizophrenia and bipolar disorder, the FDA reviewers said.
To contact the reporter on this story: Molly Peterson in Silver Spring, Maryland at firstname.lastname@example.org
Antares' Oxybutynin Gel Product Approved by FDA for the Treatment of Overactive Bladder
QuotePARSIPPANY, N.J. and EWING, N.J., Dec. 8, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and Antares Pharma, Inc. (NYSE Amex: AIS) today announced that the U.S. Food and Drug Administration (FDA) has approved Antares' topical oxybutynin gel 3% product for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. OAB is a condition that affects more than 33 million Americans, and the market currently exceeds $2.0 billion annually.Display More
(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )
Antares' oxybutynin product is a clear, odorless topical gel available in a convenient, metered-dose pump that has demonstrated to be an effective and safe treatment for overactive bladder (OAB). Because the active ingredient is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin. This results in a low level of side effects, such as dry mouth and constipation. Under an exclusive licensing agreement, Watson anticipates launching the product in 2012.
"This significant achievement represents Antares' first NDA approval and is the culmination of a development program managed successfully by our clinical and regulatory team," said Paul K. Wotton, Ph.D., Antares' President and CEO. "Watson Pharmaceuticals' proven track record of commercializing transdermal products to urologists and other significant prescribers of OAB treatments makes them an ideal partner to execute a successful product launch."
"The addition of Antares' oxybutynin gel product will strategically enhance our overactive bladder product portfolio which currently includes GELNIQUE® (oxybutynin chloride) Gel 10%, and OXYTROL® oxybutynin transdermal system," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "With the addition of Antares' new gel formulation, we look forward to offering patients the added convenience of a novel pump delivery system beginning in 2012."
Affymax Rises After Winning Panel’s Backing for Anemia Drug
QuoteBy Molly Peterson - Dec 8, 2011 3:42 PM GMT+0100Display More
Affymax Inc. (AFFY) surged the most in 16 months after winning a U.S. advisory panel’s backing for an experimental anemia medicine that would compete with treatments marketed by Amgen Inc. (AMGN) and Johnson & Johnson. (JNJ)
Affymax gained 26 percent to $7.41 at 9:40 a.m. New York time, after earlier reaching $7.47 for the biggest intraday increase since August 2010. The shares had fallen 12 percent this year before today. The medicine would be Palo Alto, California-based Affymax’s first product if it gains regulatory approval for patients with chronic kidney disease.
The benefits of the drug, known as peginesatide, outweigh potential heart risks, outside advisers to the Food and Drug Administration said yesterday in a 15-1 vote in Silver Spring, Maryland. The FDA isn’t required to follow the advisory panels’ recommendations.
“Christmas came a little early this year,” Chris Raymond, an analyst with Robert W. Baird & Co., wrote in a research note today. “We view approval as significantly de-risked,” and “remain buyers.”
If approved, the therapy would compete with Amgen’s Epogen, which generated $2.5 billion in revenue last year, and J&J’s Procrit, with 2010 sales of $1.9 billion. Affymax’s medicine works as well as those treatments and had “similar safety results” for people on dialysis, the patient group for whom Affymax seeks approval, FDA staff said Dec. 5 in a report.
“We don’t have a reason to say no to this drug in the dialysis setting,” Wyndham Wilson, the panel chairman, said after the vote. Wilson is chief of lymphoma therapeutics at the National Cancer Institute’s Center for Cancer Research, in Rockville, Maryland.
Peginesatide, like Epogen, Procrit and Amgen’s Aranesp, is part of a class of drugs known as erythropoiesis-stimulating agents that boost production of red blood cells.
The FDA recommended in June that doctors use the lowest possible doses of the agents because of potential heart risks. The agency in 2006 first warned that high doses of the anemia drugs may cause heart attacks and strokes.
Peginesatide proved noninferior to Epogen, Procrit and Aranesp in late-stage clinical trials and had similar risks of death, stroke and heart attacks in dialysis patients, Affymax said yesterday in presentations to the panel. The trials consisted of 2,609 patients.
Peginesatide’s effects last longer than approved treatments, making it more convenient and less expensive to administer, according to Affymax’s September quarterly report. The drug can used once a month, compared with an initial dose of three times weekly for Epogen.
Affymax is co-commercializing peginesatide in the U.S. with Osaka, Japan-based Takeda Pharmaceutical Co. (4502)
Amgen, of Thousand Oaks, California, signed a seven-year agreement with dialysis provider DaVita Inc. (DVA) of Denver to replace a deal expiring Dec. 31 that will meet at least 90 percent of DaVita’s requirements to treat anemia, William Tanner, an analyst with Lazard Capital Markets in New York, said Nov. 18 in a note to clients.
Amgen also signed a nonexclusive agreement with Fresenius Medical Care (FME) AG for an undisclosed number of years, Tanner said. Fresenius, based in Bad Homburg, Germany, and DaVita are the largest dialysis providers respectively by annual revenue.
“With Amgen’s recent exclusive DaVita contract and partnership with Fresenius, about 70 percent of the market appears locked up,” Raymond wrote today. “We would point out 30 percent isn’t, and we’d be very surprised if various out- clauses did not exist, which may be increasingly relevant if Affymax prices this drug at a discount.”
Medicare, the U.S. health program for the elderly and disabled, began this year reimbursing for all services associated with end-stage kidney disease in one bundled payment to attempt to save money.
To contact the reporter on this story: Molly Peterson in Washington at email@example.com
CytRx's ENABLE Phase 2 Trial Results with Bafetinib in Relapsed B-Cell Chronic Lymphocytic Leukemia to be Presented at the Prestigious 53rd Annual ASH Meeting
Quote- Presentation to be given by Dr. Tapan Kadia of M.D. Anderson Cancer Center -Display More
LOS ANGELES, Oct 04, 2011 (BUSINESS WIRE) -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that an abstract with results from the Company's ENABLE Phase 2 proof-of-concept clinical trial with its Bcr-Abl, Lyn and Fyn kinase inhibitor bafetinib for the treatment of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments will be presented in a poster session at the 2011 American Society of Hematology (ASH(R)) Annual Meeting on Sunday, December 11, 2011 at 6:00 p.m. Pacific time at the San Diego Convention Center, Hall GH. The abstract, "A Pilot Phase II Study of the Lyn Kinase Inhibitor Bafetinib in Patients with Relapsed or Refractory B Cell Chronic Lymphocytic Leukemia," also will be published in print and online in the November 18, 2011, supplemental volume of the peer-reviewed ASH journal Blood. The abstract was authored by Tapan Kadia, M.D., Maria Delioukina, M.D., Hagop Kantarjan, M.D., Michael Keating, M.D., William Wierda, M.D. and Jan Berger, M.D., as well as CytRx's Chief Medical Officer, Daniel, Levitt, M.D., Ph.D, and Senior Vice President of Drug Development, Scott Wieland, Ph.D.
"We are delighted that the ASH committee accepted the ENABLE trial abstract for presentation at this prestigious medical conference," said CytRx President and CEO Steven A. Kriegsman. "Earlier this year we reported favorable preliminary results from the ENABLE trial, and believe that our drug candidate's unique kinase inhibitor formulation could be efficacious in treating B-CLL and other cancers where approved therapies have failed."
In June 2011, CytRx announced that preliminary results from its ENABLE Phase 2 trial demonstrated that bafetinib was clinically active in a group of patients with B-CLL who have failed several other treatments for their cancer. "Completion of the ENABLE clinical trial marks an important early milestone in our business strategy to advance development of our oncology pipeline using proof-of-concept trials in patients with advanced-stage cancers. This strategy allows us to assess preliminary efficacy and safety results cost-effectively and quickly following trial initiation before potentially moving into larger clinical trials," added Mr. Kriegsman. "At this point, we are now actively seeking a partner to further advance bafetinib's clinical development."
The ENABLE Phase 2 trial currently includes a total of 18 patients and is being performed at M.D. Anderson Cancer Center and City of Hope Medical Center. Patients self-administer bafetinib twice daily every day and continue treatment as long as their cancer is controlled and no intolerable side effects occur.
B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL are reported in the U.S. each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients in the high-risk B-CLL have a median overall survival of one to five years.
Hab 1000 CYTR gekauft gerade eben zu 0.334$. Hoffe auf gute Phase 2 Daten von der ASH Konferenz am Sonntag.
Ziel nach oben 0.50$
Ziel nach unten 0.19$
Die Firma hat 40Millionen Cash auf der Seite, hat mitte 2011 Geld aufgenommen zu 0.50$ je Aktie und hat keine Schulden. CYTR hat 0.28$ cash per share und einen Buchwert von 0.19$.
BPAX und das libido gel is grad an die wand geknallt..
GNBT scheint die endlose talfahrt beendet zu haben
Breast Cancer Vaccine Being Developed by Generex Subsidiary Antigen Express to be Featured on Bloomberg Television
QuoteBPAX und das libido gel is grad an die wand geknallt..
und hier die quittung. tagesdurchschnittsvolumen in 1 minute erreicht zu dem kurs:
folglich auch AIS angeschlagen:
jetzt dürfen die hardcore gamer ran und den besten einstieg finden. allerdings weiss ich nicht, was BPAX noch zu bieten hätte ausser libigel (nahe zukunft that is)