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Shares of CombinatoRx fell when it announced Neuromed, with which it has a merger pending, will have to resubmit for FDA approval of its pain drug Exalgo.
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On 11/2/09, Dendreon (NASDAQ: DNDN) announced that it has completed the submission of its amended Biologics License Application (BLA) for PROVENGE (sipuleucel-T), seeking approval for men with metastatic castrate-resistant prostate cancer (CRPC). The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.[More...]
The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.
PROVENGE is currently available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT, and NeoACT. On 4/28/09, DNDN announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.
On 11/20/09, the FDA accepted Dendreon's amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision, seeking approval for PROVENGE in men with metastatic castrate-resistant prostate cancer (CRPC). The FDA considers the amended BLA to be a complete, Class 2 Resubmission following the action letter the company received in 2007.
On 11/16/09, CombinatoRx (NASDAQ: CRXX) announced that on 11/13/09, representatives of Neuromed discussed the pending Exalgo NDA with staff from the FDA. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo. Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2), which utilizes different criteria to determine the basis for approval of a new drug candidate.
On 7/1/09, CRXX and Neuromed Pharma (privately held) announced a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Final merger terms will be adjusted based upon the outcome of a pending FDA decision for Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone) seeking approval for the treatment of moderate to severe pain in opioid tolerant patients. The rights to Exalgo have been acquired by a subsidiary (Mallinckrodt) of Covidien (NYSE: COV). A FDA Advisory Panel was conducted on 9/23/09 for Exalgo, which had an original PDUFA action date of 11/22/09 that was extended today by three months until 2/22/10.
On 11/20/09, Pozen (NASDAQ: POZN) announced the start of enrollment for the Phase 3 studies evaluating PA32540, which is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole that is being studied for the potential use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. POZN is conducting two pivotal Phase 3 studies and one long-term safety study.
The two Phase 3 pivotal trials will be conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA. These studies will involve over 100 sites, enrolling approximately 500 patients per study. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.
Key elements of this Phase 3 development program include: (1) bio-equivalency proven to enteric coated aspirin (ECASA); (2) SPA agreement with FDA for 2 replicate 6-month Phase 3 studies to demonstrate that PA32540 is associated with a significant reduction in gastric ulcers compared to ECASA 325 mg in patients requiring aspirin therapy for secondary CV prevention who are at risk for ASA-associated gastric ulcers; and (3) safety of PA32540 based on at least 100 patients with 12 months exposure.
On 6/30/09, Photocure (OSL: PHO) (OTC: PHCUF.PK) announced that a New Drug Application (NDA) was submitted to the FDA seeking approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence cystoscopy. The NDA includes clinical data from 1838 patients, comprising two recently completed clinical studies, one Phase 3 pivotal study in 789 patients from EU/US and a Phase 3 study performed in Denmark in 233 patients. All studies in the documentation demonstrate that fluorescence cystoscopy using Hexvix significantly improves detection of papillary bladder cancer compared to standard white light cystoscopy.
Photocure, in collaboration with GE Healthcare (NYSE: GE) has had several meetings with the FDA, leading up to this submission and the results of the pivotal Phase 3 study have been presented to the FDA. On 8/31/09, Photocure announced the FDA granted a priority (6-month) review for the NDA with an expected PDUFA decision date of 12/30/09. On 12/17/09, this NDA will be discussed at a meeting of the FDA Oncologic Drugs Advisory Committee.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
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Neuromed and CombinatoRx, Incorporated (NASDAQ:CRXX)has agreed to sign a definitive merger agreement valued $28.8 million USD on 30th June, 2009 according to a news published by the RTT News.
Although the “merger” declaration with privately ...
On 11/16/09, Cytori Therapeutics (NASDAQ: CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer. Interim data on the first 32 patients who have reached the six-month follow-up will be presented as a poster at the San Antonio Breast Cancer Symposium on 12/12/0 at 7am (CT) by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.[More...]
In a press release this morning, the company claims that the lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.You can read the complete press release here.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.
“We have responded to all of FDA’s previous questions. We plan to address the current questions as well,” said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. “In certain respects, the Complete Response Letter appears to be inconsistent with the FDA’s published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible.”
James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS, and leader of the Company’s raxibacumab program with the U.S. Government, said, “It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA.”
Raxibacumab represents a new way to address the anthrax threat.
Bad news for Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today. The company announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.
"We are disappointed that the trial did not meet the primary endpoint. The data indicates that more patients on the best supportive care arm received chemotherapy following progression than those on the picoplatin arm, and we believe that this may have been a significant factor contributing to the trial outcome, as picoplatin appeared to demonstrate a trend toward a survival advantage. Based on these findings and other analyses, we are contacting the FDA today to request a meeting to discuss a regulatory path forward. We look forward to presenting the full SPEAR efficacy and safety data at an upcoming medical conference early next year," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We believe that the SPEAR data, coupled with efficacy and safety data from more than 1,100 cancer patients treated with picoplatin and the proof-of-concept data from our trials in colorectal, prostate and ovarian cancers, support our continued partnering effort. Our focus will be on the regulatory pathway for picoplatin, partnering activities, and realigning the use of resources for these objectives."
Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned.
"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine."
The company has gone outside the country to look for ways to monetize their VLP vaccine technology after the CDC and other US regulators announced that they wanted to stay with older and proven technologies to continue making vaccines.
CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA). In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA).
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