Fentanyl News and Research

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Fentanyl is a powerful synthetic opiate analgesic similar to but more potent than morphine. It is typically used to treat patients with severe pain, or to manage pain after surgery. It is also sometimes used to treat people with chronic pain who are physically tolerant to opiates. It is a schedule II prescription drug.

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

Glide Pharma to utilize $4.3M funding for progressing octreotide programme into clinical development

Glide Pharma, a specialty pharmaceutical company focused on the needle-free administration of solid dose therapeutics and vaccines, today announced that it has completed an oversubscribed GBP2.7 million ($4.3 million) investment round. The fundraising was supported by a number of existing institutional and private investors, including Hygea VCT and Oxford Technology VCTs. The company has now completed four successful investment rounds, securing funding totalling approximately GBP10 million.

10 Feb 2010

Akela announces the outcomes of two legal cases involving former employees

Akela a leader in the development of therapeutics for the treatment of pain and its wholly owned subsidiary, PharmaForm, a leader in the contract pharmaceutical development and manufacturing business, today announced the outcomes of two legal cases involving former employees.

4 Feb 2010

Health Canada accepts AbstralTM New Drug Submission for review

Orexo AB today confirms that its partner, ProStrakan Group plc has announced that the New Drug Submission made by their Canadian partner, Paladin Labs Inc., for AbstralTM has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health.

4 Feb 2010

Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

Orexo AB announces today that its partner Kyowa Hakko Kirin Co., Ltd. has entered a joint distribution agreement for the cancer pain drug KW-2246 (Orexo’s sublingual fentanyl product) with the pharmaceutical company Hisamitsu Pharmaceutical Co., Inc.

2 Feb 2010

YM BioSciences-Cytopia merger complete

YM BioSciences Inc., announced that the merger of Cytopia Limited, the Australian biopharmaceutical company, into YM under a Scheme of Arrangement, has been concluded.

1 Feb 2010

Cephalon to acquire Swiss-based pharmaceutical company

Cephalon, Inc. (Nasdaq: CEPH) announced today that it has signed an agreement to acquire Mepha AG and its subsidiaries, a profitable, privately-held, Swiss-based pharmaceutical company.

1 Feb 2010

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.

27 Jan 2010

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Pfizer Inc. and Auxilium Pharmaceuticals, Inc. today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

21 Jan 2010

BDSI to discuss planned BEMA Granisetron IND with the FDA

BioDelivery Sciences International, Inc. announced that the company has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned Investigational New Drug (IND) application for BDSI’s antiemetic (anti-nausea and vomiting) product candidate, BEMA Granisetron. The meeting will take place on March 17, 2010. The company will discuss with the FDA clinical development and regulatory plans for BEMA Granisetron, which is anticipated to enter Phase 1 studies in the second quarter of 2010.

13 Jan 2010

YM BioSciences announces results of cancer antibody-radionuclide conjugate development collaboration

YM BioSciences Inc. today announced results of a collaboration with researchers at the University of Toronto for the development of highly potent antibody-radionuclide conjugates for use in the treatment of cancer. The approach has successfully concluded its first series of proof-of-principle experiments establishing promise for future development and application.

12 Jan 2010

Sales figures for Abstral presented in a press release in Europe

Orexo AB announces today that its partner ProStrakan Group plc has presented its sales figures for Abstral in Europe in a press release. ProStrakan states that sales of Abstral underwent a strong development in 2009 and sales in the range of GBP 5 M – GBP 6 M were achieved for full-year.

7 Jan 2010

FDA extends action date for its review of Cephalon's sNDA for NUVIGIL Tablets

Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV].

22 Dec 2009

Therapure Biopharma to fill/finish nimotuzumab at its Canadian GMP certified fill suite

David Allan, Chairman and CEO of YM BioSciences Inc. and Thomas Wellner, President and CEO of Therapure Biopharma Inc. today announced the signing of an agreement under which Therapure Biopharma will provide fill and finish services for nimotuzumab, the humanized monoclonal antibody licensed to YM's majority-owned Canadian subsidiary, CIMYM BioSciences Inc., by the Centre of Molecular Immunology (CIM).

17 Dec 2009

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint was achieved in the Company’s Phase 2 pain study assessing the efficacy and safety of BEMA Buprenorphine. The positive results follow BDSI’s March 2009 announcement of favorable Phase 1 study results.

17 Dec 2009

Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced top-line efficacy and safety results for the phase IIb clinical trial for XIAFLEX™ (collagenase clostridium histolyticum) in the treatment of Peyronie's disease.

16 Dec 2009

BioAlliance Pharma SA to enter Phase II clinical trial for clonidine Lauriad and Phase I clinical trial for AMEP

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces the approval from the French Drug Agency (AFFSSaPS) to enter Phase II clinical trial for clonidine Lauriad® in radiotherapy and chemotherapy-induced oral mucositis and the approval from Danish and Slovene Agencies to enter Phase I clinical trial for AMEPTM in invasive melanoma.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Update on proposed transaction that will lead to the merger of Cytopia into YM BioSciences provided

YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today provided an update on the proposed transaction which would result in the merger of Cytopia Ltd. into YM, details of which were announced on October 5, 2009.

11 Dec 2009

YM BioSciences announces results of collaborative antibody development program

YM BioSciences Inc., today announced the first results of a collaborative program between YM and the National Research Council of Canada's Biotechnology Research Institute (NRC-BRI). Utilizing YM's IntelliMab(TM) technology, the program is designed to generate novel antibodies that target cell surface receptors associated with cancer, uniquely optimized to produce efficacy with reduced toxicities.

10 Dec 2009