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.

BDSI provides update on product portfolio, key upcoming milestones

BioDelivery Sciences International, Inc. today provided a summary of its business overview webcast that was conducted on Thursday, February 25, 2010. Dr. Mark A. Sirgo, President and Chief Executive Officer, and Dr. Andrew L. Finn, Executive Vice President of Product Development, provided an update on the product portfolio, including development plans, anticipated timelines, and key upcoming milestones.

28 Feb 2010

Mylan reports total revenues of $1.35 billion for fourth-quarter 2009

Mylan Inc. today announced its financial results for the three and twelve months ended December 31, 2009.

25 Feb 2010

Orexo partner submits NDA for cancer pain drug Abstral in Japan

Orexo AB today announces that its partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA) in Japan for the cancer pain drug KW-2246 (Abstral).

25 Feb 2010

Cephalon to acquire Ception Therapeutics following positive clinical study of eosinophilic asthma

Cephalon, Inc. (Nasdaq: CEPH) announced today that it has exercised its option to acquire Ception Therapeutics, Inc., following receipt of positive data from a clinical study in adults with eosinophilic asthma.

23 Feb 2010

Meda publishes 2009 year-end report

“The Meda Group expects to achieve sales of about SEK 13,000 million and an EBITDA of about SEK 4,200 million for full-year 2009.”

16 Feb 2010

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

YM BioSciences Inc., is presenting posters on its JAK1/2 inhibiting small molecule (CYT387) and on its novel vascular disrupting agent (CYT997) at the Lorne Cancer Conference in Lorne, Victoria, Australia. CYT387 is an oral JAK1/2 inhibitor, originating from the seminal discovery of JAK1 and JAK2 kinases by Dr. Andrew Wilks, the founder of Cytopia Limited, now YM Australia. CYT997 is an orally-available agent with dual mechanisms of vascular disruption and cytotoxicity and has the potential to be broadly active against a range of tumor types.

11 Feb 2010

YM BioSciences receives additional AeroLEF patents in U.S.

YM BioSciences Inc., announced that it has been granted two additional patents in the US for AeroLEF(R), the Company's proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe acute pain. US patent numbers 7,648,981 and 7,648,982 extend the life of YM's AeroLEF patent estate in the US to 2024.

10 Feb 2010

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