Onsolis News and Research

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BREAKYL drug receives European approval

BioDelivery Sciences International, Inc. and Meda today announced approval of BEMA Fentanyl in Europe via the Decentralized Procedure, with Germany acting as Reference Member State.

20 Oct 2010

BDSI announces positive meeting with FDA, Meda on REMS program for ONSOLIS

BioDelivery Sciences International, Inc. today announced a positive meeting with the U.S. Food and Drug Administration (FDA), Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film).

3 Sep 2010

BDSI's Phase 2 study results of BEMA Buprenorphine selected for presentation at Pain Week 2010

BioDelivery Sciences International, Inc. announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain. The presentation will take place on Friday, September 10, as part of the 7:00 - 9:00 AM podium presentation session.

30 Aug 2010

BDSI partners with Kunwha to develop and commercialize BEMA Fentanyl in Republic of Korea

BioDelivery Sciences International, Inc. announced that it has entered into a license and supply agreement with Kunwha Pharmaceutical Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the U.S.) in the Republic of Korea. The agreement results in potential milestone payments to BDSI of up to $1,275,000, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.

27 May 2010

Health Canada approves BDSI's NDS for ONSOLIS

BioDelivery Sciences International, Inc. today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.

10 May 2010

Meda AB's net sales for first-quarter 2010 decrease 14% to SEK 2,943M

After a strong Q4 in 2009, net sales decreased 14% in Q1 to SEK 2,943 million (3,437). Mainly currency effects but also increased competition for Astelin and Optivar reduced sales by more than SEK 400 million, compared with the same period last year.

5 May 2010

BDSI Sciences to purchase $10M of securities in registered direct offering

BioDelivery Sciences International, Inc., a specialty pharmaceutical company, announced that it has entered into a definitive securities purchase agreement with a group of select institutional investors to purchase US$10 million of its securities in a registered direct offering. No placement agent was utilized in connection with the offering.

21 Apr 2010

BEMA Granisetron development program: BDSI announces positive meeting with FDA

BioDelivery Sciences International, Inc. announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application.

22 Mar 2010

BioDelivery Sciences International announces filing of Annual Report with U.S. SEC

BioDelivery Sciences International, Inc. has filed its Annual Report with the U.S. Securities and Exchange Commission on Form 10-K for the fiscal year ended December 31, 2009. Such Form 10-K is available on the SEC’s website at www.sec.gov.

20 Mar 2010

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

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

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

Meda receives exclusive rights to distribute AML drug in Europe and Asia

Meda has in-licensed exclusive rights to Ceplene (histamine dihydrochloride) from EpiCept Corporation, a US-based biopharmaceutical company.

11 Jan 2010

EpiCept, Meda enter into exclusive commercialization agreement for Ceplene

EpiCept Corporation announced today that it has entered into an exclusive commercialization agreement for Ceplene® (histamine dihydrochloride) with Meda AB, a leading international specialty pharmaceutical company based in Stockholm. Ceplene is EpiCept’s novel therapy approved in the European Union with orphan drug status for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

11 Jan 2010

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

Meda Pharmaceuticals introduces Onsolis for treating breakthrough cancer pain

Meda Pharmaceuticals Inc. today announced the launch of Onsolis(TM)(fentanyl buccal soluble film) in the U.S. for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

13 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

8 Oct 2009

US Army grants BioDelivery Sciences $1.3M for investigating Bioral Amphotericin B

BioDelivery Sciences International, Inc. has received a $1.3 million grant from the Walter Reed Army Institute of Research for Bioral Amphotericin B, an oral formulation of the fungicidal treatment amphotericin B in BDSI’s patented Bioral drug delivery technology, to further study the formulation in the treatment of Cutaneous Leishmaniasis.

6 Oct 2009

BioDelivery Sciences International files NDS for BEMA Fentanyl

BioDelivery Sciences International, Inc.today announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined.

3 Oct 2009