Granisetron News and Research

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Granisetron is the active ingredient in a drug used to treat nausea and vomiting caused by cancer treatment. Granisetron is a type of serotonin receptor antagonist and a type of antiemetic.

Taro's granisetron tablets receive FDA approval

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Granisetron Hydrochloride Tablets USP, 1 mg (base) ("granisetron tablets").

3 Jun 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

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

Contura submits PMA for Aquamid

Contura Inc. has submitted a Premarket Approval Application for Aquamid to the U.S. Food and Drug Administration requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

16 Apr 2010

FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the Company's two abbreviated New Drug Applications to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.

15 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

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting.

19 Mar 2010

A.P. Pharma reports net loss of $1.9M for fourth-quarter of 2009

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 31, 2009.

15 Mar 2010

China Pharma Holdings reports 21% increase in 2009 revenue

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced financial results for the fiscal year ended December 31, 2009.

5 Mar 2010

Solasia Pharma K.K. signs License and Supply Agreement with Kyowa Hakko Kirin to market SP-01

Solasia Pharma K.K. (http://www.solasia.co.jp), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the signing of a License and Supply Agreement with Kyowa Hakko Kirin that provides Kyowa Hakko Kirin with an exclusive right to market and sell SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Taiwan, Hong Kong, Singapore and Malaysia.

3 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

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

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

Almac Discovery today announced the start of Phase I clinical trial of the novel intranasal Granisetron product. This product, which uses Archimedes' proprietary ChiSys® delivery technology, is being developed as a rapidly acting, well tolerated and convenient treatment for chemotherapy-induced nausea and vomiting (CINV).

15 Dec 2009

A.P. Pharma announces financial results for its third quarter ended September 30, 2009

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2009.

16 Nov 2009

Solasia Pharma completes Phase I clinical trial for Sancuso extended release transdermal granisetron patch

Solasia Pharma K.K. (http://www.solasia.co.jp), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the completion of a Phase I clinical trial for SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Japanese volunteers.

30 Oct 2009

A.P. Pharma to raise funds through placement

A.P. Pharma, a specialty pharmaceutical company, today announced it has entered into a definitive securities purchase agreement with certain existing accredited investors providing for a private placement of up to $13.1 million in two tranches, the first consisting of common stock and warrants with aggregate proceeds of approximately $8.1 million, and a second tranche of common stock with proceeds of approximately $5 million.

20 Oct 2009

A.P. Pharma submits NDA for APF530 in chemo-induced nausea and vomiting

A.P. Pharma, Inc. has announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system.

18 May 2009

Barr receives approval for generic KYTRIL tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base).

3 Jan 2008