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.
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.
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.
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.
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.
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.
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.
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.
A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 31, 2009.
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.
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.
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.
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.
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).
A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2009.
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.
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.
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.
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).
The subcutaneous administration of granisetron, an antiemetic pharmaceutical drug (suitable for control of vomiting), achieves similar blood concentrations to those administered intravenously.
Between 10 - 28% of people benefit from taking an anti-emetic drug to prevent nausea or vomiting after surgery - this means that if everyone was given the drug the majority of patients would be exposed to the risk of side-effects without gaining any benefit.