SEATTLE, Feb. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). [more]
CHARLOTTE, N.C., Feb. 9, 2010 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced several updates related to its Phase III registration program in neurogenic orthostatic hypotension (NOH), including the selection and preliminary approval by the FDA of Northera as the U.S. brand name for Droxidopa in this indication. [more]
THE WOODLANDS, Texas--(BUSINESS WIRE)--Feb 8, 2010 - Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA's Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state. [more]
EDMONTON, Feb. 4 /CNW/ - Isotechnika Pharma Inc. (TSX: ISA) today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM). Voclosporin, a next generation calcineurin inhibitor, is proposed for the treatment of non-infectious uveitis involving the posterior segment of the eye, a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world. [more]
SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. announced today that, subject to the approval of the U.S. Food and Drug Administration (FDA), the brand name for GSK1838262/XP13512 (gabapentin enacarbil) in the United States will be Horizant. [more]
JERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye. [more]
MONTREAL, QUEBEC--(Marketwire - Feb. 4, 2010) - Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced today that it has filed a new drug submission for Abstral sublingual fentanyl. [more]
Uppsala, February 4, 2010 - Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that the New Drug Submission made by their Canadian partner, Paladin Labs Inc., for Abstral has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health. [more]
CARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. announced today that, in connection with the NDA filed by the company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the FDA has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA. [more]
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 2, 2010 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its NDA submitted on December 2, 2009 to the FDA for its investigational product candidate, Dyloject (diclofenac sodium) Injection, has been accepted for formal review. [more]
Loures, Portugal, February 2, 2010. Hovione is announcing the filing of a New Drug Application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione’s TwinCaps inhaler. [more]
PHILADELPHIA--(BUSINESS WIRE)--Feb 2, 2010 - Lannett Company, Inc. today announced plans to submit its NDA for its Morphine Sulfate products to the FDA at the end of the month. The company expects the FDA to review its application on an expedited basis. [more]
JERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. [more]
LOURES, Portugal, February 2/PRNewswire/ -- Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione's TwinCaps inhaler. [more]
Tokyo, (February 1, 2010) – Daiichi Sankyo Company, Limited (hereafter; Daiichi Sankyo), today announced that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare for approval in Japan of CS-8958, a proprietary anti-flu drug. [more]
SOUTH SAN FRANCISCO, CA/January 28, 2010 - Theravance, Inc. (NASDAQ: THRX) announced today that it has received from the U.S. Food and Drug Administration (FDA) a letter indicating that Theravance’s response to the November 2009 Complete Response letter for the telavancin New Drug Application (NDA) for the treatment of nosocomial pneumonia (NP) is incomplete and that the review clock will not start until the FDA receives a complete response. [more]
ARDEE, Ireland, Jan. 27 /PRNewswire-FirstCall/ -- Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016). [more]
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan 27, 2010 - Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the STEDESA (eslicarbazepine acetate) NDA on April 30, 2010, which is a three-month extension to the original Prescription Drug User Fee Act (PDUFA) date of January 30, 2010. [more]
AMSTERDAM, The Netherlands, January 25/PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, has reached another important milestone in the official marketing authorisation process for its lead product Glybera, AMT's proprietary product for lipoprotein lipase deficiency (LPLD). [more]
Leiden, The Netherlands, January 22, 2010. Biotech company Pharming Group NV today provided an update on the regulatory review by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) of its Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of Hereditary Angioedema (HAE). The company reports that it has received the Day 120 List of Questions (LoQ) from the CHMP. At this stage of the procedure, no 'major concerns' have been raised by the CHMP on the application. Pharming is confident on a positive outcome of the European MAA filing. [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
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