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News Breaks
February 28, 2014
16:13 EDTTKPYY, ACTActavis confirms patent challenge on generic Colcrys
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the U.S. FDA seeking approval to market Colchicine Tablets USP, 0.6 mg. Actavis' ANDA product is a generic version of Takeda's (TKPYY) Colcrys, which is a prescription medicine used in adults to prevent and treat gout flares. Takeda Pharmaceuticals U.S.A. filed suit against Actavis on February 27 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
News For ACT;TKPYY From The Last 14 Days
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February 4, 2016
08:05 EDTTKPYYSeattle Genetics to receive $20M milestone payment under ADCETRIS collaboration
Seattle Genetics (SGEN) announced that it will receive a one-time $20M milestone payment under its ADCETRIS collaboration with Takeda Pharmaceutical Company Limited (TKPYY). The milestone was triggered by Takeda surpassing annual ADCETRIS net sales of $200M in its territory during 2015. The milestone will be recognized as royalty revenue in the first quarter of 2016. In addition, the company announced that the European Commission recently approved a Type II variation that includes data on the retreatment of adult patients with relapsed or refractory Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma who previously responded to ADCETRIS and who later relapse. The label update follows a positive opinion from the Committee for Medicinal Products for Human Use in October 2015.
05:17 EDTTKPYYTakeda announces FDA PDAC supports effectiveness of Brintellix
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February 3, 2016
07:32 EDTTKPYYTaked, Mersana Therapeutics expand partnership for XMT-1522
Mersana Therapeutics and Takeda Pharmaceutical announced that they have entered a new strategic partnership granting Takeda rights to Mersana's lead product candidate, XMT-1522, outside the United States and Canada. The deal also expands an existing collaboration between the companies to provide Takeda with additional access to Mersana's Fleximer antibody-drug conjugate platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of these programs in the United States. In addition, the companies will co-develop new payloads for use with ADCs. XMT-1522 is an investigational, Fleximer-based ADC therapy that targets HER2-expressing tumors, including breast, gastric and non-small cell lung cancers. Preclinical data suggest that XMT-1522 may have anti-tumor activity in patients with HER2 low-expressing cancers as well as in patients with HER2 high-expressing cancers that do not respond to currently available HER2-targeting therapies. Mersana anticipates filing an Investigational New Drug application for XMT-1522 with the U.S. Food and Drug Administration in mid-2016. Takeda and Mersana will co-develop XMT-1522, and Mersana will lead execution of the Phase 1 trial. Mersana will retain full commercial rights in the United States and Canada while Takeda will have rights in rest of world. Beyond development and commercialization of XMT-1522, the expanded partnership also grants Takeda access to additional targets within Mersana's Fleximer-based ADC platform, with Mersana retaining the right to select one program at the end of Phase 1 for co-development and co-commercialization in the United States. Takeda and Mersana will also work together, leveraging Takeda's proprietary small molecule libraries, to identify and develop novel payloads that both parties will be able to use in new ADC therapies. Takeda signed agreements with Mersana through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc., under which, Mersana will receive an upfront payment of $40 million and an additional payment of $20 million upon clearance of the IND for XMT-1522 by the FDA. Subject to the success of the XMT-1522 and ADC programs, Mersana is eligible to receive milestone payments of more than $750 million combined, as well as royalties. Takeda will also invest up to $20 million in equity in future rounds of Mersana financing.
07:17 EDTTKPYYFDA Psychopharmacologic Drugs Advisory Committee to hold a meeting
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