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16-30 of 2253 results
European Commission approves Novartis breast cancer drug Kisqali
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Production & Manufacturing > Manufacturing > News
AstraZeneca, MedImmune, Ethris to develop mRNA therapies for respiratory diseases
By PBR Staff Writer
AstraZeneca and its research and development arm MedImmune have entered into five-year strategic research collaboration with Ethris to develop mRNA therapies for respiratory diseases.
Production & Manufacturing > Manufacturing > News
Ironwood’s Duzallo gets FDA approval for gout-associated hyperuricemia
By PBR Staff Writer
Ironwood Pharmaceuticals’ Duzallo has been approved by the US Food and Drug Administration (FDA) for the treatment of hyperuricemia in patients with uncontrolled gout.
Production & Manufacturing > Manufacturing > News
SK Capital to acquire Perrigo’s Israeli API business
By PBR Staff Writer
New York-based private investment firm SK Capital has agreed to acquire Perrigo API, the active pharmaceutical ingredients (API) business of Perrigo Company in Israel, for $110m in an all-cash deal.
Production & Manufacturing > Manufacturing > News
Celgene, Sutro revise 2014 immuno-oncology collaboration
By PBR Staff Writer
Celgene has revised the terms of its immuno-oncology collaboration with Sutro Biopharma, which was established in 2014.
Production & Manufacturing > Manufacturing > News
Roche agrees to sell eczema drug rights to Dermira
By PBR Staff Writer
Dermira has signed a licensing agreement with Roche to secure exclusive rights to lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications.
Production & Manufacturing > Manufacturing > News
Kite Pharma seeks European approval for Axicabtagene Ciloleucel
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
Production & Manufacturing > Manufacturing > News
Celgene to pay $280m to settle False Claims Act litigation in US
Celgene has reached a civil settlement with Relator Brown, the Department of Justice, 28 States, the District of Columbia, and the City of Chicago to resolve the previously disclosed False Claims Act litigation pending in the United States District Court for the Central District of California.
Production & Manufacturing > Manufacturing > News
Horizon to acquire GE's gene tech business Dharmacon
By PBR Staff Writer
Gene editing company Horizon Discovery Group (HDG) has agreed to acquire General Electric’s (GE) gene tech business Dharmacon for $85m.
Production & Manufacturing > Manufacturing > News
Emergent BioSolutions to buy GSK’s anthrax treatment raxibacumab
By PKBR Staff Writer
Emergent BioSolutions has agreed to acquire GlaxoSmithKline’s (GSK) anthrax monoclonal antibody, raxibacumab, for around $96m.
Production & Manufacturing > Manufacturing > News
CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
Production & Manufacturing > Manufacturing > News
Lilly reaches settlement deal in US Cialis patent litigation
Eli Lilly and Company has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent.
Production & Manufacturing > Manufacturing > News
ABPI applies for Judicial Review against new procedures for cost-effective medicines
The Association of the British Pharmaceutical Industry (ABPI) has applied for judicial review over new procedures that restrict access to cost-effective medicines.
Production & Manufacturing > Manufacturing > News
Lilly wins Alimta vitamin regimen patent case in UK
By PBR Staff Writer
Eli Lilly and Company has been given a favourable ruling in the UK Supreme Court in the vitamin regimen patent litigation case relating to its cancer drug Alimta (pemetrexed disodium) against Actavis.
Production & Manufacturing > Manufacturing > News
Samsung Biologics to manufacture Sun Pharma’s psoriasis drug Tildrakizumab
By PBR Staff Writer
Indian drug major Sun Pharma has signed a manufacturing agreement with South Korea-based Samsung BioLogics for psoriasis experimental drug Tildrakizumab.
Production & Manufacturing > Manufacturing > News
16-30 of 2253 results