Article Listing - GSK inks $300m rare diseases alliance with Angiochem
European Medicines Agency simplifies processing of fee reductions for orphan medicines
9 May 2013
The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the EMA's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions.
Myriad Genetics' gene patenting battle: BRACAnalysis won't suffer the consequences, says GlobalData analyst
9 May 2013
USA-based Myriad Genetics (Nasdaq: MYGN) is currently disputing its right to claim ownership to a human gene, drawing worldwide support and condemnation in equal measures. However, one GlobalData analyst asks, with the changing pace of gene testing, will the final decision make that much of a difference to the fate of Myriad's flagship BRCA gene test, BRACAnalysis?
Takeda to acquire Inviragen, gaining rights to promising vaccines
9 May 2013
Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) has entered into a definitive agreement to acquire Inviragen for an upfront of $35 million, and future payments of up to $215 million linked to the progress of clinical development and achievement of key commercial milestones.
Teva pays $40 million upfront to market Alexza's Adasuve in USA
9 May 2013
The US subsidiary of Israeli generics giant Teva Pharmaceuticals Industries (NYSE: TEVA) has entered into an exclusive US license and supply agreement for USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) Adasuve (Staccato loxapine) inhalation powder 10mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
US FDA accepts Merck & Co's BLA ragweed pollen allergy immunotherapy
9 May 2013
US pharma giant Merck & Co (NYSE: MRK) revealed yesterday (May 8) that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the US Food and Drug Administration.
MoCA report a welcome stepping stone, but access to orphan medicines remains unfinished business, say trade groups
9 May 2013
The three leading pharma/biotech trade bodies, EuropaBio, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and European Biopharmaceutical Enterprises (EBE) have welcomed the final report of the Working Group on Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA-OMPs) which was endorsed by the Steering Group of the Process on Corporate Responsibility in the field of Pharmaceuticals, and published on 6 May 2013 by the European Commission.
pSivida and Alimera's Iluvien debuts in Germany; New data on Novartis' Lucentis
8 May 2013
USA-based pSivida Corp (Nasdaq: PSDV), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today (May 8) announced that Iluvien (fluocinolone acetonide intravitreal insert), the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema (DME), is now commercially available in Germany. pSivida's licensee Alimera Sciences (Nasdaq: ALIM) reported that the first patient has been treated following the commercial launch in Germany.
Florida joins growing list of US states blocking some Biosimilars Bills provisions
8 May 2013
Last Friday, the US state of Florida joined several states, most recently Indiana, in refusing to enact legislation that would create barriers between patients and newer, lower-cost versions of biologic medicines known as biosimilars. The Florida legislature voted to approve a bill on biosimilars that follows current substitution practices for prescription medicines, rejecting efforts by US biotech majors Amgen and Genentech (part of Roche) to limit future access to these therapies once they reach the market.
Global biosimilar drug revenues will reach $2,445 million in 2013, says Visiongain
8 May 2013
The world market for biosimilar drugs will be worth $2,445 million in 2013, growing by more than 20% from 2012, according to a new report from Visiongain. In 2013 it will account for around 2% of the overall biological drugs market, and the study forecasts rapid growth to 2023 for the global biosimilars market.
Baxter shares dip as Alzheimer's drug fails to meet Ph III endpoints
8 May 2013
Shares of US drugmaker Baxter International (NYSE: BAX) fell 2.5% to $68.58 in New York trading on May 7, having fallen as much as 3.3% in the morning, after it said that the Phase III clinical study of immunoglobulin (IG), Gammagard, did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease, marking another disappointment in finding improved treatment of the condition.
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