Article Listing - Ipsen updates on pipeline at its investor day; but more US delays for Reloxin
Canada strengthens drug safety with GMP now to apply to all APIs
9 May 2013
Canada's Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active pharmaceutical ingredients (APIs) used in medicines. These amendments will come into force in the fall of this year.
Top-line financial results from Japanese drug majors
9 May 2013
Among a batch of Japanese drug majors presenting fiscal year 2013 (ended April 2013) financial results, Takeda Pharmaceuticals (TYO: 4502) reported 3.2% growth in revenues to 1,557.27 billion yen ($15.89 billion); operating profit decreased 53.8% to 122.51 billion yen; current profit fell 58.1% to 113.17 billion yen; and net income increased 5.7% to 131.24 billion yen, or 2,166.25 per share.
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.
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- HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
- Bristol-Myers' data on Yervoy and nivolumab causes a stir
- SciClone gains China rights to Zensun's Neucardin
