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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.

Ranbaxy 1st-qtr 2013 earnings plunge 90% as sales fall 34%

8 May 2013

India's largest pharma company Ranbaxy Laboratories (BSE: 500359), which is majority owned by Japan's Daiichi Sankyo, has posted first quarter 2013 financial results, showing the net income plunged 90% to 1.26 billion rupees ($23.4 million), while sales fell 34.2% to 24.40 billion rupees compared with the 2012 first quarter, when the company benefited from sales exclusivity in the USA for a generic version for a generic version of Pfizer's all-time blockbuster Lipitor (atorvastatin).

Clinical success rates for new cancer drugs doubled from the mid-1990s to early-2000s, says Tufts CSDD

8 May 2013

Clinical success rates for new cancer drugs doubled between the mid-1990s to the early 2000s, while the number of new cancer drugs entering clinical testing increased 50 percent during the same time, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.

ADHD drug development is "problematic;" drug repositioning trumps research

8 May 2013

While high disease prevalence is encouraging pharmaceuticals companies to enter into the attention-deficit hyperactivity disorder (ADHD) market, a lack of understanding surrounding the condition is making drug development problematic, states GBI Research in a new report focusing on the disease market.

Arena and Eisai finally get DEA scheduling for obesity drug Belviq

8 May 2013

The long wait to get obesity drug Belviq (lorcaserin) to the US market, where it was approved by the Food and Drug Administration nearly a year ago, is coming to a close, but not just yet. While finally getting a feedback from the US Drug Enforcement Administration, the effective date of the scheduling designation will be 30 days after today's (May 8) expected publication in the Federal Register.

Drais Pharma to develop third Astellas compound through Tacurion

8 May 2013

Japanese drug major Astellas Pharma (TYO: 4503) and USA-based Drais Pharmaceuticals have entered into a third partnership in the space of around a year to develop and commercialize an Astellas compound.

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