Article Listing - FDA clears GlaxoSmithKline's Horizant for PHN
Eisai's Fycompa shows clear therapeutic benefit in hard-to-treat epilepsy
10 May 2013
Japanese drug major Eisai's (TYO: 4523) antiepileptic drug (AED) Fycompa (perampanel), shows a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to the investigators of two new analyses on early clinical experience of perampanel, presented on May 9 at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland. Perampanel was approved for use in the Europe Union in July 2012 and is now prescribed in several European countries, including Germany, Austria and Switzerland.
Total real per capita spending on medicines in the USA fell 3.5% in 2012
9 May 2013
Total spending on US medicines fell 3.5 percent on a real per capita basis in 2012 and the use of health care services overall declined for the second consecutive year, according to a new study released today by the IMS Institute for Healthcare Informatics.
Merck & Co's Gardasil and GSK's Cervarix to be available to developing countries via UNICEF tender
9 May 2013
A new record low price for human papillomavirus (HPV) vaccines will help ensure millions of girls in developing countries can be protected against cervical cancer, thanks to the GAVI Alliance. The poorest countries will now have access to a sustainable supply of HPV vaccines for as low as $4.50 per dose. The same vaccines can cost more than $100 in developed countries and the previous lowest public sector price was $13 per dose.
Cornerstone gains US rights to Pertzye for EPI due to cystic fibrosis patients
9 May 2013
US specialty pharma company Cornerstone Therapeutics (Nasdaq: CRTX) has entered into an agreement with Digestive Care (DCI) to acquire exclusive US rights to market Pertzye (pancrelipase) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). Financial terms of the accord were not disclosed.
Recordati posts 1st-qrt revenue rise of 11%, boosted by international sales
9 May 2013
Italian drugmaker Recordati (RC: MI) has reported an 11.4% rise to 244.6 million euros ($391.8 million) in consolidated revenue for the first quarter of 2013, with international sales growing 16.1%.
US Senator Grassley questions continue about 340B discount drug program
9 May 2013
US Senator Chuck Grassley (Republican, Iowa) is looking into how hospitals are using a discount prescription drug program, known as 340B. Certain hospitals appear to be making sizeable profits from the program at the expense of Medicare, Medicaid and private health insurance, he noted. Sen Grassley asked the federal agency in the charge of the program, the Health Resources and Services Administration, about its oversight of the program.
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?
- Elan makes "transformational" acquisitions and a divestment
- Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines
- SciClone gains China rights to Zensun's Neucardin
- Bristol-Myers' data on Yervoy and nivolumab causes a stir
- HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
