Article Listing - Strong sales growth for Rhone-Poulenc in the USA, merger with Hoechst on
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?
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.
- Bristol-Myers' data on Yervoy and nivolumab causes a stir
- Boehringer Ingelheim transitions to propellant-free Combivent Respimat; names new BMD member
- Encouraging results with Sangamo's SB-728-T in HIV treatment
- Sanofi prepares for regulatory filing of MF candidate on positive JAKARTA study results
- New study shows UCB's Neupro reduces NSBP in RLS patient
