Article Listing - FDA approves first Cushing’s syndrome drug, Corcept’s Korlym
Astellas and Medivation file for approval of enzalutamide in Japan
24 May 2013
Japanese drug major Astellas Pharma (TYO: 4503) has submitted an application for marketing approval of enzalutamide to the Ministry of Health, Labor and Welfare in Japan for the treatment of prostate cancer.
Elan rejects Royalty Pharma's increased bid; prices Senior Notes offering
24 May 2013
Ireland-based takeover target Elan Corp (NYSE: ELN) says that its board of directors, after careful review and consideration, has determined that privately held investment firm Royalty Pharma's revised offer announced earlier this week (The Pharma Letter May 21) to acquire all of Elan's shares for $12.50 per share (up from $11.25 a share) substantially undervalues the company.
Proposal to list Roche's Neulastim and Actemra in New Zealand
24 May 2013
New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of a proposal to list pegfilgrastim (Neulastim) for prevention of neutropenia in patients undergoing cancer chemotherapy and tocilizumab (Actemra) for systemic juvenile idiopathic arthritis, from July 1, 2013, through an agreement with the local subsidiary of Swiss drug major Roche (ROG: SIX). This was the subject of a consultation letter dated April 12, 2013.
Pharma sector's R&D investment in Canada is chronically underreported
24 May 2013
For the third consecutive year, a KPMG study commissioned by Canada's Research-Based Pharmaceutical Companies (Rx&D) has determined that R&D investments made by Canada's innovative pharmaceutical sector continue to be consistently underreported, by around 34% for 2012.
Nordion to sell Targeted Therapies business to BTG for $200 million
24 May 2013
Canada's Nordion (TSX: NDN), a provider of products and services for the prevention, diagnosis and treatment of disease, has entered into an agreement to divest its Targeted Therapies business to UK-based BTG (LSE: BTG) for a cash purchase price of $200 million. Net of cash taxes and transaction costs, Nordion expects to realize around $185 million on closing. The transaction is anticipated to be completed by the end of June 2013.
Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial
24 May 2013
Danish insulin giant Novo Nordisk (NOV: N) has released headline results from a 56-week double-blind Phase IIIa clinical trial investigating the potential of liraglutide, the active ingredient of its type 2 diabetes agent Victoza, to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as pre-diabetes, hypertension and dyslipidemia.
FDA allows marketing of first A1c test labeled for diagnosing diabetes, from Roche
24 May 2013
The US Food and Drug Administration yesterday (May 23) announced that it is allowing marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals, a product from Swiss drug major Roche (ROG: SIX). This is the first HbA1c test that the FDA has allowed to be marketed for this use.
BRICs not delivering promises of high growth in health care markets, says F&S
24 May 2013
Health care organizations expanding into emerging markets such as the BRICs (Brazil, Russia, India and China) are realizing there are no shortcuts. This is proving particularly challenging, considering the current health care environment, especially in the USA. Companies must change the dialogue around BRIC, as it is now more about establishing value, customizing to local needs, and building regional partnerships to build a sustainable business, according to market research group Frost & Sullivan.
Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth
24 May 2013
At a meeting today with industry analysts, senior leaders from the Janssen pharmaceutical companies of US health care giant Johnson & Johnson (NYSE: JNJ) yesterday (May 23) announced they anticipate submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.
Merck & Co drops development of PD candidate preladenant
24 May 2013
Following review of three separate Phase III studies of preladenant, US pharma giant Merck & Co (NYSE: MRK) said that these did not provide evidence of efficacy for this investigational adenosine A2A receptor antagonist in the treatment of Parkinson's disease (PD).
- Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial
- Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
- Proposal to list Roche's Neulastim and Actemra in New Zealand
- Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
- Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth
