Article Listing - FDA says CFC inhalers will cease end 2008
Protalix BioTherapeutics enters Gaucher drug Uplyso deal with Brazil's Ministry of Health
19 June 2013
Israel-based Protalix BioTherapeutics (TASE:PLX) has entered into a supply and technology transfer agreement with Fundacao Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health for Uplyso (alfataliglicerase), the company's proprietary enzyme replacement therapy for the treatment of Gaucher disease.
Royalty pulls plug on Elan buy (for now?); analysts' view on what comes next
19 June 2013
In the ongoing hostile takeover saga, US private equity firm Royalty Pharma has withdrawn its request for a judicial review of the Irish Takeover Panel's decision requiring it to lapse its offer for drugmaker Elan Corp (NYSE: ELN) oration, if, among other things, Elan shareholders approved the Share Repurchase Program (The Pharma Letter June 18).
Athera and Boehringer Ingelheim enter option agreement on a novel therapy for atherosclerosis
19 June 2013
Sweden-based Athera Biotechnologies, which is 65% owned by Karolinska Development, has entered into an option agreement with Boehringer Ingelheim on a novel preclinical antibody program, whereby Athera grants the family-owned German drug major an exclusive option to acquire the entire program. Athera's fully-human monoclonal antibody is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death.
Curie-Cancer and Sanofi cooperate in research on ovarian cancer
19 June 2013
Carnot label, have established a three-year research collaboration to identify new therapeutic targets for the development of treatments for ovarian cancer. Financial terms of the accord were not disclosed.
FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv
19 June 2013
The US Food and Drug Administration yesterday (June 18) revealed it is investigating two unexplained deaths in patients who received an intramuscular injection of US drug major Eli Lilly's (NYSE: LLY) antipsychotic drug Zyprexa Relprevv (olanzapine pamoate), a formulation that can last two to four weeks as opposed to daily versions of Zyprexa (olanzapine), which had peak sales of round $5 billion before losing patent protection in 2011, but just $1.7 billion in 2012, compared with less than $60 million last year for the "Relprevv" version.
Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site
19 June 2013
UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday (June 18) that it has received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global and Aspen Pharmacare (JSE: APN), South Africa's largest drugmaker. A period of exclusivity has been agreed with Aspen and GSK will respond to the offer subject to consultation with employees and the relevant works councils.
Negative US patent ruling for Novo Nordisk on Prandin
19 June 2013
Denmark-based insulin giant Novo Nordisk (NOV: N) says that the US Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a two to one ruling that a claim in a company patent related to the use of repaglinide (trade name Prandin) in combination with metformin for the treatment of type 2 diabetes was invalid. This decision favors approval and launch of a generic repaglinide product.
Daiichi Sankyo files for Japanese approval of Prasugrel
18 June 2013
Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent prasugrel for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI). Analysts at Credit Suisse have a net present value for prasugrel of 78.19 yen per share (4% of total) for Daiichi Sankyo.
Genmab and ADC Thera link for antibody drug conjugate combining HuMax-TAC and PBD warhead
18 June 2013
Denmark's Genmab (OMX: GEN) and Switzerland-based ADC Therapeutics have entered an agreement to develop a new antibody-drug conjugate (ADC) product combining Genmab's HuMax-TAC antibody and ADC's PBD-based warhead and linker technology. The companies have been conducting in vitro and in vivo studies since 2012 to investigate different warhead and linker combinations with HuMax-TAC, and now have the product ready for pre-IND preclinical development. The product will be developed for multiple cancer indications.
Ipsen reports mixed Ph III results with Somatuline Autogel in patients with acromegaly
18 June 2013
French drugmaker Ipsen (Euronext: IPN) announced the results of an international Phase IIIb study, PRIMARYS, assessing an investigational use of Somatuline Autogel (lanreotide) 120mg as first line therapy in newly diagnosed acromegaly patients with a macroadenoma, reporting mixed results. Somatuline is already approved and marketed for acromegaly, and generated sales of 225 million euros ($300 million) in 2012.
- Takeda debuts three new diabetes drugs, Nesina, Kazano and Oseni, in USA
- Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site
- Athera and Boehringer Ingelheim enter option agreement on a novel therapy for atherosclerosis
- It's official: "obesity is a disease," says AMA
- Mixed results for AstraZeneca/B-MS' Onglyza; Newron's safinamide does well in PD
