Article Listing - Merck & Co to start $4.85B Vioxx payout
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.
AOP Orphan spins off stake in Activartis as Elan shareholders vote down acquisition
18 June 2013
In the wake of yesterday's shareholders vote against Irish drugmaker Elan Corp's (NYSE: ELN) planned $340 million acquisition of Austrian firm AOP Orphan (The Pharma Letter June 18), the latter announced the spinoff of its 80 % stake in Activartis GmbH, a Vienna-based biotech company with a strong platform for immune-based cancer vaccines, to a group of private investors.
US FDA accepts Ruconest filing from Santarus and Pharming
18 June 2013
US drugmaker Santarus (Nasdaq: SNTS) and Netherlands-based Pharming Group (NYSE Euronext: PHARM) say that the US Food and Drug Administration has accepted for filing the Biologics License Application for the investigational drug Ruconest (recombinant human C1 esterase inhibitor) 50IU/kg. Ruconest is approved in Europe for the treatment of acute angioedema attacks in patients with HAE.
Australia's pharma industry applauds R&D regulatory reform
18 June 2013
R&D-based pharma trade group Medicines Australia today (June 18) welcomed the coalition government's announcements that it will reduce red tape, protect medical research funding and provide policy certainty in medical research.
New long term biotech research cooperation deal signed by Brazil and UK
18 June 2013
The British Biotechnology and Biological Sciences Research Council (BBSRC) and the Brazilian National Council for Scientific and Technological Development (CNPq) have signed a Letter of Understanding to implement a new cooperation program to extend the long-term collaboration between the parties. Steve Visscher, deputy chief executive, signed for the BBSRC while CNPq was represented by its president, Glaucius Oliva.
- US Supreme Court says patent settlement can "sometimes" be illegal
- InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against
- Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
- Daiichi Sankyo files for Japanese approval of Prasugrel
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
