Article Listing - US new drug approvals hit 24-year low
Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
16 June 2013
Among presentations over the weekend at the Congress of European Hematology Association (EHA) being held in Stockholm, Sweden, Swiss drug major Novartis (NOVN: VX) announced results from a Phase III three-year follow-up study that showed Jakavi (ruxolitinib) demonstrated improved overall survival and sustained reductions in spleen size compared to conventional therapy. Jakafi, an oral JAK1 and JAK2 inhibitor, is licenses from USA-based Incyte (Nasdaq: INCY) and is cleared for marketing in the USA and Europe under the trade names Jakavi and Jakafi.
Global asthma market to reach 159 million lifetime cases by 2022
16 June 2013
Over 300 million people suffer from asthma, which translates to a drug market worth over $15 billion. While drugs to manage asthma have existed for several decades, pharmaceutical companies have developed faster acting and more effective products over the years, according to a new report added to the offering of companiesandmarkets.
Bristol-Myers and Simcere agree to co-develop/commercialize Orencia SC in China
14 June 2013
US pharma major Bristol-Myers Squibb (NYSE: BMY) and China-based Simcere Pharmaceutical (NYSE: SCR) have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the co-development and commercialization of the subcutaneous (SC) formulation of B-MS' biologic Orencia (abatacept), for the treatment of rheumatoid arthritis. Orencia SC is already on the market for the treatment of rheumatoid arthritis in the USA, Europe and Japan and generated first-quarter 2013 sales of $320 million.
June meeting highlights from EMA Pharmacovigilance Risk Assessment Committee
14 June 2013
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has made several recommendations on safety referrals at its June 2013 meeting, including a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
Canadians have access to fewer new medicines than in most OECD countries
14 June 2013
Compared to 32 other developed countries, Canada's public drug plans perform poorly in providing access to new medicines and vaccines, according to the 2011-2012 International Report on Access to Medicines released by Canada's Research-Based Pharmaceutical Companies (Rx&D).
Royalty bid for Elan could be withdrawn; J&J sells 25.4 million Elan shares
14 June 2013
Ireland-based hostile takeover target Elan (NYSE: ELN) fell 5.2% to 9.29 euros on June 13, the most in four months, after Royalty Pharma said it may be forced to end its $6.7 billion bid to take over the biotechnology company. Elan shareholders may approve a share-repurchasing program at their meeting on June 17, Royalty Pharma said in a statement after reviewing votes cast as of the day earlier.
Boehringer Ingelheim's all-oral interferon-free combination achieved 95% viral cure rates in genotype-1b hepatitis C
14 June 2013
New data from German family-owned drug major Boehringer Ingelheim's interferon-free SOUND-C3, presented during the APASL Liver Week in Singapore, showed strong results for the firm's investigational all-oral interferon-free combination in the treatment of genotype-1b hepatitis patients.
Data on Novo Nordisk's Victoza further supporting safety presented at expert workshop
14 June 2013
Danish Insulin giant Novo Nordisk (NOV: N) presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI).
Lilly stops Ph II study of Alzheimer's candidate LY2886721 due to abnormal liver tests
14 June 2013
US drug major Eli Lilly (NYSE: LLY) says it has stopped its Phase II study (BACC) for LY2886721, a beta secretase (BACE) inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease. The decision was due to abnormal liver biochemical tests. The cases of abnormal liver biochemical tests were identified as part of routine monitoring. Lilly will continue to monitor all participants with abnormal liver biochemical tests.
FDA backs Amgen's Xgeva for new use, to treat giant cell tumor of the bone
14 June 2013
The US Food and Drug Administration late yesterday (June 13) expanded the approved use of biotech major Amgen's (Nasdaq: AMGN) Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
- 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
