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Stockwatch: A slimmer AstraZeneca starts to look tasty
The headline number when AstraZeneca announced its full-year 2011 results on February 2 was not the sales or earnings numbers, but the 7,300 further job losses from R&D, sales and marketing, and manufacturing (
StemCells gets FDA nod for dry AMD trial using neural stem cells
Cell therapy specialist StemCells has received authorisation from the US FDA to start a Phase I/II trial of its purified human neural stem cells (HuCNS-SC) for dry age-related macular degeneration, or dry AMD.
Dry AMD, the most common form of.....
Dynavax expands target indication for hep B vaccine
Dynavax Technologies is to change its planned indication for approval for its novel hepatitis B vaccine Heplisav following a pre-BLA meeting with the US FDA.
It will file the product first for approval in healthy adults aged 18-70 years, it.....
First half filing for lubiprostone in opioid-induced bowel dysfunction
Takeda and Sucampo Pharmaceuticals say they now have the data to support a supplemental new drug application (sNDA) for the use of the gastrointestinal product, lubiprostone, in the treatment of opioid-induced bowel dysfunction (OBD) and are.....
Bottle and glass: Cephalon recalls Treanda after glass fragments found in vial
Teva's Cephalon has voluntarily recalled one lot of its injectable leukaemia drug Treanda (bendamustine HCL), after glass fragments were found in one of the vials. The affected lot was distributed between March and October 2011, and Teva does not.....
Once-daily Janumet finally gets US FDA OK, boosting Merck's diabetes franchise
Merck & Co's once-daily combination diabetes treatment Janumet XR has now received US approval a year after the acceptance of the NDA and following a complete response letter last summer.
The extended-release combination of.....
What do promising prostate cancer drug results mean for Dendreon?
Three months ago, Medivation announced encouraging top-line results for the prostate cancer androgen receptor signalling inhibitor it is developing in conjunction with Astellas Pharma (
No exception for Agennix as sepsis claims another hopeful victim - talactoferrin
Shares of Agennix succumbed to their biggest percentage fall in more than two years in Frankfurt trading upon an announcement that it was halting the Phase II/III OASIS trial of its oral immunotherapy talactoferrin (recombinant human lactoferrin) for.....
Ipsen's stock hit by triple whammy of charges
French pharma company Ipsen saw its share price fall by 5.6% to €21.70 yesterday after it said that it was likely to have to report impairment charges of €150-180 million for 2011, reflecting negative developments in three unrelated areas.....
AB Science jumps as masitinib outperforms in Phase II trial
Shares in French biotech firm AB Science increase shot up by as much as 72% on 2 February on Phase II data showing its investigational targeted anticancer compound masitinib was more effective and better tolerated than the current standard of care,.....
EUSA licenses from Alize's L-asparaginase to complement Erwinaze for ALL
EUSA Pharma, a private equity backed specialty pharmaceutical company focused on oncology, has acquired the exclusive worldwide development and commercialisation rights to a new L-asparaginase product in Phase I development, Asparec, from the French.....
Fermenta readies for more sunshine; plans multi-forked growth for vitamin D3
Fermenta Biotech, the only Indian manufacturer of vitamin D3, has doubled production capacity and expects to raise that further as the growing recognition and understanding of the nutritional and medical benefits of vitamin D3 expand global market.....
Merck Serono taps Threshold for Ph III cancer drug
Merck KGaA has paid €19 million ($25 million) up front to access a small-molecule drug targeting tumour hypoxia from Threshold Pharmaceuticals of South San Francisco, California. The compound, TH-302, is in Phase III for soft tissue sarcoma and.....
Italy's €1bn savings plan could spark price wars between generics and originators
A new law introducing stricter prescribing restrictions could save up to €1 billion and lead to a price war between originators and generics manufacturers in Italy, says AssoGenerici, the Italian generic medicines association......
EMA lays out drug safety priorities for 2012
Priorities for the European Medicines Agency in the drug safety area this year include a new urgent referral procedure, guidance on post-authorisation efficacy studies, and more effective ways of detecting and acting on significant safety signals......
Nycomed helps keep Takeda's head above water but deal costs hit profits
Takeda's first financial figures since the completion of the Nycomed acquisition show that the deal mainly helped Asia's largest pharmaceutical company weather the impact of the strong yen and falling sales of its top products, rather than.....
Filing shuffle for ThromboGenics' ocriplasmin
ThromboGenics has withdrawn its December US approval submission for its lead product, the eye drug ocriplasmin, so that it can refile it with an application for priority review. The FDA has already said that it intended to grant priority status to.....
First drug to treat underlying cause of cystic fibrosis approved in the US
The US FDA has approved Vertex Pharmaceuticals' Kalydeco (ivacaftor; previously known as VX-770) as the first medicine to treat the underlying cause of cystic fibrosis (CF).
"Kalydeco is an excellent example of the promise of personalised.....
Commentary: Is Amgen exploiting poor European immigrants?
Amgen, it appears, likes to exploit European immigrants as a shield against poor financial performance.
Just one year ago, on 24 January 2011, in the same breath as it was revealing its 2010 full year financial results, Amgen announced a $1.....
Sangamo receives $13m upfront in Shire haemophilia deal
Shire has signed a collaboration and licence agreement with Sangamo BioSciences to develop therapeutics for haemophilia and other monogenic diseases based on Sangamo's zinc finger DNA-binding protein (ZFP) technology. Shire is to pay Sangamo $13.....


