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Novartis' Kisqali has been approved for breast cancer in the US less than one month after being filed with the US Food and Drug Administration. [...]
Thu, Jul 19, 2018
Source PharmaTimes
Martindale Pharma, Pierre Fabre, Janssen and Pharmasure have all been named in advertisements for breaching the Association of the British Pharmaceutical Industry's Code of Practice. [...]
Thu, Jul 19, 2018
Source PharmaTimes
New data has revealed that Alzheimer's disease and other forms of dementia accounted for 13 percent of all UK deaths in 2018. [...]
Thu, Jul 19, 2018
Source PharmaTimes
Novartis has signed an exclusive global license agreement with Galapagos and MorphoSys for MOR106, a novel antibody directed against IL-17C. [...]
Thu, Jul 19, 2018
Source PharmaTimes
FDA
The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. [...]
Wed, Jul 18, 2018
Source WorldPharmaNews
Baxter has been nailed with a warning letter for a plant in India that it got in its $625 million buyout of Claris Injectables. [...]
Wed, Jul 18, 2018
Source FiercePharma
Roche's Tecentriq is on a much-needed hot streak. On Tuesday, the immuno-oncology drug—in combination with Roche's Avastin—picked up a breakthrough designation from the FDA in previously untreated liver cancer patients, putting it on a path to speedy approval. [...]
Wed, Jul 18, 2018
Source FiercePharma
Even before Pfizer faced the wrath of U.S. President Donald Trump for July price hikes, Novartis decided increasing its own prices wouldn't be a prudent move, its CEO said Wednesday. [...]
Wed, Jul 18, 2018
Source FiercePharma
More than six years after winning approval, obesity drug Belviq has finally shown it's heart safe. But whether that claim can jump-start sales in an ice-cold market—a veritable sinkhole for several once-ballyhooed drugs—remains to be seen. [...]
Wed, Jul 18, 2018
Source FiercePharma
Sanofi
Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations. This collaboration builds on precision oncology discoveries by REVOLUTION Medicines [...]
Wed, Jul 18, 2018
Source WorldPharmaNews
SMi Group
15 - 16 November 2018, New Jersey, USA. 16% of the top 100 pharmaceutical drugs and 35% of biologic drugs are lyophilized. With more than 30% of the FDA-approved parenterals lyophilized and soon more than half injectable drugs to require lyophilization there is ample room for standardization and expansion of the [...]
Tue, Jul 17, 2018
Source WorldPharmaNews
The components of the immune system that trigger allergic reactions may also help protect the skin against cancer, suggest new findings. The research, led by Imperial College London, highlights previously unknown skin defences - and could open avenues for developing new skin cancer treatments. [...]
Tue, Jul 17, 2018
Source WorldPharmaNews
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. [...]
Fri, Jan 16, 2015
Source FDANews