Perjeta regimen approved in EU for early stage breast cancer
31 July 2015 | By Victoria White
The EC has approved the use of Perjeta in combination with Herceptin and chemotherapy for use before surgery in patients with early stage breast cancer...
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Allergan confirms generic Tyvaso patent challenge
30 July 2015 | By Victoria White
Allergan has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of United Therapeutics' Tyvaso...
Astellas’ Phase 3 isavuconazole study fails to meet endpoint
30 July 2015 | By Victoria White
Astellas has announced that a Phase 3 study evaluating the efficacy and safety of isavuconazole in candidemia did not meet its primary endpoint...
Positive top-line results for Ascendis Pharma’s TransCon Growth Hormone
30 July 2015 | By Victoria White
Ascendis Pharma has announced positive top-line results from a study evaluating the safety and efficacy of TransCon Growth Hormone in children with GHD...
Cherwell launches refreshed website for Cleanroom Microbiology Solutions
30 July 2015 | By Cherwell Laboratories
Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, have announced the launch of a refreshed website....
Phase 1/2 trial of Mogamulizumab and Opdivo in advanced solid tumours announced
30 July 2015 | By Victoria White
Kyowa Hakko Kirin and Bristol-Myers Squibb are to conduct a Phase 1/2 combination study with mogamulizumab and Opdivo in advanced solid tumours...
CHMP grants label extension for GSK’s Synflorix
30 July 2015 | By Victoria White
CHMP has granted a label extension for Synflorix to include protection against IPD caused by pneumococcal serotype 19A in children aged 6 weeks to 5 years...
PLX3397 demonstrates prolonged tumour regression in TGCT
30 July 2015 | By Victoria White
Clinical trial results demonstrate that PLX3397 induced prolonged tumour regressions in most patients with tenosynovial giant cell tumour (TGCT)...
Eisai’s Lenvima receives Breakthrough Therapy designation for renal cell carcinoma
29 July 2015 | By Victoria White
Eisai has received a Breakthrough Therapy designation for Lenvima for the potential indication of advanced and/or metastatic renal cell carcinoma...
Study finds pharma firms “underinvest” in long-term cancer research
29 July 2015 | By Victoria White
A study has found firms "underinvest" in long-term research to develop new cancer drugs due to the greater time and cost required to conduct such research...
Mereo BioPharma raises $119m and acquires a clinical product portfolio from Novartis
29 July 2015 | By Victoria White
Mereo BioPharmahas successfully raised $119m and simultaneously acquired a portfolio of three innovative clinical-stage development programmes from Novartis...
NICE recommends three new treatments for hepatitis C in draft guidance
29 July 2015 | By Victoria White
The UK National Institute for Health and Care Excellence has published draft guidance recommending three different treatment options for hepatitis C...
MaSTherCell to manufacture TxCell’s lead product Ovasave
29 July 2015 | By Victoria White
TxCell and MaSTherCell have signed a Memorandum of Understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave...
Sanofi’s first LixiLan Phase III study meets primary endpoint
29 July 2015 | By Victoria White
Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin...
Teva files MAA for asthma treatment reslizumab
28 July 2015 | By Victoria White
Teva has successfully filed a MAA with the EMA for reslizumab -a humanised anti-IL-5 monoclonal antibody for the treatment of inadequately controlled asthma...
