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27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
27 April 2017 | By Niamh Marriott, Junior Editor
Polyphor presented promising data for their novel class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA)...
26 April 2017 | By Niamh Marriott, Junior Editor
The FDA posted warning letters to 14 US-based companies illegally selling over 65 products that fraudulently claim to prevent, treat or cure cancer...
26 April 2017 | By Niamh Marriott, Junior Editor
Girish Malhotra argues time reduction for ANDA approvals, arguing that if the current approval time can be reduced, drug costs will decrease...
26 April 2017 | By Niamh Marriott, Junior Editor
Gilead Sciences’ Phase II studies demonstrated HCV cure rates of 99% in children, and 100% in patients co-infected with HCV and hepatitis B virus...
26 April 2017 | By Niamh Marriott, Junior Editor
RedHill Biopharma has enrolled the last patient in the Phase II study with Bekinda for the treatment of diarrhoea-predominant irritable bowel syndrome...
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
25 April 2017 | By Niamh Marriott, Junior Editor
The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz's (a Novartis division) biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
25 April 2017 | By Niamh Marriott, Junior Editor
Pfizer's results show patients diagnosed with hospital-acquired pneumonia (HAP) treated with Zavicefta or Meropenem experienced comparable rates of cure...
25 April 2017 | By Niamh Marriott, Junior Editor
North Carolina based Biomarck Pharmaceuticals has received FDA allowance to begin human trials for their patented compound BIO-11006, for adults with lung cancer.
24 April 2017 | By Niamh Marriott, Junior Editor
BMS-986036 is a pegylated analogue of human fibroblast growth factor 21, a key regulator of metabolism. In preclinical models of non-alcoholic steatohepatitis (NASH), BMS-986036 improved steatosis, inflammation, hepatocyte ballooning, and fibrosis.
24 April 2017 | By Niamh Marriott, Junior Editor
AbbVie announced that 99% (145/146) of chronic hepatitis C virus (HCV) infected patients with genotype and compensated cirrhosis (Child-Pugh A)...
24 April 2017 | By Niamh Marriott, Junior Editor
After Danish and Swedish, Solidsoft Reply has signed an agreement to implement and operate the Irish National Medicines Verification System...
21 April 2017 | By Niamh Marriott, Junior Editor
Allergan will collaborate with TARGET PharmaSolutions, a clinical data company focused on real world evidence, on its TARGET-NASH study.
