Pharma News

Merck KGaA, Darmstadt, Germany and Pfizer announced the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.

Psychiatric symptoms such as depression, mania, hallucinations, anxiety disorders and anorexia nervosa, even without any neurological signs, may be signs of a brain tumour, according to doctors who treated a woman thought to have treatment-resistant depression.

President Pranab Mukherjee on Wednesday voiced concern over the unabated spread of cancer and said steps taken against it were inadequate.

Colombian President Juan Manuel Santos signed a decree legalising the medical use of marijuana.

Survivors of Ebola virus disease (EVD) experience complications relating to vision, hearing and joint pain for months after being discharged from hospital, say researchers, including one of Indian-origin.

India has significant talent and expertise in traditional head and neck surgical procedures and the country is poised to take a giant leap with robot-assisted surgeries for head and neck patients in the days to come, a leading US robotic surgeon has said.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

[adsense:336x280:8701650588]

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Boehringer Ingelheim's novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The BTD is based on results from the phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore.

AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets 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).

The US Food and Drug Administration approved Torax Medical In's Fenix continence restoration system to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.