Cellect, denovoMATRIX to combine stem cell production technologies

Cellect Biotechnology, a developer of a stem cell production technology, has signed a collaboration and material transfer agreement with the denovoMATRIX group of the Technische Universität Dresden (TU Dresden).

EC approves expanded indication for BMS’ Sprycel

Bristol-Myers Squibb (BMS) has announced that the European Commission (EC) has expanded the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation.

Zynerba halts development of THC prodrug ZYN001

A failure in a phase 1 clinical program has forced Zynerba Pharmaceuticals to stop development of ZYN001, its pro-drug of tetrahydrocannabinol (THC) intended for the treatment of neuropsychiatric disorders including Tourette Syndrome.

EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer

The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.

NSF Release New Pharma eLearning Session – Update on EU Legislation and Guidance

NSF International provides a comprehensive range of support services for the pharmaceutical industry covering consulting, training, auditing, remediation, quality systems and regulatory guidance on a global basis.

ASLAN Pharmaceuticals submits clinical trial authorisation application for first in man studies for ASLAN004

ASLAN Pharmaceuticals has submitted a clinical trial authorisation application with the Singapore Health Sciences Authority (HSA) to initiate a phase 1 trial of ASLAN004.

Elite secures FDA approval for generic Percocet pain tablets

Elite Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets.

Anavex gets approval to begin phase 2b/3 trial of Alzheimer’s disease treatment

Anavex Life Sciences has secured approval from the Australian Human Research Ethics Committee to begin its phase 2b/3 trial of Anavex 2-73 to treat early Alzheimer’s disease.

Cyprium Therapeutics’ CUTX-101 gets FDA fast track designation to treat classic Menkes disease

Fortress Biotech announced that the US Food and Drug Administration (FDA) has granted fast track designation to Cyprium Therapeutics Copper Histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.

Aveo, Novartis scrap $326m antibody licensing deal

US-based Aveo Pharmaceuticals and Swiss drugmaker Novartis have scrapped their $326m worth licensing agreement to develop and commercialize the former’s humanized inhibitory antibody AV-380 and other related antibodies.