Regulatory

US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3

Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.

Ergomed plc, a company focused on providing specialised services to the global pharmaceutical industry, announces its unaudited interim results for the six months ended 30 June 2019.

Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), part of the of the European Medicines Agency (EMA), recommended an update to marketing authorizations of approved interferon beta treatments, including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a), to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS).

Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease

Faron announces its unaudited interim results for the six months ended 30 June 2019.

Heidelberg Pharma AG announced that its subsidiary Heidelberg Pharma Research GmbH will receive a research grant from the European Union.

CloudLIMS, a leading laboratory data management informatics provider, announces the release of the Training Module for its Laboratory Information Management System, CloudLIMS.

U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patientsbwith Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

MorphoSys AG announced that its licensee Janssen Research & Development, LLC issued a press release to report the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of Tremfya for the treatment of adult patients with active psoriatic arthritis.