Industry News

U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Ninlaro is marketed by Takeda Pharmaceuticals based in Osaka, Japan.

Pfizer Inc. announced that PROFILE 1029, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor XALKORI® (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet. In this study, XALKORI was used as the first systemic therapy for patients with advanced ALK-positive NSCLC, and patients could have received therapy and/or surgery for early stage disease before they were diagnosed with metastatic disease.

Merck KGaA, Darmstadt, Germany, and Pfizer announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over current available therapies.

Medtronic plc announced US Food and Drug Administration (FDA) approval and US commercial availability of the MyCareLink Smart Monitor, the world's first app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, patients with a Medtronic pacemaker can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions.

U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

Two £10 million manufacturing research Hubs that will address major, long-term challenges facing the UK’s manufacturing industries, and capture opportunities from emerging research were announced today by Universities and Science Minister Jo Johnson.

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(BWI); Portea Medical, India’s largest home healthcare company, today announced that it has acquired specialty pharmaceutical distributor MedybizPharma in a move that will enable Portea to strengthen patient engagement and provide better care for chronic disease patients in India.

TESARO, Inc., an oncology-focused biopharmaceutical company, announced that VARUBI™ (rolapitant), an NK-1 receptor antagonist, is now available in the United States. The U.S. Food and Drug Administration (FDA) approved VARUBI on Sept. 1, 2015, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

The European Commission (EC) has granted orphan drug designation to Retrophin Inc's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

Meridian Bioscience, Inc. announced it has received clearance from the U.S. Food and Drug Administration (FDA) for new claims for its illumigene® Pertussis molecular amplification test. The upgraded test reduces the effect of inhibitors in biologic samples and significantly expands Meridian’s customer base by including specimens collected by ESwab™ (Copan Diagnostics, Inc.).
ESwab is a multipurpose universal transport system that a significant portion of laboratories in the United States currently use to streamline workflows and eliminate costs associated with stocking multiple swab types.