(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.
BioSyent Inc. ("BioSyent") announced that its subsidiary BioSyent Pharma Inc. has commenced the Canadian launch of CYSVIEW®, a new photosensitizer for the detection and management of papillary Non-Muscle Invasive Bladder Cancer (NMIBC).
The Union Cabinet, chaired by Prime Minister Narendra Modi has approved the proposal of the Department of Health Research in the Ministry of Health and Family Welfare for setting up of a National Resource Facility for Bio-medical Research (NARF) at Genome Valley in Hyderabad by the Indian Council for Medical Research (ICMR).
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The merger of the world's two largest beer manufacturers represents a major threat to global health, warn health experts, adding that the funders and regulators must respond more effectively to this threat. Last month, Belgium-based Anheuser-Busch InBev (AB InBev) and London-based SABMiller agreed in principle to merge.
Zydus Cadila has received US health regulator's nod to initiate phase II clinical trials of Sarolitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits.
Sandoz, a Novartis company and the global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta® (pegfilgrastim) - a recombinant human granulocyte colony-stimulating factor (G-CSF).
Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura. In adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
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