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5:29 PM, Jul 20, 2018  |  BC Extra | Company News

Court denies appeal in Mohawk case, clarifies IPR's role

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled Friday that the Saint Regis Mohawk Tribe cannot assert sovereign immunity in an inter partes review challenging patents on Restasis cyclosporine, affirming a February...
4:51 PM, Jul 20, 2018  |  BC Extra | Company News

FDA approves Krintafel to prevent malaria relapse

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Medicines for Malaria Venture (MMV) said FDA approved single-dose Krintafel tafenoquine to prevent relapse of Plasmodium vivax malaria in patients ages 16 and older who are receiving antimalarial therapy for...
4:16 PM, Jul 20, 2018  |  BC Extra | Preclinical News

PI3K inhibitors may block cancer's access to CNS

Researchers from Duke University, Gilead Sciences Inc. (NASDAQ:GILD) and colleagues suggested that acute lymphoblastic leukemia (ALL) cells metastasize to the CNS by traveling along vessels rich in laminin, a protein associated with motility of neuronal...
3:59 PM, Jul 20, 2018  |  BC Extra | Politics & Policy

FDA guidance sheds light on including EHR data in trials

In a new guidance, FDA outlined ways to use electronic health record data in clinical trials. The guidance is intended to modernize and streamline trials through the inclusion of real-world data. The guidance applies to prospective...
3:53 PM, Jul 20, 2018  |  BC Extra | Preclinical News

RIPK1 mutations in humans linked to IBD, arthritis

A study published in Science provides the first glimpse of clinical outcomes of receptor-interacting serine-threonine kinase 1 (RIPK1; RIP1) deficiency in humans, a target sought after by at least two companies trying to curb its...
3:41 PM, Jul 20, 2018  |  BC Extra | Company News

Management tracks: Merck KGaA, Aeglea

Merck KGaA (Xetra:MRK) hired Maria Rivas as SVP, head of global medical affairs. She was SVP, head of medical affairs at Merck & Co. Inc. (NYSE:MRK). Enzyme therapy company Aeglea BioTherapeutics Inc. (NASDAQ:AGLE) said interim CEO...
3:29 PM, Jul 20, 2018  |  BC Extra | Company News

PureTech, Roche to use exosomes for oral drug delivery

PureTech Health plc (LSE:PRTC) partnered with Roche (SIX:ROG; OTCQX:RHHBY) to develop PureTech's milk-derived exosome platform to orally deliver Roche's antisense oligonucleotides. PureTech will receive up to $36 million comprising an upfront payment, early preclinical milestone payments...
3:27 PM, Jul 20, 2018  |  BC Extra | Financial News

Ellias joins JDRF fund as Managing Director

Katie Ellias joined the JDRF T1D Fund, a venture philanthropy vehicle which aims to accelerate development of therapies for Type I diabetes, as a managing director. She was a senior investment director at healthcare and...
3:26 PM, Jul 20, 2018  |  BC Extra | Company News

Roche, other pharmas follow suit to halt price increases

Roche (SIX:ROG; OTCQX:RHHBY) is following the trend of suspending price increases in the U.S. for this year after President Donald Trump and HHS Secretary Alex Azar publicly demanded changes in drug pricing. Roche said in a...
3:22 PM, Jul 20, 2018  |  BC Extra | Company News

FDA approves Pfizer's Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The approval comes two days after FDA Commissioner...

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