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Home » Newsletters » BioWorld

BioWorld

June 8, 2017

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Finding the best pearls when the world is your oyster

CHICAGO – With the firm establishment of immunotherapy, so far in the form of checkpoint blockade, as a pillar of cancer therapy, drug developers are finding themselves with an enviable problem right now: how to pick the most promising of many promising combination strategies to move forward in combination with PD-1 and PD-L1 blockers. Read More

GHIT injected with $200M in funding

TOKYO – With $200 million in new funding, the Global Health Innovative Technology (GHIT) Fund is poised to continue funding early and midstage drug development projects for the next five years, particularly for neglected diseases that disproportionately affect developing markets. Read More

Chugai slapped with lawsuit by Baxalta, could affect pipeline

TOKYO – Japan's Chugai Pharmaceutical Co. Ltd. said it plans to "vigorously challenge" patent infringement claims made by U.S.-based biopharma Baxalta, which has filed suit in regards to the investigational monoclonal antibody emicizumab, in a move that could put in danger the Japanese company's pipeline and development plans. Read More

House user fee bill eyes generic drugs, device surveillance

The House Energy and Commerce Committee passed by a vote of 54-0 the legislation carrying the FDA user fee agreements with several provisions added, including amendments intended to bolster drug competition and a seemingly duplicative pilot program for medical device surveillance. Read More

Conflict between India state and national regulator hits pharmas

NEW DELHI – India's national drug regulator has stopped individual state drug regulators from independently issuing manufacturing licenses to companies that have not acquired prior manufacturing approval from the Drug Controller General of India. Read More

Regulatory front

President Donald Trump announced Tuesday that Francis Collins' tenure as director of the NIH will continue. With eight years at the helm come August, Collins is already the longest serving NIH director in nearly 50 years. Although he is a holdover from the Obama administration, news of his reappointment was welcomed by several Republican lawmakers, who had already signaled that they'd like Collins to stay on. Read More

Financings

Antares Pharma Inc., of Ewing, N.J., entered an agreement for a term loan of up to $35 million with Hercules Capital Inc. The first tranche of $25 million was funded upon execution of the loan agreement. Read More

Appointments and advancements

Alkermes plc, of Dublin, named Craig Hopkinson chief medical officer, and senior vice president of clinical development and medical affairs. Read More

Other news to note

Caris Life Sciences Inc., of Irving, Texas, announced a collaboration with the National Cancer Institute for the NCI-Molecular Analysis for Therapy Choice, NCI-MATCH or EAY131 precision medicine trial, which is being implemented by the ECOG-ACRIN Cancer Research Group. Read More

In the clinic

Teva Pharmaceutical Industries Ltd., of Jerusalem, reported results from the second phase III HALO study of anti-CGRP drug fremanezumab (TEV-48125) for the prevention of migraine. Read More

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