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Home » Newsletters » BioWorld

BioWorld

May 30, 2018

View Archived Issues

European Commission proposes waiver for generic, biosimilar exports despite SPCs

LONDON – The biotech industry has hit out at a proposal by the European Commission to make it legal for generics and biosimilars companies to manufacture and export products before EU intellectual property rights (IPR) expire. Read More

DBV to meet with FDA on next steps for its Viaskin Milk therapy

DUBLIN – DBV Technologies SA hopes to move its Viaskin Milk (VM) desensitization therapy for IgE-mediated cow's milk protein allergy (CMPA) into phase III trials next year, on the back of phase I/II efficacy data it unveiled Sunday at the European Academy of Allergy and Clinical Immunology (EACCI) congress in Munich. That depends on FDA agreement, however, and the Paris-based firm plans to meet with the regulator to discuss its next steps later this year. The treatment missed the primary endpoint of the trial but at the same time showed definite efficacy trends. Read More

Many hurdles remain in scaling up for digital health

The technologies underlying the switch to digital health are here and now, but alongside technical complexities of connecting silos of information spread around medical specialties and perfecting the interoperability of IT systems, a number of issues stand in the way of applying digital health at scale. Read More

Isomer discovery could yield countless new drugs

Australian scientists have found a new way to make molecular isomers, opening up the possibility of a new area of chemistry and the development of countless new drugs and other useful new materials. Read More

Industry opinion mixed as TGA implements new fee structure for GMP inspections

PERTH, Australia – In response to industry comments, Australia's Therapeutic Goods Administration (TGA) is getting ready to implement a new fee structure for drug GMP inspections. Read More

Other news to note

Curis Inc., of Lexington, Mass., effected its previously disclosed 1-for-5 reverse stock split, as of 5 p.m. Tuesday. Read More

Regulatory front

A week after the U.S. Trade Representative released a joint statement with Chinese trade officials acknowledging "constructive" trade consultations between the two countries, the White House announced that President Donald Trump has signed a memorandum detailing steps the U.S. will take to protect its domestic technology and intellectual property from certain discriminatory and burdensome trade practices by China. Read More

Financings

Lion TCR Pte. Ltd., of Singapore, said it raised $20 million in a series A financing round. The proceeds will be primarily used to advance its ongoing clinical trials of lead candidate Liocyx (personalized HBV specific TCR T-cell therapy against HCC) in major hospitals in China and Singapore, as well as for broadening its products pipeline to fight viral-related solid tumors and clearance of chronic hepatitis B. Read More

Clinical data for May 29, 2018

Read More

Regulatory actions for May 29, 2018

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