DUBLIN – Inflarx NV's stock collapsed during early trading Wednesday on news that its lead drug IFX-1 missed the primary endpoint of a phase IIb trial in patients with hidradenitis suppurativa (HS). The stock was down over 90% during early morning trading, as the antibody-based Complement factor C5a inhibitor appeared to be no better than placebo. The news is a big shock for investors, who had pushed the stock to an all-time high as recently as April, in the expectation of positive news. The top-line data are anything but. Read More
PHILADELPHIA –The escalating trade war between the United States and China dominated most of the discussion during the China Summit meeting at the Biotechnology Innovation Organization' (BIO) international convention here on Tuesday. Read More
PHILADELPHIA – Developing new therapeutics for small patient populations is a challenging endeavor for researchers, but a collective 30 million patients in the U.S. with an estimated 7,000 rare diseases continue to wait for treatments. Read More
PHILADELPHIA – Against a backdrop of President Donald Trump's controversial comments about U.S.-Britain trade Wednesday, panelists at the Biotechnology Innovation Organization's (BIO) international convention painted a mixed picture of Brexit's potential impacts. Preparations for likely disruptions started at day one following the referendum, an EMA representative said. Despite that, "if there's one thing certain about Brexit, it's that's there's lots of uncertainties," said Tineke Van hooland, chairwoman of Bio.be, a trade organization representing Belgian biotechs. Read More
The stakes are high as U.S. lawmakers consider how to bring more certainty to patent eligibility following several Supreme Court decisions that have created what some say is a messy, confusing patent system that's threatening innovation and investment, especially in the life sciences, and holding back advances in artificial intelligence. Read More
The FDA has approved Indianapolis-based Eli Lilly and Co.'s Emgality (galcanezumab-gnlm) solution (300 mg) for injection for treating episodic cluster headache in adults, making it the first and only calcitonin gene-related peptide (CGRP) inhibitor that reduces the frequency of these attacks. Read More
Genomic diagnostic tests that help to guide toward personalized treatment for cancer patients seized the stage at this year's American Society of Clinical Oncology (ASCO) conference in Chicago. Most prominently, a study of more than 10,000 women funded by the NIH's National Cancer Institute that reported results at last year's conference now offered the basis of dramatically revised ASCO guidelines limiting the use of chemotherapy in early stage breast cancer. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., said it closed its offering of common stock with gross expected to be $201 million. The company expects to use the net proceeds of the offering for investment in the development of an expanded gene therapy pipeline, manufacturing capabilities for Pompe biologic AT-GAA and gene therapy product candidates. Read More
In its recent draft guideline for combination products, the EMA divided the scope of the draft into integral and nonintegral drug-device combinations (DDCs), the latter of which are co-packaged but not combined until the time of administration of the drug component. Read More
Les Laboratoires Servier SAS, of Suresnes, France, and Yposkesi, a contract development and manufacturing firm for gene therapy viral vector manufacturing, said they signed a service agreement for Yposkesi to develop and GMP manufacture lentiviral vectors to support allogenic CAR T-cell technology development. Financial terms were not disclosed. Read More
Castle Creek Pharmaceuticals LLC, of Parsippany, N.J., appointed Mary Spellman chief medical officer and senior vice president of research and development. Read More
