It was a trifecta to remember for Neurotrope Inc. on Wednesday as the company cast revealing light on a seemingly failed clinical program involving its lead candidate, had the NIH offer a grant to create a phase II trial to explore the program’s strengths, and then found institutional investors and individuals to pony up an $18 million registered direct offering for the company’s securities. It was a re-examination of data that resurrected Neurotrope’s hopes for its lead candidate months after a confirmatory phase II of bryostatin-1 failed to outperform a placebo in people with moderately severe to severe Alzheimer’s disease (AD) in the absence of Namenda (memantine, Allergan plc), an NMDA receptor antagonist. Read More
LONDON – The World Health Organization held off declaring the novel coronavirus infection that has emerged in Wuhan, China, an international public health emergency, despite the fact that the number of confirmed cases tripled in the past week and the infection has spread to several other countries, including the U.S. Read More
According to Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), in her delivery of the international advocacy group’s state of the industry briefing at Biotech Showcase in San Francisco, 2019 proved to be a significant year of growth for the regenerative medicine sector. Read More
PDC*Line Pharma SA raised €13.9 million (US$15.4 million) in a series B round plus another €6.1 million in loans and grants from the Walloon region of Belgium to take its allogeneic cell-based cancer immunotherapy, PDC*lung-01, into a phase I/II trial in patients with metastatic lung cancer. Read More
Kintai Therapeutics Inc. CEO, president and board member Paul-Peter Tak told BioWorld that the company aims to reach the clinic in the first quarter of next year with obesity agent KTX-0200, which has begun IND-enabling studies after showing sustained weight loss and improved markers of health in preclinical experiments. Read More
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections. Read More
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life sciences via various vehicles, including the Founders Fund, suggested that as academic and government bureaucracies have scaled up and rigidified over the last 50 or 60 years, that has eroded the ability of researchers to pursue innovative science. Read More
SANTA CLARA, Calif. – Diabetes seems likely to be the first area to really show concrete products and results for the ambitious Verily Life Sciences, which is the med-tech business of Mountain View, Calif.-based Google parent Alphabet Inc. However, its two major diabetes partners both have been rethinking the relationship. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axsome, Cytodyn, LB Pharmaceuticals, Metacrine, Moberg, Neurotrope, Vaxart Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Baudax Bio, Celularity, Genprex, Inhibitor, Jazz, Ra, Supernus Read More
The latest global regulatory news, changes and updates affecting biopharma: Aegerion Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Insys Therapeutics Inc. Read More