In a fast-paced J.P. Morgan interview that traversed much of the drug and device landscape, FDA Commissioner Scott Gottlieb discussed a busy agenda Tuesday as he committed the agency to keeping up with innovation, speeding competition and pacing the opioid epidemic. Read More
SAN FRANCISCO – Aspiring entrepreneurs looking to get the attention of big pharma got a healthy helping of practical pointers from gatekeepers at Abbvie Inc., Astrazeneca plc, Bayer AG, Medimmune Inc. and Merck & Co. Inc. during RESI's annual meeting. Panelists said that in recent years, their attentions have gravitated toward ever-earlier-stage opportunities but that best practices, such as not spamming their colleagues via email, remained unchanged. Read More
HONG KONG – South Korean pharmaceutical company Yuhan Corp. is banking $15 million up front in a potential $785 million deal with U.S. biotech Gilead Sciences Inc. to develop novel therapeutic candidates that treat patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
With a new CEO imported from Novartis AG, Urogen Pharma Ltd. popped the cork on eagerly awaited top-line data from the ongoing pivotal phase III trial called Olympus with UGN-101 (mitomycin gel) for instillation, a nonsurgical treatment of low-grade upper tract urothelial cancer. "It's a very creative solution to a nagging problem, which is how to take care of these patients, most of whom end up losing their kidneys because we don't have a lot of alternatives," New York-based Urogen's chief medical officer, Mark Schoenberg, told BioWorld. Read More
LONDON – If landing a probe on the far side of the moon confirmed China's arrival as a scientific superpower, the scandal of the CRISPR/Cas9 gene-edited babies looks a prime example of how the race to be first at all costs can threaten scientific progress. Read More
HONG KONG – GNT Pharma Co. Ltd., of Yongin City, South Korea, has finished the patient enrollment for a phase II trial of its multitarget neuroprotection candidate, Neu-2000, in China, with top-line results from the trial, known as ENIS, expected in the first half of this year. Read More
Year-old startup Neurobo Pharmaceuticals Inc. plans to move lead candidate NB-01 into a phase III trial early in the second quarter that will evaluate the efficacy of the natural product-based nerve growth factor ligand modulator to treat diabetic neuropathic pain. Read More
SAN FRANCISCO – What is the prognosis for the near and long term for life sciences in China? Representatives from venture capital (VC) groups tackled that question, with answers ranging from "tempered enthusiasm" to "pessimistic," at least for the next 18 months. They made those responses during the second annual China Showcase, held in conjunction with the Biotech Showcase this week. Read More
Axsome Therapeutics Inc., of New York, said it raised approximately $23.3 million through the sale of 2.88 million shares under its existing at-the-market (ATM) facility with Leerink Partners LLC. The company intends to use the proceeds to continue to fund the ongoing clinical development of its late-stage product candidates and for other general corporate purposes. Read More
On his first day as governor of California Monday, Gavin Newsom issued an executive order intended to strengthen the state's bargaining power when negotiating prescription drug prices by creating the largest-scale single-purchaser system for prescription drugs in the U.S. The order directs California state agencies to purchase prescription drugs together, replacing the current fragmented negotiations with drug companies conducted by various public and private purchasers for Medi-Cal, the state's largest purchaser of pharmaceutical services. Read More
Generex Biotechnology Corp., of Miramar, Fla., completed its acquisition of 51 percent of New York-based Olaregen Therapeutix Inc. for $400,000 up front plus $11.6 million in milestones. Olaregen is preparing to launch Excellagen, a wound conforming gel matrix. Read More
