Apexigen Inc. announced the initiation of patient enrollment in a phase II trial in collaboration with the University of California San Francisco. The trial is designed to evaluate Apexigen's CD40 agonistic antibody, APX-005M, in combination with chemotherapy and radiation therapy in patients with resectable esophageal and gastro-esophageal junction cancers.

Doing its part to increase competition so as to lower drug prices, the FDA launched a new biosimilars education campaign this week aimed at health care providers. The campaign includes a biosimilars website and educational materials in the form of fact sheets and graphics that define key terms, describe the standards a biosimilar must meet, explain the FDA approval path for the follow-ons and provide information about the data the agency reviews to determine biosimilarity. As its next step to promote market acceptance of biosimilars, the FDA said it is planning additional research to learn more about the types of information prescribers need to properly communicate with their patients about the follow-ons.

United Therapeutics Inc., of Silver Spring, Md., reported net revenues of $445.5 million for the third quarter. Sales of pulmonary arterial hypertension drugs Remodulin (treprostinil injectable), Tyvaso (treprostinil inhaled), Orenitram (treprostinil extended-release tablets) and Unituxin (dinutuximab) reached $187.3 million, $88.9 million, $52.5 million and $17 million, respectively. United reported net income of $276.3, and non-GAAP net earnings of $206.9 million, or $4.69 per diluted share, beating analyst estimates of $3.87 per share. The company ended the quarter with total cash and equivalents of about $1.6 billion. Shares of United (NASDAQ:UTHR) rose $4.24, to close Wednesday at $123.14.

Hutchison China Meditech Ltd., of London, said intends to offer $262 million of American Depositary Shares (ADSs), each representing one-half of one ordinary share, par value $1 each of Chi-Med on the Nasdaq Global Select Market. The company intends to grant the underwriters a 30-day option to purchase up to $39.3 million of additional ADSs at the offering price. The proceeds from the offering, if completed, are expected to be used to fund the on-going research and development of the Chi-Med innovation platform drug pipeline and for working capital and general corporate purposes.

Cellect Biotechnology Ltd., of Tel Aviv, Israel, reported results from a study of 20 patients testing Aprograft on stem cells derived from fat tissue. Apograft increased the number and activity of the fat-derived stem cells from samples obtained through liposuction. Cellect plans to test the process in additional clinical programs and establish licensing deals for the technology.

Vascular Biogenics Ltd., also known as VBL Therapeutics, announced the opening of its new gene therapy manufacturing plant in Modiin, Israel.

Scpharmaceuticals Inc., of Burlington, Mass., has filed to raise up to $100 million in an IPO. The company is developing an innovative platform that may improve patient care through subcutaneous delivery of IV-equivalent drugs.

If Puerto Rico's power grid isn't restored by the end of the year, many of the drug and device companies with manufacturing facilities there may need to relocate some of their production, FDA Commissioner Scott Gottlieb told a House subcommittee Tuesday.

The question of NIH research dollars going toward facilities and administrative costs underwent a second going-over this year in the U.S. House of Representatives, and Keith Yamamoto of the University of California-San Francisco (UCSF) told a congressional committee that a hard cap of 10 percent on these indirect costs would have "a very strong detrimental effect on capacity to start up new [life science] companies and keep them healthy."

CLEVELAND – Cleveland Clinic CEO Toby Cosgrove called genomics and precision medicine the "fastest-moving elements of today's medical universe. Barely on the radar 15 years ago, today they fill the screen." As this year's focus at the Medical Innovations Summit, genomics and precision medicine are considered the future in health care, but, as many panelists noted, as the technology side of the equation continues advancing toward the end goal, clinicians and regulators will need to keep up.