After years of continuing resolutions and congressional hustling to avoid government shutdowns, the U.S. Senate Wednesday took a big step toward the "regular order" of getting spending bills passed well before the Oct. 1 start of the new fiscal year with its 92-6 passage of a minibus that includes more than $5.4 billion for the FDA. Read More
LONDON – Reviral Ltd. has closed a $55 million series B round, providing the means to conduct pediatric and adult phase IIa trials of RV-521, an orally available fusion inhibitor for treating respiratory syncytial virus (RSV). Read More
With about $77 million in hand from a public offering and a phase II trial in progress with its farnesyl transferase inhibitor, tipifarnib (tipi), Kura Oncology Inc. is gearing up for a 59-patient pivotal study in squamous head and neck cancer patients with mutations in the HRAS oncogene. Enrollment could take two years, but the experiment puts the company "at the cutting edge" of research into a notoriously tough disease, CEO Troy Wilson told BioWorld. Read More
Biopharma veteran Geert Cauwenbergh, president and CEO of Rxi Pharmaceuticals Corp., has maintained steadfast faith in the potential of RNAi therapeutics even when the market has not. The Marlborough, Mass.-based RNAi company that he helms has struggled of late, forced in January to execute a 1-for-10 reverse stock split to regain compliance with Nasdaq's minimum bid price rule and to prioritize its pipeline by seeking to out-license dermatology and ophthalmology assets while focusing on immuno-oncology (I-O). Read More
Laekna Inc., a Shanghai-based company that recently completed an $18.5 million series A financing led by Orbimed Asia, has licensed rights to develop and commercialize two cancer-focused oral Akt kinase inhibitors from Novartis AG. The deal gives the Swiss drugmaker an equity stake in the Chinese company as well as undisclosed up-front and development milestone payments, plus potential royalties on future sales. Laekna, which has indicated plans to seek regulatory approvals in China and beyond, said that it has "mapped out several clear registration paths for NDA approval" for the drugs. Read More
Pepvax Inc., of Bethesda, Md., said it launched its Smartmid platform for delivery of nucleic acid and amino acid-based drugs and cell therapies, which is in preclinical development. Read More
United Therapeutics Corp., of Silver Spring, Md., reported that for the three months ended June 30, net revenues totaled $444 million. Sales of its pulmonary arterial hypertension drug, Remodulin (treprostinil injected), increased by $1.8 million over the 2017 period to $158.5 million. Read More
Cellectar Biosciences Inc., of Madison, Wis., said it closed an underwritten public offering for gross proceeds of $16.56 million, which includes the full exercise of the underwriters' overallotment option to purchase additional shares of common stock and warrants. Read More
EMD Serono Inc., of Rockland, Mass., the biopharmaceutical arm of Darmstadt, Germany-based Merck KGaA, appointed Cheryl Schwartz senior vice president and head of U.S. fertility and endocrinology. Read More
