Tremelimumab flopped, again, as monotherapy, this time with Astrazeneca plc. The drug failed to demonstrate effectiveness in overall survival (OS) compared to placebo in a randomized, double-blind phase IIb study in second- or third-line treatment of patients with unresectable pleural or peritoneal malignant mesothelioma. Read More
With the first-ever human data on the efficacy and safety of aldehyde-trapping in hand from a phase IIa trial against allergic conjunctivitis (AC), Aldeyra Therapeutics Inc. said it will wait to consult U.S. regulators until the next quarter when outcomes from another study testing the same compound, NS2, in non-infectious anterior uveitis (AU) become available. Read More
LONDON – The life sciences industry and the great and the good of science have put their weight behind the campaign for the U.K. to remain in the European Union (EU), following the announcement of an in/out referendum to be held on June 23. Read More
Gensight Biologics SA launched a pair of phase III studies aimed at testing gene therapy candidate GS010's ability to preserve and restore vision in patients with blindness-causing Leber's hereditary optic neuropathy (LHON), a disease in which "time is of the essence," said Chairman and CEO Bernard Gilly. Read More
In labs all around the world, big data have researchers "acting like kids in a candy store," the NIH's Charles Rotimi said at an FDA meeting on enhancing demographic subgroup data for drugs, biologics and devices. Read More
DUBLIN – Onxeo SA is picking up a new, clinical-stage approach to tackling cancer for a minimal outlay. The company is acquiring fellow French firm, DNA Therapeutics SA, for just €1.7 million (US$1.85 million) in stock initially, plus a second payment of €1 million in stock, to be triggered by the start of a phase II trial of DNA Therapeutics' lead drug candidate DT01. Most of the deal value is back-end-loaded. Read More
HONG KONG – After an 11-month suspension in trading, shares of Hong Kong-listed Sihuan Pharmaceutical Holdings Group Ltd. (HK:0460) plunged more than 54 percent on Monday. Read More
Orexigen Therapeutics Inc., of San Diego, reported fourth quarter revenue of $4.9 million, which included $2.6 million in royalties earned on U.S. net sales of Contrave of $13 million reported by their U.S. partner, Takeda Pharmaceuticals U.S.A. Inc., part of Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan. Read More
Northwest Biotherapeutics Inc., of Bethesda, Md., inked definitive agreements with current institutional investors for a registered direct offering with gross proceeds of up to approximately $27.6 million and will exercise in full an overallotment option. The company will immediately sell about 5.88 million shares of common stock at a purchase price of $1.70 per share resulting in gross proceeds to the company of $10 million. Read More
Alexza Pharmaceuticals Inc., of Mountain View, Calif., said it entered a nonbinding letter of intent with Grupo Ferrer Internacional SA, of Barcelona, to facilitate an acquisition of Alexza's outstanding common shares by Grupo Ferrer. Read More
Thrasos Therapeutics Inc., of Montreal, said its phase II dose-ranging study of THR-184 to prevent acute kidney injury (AKI) in at-risk patients undergoing cardiac surgery showed a reduction in the incidence of AKI in patients treated with the highest dose. Read More
