HONG KONG – Chinese biopharma Impact Therapeutics Inc., of Nanjing, has received $30 million in series C financing to advance the clinical development of its lead candidate, IMP-4297, a PARP inhibitor, to treat multiple tumors. Read More
Portage Biotech Inc., of Toronto, said it reached agreement to acquire 100 percent of Salvarx Ltd., of the British Virgin Islands, issuing about 805 million common shares priced at about 8.9 cents per share for an aggregate acquisition cost of $71.7 million. The deal brings Portage interest in 10 products in immuno-oncology. Read More
Drugs from Apotex Research Private Ltd., of Bangalore, are once again on import alert following an FDA inspection, and the company was slapped with another warning letter. The latest letter cited the company for inadequate quality systems and a quality unit that doesn't fully exercise authority, such as ensuring that appropriate investigations are performed with sound conclusions, identifying root causes and supporting scientific justification. Read More
Blueberry Therapeutics Ltd., of Alderley Edge, U.K., completed a £10 million (US$12.7 million) series B fundraising with investment from China Medical Venture Investment Ltd., a wholly owned subsidiary of China Medical System Holdings Ltd., and A&B (HK) Co. Ltd. Blueberry, which develops nano-formulated treatments, will use the net proceeds to fund its development program for BB-2603 for the treatment of onychomycosis and tinea pedis, as well as progressing its earlier-stage acne, topical analgesia and atopic dermatitis programs. Read More
The FDA has tasked drug developers to try to treat neurodegenerative diseases such as Alzheimer's before symptoms start to appear. That approach is expected to enhance efficacy in a field that remains long-challenged. One of the hardest parts is finding those patients as early as possible to treat them in trials with promising clinical candidates. Read More
HONG KONG – In late May, the China National Drug Administration (CNDA), along with four other bodies, published the list of rare diseases that includes 121 indications, with the aim of encouraging research and development of orphan drugs and speeding up their marketing in China, all the while making those drugs more affordable for patients. Read More
The saga continues for Orexigen Therapeutics Inc. now that the Ninth Circuit has opened the door for an amended shareholders' complaint alleging securities fraud stemming from SEC filings and statements company officials made about interim study results for obesity drug Contrave (naltrexone and bupropion). Read More
An elevated tumor mutational burden (TMB) in the blood has now demonstrated its potential as a reliable clinical biomarker for predicting the clinical efficacy of the checkpoint inhibitor Tecentriq (atezolizumab, Roche Holding AG) in treating patients with advanced non-small-cell lung cancer (NSCLC), a Sino-U.S. study has shown. Read More
Realm Therapeutics plc led its second-quarter earnings with a dud: Top-line data from its randomized, double-blind phase II study in atopic dermatitis showed that PR-022 performed no different from placebo, compared to baseline, on the primary endpoint of percent change in Eczema Area Severity Index, or EASI, at day 29. The company did not disclose details. CEO Alex Martin commented only that a full review of the data was underway "to determine whether there is a path forward for our proprietary technology in atopic dermatitis and to evaluate the implications for our acne and psoriasis programs." Read More
