A phase III study designed to support use of Alexion Pharmaceuticals Inc.'s long-acting C5 complement inhibitor, Ultomiris (ravulizumab), in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS) met its primary endpoint, putting the company on track to seek FDA approval for the indication by midyear, with EU and Japanese filings to follow. Though met with skepticism in some quarters over a perceived lack of differentiation from Soliris (eculizumab), Piper Jaffray analyst Christopher Raymond said the results showed Ultomiris holding its own in patients sicker than those in an earlier Soliris trial. Read More
DUBLIN – Shares in Morphosys AG (NASDAQ:MOR) closed at $28 Monday, 6.6 percent below Friday's closing price, on news that it lost a long-running patent dispute over CD38-directed antibodies against Genmab A/S and Johnson & Johnson Co. Genmab A/S's stock (Copenhagen:GEN), in contrast, opened Monday 3.5 percent higher, and ended the day at DKK$974.20 (US$149.11). Investors on each side appear to have concluded that Morphosys' chances of getting a slice of Genmab's lucrative royalty payments have evaporated. Read More
Despite the sector coming off a terrible fourth quarter when investors shied away from biopharmaceutical company equities big time, the start to 2019 hasn't followed the same trend, thanks to an easing of capital market volatility. The BioWorld Biopharmaceutical index, a price-weighted index comprising 21 of the leading biotech and big pharma companies by market cap, has risen in value by an impressive 7 percent so far this month, ahead of the performances of the Dow Jones Industrial Average and the Nasdaq Composite at 5 percent and 6.6 percent, respectively. Read More
Trevena Inc. had a painful end to 2018 with the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voting 7-8 against recommending the proposed 0.1-mg and 0.35-mg doses of oliceridine, followed by a complete response letter (CRL) from the FDA the subsequent month. Read More
HONG KONG – CAR T biotech Immunochina Pharmaceuticals Co. Ltd. raised ¥140 million (US$20.7 million) in a series C funding round to further develop its lead CAR T therapy targeting CD19, known as IM-19, to compete with Novartis AG's Kymriah (tisagenlecleucel). Read More
PERTH, Australia – Stress is often a factor that contributes to many conditions ranging from psoriasis to irritable bowel syndrome, but it also has an effect on the brain, and recent evidence has shown that stress may be involved in accelerating the onset of Alzheimer's disease as well as worsening the course of the disease. Read More
Drug companies with issues pending at the FDA's Center for Drug Evaluation and Research (CDER) shouldn't expect a timeframe, or even an estimate of one, for at least a few days. In welcoming staff back Monday following the historic partial U.S. government shutdown, CDER Director Janet Woodcock advised employees not to provide timeframe estimates, as the agency and the center need to make collective decisions about working through the backlog that has formed since Dec. 22. Read More
Kowa Pharmaceuticals America Inc., of Montgomery, Ala., a subsidiary of Kowa Co. Ltd., of Nagoya, Japan, said it will co-promote Dublin-based Allergan plc's Bystolic (nebivolol), a beta blocker approved for the treatment of hypertension to lower blood pressure, in the U.S. Under their agreement, Kowa's nationwide sales force will co-promote the drug to cardiologists and select primary care health care providers across the country along with the company's cholesterol-lowering drug Livalo (pitavastatin) tablets. Read More
Bellerophon Therapeutics Inc., of Warren, N.J., reported the closing of its public offering of 10 million shares at 70 cents each for gross proceeds of $7 million. In addition, the underwriter has also been granted a 45-day option to purchase up to an additional 1.5 million shares. The company said it intends to use the net proceeds to fund working capital and other general corporate purposes. Read More
