The Federal Circuit split the baby down the middle Tuesday, ruling that a biosimilar maker can choose to ignore the patent exchange dance laid out by Congress, but it must give the required 180-day notice of commercial marketing after the FDA has licensed the biosimilar. Read More
Analysts mulled what the approval in the European Union (EU) of Amgen Inc.'s cholesterol drug Repatha (evolocumab) might mean for the compound's fate in the U.S., and for same-class competitor Praluent (alirocumab) from Regeneron Pharmaceuticals Inc. and Sanofi SA in both regions. Read More
DUBLIN – Actelion Pharmaceuticals Ltd. reported Tuesday on its ongoing delicate balancing act of ramping up sales of its next-generation endothelin receptor antagonist (ERA), Opsumit (macitentan), while managing the decline of its venerable blockbuster, Tracleer (bosentan), the first product of that class to gain approval for treating pulmonary arterial hypertension (PAH). Read More
Cytrx Corp. shares (NASDAQ:CYTR) fell 20 percent, or 76 cents, to close at $3.04 as the cancer drug developer priced a 9.1 million share offering at $2.75 per share, a 27.6 percent discount to Monday's close. Reaction to the offering, which will raise gross proceeds of about $25 million to support pre-commercial preparations for aldoxorubicin and other programs, made Tuesday the company's second most active trading day year to date. Read More
Dauntless Pharmaceuticals Inc. had a smooth initial take-off, fueled by a $12 million series A supporting a single asset, and that's just the way the San Diego-based company and backer Sofinnova Ventures plan to keep rolling off the runway. Read More
HONG KONG – For five years in a row, China has seen the number of adverse effects from pharmaceuticals rise, but while the numbers are negative at first blush they do point to an improved and much broader monitoring network that has increased the country's pharmacovigilance capability. Read More
Califia Bio Inc., of San Diego, was awarded a $1.7 million fast track phase II Small Business Innovation Research grant from the NIH to develop a selective MLK3 inhibitor to treat cognitive deficits associated with multiple sclerosis. Read More
Beech Tree Labs Inc., of Providence, R.I., completed a second phase II trial in which its candidate product, Btl-tml, was evaluated as an antiviral for treating recurrent oral herpes infections. Read More
DBV Technologies SA, of Bagneux, France, closed its supersized public offering of about 4.1 million ordinary shares in the form of about 8.3 million American depositary shares, or ADSs, at a price to the public of $34 per ADS, which included nearly 1.1 million ADSs purchased by underwriters excercising in full their option to purchase additional ADSs. Read More
