Siga Technologies Inc., of New York, said it started enrolling the second and final cohort of healthy subjects for the phase III trial of lead antiviral candidate Tpoxx (tecovirimat; ST-246) for the treatment of orthopoxvirus. The study, which is wholly funded by the Biomedical Advanced Research and Development Authority, will enroll about 360 subjects and is designed to generate safety and pharmacokinetic data in support of the prescribing information that will be part of the new drug application filing. Read More

Arch Biopartners Inc., of Toronto, said the EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending AB569 for designation as an orphan medicinal product for the treatment of patients with cystic fibrosis. The orphan medicinal products designation is recommended for the two active ingredients of AB569, sodium nitrite and ethylenediaminetetraacetic acid. Read More

Neurovive Pharmaceutical AB, of Stockholm, said board members, other insiders and employees intend to subscribe for a minimum of 129,000 units, equivalent to at least SEK5.4 million (US$555,666) in the company's previously disclosed preferential rights issue with the subscription period between April 18 and May 2. Read More

The Patient-Centered Outcomes Research Institute Board of Governors approved $44.4 million in funding for 21 new patient-centered comparative clinical effectiveness research studies. The funds will support projects on a range of conditions and problems that impose high burdens on patients, caregivers and the health care system, including post-partum depression, misuse of antibiotics, post-traumatic stress disorder among veterans and joint replacement, among others. Read More

Japan has a longstanding relationship with immuno-oncology. In 1992, Japanese research scientists first discovered the programmed cell death-1 (PD-1) target. Since then, the T-cell receptor has received an influx of attention from drug developers seeking to use checkpoint inhibitors to stop cancer in its tracks. Read More

The FDA budget may be stretched thin, but a global health coalition is pushing a recommendation that the agency and other U.S. government agencies set aside a specific percentage of existing funds for programs to battle viral outbreaks, such as the Zika virus. Read More

Shares of Catalyst Pharmaceuticals Inc. dove 49.2 percent on Tuesday after the company reported that the FDA will require it to submit positive results from an additional study of Firdapse (amifampridine phosphate) in patients with the rare autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS) prior to accepting its new drug application (NDA). Read More

LONDON – The U.S. technology commercialization specialist Allied Minds plc has raised $80 million from U.K. investors to fund drug discovery programs in-licensed through its partnership with Bristol-Myers Squibb Co. (BMS). Read More

Four years after paying $1.26 billion to bring aboard the gout drug Zurampic (lesinurad), Astrazeneca plc's decision to let Ironwood Pharmaceuticals Inc. pay $100 million for the since-approved therapy amounted to "largely a strategic question at the corporate level" of the pharma giant, said Ironwood CEO Peter Hecht. Read More

The FDA's slow pace of developing a U.S. biosimilar path that already trails that of other markets has drawn sharp rebukes from Congress and critics, but the regulator isn't the only force shaping the path. Read More

As the dust settled from Monday's grueling meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (adcom), companies, investors, analysts and, most importantly, patients and family members were left to ponder the road forward for therapies to treat Duchenne muscular dystrophy (DMD). Although the outcome of the adcom for sponsor Sarepta Therapeutics Inc. was generally deemed a step backward for its lead candidate, eteplirsen, adcom members didn't shut the door entirely in their nonbinding votes on the exon-skipping drug. Read More