Combination products. Breakthrough therapies. Sentinel. Biomarkers. And the patient voice. Those were the words buzzing Monday throughout the FDA’s public meeting on the PDUFA VI agreement it’s reached with industry and patient groups. Read More

Paratek Pharmaceuticals Inc., of Boston, dosed the first patient in its second pivotal phase III study of omadacycline in patients with acute bacterial skin and skin structure infections. The study will assess the efficacy and safety of once-daily oral-only omadacycline compared with twice-daily oral-only linezolid (Zyvox, Pfizer Inc.). Omadacycline is described as a new once-daily oral and intravenous, well-tolerated, broad-spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections. Read More

Amarin Corp. plc, of Dublin, said the underwriters of its public offering of American Depositary shares (ADSs) have exercised in full their option to purchase up to 3.16 million additional ADSs, which increases the size of the offering to 24.26 million ADSs at $2.85 per ADS. The net proceeds from this offering are expected to be approximately $64.6 million. Jefferies LLC and Citigroup Global Markets Inc. are acting as joint book-running managers in the offering. Cantor Fitzgerald & Co. is acting as lead manager and H.C. Wainwright & Co. and Suntrust Robinson Humphrey are acting as co-managers in this offering. Read More

What should have been a big win for Aurinia Pharmaceuticals Inc.’s stock (NASDAQ:AUPH) Monday on the back of positive phase IIb data in the particularly tough lupus nephritis (LN) indication turned into a drubbing for the shares, which plunged 56 percent as investor attention focused – perhaps unfairly – on the study’s death rate. Read More

Acelrx Pharmaceuticals Inc. moved its sublingual sufentanil candidate ARX-04 (sufentanil sublingual tablet, 30 mcg) closer to an anticipated FDA new drug application (NDA) filing this year, announcing top-line results of a small phase III results that showed emergency room (ER) patients realizing an average 35 percent drop in pain intensity one hour after treatment. The trial bolstered safety data for inclusion in the NDA while also ruling out any cognitive impairment issues, chief medical officer and co-founder Pamela Palmer told BioWorld Today. Read More

TOKYO – Japan’s major pharmaceutical companies have, by-and-large, managed to overcome a series of reverses including drug price reductions and a slowing economy. Read More

LONDON – The U.K. government has moved to end uncertainty about access to European research and development grants following the vote to leave the EU, saying it will underwrite payments on projects that continue beyond the date at which the country finally pulls out. Read More

HONG KONG – Samsung Group is taking its Samsung Biologics Co. Ltd. subsidiary public in Korea as it renews its commitment to develop more biosimilars. Read More

HONG KONG – A protein that promotes angiogenesis can successfully be used to treat acute myocardial infarction (MI) in mice, offering the prospect of heart bypass without the need for surgery. Read More

Tivorsan Pharmaceuticals Inc., of Providence, R.I., said the FDA granted orphan drug designation to its lead candidate, human recombinant biglycan, to treat Duchenne muscular dystrophy. Read More