Allegro – the musical term indicating a fast or bright tempo – seems equally appropriate to describe a biotech that moved its lead compound from discovery to the clinic in just two years. That was two years ago, and the compound, ALG-1001, is now in a Phase II study in vitreomacular traction.
Can-Fite Biopharma Ltd. wowed investors with top-line results from its Phase IIb study of CF101 as a monotherapy for rheumatoid arthritis (RA). In the 12-week, placebo-controlled study of 79 patients with active RA, CF101 met the primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of RA.
Love it or hate it, the Affordable Care Act (ACA) is poised for implementation in 2014, likely creating winners and losers across the health care landscape. To date, the impact on biotechs and pharmas has been relegated to background noise, but the tenor of those discussions is growing as implications of the law pervade every corner of the delivery system.
The FDA raised the bar in long-term treatment of chronic obstructive pulmonary disease (COPD) with the approval of combination product Anoro Ellipta. Developed by Glaxosmithkline plc (GSK) and partner Theravance Inc., Anoro (vilanterol plus umeclidinium bromide), delivered by inhaler, pairs a long-acting muscarinic antagonist (LAMA) with a long-acting beta2 agonist (LABA).
As expected, Cempra Inc. initiated Solitaire-IV, its global intravenous (I.V.)-to-oral Phase III trial of solithromycin (CEM-101) before year-end in patients with community-acquired bacterial pneumonia (CABP). The trial, which the company disclosed after Monday’s market close, joins Solitaire-Oral, the first global Phase III study of solithromycin in CABP patients, which initiated enrollment in December 2012. (See BioWorld Today, Dec. 20, 2012.)
With the goal of delivering early clinical data over the next 18 months to demonstrate the validity of its scientific approach and move from the pink sheets to a registered exchange, Ampliphi Biosciences Corp. inked agreements with a group of investors for an $18 million private placement.
Awaiting multiple gevokizumab (XOMA 052) data readouts in 2014, including the first Phase III data by midyear, on Friday Xoma Corp. priced a public offering of 9.5 million shares of common stock at $5.25 apiece, seeking to raise $50 million. The Berkeley, Calif.-based company granted underwriters a 30-day option to purchase up to an additional 1.4 million shares, potentially increasing its haul by $7.5 million.
Awaiting multiple gevokizumab (XOMA 052) data readouts in 2014, including the first Phase III data by midyear, on Friday Xoma Corp. priced a public offering of 9.5 million shares of common stock at $5.25 apiece, seeking to raise $50 million. The Berkeley, Calif.-based company granted underwriters a 30-day option to purchase up to an additional 1.4 million shares, potentially increasing its haul by $7.5 million.
Emergent Biosolutions Inc. took another step in its quest to expand its pipeline and ramp up commercial revenues by sealing a deal to acquire Canada’s Cangene Corp. for $222 million, or $3.24 per share on a fully diluted basis. The boards of directors of both companies approved the transaction, which gives Emergent three specialty products included in the U.S. Strategic National Stockpile and four commercial specialty therapies.
Any notion that sponsor Amylin Pharmaceuticals LLC, a wholly owned subsidiary of Bristol-Myers Squibb Co. (BMS), might receive limited support from the FDA during the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting evaluating its biologics license application (BLA) for metreleptin (recombinant methionyl human leptin) was quashed early Wednesday morning.
