Gilead Sciences Inc. reported that Sovaldi (sofosbuvir) sales hit nearly $3.5 billion for the second quarter, blowing past analyst forecasts of about $2.6 billion for the quarter and accounting for more than half its total antiviral sales.
Amgen Inc.'s pipeline news of late has been dominated by the flood of data from its promising PCSK9-inhibiting cholesterol drug evolocumab, but the Thousand Oaks, Calif.-based firm reported more quietly late Thursday good news for its blockbuster secondary hyperparathyroidism (SHPT) franchise as AMG 416 hit all primary and secondary endpoints in its first phase III trial.
Otonomy Inc. is hoping public investors will prove as enthusiastic as private investors in backing otology-focused drug development, adding its name to the growing biotech initial public offering (IPO) queue, seeking as much as $86.3 million and a listing on Nasdaq under the ticker OTIC.
The final day of the second quarter ended with two more European biotechs filing for proposed initial public offerings (IPOs), both taking advantage of the emerging growth provision under the JOBS Act to pick up a U.S. public listing and pad their balance sheets.
On its third try before the FDA, Mannkind Corp.'s inhaled insulin Afrezza (insulin human [rDNA origin]) finally won approval Friday, capping nearly eight years of dogged pursuit in the wake of the spectacular commercial failure of first-generation inhaled insulin Exubera, but an FDA nod is only the first battle; the Valencia, Calif.-based firm still faces challenges of proving the drug's worth in the marketplace.
Following the recent spate of scaled-back initial public offerings (IPOs) from the likes of Radius Health, Agile Therapeutics Inc., Aldeyra Therapeutics Inc. and Scynexis Inc., this week's IPO pricing by ZS Pharma Inc. – and its warm reception on Wall Street – is impressive by comparison.
Already trailing approvals of obesity drugs Belviq (lorcaserin) and Qsymia (phentermine/topiramate) by two years, Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion) is facing another delay at the hands of the FDA, which pushed back the PDUFA date by three months to Sept. 11.
Vascular Biogenics Ltd. (VBL), a 2000 start-up developing drugs for cancer and inflammatory diseases, added its name to the initial public offering (IPO) queue, filing an F-1, as an emerging growth company, to raise a proposed $75 million.
After a month's postponement, Radius Health Inc. scooted through the initial public offering window on its second attempt, pricing, as expected, an offering of 6.5 million shares at $8 apiece for gross proceeds of $52 million.
Elevated glucose levels emerging in roughly one-fourth of lung cancer patients receiving Clovis Oncology Inc.'s next-generation EGFR inhibitor CO-1686 may have overshadowed the promising interim progression-free survival (PFS) rate presented at the American Society of Clinical Oncology meeting over the weekend, at least on Wall Street, but analysts say the targeted covalent inhibitor remains a contender against Astrazeneca plc's AZD9291.
