The biotech industry's interest in companion diagnostics has grown in concert with the recognition that those tests can offer an approval pathway for narrowly effective and costly biologics targeting specific biomarkers.
Ariad Pharmaceuticals Inc. used the American Society of Clinical Oncology's (ASCO) annual meeting in Chicago as its forum to confirm that the next steps for its investigational pan-BCR-ABL inhibitor, ponatinib, will be regulatory filings in the U.S. and Europe, expected in the third quarter.
As it prepares for the readouts from a handful of clinical trials in the second half of the year, rare disease developer BioMarin Pharmaceutical Inc. turned to the markets to seek $248.8 million from an underwritten public offering of 6.5 million shares of common stock.
Just in time for the American Society of Clinical Oncology (ASCO) meeting in Chicago, Exelixis Inc. completed the filing of its rolling new drug application (NDA) with the FDA for cabozantinib (XL184) in the lead indication of progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).
The use of antisense oligonucleotides in biotech drug development took another step forward with the FDA's acceptance of the new drug application (NDA) for Kynamro (mipomersen sodium) filed by Genzyme, a unit of Sanofi SA.
Members of the FDA's Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee delivered a split opinion Thursday on the use of a single study by sponsor Pfizer Inc., which is seeking approval for Vyndaqel (tafamidis meglumine) in the orphan indication transthyretin (TTR) familial amyloid polyneuropathy (FAP).
At a family wedding earlier this month, an uncle was salivating over the prospect that the Vivus Inc. drug Qnexa could soon become the first in a new generation of obesity drugs to gain FDA approval. He needed to lose 50 pounds, he confided, and the drug seemed the answer to his prayers. Since we’ve written extensively about obesity and these drugs in BioWorld Today, he wanted my opinion. I politely inquired whether he had considered dieting and exercise, which could produce similar results without the potential side effects of a prescribed drug – especially one in a category that’s...
To almost no one's surprise, another potential treatment in non-small-cell lung cancer (NSCLC) bit the dust as Nexavar (sorafenib) failed to meet the primary endpoint of improving overall survival (OS) in the Phase III MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial in patients with advanced relapsed or refractory nonsquamous disease.
Shares of Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) jumped more than 30 percent at Monday's opening bell before settling back to a 20.5 percent gain on positive top-line results from the company's randomized, double-blind, placebo-controlled Phase IIb study evaluating two dose levels of bavituximab plus docetaxel compared to docetaxel plus placebo in patients with second-line non-small-cell lung cancer (NSCLC).
Aesthetic specialist Kythera Biopharmaceuticals Inc. filed an S-1 with the SEC seeking to raise $86.2 million in an initial public offering, with "substantially all" of the net proceeds used to fund U.S. Phase III trials of lead compound ATX-101, according to the filing.
