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Home » Newsletters » BioWorld

BioWorld

Jan. 25, 2013

View Archived Issues

Value of Exclusivity Leads to FDA Challenges, Debate

With exclusivity assuming a bigger role in the life cycle of a drug, Gilead Sciences Inc. wants more for its Stribild HIV drug than the three-year exclusivity the FDA typically grants to new fixed-dose combination (FDC) drugs. Read More

Ariad Pads Cash with $300M For Iclusig Launch, Clinic Work

A month after the earlier-than-expected approval of Iclusig (ponatinib) in chronic myelogenous leukemia (CML), Ariad Pharmaceuticals Inc. is taking advantage of the current public markets to more than double its cash balance. Read More

Biogen Idec's MS Therapy Yields Positive Results in Phase III

Biogen Idec Inc.'s peginterferon beta-1a produced a significant reduction in annualized relapse rate in patients with multiple sclerosis according to primary efficacy analysis from a Phase III study. Read More

Enbrel Drives Amgen Earnings; Company Shoots High for Year

Detailing mixed fourth-quarter financial results, Amgen Inc.'s officials adopted a look-ahead approach in the earnings conference call, putting forth optimistic guidance for 2013 and pledging more detail on pipeline strategies during the business review slated for early next month. Read More

Stock Movers

Read More

Other News To Note

• Genentech, of South San Francisco, a member of the Roche Group, said the FDA gave its go-ahead to a new use of already approved cancer drug Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). Read More

Clinic Roundup

• Curis Inc., of Lexington, Mass., said the first patient has been treated in a Phase I study of CUDC-907 in patients with relapsed or refractory lymphoma or multiple myeloma. Read More

Pharma: Other News To Note

• Watson Pharmaceuticals Inc., of Parsippany, N.J., changed its name to Actavis Inc. following its 2012 acquisition of the Actavis Group, of Zug, Switzerland. Read More

Pharma: Clinic Roundup

• Pfizer Inc., of New York, reported data from a Phase IV study showed that Toviaz (fesoterodine fumarate) 8 mg once daily reduced urge urinary incontinence episodes in patients with overactive bladder per 24 hours from baseline to week 12, which was statistically significantly more than Toviaz 4 mg. Read More

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