FDAnews Drug Daily Bulletin

In observance of the Independence Day holiday, FDAnews Drug Daily Bulletin will not be published Wednesday, July 4. The next issue will be published Thursday, July 5.

Drugmakers keen to infuse quality by design (QbD) concepts into regulatory filings are urged to fold endotoxin testing into their overall risk-management plans, an FDA draft guidance states.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is seeking public input as it works to update its points-to-consider document on multiplicity issues in clinical trials.

With the final FDA user fee legislation lacking language to support a national track-and-trace system, Congress must now act fast to preempt California’s e-pedigree law, slated to go into effect in 2015, Sen. Michael Bennet (D-Colo.) says.

AstraZeneca has the cash and appetite for more new acquisitions, the acting head of the Anglo-Swedish pharmaceutical group said, after finalizing his innovative $7 billion joint purchase of Amylin with Bristol-Myers Squibb over the weekend.

Over the past 18 months, 81-year-old Bill Bunnell has visited the doctor a half-dozen times to take memory tests, provide blood samples, and undergo a spinal tap and imaging scans.

The department of pharmaceuticals will meet drug manufacturers on July 18 to discuss making the drug marketing code mandatory.

Onyx Pharmaceuticals announced that the company has begun enrollment in the ENDEAVOR trial, a Phase III trial evaluating Kyprolis (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.

Cornerstone Therapeutics announced that the FDA approved its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product.

Teva Pharmaceutical announced the presentation of clinical results for its biologic oncology candidates, lipegfilgrastim and balugrastim, at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology 2012 International Symposium on Supportive Care in Cancer.