FDA to host public hearing regarding the implementation of GDUFA
SILVER SPRING, Md. — The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. Requests to make oral presentations at the hearing are due Sept. 3.
The five draft guidance documents include:
- Abbreviated new drug application submissions, including content and format of ANDAs;
- Guidelines on the refusal to receive submissions for lack of proper justification of impurity limits;
- Amendments and easily correctable deficiencies under GDUFA;
- Prior approval supplements under GDUFA; and
- Controlled correspondence related to generic drug development.
Another purpose of the hearing will be to solicit feedback on issues that may arise in FDA’s consideration of 180-day exclusivity provided for in section 505(j)(5)(B)(iv) of the FD&C Act, the agency announced. "Timing of ANDA approval is directly affected by an applicant’s eligibility for 180-day exclusivity, and thus FDA’s consideration of any issues related to 180-day exclusivity is a component of approval actions," the agency stated. "FDA decisions regarding 180-day exclusivity are fact-specific, and the facts that have the potential to determine eligibility for exclusivity may shift up to the time when an ANDA that is eligible for 180-day exclusivity, or another ANDA referencing the same listed drug, is ready for approval."
Study: NSAID use cuts breast cancer recurrence in obese and overweight women by half
PHILADELPHIA — Recurrence of hormone-related breast cancer was cut by half in overweight and obese women who regularly used aspirin or other nonsteroidal anti-inflammatory drugs, according to data published last week in Cancer Research, a journal of the American Association for Cancer Research.
"Our studies suggest that limiting inflammatory signaling may be an effective, less toxic approach to altering the cancer-promoting effects of obesity and improving patient response to hormone therapy," stated Linda deGraffenried, associate professor of nutritional sciences at The University of Texas in Austin.
The study found that women whose body mass index was greater than 30 and had estrogen receptor alpha (ERα)-positive breast cancer had a 52% lower rate of recurrence and a 28-month delay in time to recurrence if they were taking aspirin or other NSAIDs.
"These results suggest that NSAIDs may improve response to hormone therapy, thereby allowing more women to remain on hormone therapy rather than needing to change to chemotherapy and deal with the associated side effects and complications," deGraffenried said. "However, these results are preliminary and patients should never undertake any treatment without consulting with their physician."
Using blood from obese patients, deGraffenried and colleagues conducted experiments in the laboratory to recreate a tumor environment containing cancer cells, fat cells and the immune cells that promote inflammation. They found that the factors associated with obesity initiate a network of signaling within the tumor environment to promote growth and resistance to therapy.
"These studies show that the greatest benefit from aspirin [and other NSAIDs] will be in those with a disease driven by inflammation, and not just obesity," deGraffenried noted.
Researchers used data from 440 women diagnosed with invasive, ERα-positive breast cancer and treated at The University of Texas Health Science Center and the START Center for Cancer Care clinic, both in San Antonio, between 1987 and 2011.
Of the women studied, 58.5% were obese and 25.8% were overweight. About 81% took aspirin, and the rest took another NSAID. About 42% and 25% took statins and omega-3 fatty acid, respectively.
There was an indication of protection from aspirin and other NSAIDs even after controlling for statins and omega-3 fatty acid use, which also have anti-inflammatory effects, the researchers reported.
Kroger completes tender offer for Vitacost.com
CINCINNATI — Kroger and Vitacost.com on Monday announced the successful completion of Kroger's tender offer to purchase all outstanding shares of common stock of Vitacost.com for $8 per share in cash.
The tender offer expired at 5:00 p.m., eastern daylight time, on Aug 15.
Kroger expects to complete the acquisition of the remaining eligible Vitacost.com shares not acquired in the tender offer later today through a merger under Section 251(h) of the General Corporation Law of the State of Delaware.
As of the expiration of the tender offer, approximately 29.8 million shares were validly tendered and not withdrawn in the tender offer, representing 86.7% percent of Vitacost.com's outstanding shares, according to the depositary.
The condition to the tender offer that a majority of Vitacost.com's outstanding shares on a fully diluted basis be validly tendered and not withdrawn has been satisfied. As a result, Kroger has accepted for payment and will promptly pay for all validly tendered shares. The depositary has also informed Kroger that Notices of Guaranteed Delivery have been delivered with respect to 836,275 additional shares, representing approximately 2.4% percent of Vitacost.com's currently outstanding shares.
As a result of the merger, all remaining eligible Vitacost.com shares will be converted into the right to receive $8 per share in cash, without interest and less any applicable withholding taxes, the same price that was paid in the tender offer.
Following completion of the merger, Vitacost.com shares will cease to be traded on the NASDAQ Global Market, which is expected to take effect later today.
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