The Worldwide Biotech’s Approval or Restricting by FDA (From Feb. 15 to Feb. 22)
On Feb 22, 2013, Roche's ($RHHBY) Genentech picked up FDA approval for its late-stage breast cancer therapy Kadcyla, formerly T-DM1, which uses antibodies to deliver cancer drugs directly to the offending cells. The treatment combines ImmunoGen's ($IMGN) taxane chemotherapy drug, DM1, with an antibody, trastuzumab, that targets the cell-growth protein HER2. The result: a combo cancer 'smart bomb' that homes in on tumors. Kadcyla is Genentech's fourth advanced-cancer treatment to be approved by the FDA in two years.
On Feb 22, 2013, Roche ( $RHHBY ) shares quickly ticked up after the FDA approved its highly anticipated breast treatment Kadcyla. That will only add to the wealth of a dozen shareholders tied to the families that control the Swiss company and who quietly have been made billionaires by its success. Roche and its biotech subsidiary Genentech have the best-selling cancer treatments in the world. Drugs like the multifaceted Rituxan and Avastin and breast cancer treatment Herceptin dominate.
On Feb 22, 2013, Johnson & Johnson's ($JNJ) DePuy unit is recalling the diaphyseal sleeve shipped with its Limb Preservation System, warning that the sleeve may fracture as patients walk, possibly resulting in infection or loss of limb. The FDA has assigned its most-serious Class I label to the recall, saying the malfunction could lead to serious injury or death. The Limb Preservation System is used to reconstruct severe soft tissue and bone defects in patients' knees, and the sleeve is designed to help fit the implant in place.
On Feb 21, 2013, Allergan, Inc. (AGN) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery. The Natrelle® 410 shaped gel implant is designed to mimic the slope of the breast and is filled with a highly cohesive silicone gel, which is intended to enable the implant to hold its shape over time while remaining soft to the touch. The FDA approval was based on an extensive review of various studies and data, including pre-clinical device testing and clinical data from Allergan’s 10-year prospective, multi-center pivotal study, involving nearly 1,000 women who have undergone breast reconstruction, augmentation or revision surgery.
On Feb 15, 2013, Dako A/S, which has been acquired by Agilent Technologies Company, introduced IQISH technology in the United States. HER2 IQFISH pharmDx, a fluorescence in situ hybridization (FISH) assay, is the first product approved by the U.S. Food and Drug Administration that uses the Dako IQISH technology, which is based on Dako's fast IQISH hybridization buffer chemistry. The technology will reduce the turnaround time for cancer evaluation from two days to three and a half hours. This will ease the waiting time and associated anxiety for the patient and allow physicians to more quickly initiate targeted cancer treatments.