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 Below is a list of the companies that made news in the healthcare sector on Friday, August 27, 2010.
ImmunoGen, Inc (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010. Genentech also stated that as planned, it will continue with its ongoing Phase III registrational T-DM1 trial, known as EMILIA, and that it will continue to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012.
Genentech noted that in its review of the BLA, the FDA stated that the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population. Genentech re-affirmed its confidence in T-DM1 as "an important, novel HER2-targeted medicine," and indicated that it remains fully committed to its ongoing development. In particular, as noted above, it intends to continue the EMILIA study which compares T-DM1 to lapatinib in combination with capecitabine in people with advanced, HER2-positive breast cancer whose disease has worsened after receiving initial treatment.
"It is a significant disappointment that there will be a delay in the opportunity for T-DM1 to be approved for patients with advanced HER2 positive breast cancer," commented Daniel Junius, President and CEO of ImmunoGen. "In the meantime we continue to focus on the development of our robust and expanding pipeline as well as advancing our technology through new partnerships."
Shares of ImmunoGen fell $3.23 or 38.50% to $5.16.
Also Friday:
BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, is pleased to announce the appointment of Federico Pignatelli as Executive Chairman effective August 24, 2010.
Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has implemented an accelerated stock repurchase (ASR) program to repurchase $300 million of common stock, as part of its previously announced authorization from its Board of Directors to repurchase up to $500 million of common stock.
Exactech, Inc. (NASDAQ:EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today the acquisition of several innovative spine product lines and all related technology from VertiFlex, Inc. a leading developer of minimally invasive and motion preserving spinal surgery technologies.
GeoVax Labs, Inc. (OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, today announced the results of its Annual Shareholders Meeting, held on August 24, 2010.
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany.
LC LUXURIES LIMITED (PINK SHEETS:LLUX) announces that its newly established subsidiary, U.S. Cannabis, Inc., a Nevada corporation, will begin supporting the U.S. medical marijuana market through the management of medical clinics in California.
MOCON, Inc. (Nasdaq: MOCO) announced today that on August 26, 2010, its Board of Directors declared a quarterly cash dividend of nine and one-half cents ($0.095) per share, payable on November 19, 2010, to shareholders of record on November 5, 2010.
Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that on August 25, 2010 the Compensation Committee of the Company's Board of Directors approved the grant of inducement stock options to purchase a total of 10,000 shares of common stock to two new employees.
PPJ Enterprise (PPJ) (PINKSHEETS: PPJE) a leader in proprietary automated health care reimbursement cycle (all specialties), online health information digital systems and practice information management digital system software for health care and general businesses worldwide, has announced that its subsidiary, Professional Billing Service (PBS), has exceeded its gross revenue over $85,000 during the first 26 days in August of 2010.
SOHM, Inc. (PINKSHEETS: SHMN) announced today that it has further broadened its international sales channels in Southeast Asia by signing an exclusive distribution agreement for the marketing and distribution of SOHM's private label generic pharmaceutical products in Sri Lanka.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.
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