|Perrigo Confirms Patent Challenge For Generic Version Of ProAir HFA; Eli Lilly Says Phase III Study on Pointbreak Did Not Meet Primary Endpoint|
|By Staff and Wire Reports|
|Thursday, 06 September 2012 18:59|
Perrigo Company (Nasdaq: PRGO) announced it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for albuterol sulfate HFA inhalation aerosol, the generic version of ProAir® HFA. The ANDA filing involved contributions from both Perrigo and Catalent Pharma Solutions, Inc., who partnered on the development of this project.
Eli Lilly and Company (NYSE: LLY) announced the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small cell lung cancer (NSCLC) who were randomized to receive a combination of ALIMTA® (pemetrexed for injection) with bevacizumab (AVASTIN®) and carboplatin induction followed by ALIMTA plus bevacizumab maintenance–the ALIMTA arm–compared to the combination of paclitaxel with bevacizumab and carboplatin followed by bevacizumab maintenance–the paclitaxel arm.
The study did meet one of its secondary endpoints of improved progression-free survival for the ALIMTA arm. Results will be presented on September 7 at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Affymetrix, Inc. (NASDAQ: AFFX) today announced the expansion of its license agreement with Siemens Healthcare Diagnostics for the company’s branched DNA (bDNA) technology whereby Affymetrix is the exclusive licensee for in situ products, including in vitro diagnostics.
Affymetrix, Inc., (NASDAQ:AFFX) today reported its operating results for the second quarter of 2012.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that it will report financial results for the second quarter ending June 30, 2012 on Monday, August 6, 2012, after the U.S. financial markets close.
Array BioPharma (NASDAQ: ARRY) today announced that ARRY-797 met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase 2 clinical trial in 157 osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs).
Astro-Med, Inc. (NASDAQ: ALOT) announced today that Gregory A. Woods was appointed as its Executive Vice President and Chief Operating Officer, effective immediately.
Baxter International Inc. (NYSE:BAX) today announced that the company has begun dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company’s efforts to extend its oncology portfolio with advanced biological research and development.
BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, announced today that Isis Pharmaceuticals will expand its current use of BioClinica’s Express Electronic Data Capture (EDC) solution to several upcoming trials.
Bristol-Myers Squibb Company (NYSE: BMY) (“Bristol-Myers Squibb”) announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended (HSR), for its tender offer for Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) (“Amylin”) has expired.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) (the “Company”), a retail and wholesale distributor of pharmaceutical and other healthcare products in China, today announced that on August 31, 2012, it was notified by The NASDAQ Stock Market LLC (“NASDAQ”), notifying it of its failure to maintain a minimum closing bid price of $1.00 over the then preceding 30 consecutive trading days for its common stock as required by NASDAQ Listing Rule 5550(a)(2).
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the publication of SURFAXIN®(lucinactant) preclinical data in Pediatric Research.
InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma conditions, today announced that CEO Frank Reynolds is scheduled to present to investors at the 2012 14th Annual Rodman and Renshaw Healthcare Conference to be held September 9-11, 2012 at the Waldorf Astoria in New York City.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceuticals, today announced that Cornelia Reininger, M.D., Ph.D., has been named Chief Medical Officer of Navidea, effective November 1, 2012.
NovaDel Pharma Inc. (NVDL.PK) reported unaudited financial results for the six months ended June 30, 2012.
Palatin Technologies, Inc. (NYSE MKT: PTN) will announce its fourth quarter, fiscal year 2012 financial results on Tuesday, September 11, 2012 before the open of the U.S. financial markets.
PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced royalty revenue guidance for the third quarter ending September 30, 2012, of approximately $85 million, as compared with actual royalty revenue of $83 million for the third quarter of 2011, a two percent increase.
Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for albuterol sulfate HFA inhalation aerosol, the generic version of ProAir® HFA.
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter ended June 30, 2012.
Prosetta Antiviral Inc today announced the execution of a strategic alliance with Bristol-Myers Squibb Company (NYSE: BMY) to further discover and develop select drug candidates representing new, novel classes of antiviral drugs.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, will present at the Rodman & Renshaw 14th Annual Healthcare Conference in New York City on September 11, 2012 at 2:00 p.m. EDT, at The Waldorf-Astoria.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today reported that its licensee Alimera Sciences, Inc. has indicated its intention to resubmit its application for ILUVIEN® for diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA).
PURE Bioscience (NASDAQ: PURE), today announced that with 86% of shares outstanding voted at its annual meeting of stockholders convened July 31, 2012, Gregory Barnhill, Dennis Brovarone, John Carbone, MD, Michael Krall, Paul Maier and Donna Singer were re-elected to the Company’s Board of Directors, all with at least 83% support of votes cast.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has accepted for review additional data relating to the pseudophakic subgroup of patients with chronic diabetic macular edema (DME), meaning those patients who already had cataract surgery and had received an artificial lens when they entered the FAME™ Study conducted by pSivida’s licensee, Alimera Sciences, Inc. (Alimera).
Rite Aid Corporation (NYSE: RAD) today announced sales results for August.
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Anchen Pharmaceuticals, Inc., and Anchen, Inc.("Anchen") and TWi Pharmaceuticals, Inc. ("TWi") in connection with TWi's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV® ( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.
Sigma-Aldrich Corporation (Nasdaq: SIAL) today signed an OEM agreement with AB SCIEX, a leading company for high end mass spectrometry instruments, to globally distribute its mass spectrometry based tagging chemistries called SCIEX iChemistryTM Solutions for applications in basic research and applied markets.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology today announced the successful completion of the acquisition of Allos Therapeutics, Inc. (NasdaqGS: ALTH) (Allos), on September 5, 2012 through a “short-form” merger of Sapphire Acquisition Sub, Inc., a wholly-owned subsidiary of Spectrum, with and into Allos with Allos surviving the merger and continuing as a wholly-owned subsidiary of Spectrum.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the second quarter 2012 financial results, provide an update on the Company's business, and discuss expectations for the future.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, today announced that it plans to pursue development of TC-5214 as a treatment for overactive bladder (OAB).
TNI BioTech Inc (PINKSHEETS: TNIB), a public company operating in the biotech sector, announced today that Dr. Ronald Herberman joined the company as Senior Vice President of Research and Development and Chief Medical Officer effective immediately.
University General Health System, Inc. (OTCQB: UGHS), a diversified, integrated multi-specialty health care delivery system, today announced the execution of an agreement between its wholly-owned subsidiary, Sybaris Group, Inc., and Rice University Athletics, whereby Sybaris has been selected as the official catering company for Rice Athletics.
VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue and novel pharmaceutical assays for predictive heart and liver toxicology and drug metabolism screening, today announced that Platinum Long Term Growth VII, LLC (Platinum) purchased a $750,000 secured convertible promissory note from the Company, supplementing its purchase in July 2012 of a similar note in the principal amount of $500,000.