GSK and Theravance Announce Regulatory Submissions for FF/VI; ACADIA's AM-831, Discontinued from Further Development Print E-mail
By Staff and Wire Reports   
Friday, 13 July 2012 19:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 13, 2012
GlaxoSmithKline plc (NYSE:GSK) and Theravance, Inc. (Nasdaq: THRX) announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.

A Marketing Authorisation Application (MAA) for FF/VI, with the proposed brand name Relvar™, administered by a new dry powder inhaler called Ellipta™, has been submitted to the European Medicines Agency (EMA) for the following indications:

The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.



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ACADIA (NASDAQ:ACAD)
is reporting that AM-831, a compound under development for schizophrenia in collaboration with Meiji Seika Pharma Co., Ltd., did not meet pre-determined criteria for further development in Phase I testing and, as a result, the parties jointly have decided to discontinue the development of AM-831.

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) is scheduled to present at the 7th Annual JMP Securities Healthcare Conference on Friday, July 13, 2012, at 11:00 a.m. Eastern Time. During the presentation, ACADIA will provide an update on its pipeline, including the status of its ongoing Phase III efficacy, tolerability and safety trial with pimavanserin for Parkinson's disease psychosis (the "-020 Study"). ACADIA is approaching completion of enrollment in the -020 Study with 90 percent of the planned patient enrollment completed. ACADIA expects to complete enrollment in this trial during August 2012.



Also Friday:




Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, and collaborators announced today the publication of a scientific paper documenting the discovery of novel lipids used in second generation lipid nanoparticles (LNPs) for systemic delivery of RNAi therapeutics.

Derma Sciences, Inc. (Nasdaq: DSCI)
, a medical device and pharmaceutical company focused on advanced wound care, and Quick-Med Technologies, Inc. (OTCQB: QMDT.PK), a life sciences company that is developing innovative technologies for the healthcare and consumer markets, announce the signing of an agreement whereby Quick-Med Technologies has granted Derma Sciences an exclusive global license to intellectual property related to the novel NIMBUS® antimicrobial technology, which is available in BIOGUARD® dressings.

Illumina, Inc. (NASDAQ:ILMN)
today announced that it will issue results for second quarter 2012 following the close of market on Tuesday, July 24, 2012.

Laboratory Corporation of America® Holdings (NYSE: LH)
today announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 applicable to the acquisition of MEDTOX Scientific, Inc. (“MEDTOX”) (NASDAQ: MTOX) by LabCorp.

Medistem Inc. (PINKSHEETS: MEDS)
and the Chinese Conglomerate, Shanghai Jia Fu Medical Apparatus Inc, announced today successful administration of Medistem's Endometrial Regenerative Cell (ERC) universal donor stem cell product in 2 patients with critical limb ischemia as part of a 15 patient study.

Misonix, Inc. (NasdaqGM: MSON)
, a surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products worldwide for spine surgery, skull-based surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical applications, has entered into a new, three year, exclusive distribution agreement with Soelim, Inc. based in  Seoul, South Korea, for the distribution of the SonaStar® Ultrasonic Surgical Aspiration System and the BoneScalpel™ Ultrasonic Bone Cutting System.

Osiris Therapeutics, Inc. (NASDAQ: OSIR)
announced today that the company has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to submit a full proposal for a Broad Agency Announcement (BAA) to fund advanced research and development of countermeasures, specifically in the area of mass casualty thermal burn injuries.

RXi Pharmaceuticals Corporation (OTCBB: RXII.OB)
today announced the appointment of Dr. Jeannette Graf and Dr. Leroy Young to its Scientific Advisory Board.

Solos Endoscopy, Inc.'s (PINKSHEETS: SNDY)
is pleased to announce that the Company has begun marketing its new endoscopic instrument line, SteriTAP™.

Synageva BioPharma Corp. (NASDAQ:GEVA)
, a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today announced the closing of a $115 million underwritten public offering of 2,792,200 shares of common stock, including 364,200 shares of common stock which were issued pursuant to the exercise of the underwriters’ over-allotment option, at a price of $41.20 per share.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
announced today that it will release its second quarter 2012 financial results on Thursday, August 2, 2012 at 7:00 a.m. EDT.




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