Delcath Says FDA Posted Briefing Documents Ahead of ODAC Meeting; FDA: Morning-After Pill to Move Over-the-Counter Print E-mail
By Staff and Wire Reports   
Tuesday, 30 April 2013 20:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 30, 2013.

Delcath Systems, Inc. (NASDAQ: DCTH) announced the U.S. FDA has published on its website the briefing documents for the upcoming May 2, 2013 Oncologic Drugs Advisory Committee (ODAC) meeting. The ODAC will review Delcath's New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver.

In addition to the briefing materials, the FDA plans to provide a live webcast of the meeting. The briefing materials from Delcath and the FDA, and information regarding the webcast including the web address for the webcast, can be accessed on the FDA webpage at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm341089.htm


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The Plan B morning-after pill is moving over-the-counter, a decision announced by the Food and Drug Administration just days before a court-imposed deadline.

Tuesday, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription — and said it no longer has to be kept behind pharmacy counters.

Instead, the pill can sit on drugstore shelves just like condoms, but that buyers would have to prove their age at the cash register.

Earlier this month, a federal judge had ruled there should be no age restrictions and gave the FDA 30 days to act. The FDA said its latest decision was independent of the court case.


Also Tuesday:



BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today that the Company will host a conference call on Tuesday, May 7th, at 4:30 p.m. Eastern Daylight Time to discuss its operating results for the first quarter ended March 31, 2013, and to answer questions.

Cardium Therapeutics (NYSE MKT: CXM)
today announced that the Company will present a poster demonstrating the clinical benefits of Excellagen® in advanced regenerative wound management at The Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS) meeting to be held May 1-5, 2013, in Denver, Colorado.

Celsus Therapeutics (OTCQB: MRRBY), an emerging growth, development-stage biotech company, announced the addition of Pharma/Biotech industry veteran Fredric Price to the Company's Board of Directors.

Dr. Reddy's Laboratories (NYSE: RDY)
will announce results for the Fourth Quarter and Full year ended March 31, 2013 on Tuesday, May 14, 2013 after the Board Meeting.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it will release its financial and operating results for the first quarter ended March 31, 2013 after market close on Wednesday, May 8, 2013.

MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") and Unis-Tonghe Technology (Zhengzhou) Co., Ltd. ("UNIS") today announced that the two companies will begin offering an Electronic Medical Records ("EMR") system with an integrated MyMedicalRecords Personal Health Record ("PHR") to be sold through the two companies previously announced Joint Venture, Unis Tonghe MMR International Health Management Service Co., Ltd. ("UNIS/MMR").

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the results from a recently published pre-clinical study describing potential benefits of Hansen Medical's robotic technology for the treatment of carotid arteries.

Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the AQ-Flex™ 19 miniprobe to provide real-time optical biopsies during endoscopic ultrasound-guided fine needle aspiration (EUSFNA) procedures in the digestive tract.

Nanosphere, Inc. (NASDAQ: NSPH)
, a leader in the development and commercialization of advanced molecular diagnostics systems, today announced that it will report its results for the first quarter of 2013 before the market opens on Wednesday, May 8, 2013.

Net Medical Xpress (OTCBB: NMXS), a developer of medical IT solutions and services, has implemented Tely Labs' telyMed™ videoconferencing system as part of its new range of remote, telemedicine-based clinical and diagnostic programs for hospitals.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, today announced that Dr. Arun Menawat, the company's President and Chief Executive Officer, will present Novadaq's corporate overview at three investor healthcare events in May.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
today announced initiation of the Borealis-2™ clinical trial, an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy treatment.

PAREXEL International Corporation (NASDAQ: PRXL) today reported financial results for the third quarter of Fiscal Year 2013, which ended on March 31, 2013.

PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that the Company has appointed Peter S. Garcia to the position of vice president, chief financial officer (CFO) and acting chief accounting officer, effective as of May 13, 2013.

Premier Biomedical, Inc. (OTCBB: BIEI) today announced that President and Chief Executive Officer William Hartman was recently interviewed by The Wall Street Transcript (TWST), an independent investment publication of interviews with company CEOs, money managers, and Wall Street analysts.

Raptor Pharmaceutical Corp. (Nasdaq: RPTP)
, today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), today announced publication of a peer-review article on Clostridium difficile ("C. difficile") in the current issue of Expert Review of Vaccines (April 2013, Vol. 12, No.4.).

TNI BioTech, Inc. (OTC PINK: TNIB)
announced today the appointment of industry veteran, Dr. Joseph M. Fortunak, as a strategic consultant to the company. Dr. Fortunak is the former director and head of Global Chemical Development at Abbott Laboratories Corporation, where he managed more than 350 scientists and technical experts.

Zynex, Inc. (OTCQB: ZYXI)
, a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced the appointment of Kevin M. Smith to the Zynex Board of Directors.



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