Mylan Launches Generic Microner Tablets; Medtronic Issues Medical Device Alerts Related to SynchroMed System Print E-mail
By Staff and Wire Reports   
Wednesday, 26 June 2013 18:38

Below is a look at some of the headlinesfor companies that made news in the healthcare sector on June 26, 2013. Mylan Inc. (Nasdaq: MYL) announced its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg. Norethindrone Tablets USP, 0.35 mg, are the generic version of Janssen Pharmaceuticals, Inc.'s Micronor® Tablets, 0.35 mg (28-Day Cycle), which are indicated for the prevention of pregnancy. Mylan's partner, Famy Care Ltd., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Norethindrone Tablets USP, 0.35 mg, had U.S. sales of approximately $57.2 million for the 12 months ending March 31, 2013, according to IMS Health.

Currently, Mylan has 176 ANDAs pending FDA approval representing $83 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.5 billion in annual brand sales, for the 12 months ending December 31, 2012, according to IMS Health.


In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.

The United States Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls.The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.

Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. No action is required of physicians beyond the recommendations provided in the notifications.

Medtronic's intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.

Specifically, the Neuromodulation business of Medtronic has initiated the following field corrective actions:

SynchroMed Implantable Infusion Pump Priming Bolus Medtronic has issued an Urgent Medical Device Correction notification which provides physicians with important safety information and patient management recommendations regarding the SynchroMed Implantable Infusion System priming bolus function. The FDA has classified this notification as a Class I recall.

The priming bolus function is used to quickly move drug from the SynchroMed pump reservoir to the catheter tip to initiate intrathecal drug delivery therapy while a patient remains under medical supervision. Medtronic has found that any time the priming bolus is used with a SynchroMed pump, drug mixes with the sterile water or cerebrospinal fluid already in the catheter.  This mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. This can contribute to an increased risk of adverse events involving drug overdose or underdose following an initial system implant or revision.The effects of a drug overdose or underdose will vary depending on the drug being infused but may include, for example, a reduced level of consciousness or a return of underlying symptoms.

Also Wednesday:

Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced that Chief Executive Officer Gerald Commissiong will present at the OneMedForum New York Conference on Thursday, June 27, 2013, at the Metropolitan Club in New York City.

American CryoStem Corporation (OTCQB:CRYO)
, a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced that the Company has been invited to present at OneMedForumNY 2013 to be held at the Metropolitan Club in New York City, June 26-27, 2013.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today unveiled the 2013 PayerView Report, an annual quantitative report that uses athenahealth's cloud-based data, spanning a national network of more than 40,000 health care providers, to deliver insight into the provider-payer relationship.

Atossa Genetics, Inc.(NASDAQ: ATOS)
, the Breast Health Company™, today announced that Kyle Guse, CFO and General Counsel, will be presenting at two upcoming investor conferences: the JMP Securities Healthcare Conference in New York City and the Life Science Innovation Northwest 2013 Conference in Seattle.

, the world's leading manufacturer and distributor of dental lasers, announced today that its EPIC 10® diode soft-tissue laser platform won the gold medal for Dental Instruments, Equipment, and Supplies at the 15th Annual Medical Design Excellence Awards ("MDEA"), the MedTech Industry's premier design competition.

BrainStorm Cell Therapeutics (OTCQB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has signed a Memorandum of Understanding (MOU) with PRC Clinical™, a Contract Research Organization (CRO) based in the San Francisco Bay Area, in anticipation of its planned Phase II multi-center ALS clinical trial in the United States.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that Cowen and Company has initiated sell-side coverage of Hansen Medical.

Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received European CE Mark for its Integra® Smart Cervical Solution, a device approved in the European Union for treating degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician practice company, announced today that it has acquired Sound Senior Geriatrics LLC [SSG], a post-acute hospitalist practice based in Mystic, Connecticut.

Life Technologies Corporation (NASDAQ: LIFE) announces that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is suitable for use with the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay, which has received Emergency Use Authorization for detection in patient specimens of the novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

Medistem, Inc. (PINKSHEETS: MEDS)
announced today that its clinical-stage stem cell product, the Endometrial Regenerative Cell (ERC), was named by the independent industry group Terrapinn as the "Top 15 Most Promising Stem Cell Therapies."

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has closed a $25 million debt financing transaction led by GE Capital, Healthcare Financial Services.

OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that it has teamed up with The Reed For Hope Foundation and their new ambassador, award-winning singer/songwriter/actress Keri Hilson, and medical doctor and sexologist Dr. Rachael Ross, to encourage individuals to get tested for HIV on National HIV Testing Day on June 27th using the new OraQuick® In-Home HIV Test.

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) today announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech  (Kosdaq:CHA) for the use of Pluristem’s PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), specifically in two indications: the treatment of Critical Limb Ischemia (CLI), and Intermediate Claudication (IC) in South Korea.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that it is set to join the Russell 3000® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, 2013.

ScripsAmerica Inc. (OTCBB:SCRC)
, a supplier of prescription, OTC and nutraceutical drugs, today announced that the Company has entered into a Representation Agreement with DPG Distribution ("DPG") for the exclusive right to purchase, promote and resell its RapiMed® OTC products throughout North America, commencing with its children's pain reliever and fever reducer.

VIVUS, Inc. (Nasdaq:VVUS)
today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA™ (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU).

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