Paul Quintaro,

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ZOLL Medical wins patent infringement case against ELan Med GmbH

ZOLL Medical wins patent infringement case against ELan Med GmbH

March 11, 2013 11:31 am by | 0 Comments

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the District Court of Munich, Germany, ruled in favor of ZOLL in granting an injunction against ELan Med GmbH of Cologne, Germany, for infringing on a ZOLL patent through the distribution and sale of certain ELan products for use with ZOLL’s Intravascular Temperature Management (IVTM™) systems.


Avanir Pharma to collaborate on research with VA Department for screening PBA symptoms

Avanir Pharma to collaborate on research with VA Department for screening PBA symptoms

March 6, 2013 9:03 am by | 0 Comments

Avanir Pharmaceuticals, Inc. in collaboration with the Department of Veterans Affairs (VA) and United BioSource Corporation (UBC) today announced a pilot study to screen for pseudobulbar affect (PBA) symptoms in approximately 1,000 veterans with traumatic brain injury (TBI) .



Abiomed reimbursement update: Four commercial insurers start broad Impella coverage

Abiomed reimbursement update: Four commercial insurers start broad Impella coverage

March 4, 2013 8:16 am by | 0 Comments

Abiomed, Inc. (Nasdaq: ABMD), a leading provider of breakthrough heart support technologies, today provided a reimbursement update. Abiomed announced several recent Impella coverage decisions from national payers including Humana, UnitedHealthcare, Ind…


FDA-approved obesity drug stalled in Europe

FDA-approved obesity drug stalled in Europe

February 21, 2013 5:01 pm by | 0 Comments

VIVUS, Inc. (Nasdaq: VVUS) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) confirmed its October 18, 2012 decision to decline the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union.

VIVUS had requested a re-examination of the opinion. After considering the grounds for this request, CHMP again declined the marketing authorization on February 21, 2013. In its consideration of the Qsiva MAA, CHMP indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety.

“We are disappointed with the CHMP decision regarding Qsiva and the position the Committee adopted with respect to the need for a preapproval cardiovascular outcomes trial,” said Peter Y. Tam, president of VIVUS.  “We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favorable safety and efficacy profile of Qsiva. Despite the positive recommendation of CHMP’s own Scientific Advisory Group (SAG) and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery.”

Qsiva was approved by the U.S. FDA in July 2012 and is sold under the trade name Qsymia™.  The pivotal Phase 3 clinical trial program included over 4,500 subjects studied up to two years, establishing Qsymia as a safe and effective treatment for obesity.

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Merck resolves securities class-action suit related to ENHANCE, to record $493M charge

Merck resolves securities class-action suit related to ENHANCE, to record $493M charge

February 14, 2013 8:01 am by | 0 Comments

Merck (NYSE: MRK) known as MSD outside the United States and Canada, announced today that it has reached an agreement in principle with plaintiffs to resolve two federal securities class-action lawsuits. The suits are pending in the U.S. District Court for the District of New Jersey against Merck, Schering-Plough Corporation and certain of their current and former officers and directors.

Under the proposed agreement, which will have no impact on Merck’s 2013 results of operations, the company will pay $215 million to resolve the securities class action against all of the Merck defendants and $473 million to resolve the securities class action against all of the Schering-Plough defendants. In connection with the settlement, Merck recorded a pre-tax and after-tax charge of $493 million, which reflects anticipated insurance recoveries. This charge reduced the company’s previously reported fourth-quarter 2012 GAAP (generally accepted accounting principles) EPS (earnings per share) results from $0.46 to $0.30 per share and full-year 2012 GAAP results from $2.16 to $2.00 per share, but did not change its previously reported non-GAAP results.

The plaintiffs are investors who purchased certain securities issued by Merck and Schering-Plough between December 2006 and March 2008 and claim that they lost money when the results of the ENHANCE trial were published in early 2008. Merck continues to believe that both companies acted responsibly in connection with the ENHANCE study, and this agreement contains no admission of liability or wrongdoing. The agreement is subject to court approval.

“This agreement avoids the uncertainties of a jury trial and will resolve all of the remaining litigation in connection with the ENHANCE study,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. “We believe it is in the best interests of the company and its shareholders to put this matter behind us, and to continue our focus on scientific innovations that improve health worldwide.”

Judge Dennis M. Cavanaugh is presiding over the cases. Merck is represented by Theodore V. Wells, Jr. and Daniel J. Kramer of Paul, Weiss, Rifkind, Wharton & Garrison LLP.

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Life Technologies’ genetic analyzers, HLA typing kits get FDA 510(k) ok for diagnostic use

Life Technologies’ genetic analyzers, HLA typing kits get FDA 510(k) ok for diagnostic use

February 11, 2013 8:03 am by | 0 Comments

Life Technologies Corporation (NASDAQ: LIFE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits. The development represents additional execution against the company’s strategy to become a leader in the diagnostics market by offering both novel clinical assays and best- in-class molecular testing products.

“This successful application for our Sanger sequencer with HLA typing kits is further demonstration of Life Technologies’ track record in obtaining FDA regulatory clearance for genetic analysis in the clinical market,” said Greg Lucier, chairman and chief executive officer of Life Technologies.  “We will continue to aggressively pursue a regulatory pathway for our leading technologies in the clinical space, including next-generation sequencing.”

The company’s 7500 Fast Dx Real-time PCR system was cleared for diagnostic use with the Center for Disease Control’s H1N1 assay in 2008.  Life Technologies has also announced plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM™) for 510(k) clearance.

The Applied Biosystems™ 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore® HLA Sequencing Kits, and uTYPE® Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the United States. Tissue typing is an essential component of determining compatibility between donors and patients for organ and bone marrow transplantation. HLA typing on the 3500 Dx offers labs an optimized, streamlined workflow with higher resolution than other molecular HLA typing technologies such as sequence-specific oligonucleotide (SSO) methods. 

“With clearance of this system, transplant patients can now have the confidence that their HLA tissue typing was performed utilizing a thoroughly tested, high resolution technique that has passed the strict test requirements of the FDA,” said Ronnie Andrews, president of medical sciences at Life Technologies. “Precise HLA matching between donor and patient significantly improves overall transplant survival.”

The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Sanger, also known as capillary electrophoresis, sequencing is the technology that powered the Human Genome Project and remains the “gold-standard” for its accuracy, reliability and ease of use.  It is expected that clearance will facilitate development of additional assays using the 3500 Dx and open up new partnerships with assay developers.

“Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab,” said Andrews. “The instrument was designed with the clinical laboratory in mind, featuring a novel design that incorporates the ability to track patient samples with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software.”

Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore® HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe, has been approved by China’s State Food and Drug Administration (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.

Additional products offered by Life Technologies for the diagnostics lab market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument, which is CE-IVD marked for use in Europe and under review by FDA; the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool is available for assisting in the validation and verification of molecular tests.

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Kimberly-Clark boosts production of face mask products to address flu epidemic-related needs

Kimberly-Clark boosts production of face mask products to address flu epidemic-related needs

February 8, 2013 9:03 am by | 0 Comments

With the 2012-2013 influenza season reaching epidemic levels across the U.S., Kimberly-Clark (NYSE: KMB) is continuing to increase production of face masks and other Personal Protective Equipment (PPE) products in response to increased customer demand from acute care facilities across the country.

The Centers for Disease Control and Prevention (CDC) reported that the flu season began earlier than usual this year and is shaping up to be more severe than in years past[1]. Kimberly-Clark, the market leader in facial protection in the U.S., has been closely monitoring CDC data and adjusting manufacturing schedules and inventory management in anticipation of continued increased demand from current customers for PPE, including face mask products.

“The health and safety of our valued customers and their patients is our most important priority,” said John Amat, Vice President of Sales and Marketing, Kimberly-Clark Health Care. “Kimberly-Clark representatives are proactively reaching out to all of our current customers to assure them that with our North America-based product supply, we can continue to provide the highest quality facial protection products throughout the flu season.”  

To further help customers, their patients and consumers prevent the spread of the flu, Kimberly-Clark recommends these simple prevention precautions: 

o Get vaccinated – The CDC recommends a yearly flu vaccine as the first and most important step in protecting against this serious virus.[2] o Pay attention to hand hygiene – One of the best ways to help prevent the spread of the flu is to wash your hands with soap and water. If soap and water are not available, use an alcohol-based hand rub.[3] o Contain the germs – Cover your nose and mouth with a tissue when you cough or sneeze. This will block the spread of droplets from your mouth or nose that could contain germs.[4]

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.



St. Jude’s RESPECT trial for PFO closure highlighted at International Stroke Conference

St. Jude’s RESPECT trial for PFO closure highlighted at International Stroke Conference

February 8, 2013 8:10 am by | 0 Comments

St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu. The RESPECT trial evaluated whether closing an opening in the heart, called a patent foramen ovale or PFO, with the AMPLATZER^™ PFO Occluder lowered the patient’s risk of having another stroke.

“Data from the RESPECT trial indicates that patients with a device were less likely to suffer stroke, had smaller strokes, and were less likely to have the type of stroke linked to paradoxical embolism,” said Dr. Jeffrey L. Saver, director of the UCLA Stroke Center and professor of Neurology at the David Geffen School of Medicine. “Indications of preventing strokes on the surface of the brain and large strokes provide additional evidence of a genuine biological effect of closure with the AMPLATZER PFO Occluder in preventing recurrent cerebral infarcts due to a blood clot crossing through the PFO.”

An ischemic stroke occurs when a blood clot blocks a vessel, interrupting blood flow to an area of the brain (the other type of stroke is hemorrhagic, which occurs when a blood vessel in the brain ruptures). When a blood clot blocks a vessel, brain cells begin to die and brain damage can occur. The origin of the blood clot can impact where it becomes lodged in the brain, thereby creating strokes in different areas. A paradoxical embolism occurs when a blood clot travels from the right side of the heart to the left side of the heart, often through a PFO, and can then travel directly to the brain, causing an ischemic stroke. Statistics from the World Health Organization show an estimated 15 million strokes occur worldwide each year, of which approximately 80 percent are ischemic.

The purpose of analyzing these additional data from the RESPECT trial was to determine if patients in the device and medical therapy group suffered different types of recurrent strokes, and to identify the potential origin of the strokes. The results confirm that patients with a device in place were less likely to suffer another stroke and patients in the medical group experienced larger strokes. PFO closure with the AMPLATZER PFO Occluder demonstrates clinical evidence of risk reduction and is an important option for the prevention of recurrent stroke in carefully selected patients over conventional medical management alone.

“The overall trial demonstrates that PFO closure with the AMPLATZER PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Merck Serono, Opexa Therapeutics enter option, license agreement to develop Tcelna

Merck Serono, Opexa Therapeutics enter option, license agreement to develop Tcelna

February 5, 2013 7:41 am by | 0 Comments

Opexa Therapeutics, Inc. (NASDAQ: OPXA) today announced the execution of an agreement with Merck Serono, a division of Merck, Darmstadt, Germany, for the development and commercialization of Tcelna^™ (imilecleucel-T), a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis (MS). Tcelna (imilecleucel-T) is being developed by Opexa and currently is in a Phase IIb clinical trial in patients with Secondary Progressive MS (SPMS). Potential payments to Opexa from the option and license agreement could total $225 million based upon the successful development and commercialization of Tcelna for MS.

Tcelna (imilecleucel-T) is being developed as a personalized therapy specifically tailored to each patient’s individual disease profile and has been evaluated in Phase I and II clinical studies in MS that included SPMS patients. Tcelna (imilecleucel-T) has received Fast Track Designation from the United States Food and Drug Administration as a potential treatment for SPMS.

Under the terms of the agreement, Opexa will receive an upfront payment of $5 million for granting an option to Merck Serono for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck Serono would pay an upfront license fee of either $25 million or $15 million (depending upon whether certain conditions are met), and in return receive worldwide development and commercial rights to Tcelna (imilecleucel-T) in MS, excluding Japan. After exercising the option Merck Serono would be wholly responsible for funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialization activities for the MS program. Additional financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195 million and a tiered royalty rate from the high single digits to the mid-teens based on net sales payable to Opexa. The potential payments to Opexa could, therefore, total $225 million excluding royalty payments.

Under the agreement, Opexa will have an option right to co-fund development, under which the Company would participate in economic support for future clinical development of the program in exchange for additional royalty consideration. In addition to retaining all rights outside of MS as well as retaining the ability to commercialize Tcelna (imilecleucel-T) in Japan, Opexa also retains certain manufacturing rights related to the program. Further details of the transaction are included in a Form 8-K that was filed this morning by Opexa with the United States Securities and Exchange Commission.

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Pfizer’s Zoetis IPO is the biggest since Facebook went public

Pfizer’s Zoetis IPO is the biggest since Facebook went public

February 1, 2013 9:58 am by | 0 Comments

Pfizer had a fantastic week with the successful initial public offering of its animal health unit. The IPO raised $2.2 billion and shares closed at $31.01 Friday.


Medtronic completes enrollment in PAD study

Medtronic completes enrollment in PAD study

January 23, 2013 10:04 am by | 0 Comments

Medtronic, Inc. (NYSE: MDT), today announced completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries (SFA and PPA). 

IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that enrolled 181 patients at more than 40 U.S. sites and randomized them 2:1 to treatment with either the IN.PACT Admiral drug-eluting balloon (study arm) or a traditional, non-coated angioplasty balloon (control arm). Its primary efficacy endpoint is primary patency, a measure of blood flow through the treated arterial segment, at 12 months.

The principal investigators of IN.PACT SFA II are interventional cardiologist Dr. John Laird, professor of medicine at the University of California Davis and medical director of the UC Davis Vascular Center, and vascular surgeon Dr. Peter Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu.

Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I, which previously completed enrollment of 150 patients in Europe, to support a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).

(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.


Health Net walks from 6 Tenet hospitals in California over reimbursement

Health Net walks from 6 Tenet hospitals in California over reimbursement

December 27, 2012 11:32 am by | 0 Comments

Health Net, Inc. (NYSE: HNT) today announced that its subsidiaries exercised their contractual option to terminate agreements with all six of Tenet Healthcare’s (NYSE: THC) Southern California hospitals.
The terminations were effective midnight on Dec….


Will new skin ulcer patent boost the fortunes of Oculus Innovative Sciences?

Will new skin ulcer patent boost the fortunes of Oculus Innovative Sciences?

December 27, 2012 9:13 am by | 0 Comments

Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) a healthcare company that designs, produces and markets innovative, safe and effective anti-infective products and medical devices while also developing multiple drug candidates, today announced the issua…


Kindred Healthcare to buy Homecare Advantage for $2M in cash

Kindred Healthcare to buy Homecare Advantage for $2M in cash

December 17, 2012 5:26 pm by | 0 Comments

Kindred Healthcare, Inc. (NYSE: KND) today announced that its subsidiary has acquired Homecare Advantage, Inc. for a purchase price of approximately $2 million in cash. Homecare Advantage is a high-quality provider of home health services which operate…


Janssen R&D submits NDA for canagliflozin/metformin fixed-dose combo therapy

Janssen R&D submits NDA for canagliflozin/metformin fixed-dose combo therapy

December 12, 2012 2:05 pm by | 1 Comments

Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metfo…