JetBlue Airways (JBLU) Issues Statement on Outcome of Unionization Election Apr 22, 2014 03:03PM

JetBlue Airways Corp. (NASDAQ: JBLU) today issued the following statement from CEO Dave Barger responding to the unionization vote among JetBlue's 2,529 pilots, in which a majority of JetBlue pilots who cast a vote elected ALPA as their representative.

The National Mediation Board will authorize ALPA as the representative body for JetBlue pilots, and then both JetBlue and ALPA will organize negotiating committees.

Quidel Corp (QDEL) Cleared by FDA to Market Lyra Direct Strep Assay Apr 22, 2014 02:31PM

Quidel Corporation (Nasdaq: QDEL) announced that it has received clearance, via the De Novo Request process, from the United States Food and Drug Administration (FDA) to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay. This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.

Group A Streptococcus are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from strep throat or skin infections to severe illnesses (necrotizing faciitis, or streptococcal toxic shock syndrome).(1) Strep throat, or streptococcal pharyngitis, is the most common illness from Group A Streptococcus infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.(2) Group C and G Streptococcus (GCS and GGS, respectively) bacteria are less understood than Group A bacteria, although some strains of GCS and GGS have been increasingly reported to cause infections similar to those caused by GAS.(3) Most are treated with penicillin or other beta-lactams.

Lyra Direct Strep Assay accurately identifies pyogenic Group A and pyogenic Group C or G. Non-group A strains, especially Group C&G, are found in a significant number of Group A negative symptomatic patients (e20%) and treatment appears to shorten the symptomatic period of the disease.(4)

Quidel's Direct Strep Assay is part of the exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler. The Lyra reagent kits provide attractive features that include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.

The Lyra Direct Strep Assay kit includes an extraction-free, three-step sample preparation process that does not require time-consuming automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in just over an hour.

"We are pleased to receive FDA clearance for our Lyra Direct Strep Assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "This assay allows hospital laboratories to detect possible Strep infections in patients who have Group Strep A, C or G infections."

Quidel also offers FDA-cleared, molecular diagnostic assays under the Lyra brand for the accurate detection of other infectious diseases, such as those caused by Influenza A and B, Respiratory Syncytial Virus, Human Metapneumovirus, and C. difficile.

1. 2. 3. 4. Zwart, S. et al BMJ 2000;320:150-4

Twitter, Inc. (TWTR) Announces Native Ads for MoPub Publishers Apr 22, 2014 11:58AM

Twitter's (NYSE: TWTR) Kevin Weil, VP of Product, Revenue, made the following announcement on the company's official blog:

In December, together with MoPub we announced we’d begin testing MoPub’s programmatic native ads platform with mobile app developers. After four months of testing and gathering feedback, today we’re pleased to announce the global launch of native ads for all publishers.

Not only are native ads a significant improvement for publisher monetization in general, but users engage with these ad formats at a higher rate than the desktop-era banners and interstitials which are so prevalent in mobile apps today. Because of this, monetization through native ads can deliver a considerably better experience for users and also a better ROI for marketers.

We’re excited to fully release this native ad capability to the many thousands of publishers who are using MoPub’s monetization and app discovery platform.

More information was posted to MoPub's blog, which you can view here.

General Motors (GM) Restructures Global Vehicle Engineering Organizations; Assigns Leadership Apr 22, 2014 11:05AM

General Motors today announced the restructuring of its Global Vehicle Engineering organization to improve cross-system integration, deliver more consistent performance across vehicle programs and address functional safety and compliance in its vehicles.

“A vehicle is a collection of 30,000 individual parts. Fully integrating those parts into cohesive systems with industry-leading quality and safety is key in this customer-driven business,” said Mark Reuss, executive vice president of Global Product Development, Purchasing and Supply Chain.

Global Vehicle Engineering is being restructured to form two new organizations: Global Product Integrity and Global Vehicle Components and Subsystems.

The Global Product Integrity organization, which is effective immediately, will build on specific actions GM has taken in recent years to lead the industry in vehicle dynamics including ride and handling, steering and braking. GM is applying the same approach to overall quality and safety performance and ensure the highest levels of execution across all its vehicles.

  • Ken Morris, currently executive director, Global Chassis Engineering, has been named vice president, Global Product Integrity. The newly created role and organization will include vehicle, powertrain and electrical systems engineering as well as vehicle performance, industrial engineering and validation. It also includes the recently formed Global Vehicle Safety organization led by Jeff Boyer, who is overseeing the addition of 35 product investigators. Supplier Quality will now become part of the new Global Product Integrity organization.
  • Ken Kelzer, currently vice president, GM Europe Powertrain Engineering, has been named vice president, Global Vehicle Components and Subsystems. His new role and organization includes engineering operations, components development, advanced vehicle development and other engineering business initiatives.

The Global Product Integrity organization will use advanced analysis tools and processes to flag and prevent issues during vehicle development, while also mining field data to react quickly to safety and product quality issues customers may experience.

Morris joined GM in 1989 as a brake systems engineer from Borg Warner Automotive Transmission Systems where he was a test engineer. He has held several key engineering roles at GM, most recently executive director for Global Chassis Engineering, where he was responsible for design and execution for the fuel systems, suspensions, steering, brakes, tires and wheels as well as powertrain interface systems for all GM vehicles. Morris previously was executive director for Global Vehicle Performance, Proving Grounds and Test Labs.

Morris holds a bachelor’s degree of science from Purdue University in Mechanical Engineering.

Kelzer joined GM as an intern in 1982. Most recently, he was vice president of General Motors Europe Powertrain Engineering, where he was responsible for GM’s powertrain operations in Europe. Some of Kelzer’s prior roles include executive chief engineer of full and midsize vehicles, global vehicle chief engineer for rear-wheel drive and performance vehicles, and global functional leader of chassis and accessories.

Kelzer holds a bachelor's degree in Mechanical Engineering from the University of Minnesota and a master’s in Business from the University of Michigan.

With the restructuring, John Calabrese, vice president of Global Vehicle Engineering, has elected to retire after more than 33 years with GM. Calabrese began his GM career in 1981 as an experimental engineer, and has served in a variety of leadership roles in Engineering and Purchasing. He will remain with the company through August to assist with the transition.

“Under John’s leadership, GM has developed industry-leading vehicles in practically every segment in which we compete,” Reuss said. “He raised the bar in Engineering and has us well-positioned for the future. We thank John for his many contributions – and I thank him for his friendship – and wish him the best."

AbbVie, Inc. (ABBV) Reports Submission of GT1/HCV Treatment NDA to FDA Apr 22, 2014 08:48AM

AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The NDA is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,1 with six Phase III studies that included more than 2,300 patients in over 25 countries.

"This NDA submission is a significant advancement for AbbVie's HCV development program," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "Based on the robust data that have been generated in our international Phase III HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection."

In May of 2013, AbbVie's investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1 was designated as a Breakthrough Therapy by the U.S. FDA. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.

AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.

In the U.S., an estimated 3.2 million people are living with HCV and the infection is most prevalent among those born between 1945 and 1965.2.

AbbVie's HCV Development Program

The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

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