FDA approves Kalydeco to treat rare form of cystic fibrosis

Breakthrough therapy targets defective protein

January 31, 2012 (MMD Newswire) -- The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

"Kalydeco is an excellent example of the promise of personalized medicine - targeted drugs that treat patients with a specific genetic makeup," said FDA Commissioner Margaret A. Hamburg, M.D. "The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development."

The FDA reviewed and approved Kalydeco in approximately three months under the agency's priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug's April 18, 2012 prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

"Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease."

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient's mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

Kalydeco is manufactured by Vertex Pharmaceuticals Inc. of Cambridge, Mass.

National Voice Gazette

LEGENDARY ASTRONAUT SHANNON LUCID RETIRES FROM NASA

HOUSTON -- Shannon Lucid, a member of NASA's first astronaut class to
include women, has retired after more than three decades of service
to the agency.

A veteran of five spaceflights, Lucid logged more than 223 days in
space, and from August 1991 to June 2007, held the record for the
most days in orbit by any woman in the world. Lucid is the only
American woman to serve aboard the Russian Mir space station. She
lived and worked there for more than 188 days, the longest stay of
any American on that vehicle. Her time on Mir also set the single
flight endurance record by a woman until Suni Williams broke it in
2006.

"Shannon is an extraordinary woman and scientist. She paved the way
for so many of us," said Peggy Whitson, chief of NASA's Astronaut
Office at the Johnson Space Center in Houston. "She was a model
astronaut for long-duration missions, and whether she was flying
hundreds of miles up in space or serving as Capcom [capsule
communicator] during the overnight hours for our space shuttle and
space station crews, she always brought a smile to our faces. Like so
many others, I always will look up to her."

Lucid, who holds a doctorate in biochemistry, was selected by NASA in
1978. She joined five other women as the agency's first female
astronauts. Her first three shuttle missions deployed satellites.
STS-51G in 1985 deployed and retrieved the SPARTAN satellite; STS-34
in 1989 deployed the Galileo spacecraft to explore Jupiter; and
STS-43 in 1991 deployed the fifth Tracking and Data Relay Satellite
(TDRS-E). Her fourth shuttle mission, STS-58 in 1993, focused on
medical experiments and engineering tests.

Lucid traveled aboard Atlantis on STS-76 in March 1996 to the Russian
Mir space station. She performed numerous life science and physical
science experiments during the course of her stay. She returned from
the station aboard Atlantis on STS-79 in September 1996.
In 2002, Lucid served as NASA's chief scientist at the agency's
headquarters in Washington. She returned to Johnson in the fall of
2003 and resumed technical assignments in the Astronaut Office. She
served as a Capcom in the Mission Control Center for numerous space
shuttle and space station crews, representing the flight crew office
and providing a friendly voice for dozens of friends and colleagues
in space.

NASA Releases First Multi-Player Facebook Game

WASHINGTON (MMD Newswire) January 30, 2012 -- NASA has launched its first multi-player online game to test players' knowledge of the space program. Who was the first American to walk in space? Who launched the first liquid-fueled rocket? These are only a few of the questions players can answer in Space Race Blastoff.

Available on Facebook, Space Race Blastoff tests players' knowledge of NASA history, technology, science and pop culture. Players who correctly answer questions earn virtual badges depicting NASA astronauts, spacecraft and celestial objects. Players also earn points they can use to obtain additional badges to complete sets and earn premium badges.

"Space Race Blastoff opens NASA's history and research to a wide new audience of people accustomed to using social media," said David Weaver, NASA's associate administrator for communications. "Space experts and novices will learn new things about how exploration continues to impact our world."

NASA chose to make the game available through Facebook to take advantage of the social media site's large audience and enable players to compete against others. Individuals also can play solo games.

Once in the game, players choose an avatar and answer 10 multiple-choice questions. Each correct answer earns 100 points, with a 20-point bonus to the player who answers first. The winner advances to the bonus round to answer one additional question for more points.

Correctly answering the bonus question earns the player a badge.

Today in religion

Court Orders Removal Of Cross Memorials

Sometimes no decision is the worst decision of all. As you may have heard, the U.S. Supreme Court recently refused to intervene at a defining moment for religious freedom in America. The Court chose to leave six states completely defenseless in the face of an aggressive campaign by atheists to sterilize the public square of any expression of faith. For 13 years, Utah's fallen highway patrolmen have been honored with roadside crosses as a way to honor the troopers' sacrifice and comfort their families. American Atheists, Inc. took the state to court for allowing a private association to memorialize the officers with its own dollars.

The Court's refusal to hear the case has severe implications. Every state in the 10th Circuit's jurisdiction -- and that includes Utah, Kansas, Colorado, Oklahoma, New Mexico, and Wyoming -- is officially on notice. None of their crosses on public property will be tolerated either. This decision could have future implications for Arlington National Cemetery and other landmarks across the country. Of course, the irony is that these roadside crosses are not only constitutional, but they also represent the very values that our Constitution celebrates.

On Thursday, our Values Voter Bus rolled into Murray, Utah to take our stand with the Utah state troopers. There we announced a national petition urging the courts, Congress, and state legislatures to stand with us in solidarity for national monuments and memorials across the nation.

The fact that America has even arrived at this point in this case points to how far our understanding of the Establishment Clause has fallen from its original meaning. The Founding Fathers erected several monuments of this nature -- and they obviously didn't see their Bill of Rights as a barrier to them! Please join us by adding your name to the more than 26,000 who recognize that the U.S. Constitution celebrates religious liberty -- not censors it!

Got Jesus?

Rev. 3:20 Behold, I stand at the door, and knock: if any man hear my voice, and open the door, I will come in to him, and will sup with him, and he with me. 3:21 To him that overcometh will I grant to sit with me in my throne, even as I also overcame, and am set down with my Father in his throne.

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Ten absolute, irrefutable, God-approved proofs that Christians are right and atheists are dumb and deluded!

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The Divine Creation Theory

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If you met Jesus on the street today

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Remember the Troops

Support the Mission

Bold Alligator' Helps to Sustain Amphibious Operations

By Army Sgt. 1st Class Tyrone C. Marshall Jr.
American Forces Press Service

WASHINGTON, Jan. 31, 2012 - As the Navy and Marine Corps continue "Bold Alligator," their largest joint, multinational amphibious assault exercise in 10 years, it is important that both services to sustain amphibious operations, the commander of U.S. Fleet Forces Command said today.

"It's enormously important for the Navy to start learning an awful lot about Marine Corps operations and getting a landing force ashore, and how that land force operates," Navy Adm. John C. Harvey Jr. said at a Defense Writers Group breakfast.

"And it's enormously important for the Marine forces to understand what it took to get the naval force to the position where you could land the assault forces and sustain those assault forces," he added. "That part of this education, I think, will be the greatest benefit to this exercise."

Bold Alligator 2012 began Jan. 30 and is scheduled to run through until Feb. 12, on and off the coasts of Virginia, North Carolina and Florida. The exercise's intent is to revitalize Navy and Marine Corps amphibious expeditionary tactics, techniques and procedures, and reinvigorate its culture of conducting combined Navy and Marine Corps operations from the sea, a Navy statement said.

Although Bold Alligator is the largest exercise of the past decade, Marines never completely left the seas, Lt. Gen. Dennis J. Hejlik, commander of U.S. Marine Corps Forces Command, emphasized.

"We have the seven [Marine Expeditionary Units] out there," he said. "So we have a percentage of Marine Corps officers and Marine enlisted that have always been out there."

Harvey said these types of exercises test commanders and their staffs in preparation for tough real-world scenarios.

"Commanders are going to make decisions based on the kinds of situations they are confronted with," he said. "We're going to test that commander's ability to make these decisions and apportion those forces. The biggest stress for any commander is the apportionment of the forces under his command for the multitude of tasks they've been given."

Harvey and Hejlik said the naval exercise is not based on current events in the Persian Gulf, but is "certainly informed by recent history."

"This exercise deals with large numbers of small-boat threats, irregular threats, not easy to identify in the complex battle space, ... which could be used to describe just about the entire Persian Gulf," Harvey noted. The exercise deals with both regular and irregular threats, as well as with shore-based cruise missiles, the admiral said.

"When we constructed the scenario, we put it against what we called a moderate force, or a medium force with moderate ability, who denies access into theater and actually on land," Hejlik said. "And we did that purposely because of the force that we're exercising, ... so it's not patterned after any contingency planning, if you will."

Hejlik also cited working with conventional and special operations forces as an important objective during Bold Alligator.

Harvey noted that Gen. James F. Amos, Marine Corps commandant, refers to the Marine Corps as a "middleweight" force.

"We can go high, we can go low, but are a middleweight force that can strike with power," Harvey said.

The admiral said he hopes the Navy and Marine Corps continue exercises like Bold Alligator to "keep that institutional learning going."

"When did we bring it all together?" he asked, referring previous training. "When did we bring the parts together in a purposeful manner and challenge ourselves to do what we are expected to be able to do in 10 years?

"That's really what this is all about," Harvey added. "And I hope that we continue that cycle."

Kearsarge Departs for Bold Alligator 2012

By Mass Communication Specialist 1st Class (SW/FMF) Chad V. Pritt, USS Kearsarge Public Affairs

USS KEARSARGE, Atlantic Ocean (NNS) -- The amphibious assault ship USS Kearsarge (LHD 3) departed Naval Station Norfolk Jan. 30 to participate in Exercise Bold Alligator 2012.

Bold Alligator 2012 is taking place over a two-week period and is a multi-national joint effort hosted by the U.S. Navy and Marine Corps to strengthen core competencies in the areas of amphibious operations and bi-lateral cooperation.

The Kearsarge Amphibious Ready Group (ARG), as part of Expeditionary Strike Group (ESG) 2, joins 2 Marine Expeditionary Brigade (2 MEB), the Enterprise Carrier Strike Group, units from Navy Expeditionary Combat Command, and various ships and units from foreign partners.

"Our allies will be as equally engaged as we are during the exercise," said Capt. Dorian F. Jones, Kearsarge commanding officer. "We will have land, sea and air units from eight countries as we strive to develop bi-lateral relationships and execute the CNO's (Chief of Naval Operations) Maritime Strategy as it pertains to maritime security cooperation."

The exercise, which will be the largest of its kind in a decade, will consist of live, virtual and constructive scenarios, and will showcase the full spectrum of amphibious capabilities.

"It's a revitalization of the Navy and Marine Corps amphibious expeditionary tactics," said Jones. "It's about re-invigorating the Navy and Marine Corps interoperability and our culture of combined operations from the sea."

While the end result of the exercise will be a strengthened ability to respond to man-made and natural crises around the world, the broader purpose is to showcase the advantages of sea basing. Sea basing is the ability for theater commanders to project power ashore without relying on shore-based infrastructure. Amphibious forces thereby limit the vulnerability and sustainment requirements for shore-based personnel.

"As we learned in Haiti, and historically in other operations, a prepositioned amphibious ready group becomes a force multiplier," said Jones, referring to the humanitarian relief operations in that country following a 7.0 magnitude earthquake two years ago. "Our quick response to a limited engagement in Libya was also due to sea basing. It's a concept that works in practice, and our ability to train to those expectations with our partners is what sets us apart from our enemies."

Bold Alligator 2012 is scheduled to conclude Feb. 12.

"The exercise will run 24 hours a day, seven days a week until all of our training objectives are met," said Jones. "We train like we fight, and I expect all of Kearsarge's Sailors will put forth their best effort to ensure the greatest success."

Wasp Sets Stage For Bold Alligator 2012

By By Mass Communication Specialist Seaman Caleb Cooper, USS Wasp (LHD 1) Public Affairs

ATLANTIC OCEAN (NNS) -- Sailors and Marines aboard the amphibious assault ship USS Wasp (LHD 1) set sail Jan. 30 to initiate the live phase of exercise Bold Alligator 2012.

Wasp is serving as the flagship for Bold Alligator, the largest amphibious exercise conducted by the Navy/Marine Corps team in the past 10 years. It is also the first live, East Coast, Expeditionary Strike Group/Marine Expeditionary Brigade-level exercise in about a decade.

"Realistic training at sea is essential to the Navy and Marine Corps' ability to train like we fight," said Capt. Gary M. Boardman, Wasp's commanding officer.

Twenty-five ships, and 20,000 Sailors, Marines and Coastguardsmen are participating in the two-week exercise, which runs through Feb. 13. Commands involved include Enterprise Carrier Strike Group (CSG), Expeditionary Strike Group 2 (ESG-2), 2nd Marine Expeditionary Brigade (MEB), Iwo Jima Amphibious Ready Group (ARG), 24 Marine Expeditionary Unit (MEU), Naval Expeditionary Combat Command (NECC) as well as coalition ships, units, and observers from 12 other countries.

Training scenarios are based on a continuum of situations that the Navy/Marine Corps team is likely to face in today's environment and are built in order to enhance the varied capabilities that allow amphibious forces to conduct forcible entry against an opposing military force; as well as crisis response, humanitarian assistance, and building partnerships.

"Exercises like Bold Alligator allow the Navy and Marine Corps team to exercise its full spectrum of expeditionary capabilities, to include working with our coalition partners, in complex environments," said Boardman.

"Bold Alligator is about building partnerships and ensuring the amphibious force is ready when called. Wasp is looking forward to leading the way as the flagship for Expeditionary Strike Group Two and 2nd Marine Expeditionary Battalion."

Wasp's underway is the culmination of weeks of certification training and ship preparations to include taking on numerous supplies, food stores, and hundreds of Marines, foreign officers and support staffs

"We have been extremely busy onloading the personnel and resources needed to conduct an exercise of this magnitude," said Chief Warrant Officer Chad Mader, Wasp's Combat Cargo Officer. "Getting everyone to work together is one of the goals of this evolution, so when we need [this force], we have the ability and knowledge to operate as one cohesive unit."

Bold Alligator 2012 serves as an opportunity to revitalize an integrated, Navy/Marine Corps approach to amphibious operations, strengthening their traditional role as fighters from the sea.

From Abraham Lincoln Carrier Strike Group Public Affairs

ARABIAN GULF (NNS) -- Abraham Lincoln Carrier Strike Group (ALCSG) assets responded to a distressed Iranian fishing dhow in the Arabian Gulf, Jan. 31.

At 12:37 p.m. local time, an MH-60S Seahawk helicopter, assigned to the Golden Falcons of Helicopter Sea Combat Squadron (HSC) 12 and embarked on aircraft carrier USS Abraham Lincoln (CVN 72), spotted the disabled Iranian fishing dhow M/V Sohaila with nine crew members aboard.

Sohaila's master issued a distress call reporting that his crew was in good condition, but the dhow's engine had overheated, preventing it from operating at sea.

Guided-missile destroyer USS John Paul Jones (DDG 53), operating nearby, responded, offering assistance to the Iranian fishermen who were waving a cloth as a signal for help.

The dhow's master permitted the destroyer's visit, board, search and seizure (VBSS) team to board allowing the team better determine the nature and extent of the boat's engine problems.

John Paul Jones engineers repaired the fan belt in the dhow's engine and assessed it had a foul propeller.

Navy divers assigned to Explosive Ordnance Disposal Mobile Unit (EODMU) 1131, embarked aboard aircraft carrier USS Abraham Lincoln (CVN 72), were flown using one of Abraham Lincoln's helicopters to John Paul Jones and then, sent by rigid hull inflatable boat (RHIB) to the dhow.

"We have the capability and training to handle these jobs when they come up and we're just happy to assist whenever we get the call," said Explosive Ordnance Disposal Senior Chief Michael J. Negri. "The best part of the day was when they finally started up their engines and were able to get underway again."

After ensuring the dhow was operational, and the crew was safe with sufficient amounts of food, water and fuel to continue its transit, the VBSS and EODMU teams departed the scene and returned to their ships.

Rear Adm. Mike Shoemaker, commander, ALCSG, said the U.S. Navy has a longstanding tradition of coming to the aid of mariners in distress and conducting search and rescue operations at sea.

"This is one of the reasons our Navy exists," Shoemaker said. "We preserve freedom of navigation and the unimpeded flow of commerce on the high seas. But anytime we come across a vessel in need of engineering or medical assistance, our Sailors are ready to assist with their expertise - in this case engineers and divers."

ALCSG, comprised of Abraham Lincoln, Carrier Air Wing 2, Destroyer Squadron (DESRON) 9, guided-missile cruiser USS Cape St. George (CG 71), and guided-missile destroyers, USS Momsen (DDG 92) and USS Sterett (DDG 104), are supporting maritime security operations and theater security cooperation efforts in the U.S. 5th Fleet area of responsibility.

NECC participates in Bold Alligator

By Mass Communication Specialist Seaman Kay Savarese, Navy Expeditionary Combat Command Public Affairs

VIRGINIA BEACH, Va. (NNS) -- Riverine Group (RIVGRU) 1 will command the Navy's expeditionary forces for Bold Alligator 2012 (BA12), the nation's largest joint forces and multinational amphibious exercise on the East Coast, which began Jan. 30.

RIVGRU-1 is part of the Navy Expeditionary Combat Command (NECC) that deployed to North Carolina as headquarters for the Navy Expeditionary Force (NEF) supporting BA12.

Units from NECC participating include RIVGRU-1, Riverine Squadrons (RIVRON), Maritime Civil Affairs Team (MCAST), Navy Expeditionary Intelligence Command (NEIC), and Expeditionary Training Group (ETG).

"The NEF represents the first live play on the ground and inland waters of North Carolina for Bold Alligator 2012, representing the historic flexibility of maritime services," said Capt. Christopher Halton, the commodore of RIVGRU-1 and commander of NEF.

The NEF provides command and control necessary to integrate NECC into any Navy operation. BA12 provides NECC the opportunity to further refine partnerships for worldwide Navy support, including joint operations and allied forces, extending global partnerships. In the BA12 scenario, the NEF deploys to assist a fictitious host nation.

"The NEF was the first U.S. force placed at the maritime-ground seam to help the host nation's security forces improve their capability and capacity," said Halton. "In addition, the NEF is assisting the host nation with countering insurgent activity, maintaining or developing goodwill in the local populace as well as preparing for the follow-on amphibious landing."

Expeditionary forces operate on or near coastal and waterway areas to execute the six core capabilities of the Maritime Strategy; forward presence, deterrence, sea control, power projection, maritime security and humanitarian assistance/disaster response.

"The NEF is extending the United States' 'Blue Water Option' further into the inland waterways and harbors of nations who request help," said Halton. "There is no other Navy force that can operate from a ship or ashore with equal ease and with the same operational capability."

ETG will assist in directing BA12 and evaluate NECC performance to further refine NECC procedures by coordinating synthetic training by utilizing realistic actors and contractors. Expeditionary forces will operate in at least seven different locations throughout the duration of the exercise.

In addition to NECC, units participating in BA12 include the Enterprise Carrier Strike Group (CSG), Expeditionary Strike Group (ESG) 2, 2nd Marine Expeditionary Brigade (MEB), Iwo Jima Amphibious Ready Group (ARG), 24th Marine Expeditionary Unit (MEU), as well as various other ships and units.

BA12 is a live, scenario-driven simulation held off the coasts of Virginia, North Carolina, and Florida from Jan. 30 to Feb. 12. Its purpose is to revitalize Navy and Marine Corps amphibious expeditionary capabilities and to test and strengthen the fundamental roles of amphibious operations by focusing on force readiness and proficiency.

Eight countries will join U.S. forces in the exercise, allowing American service members and coalition partners the opportunity to exercise amphibious operations in a real-world environment.

NECC is a command element and force provider for integrated maritime expeditionary missions, serving as a single functional command for the Navy's expeditionary forces.

James 1:27 Religion that God our Father accepts as pure and faultless is this: to look after orphans and widows in their distress and to keep oneself from being polluted by the world.

1 Corinthians 1:18 For the message of the cross is foolishness to those who are perishing, but to us who are being saved it is the power of God.

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