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Marathon Pharma to sell decades-old drug to treat DMD for $89,000

Sat, 02/11/2017 - 17:24
Marathon Pharma to sell decades-old drug to treat DMD for $89,000

Marathon Pharmaceuticals will reportedly market decades-old drug deflazacort under the brand name Emflaza with a top price tag of roughly $89,000 for a year's worth of treatment, nearly 70 times higher than the drug's price overseas.

The drug in question is a common steroid that can be used to treat a rare disorder called Duchenne muscular dystrophy (DMD), which damages the patient's muscles and leaves many of patients dead by their late-20s.

According to the Wall Street Journal (WSJ), patients can shave the steroid for less than $1 through online pharmacies, while Marathon will market the drug for roughly $89,000 for a year's worth of treatment.

It is quite surprising how a company can get away with such a shocking list price for the drug in the U. S. It is because the drug was never approved in the country despite its widespread availability to treat other conditions, such as arthritis, in many other countries.

Since Marathon recently won the FDA's approval to treat a condition that afflicts fewer than 200,000 people in the U. S., and there has been a dearth of treatment options, the Illinois-based pharmaceuticals giant has carte blanche over the drug's pricing.

General: Health
Categories: US News

FedEx Launches FedEx Fulfillment for Small Business to Compete with Amazon

Sat, 02/11/2017 - 01:41
FedEx Launches FedEx Fulfillment for Small Business to Compete with Amazon

FedEx has launched a new service named FedEx Fulfillment for small and medium business owners. The service will first serve customers in the United States and Canada and business owners will be able to store their goods at FedEx warehouses. The logistics service will also offer custom delivery boxes with branding options for small and medium business owners.

The service would compete with Amazon for ecommerce based clients and small business owners. Amazon has registered strong growth in its similar program under which the company offers third-party sellers to store their goods at Amazon warehouse. Amazon directly ships the products and this reduces hassle for seller and delivery time for products.

Amazon has registered growth in its fulfillment business but many sellers are concerned about Amazon competing with them for their best-selling products. This won’t be the case with FedEx as the company is only into logistics and not into retailing.

In a report published on CNN, Ryan Kelly, senior vice president of FedEx Supply Chain informed, "We're focused on the retailer, and doing what's right for the retailer, in helping them grow their business. I think that is differentiated in the marketplace. It's why we're getting such great feedback."

Amazon has been working hard on improving delivery of goods on its network. The company has invested a lot of money in improving its logistics network. FedEx and UPS are now trying to compete by offering flexibility to small and medium business owners.

Business: Business NewsRetail SectorCompanies: FedExRegion: United StatesGeneral: Featured
Categories: US News

CDC updates 2017 advisory for recommended flu shots

Fri, 02/10/2017 - 16:15
CDC updates 2017 advisory for recommended flu shots

An advisory board of the U.S. Centers for Disease Control & Prevention (CDC) on Thursday released its 2017 advisory for recommended flu shots affecting adults.

The federal agency revised its guidelines on seasonal flu shots by modifying shot advice for individuals with egg allergy and eliminating nasal flu vaccines. In addition, it tweaked recommendations for vaccines against hepatitis B, meningococcal disease and human papillomavirus (HPV).

Doctors use the FDA’s annually updated vaccine schedule to make sure that patients get the right vaccines according to their age, medical conditions and other risk factors. The updated list includes thirteen vaccinations.

Dr. David Kim, the deputy associate director for adult immunizations in the agency’s Immunization Services Division, said, “All adults need immunizations to help them prevent getting and spreading serious disease that could result in poor health, missed work, medical bills, and not being able to care for family.”

The federal agency also suggested that there are some ways to tell if a patient have a cold or the flu, such as symptoms of a cold often come gradually, whereas symptoms of flu appear suddenly, and symptoms like stuffy nose and sore throat are more common with colds than with the seasonal disease of flu.

General: HealthCompanies: CDC
Categories: US News

Coca-Cola Helped by Strong North American Demand but Company Issues Lackluster Future Guidance

Thu, 02/09/2017 - 23:13
Coca-Cola Helped by Strong North American Demand but Company Issues Lackluster Future Guidance

Coca-Cola announced strong quarterly results as the company reported strong demand in North America. Coca-Cola reported strong numbers for quarter ending by December 2016 but the company has reduced its guidance for year 2017. Coca-Cola is offloading most of its bottling operations in North America and this will lead to additional charges in 2017. The company will be refranchising its bottling operations in North America and has announced that there could be 1-4 percent drop in earnings in 2017.

Coca-Cola reported flat sales for soda and carbonated beverages but it reported stronger earnings in other segments. As people are becoming health conscious with rising awareness about obesity, Coca-Cola and other beverage companies face challenge of reducing sugar content in their carbonated beverages. In many overseas markets, Coca-Cola has ventured in other drinks segment to keep its earnings healthy.

With price increase, Coca-Cola reported stronger revenue in North America. During fourth quarter, Coca-Cola registered 1 percent decline in sales. The sale for non-carbonated beverages increased by 2 percent during last quarter while sale of carbonated beverages declined by two percent.

A report published by USA Today informed, “Overall, the company's revenue fell 6% to $9.4 billion for the fourth quarter. The company said that included a 2% decline attributable to foreign exchange rates and a 10% decline attributable to corporate deals and one-time items, which included bottling refranchising efforts.”

“In North America, net revenue rose 8 percent during the quarter, outperforming total retail value growth for both the North America nonalcoholic ready-to-drink beverage industry and U.S. consumer packaged goods companies," CEO Muhtar Kent said.

Business: Company ResultsCompany UpdatesCompanies: Coca-ColaPeople: Muhtar KentGeneral: Featured
Categories: US News

Women with dense breasts more likely to develop breast cancer: study

Thu, 02/09/2017 - 19:12
 study

Women with breasts composed mainly of dense glandular tissue rather than fat face a significantly higher risk of developing breast cancer, according to a new study.

Led by Dr. Natalie Engmann of UC San Francisco, a team of researchers examined data on more than 18,000 women suffering breast malignancies and another 184,000 women without the deadly disease of breast cancer.

The researchers were surprised to find that breast density emerged the biggest indicator of the disease, even bigger than other common risk factors, such as family history or waiting until after age of 30 years to have babies.

Dr. Engmann called dense breasts a big problem because dense glandular tissue makes it harder for doctors to detect a potentially cancerous tumor. Nearly 60 per cent of younger women and 40 percent of older women who have attained menopause have been found to have dense breasts.

Sharing the study's findings, Dr. Engmann said, "Women with dense breasts have a roughly 2-fold higher breast cancer risk relative to women with non-dense breasts . reducing the number of women with dense breasts may prevent a substantial proportion of breast cancer cases."

A different study indicated that only a relatively small percentage of women with early-stage of breast cancer get genetic testing prior to surgery.

The findings appeared in the Wednesday, Feb. 7th, edition of the journal JAMA.

General: HealthResearchRegion: San Francisco
Categories: US News

Iranian baby with heart defect admitted to Portland hospital

Wed, 02/08/2017 - 17:32
Iranian baby with heart defect admitted to Portland hospital

An Iranian infant in need of life-saving heart surgery, who was temporarily banned by President Donald Trump’s immigration order from entering the United States, has finally made it to Portland.

Four-month-old Fatemeh Reshad’s parents told reporters that Iranian doctors told them that their little daughter needed at least one urgent heart surgery to correct heart defects, or she would die.

But, when Fatemah’s parents were on their way to Dubai to fly to the United States for the surgical procedure to save the life of their daughter, President Trump signed the controversial executive order banning visitors and refugees from seven Muslim-majority countries.

Luckily, Gov. Cuomo secured legal assistance for the infant, and a federal court judge granted a temporary injunction on the executive order. On Tuesday, the Iranian infant was admitted to OHSU Doernbecher Children’s Hospital in Portland.

Dr. Laurie Armsby, interim head of the Division of Pediatric Cardiology at the hospital, said, “Fatemeh looks well. Our tests this morning have confirmed her diagnosis and the urgent need for treatment. As we suspected, her heart condition has resulted in injury to her lungs, however the studies today indicate that she has presented to us in time to reverse this process.”

Fatemah is in need of a crucial life-saving heart surgery to fix a number of structural abnormalities and two holes in her heart.

General: HealthPeople: Donald Trump
Categories: US News

Teens trying potentially dangerous vaping method called ‘dripping’

Tue, 02/07/2017 - 17:33
Teens trying potentially dangerous vaping method called ‘dripping’

One-quarter of American teens who have experienced e-cigarettes have also tried a potentially dangerous vaping method called “dripping,” a new substance abuse behavior study revealed.

The potentially dangerous vaping method of dripping involves dropping liquid nicotine directly onto the e-cigarette’s hot coils to produce thicker and more flavorful smoke.

Dripping is drastically different from normal vaping that slowly releases the liquid. Dripping may expose users to higher levels of nicotine as well as to harmful non-nicotine toxins, like acetaldehyde and formaldehyde, which are carcinogens.

Suchitra Krishnan-Sarin, a Yale professor of psychiatry who led the study, said, “When people smoke cigarettes, they say they smoke it for, for lack of a better word, a tingling in the back of the throat … The teen brain has been shown especially sensitive to nicotine.”

Sixty-four per cent of the surveyed high school teens revealed that used dripping to get thicker smoke, 39 per cent said they did so for getting better flavor and 28 per cent said they did that for the stronger throat hit or sensation.

The researchers reported their findings in the most recent edition (Feb. 6th) of the journal Pediatrics.

General: HealthResearch
Categories: US News

South Korea confirms foot-&-mouth disease at dairy farm

Mon, 02/06/2017 - 18:10
South Korea confirms foot-&-mouth disease at dairy farm

South Korean authorities have confirmed that a cow bred at a farm in North Chungcheong Province has been tested positive for foot-&-mouth disease (FMD).

According to a statement released by the Ministry of Agriculture, Food & Rural Affairs, the confirmed case of FMD was detected at a dairy farm in Boeun county, around 170 kilometers southeast of Seoul.

Taking a precautionary step to prevent the disease from spreading further, authorities ordered culling of all the 195 cows that were raised at the farm.

It is not the first time that the agriculture ministry of South Korea has confirmed an outbreak of FMD. Previously, a case was discovered at a hog farm in the south part of the Chungcheong Province in March 2016.

The outbreak comes as South Korea, the fourth largest economy in Asia, has been grappling with a countrywide spread of virulent bird flu virus that was first detected in November 2016, prompting authorities to cull more than 33 million farm birds.

Authorities will soon hold a meeting to discuss further measures to contain the spread of the disease, including an absolute ban on movements by livestock as well as people who spent time at farms in North Chungcheong.

General: HealthRegion: South Korea
Categories: US News

Altria trying to figure out if recalled tobacco products were tampered with

Sat, 02/04/2017 - 16:17
Altria trying to figure out if recalled tobacco products were tampered with

Altria Group Inc., one of the world's largest producers and marketers of tobacco, cigarettes and related products, announced on Friday that it was working with government authorities to determine if it's recently recalled smokeless tobacco products were tampered with.

Earlier this week, Altria issued a voluntary recall for some of its smokeless tobacco products after more than half a dozen consumers complained that they found sharp metal objects in some cans.

The recall of smokeless tobacco products involved certain cans made in the company's Franklin Park, Illinois, facility. The company said there might be a deliberate, malicious act by someone familiar with the quality and safety procedures at its manufacturing facility in Illinois.

Confirming the ongoing investigation, Altria said, "We believe this was a deliberate, malicious act by an individual or individuals familiar with the quality and safety procedures at its Franklin Park, IL facility."

The tobacco giant is retrieving recalled products from wholesale, retail as well as individual consumers. Smokeless tobacco products made at a separate facility aren't affected by the recall.

General: HealthCompanies: Altria
Categories: US News

President Trump takes Hair Loss Drug Propecia: Physician

Sat, 02/04/2017 - 03:38
 Physician

President Donald Trump’s physician Dr. Harold N. Bornstein has revealed in a recent New York Times interview about the drugs he takes for hair loss and rosacea. Dr. Bornstein informed that he hasn’t had any contact with Mr. Trump after he became President. During the elections, health issues of President Trump became an election issue but his doctor gave him a certificate of perfect health to lead the country.

Dr. Bornstein informed that Trump takes propecia for hair loss and the medication has helped his condition. Additionally, Dr. Bornstein informed that President Trump also takes medication for rosacea. He also takes regular dosage of aspirin to reduce his risk of health disease.

Propecia is a popular medication for hair loss. It is a low-intensity dosage of finasteride that is prescribed to men with enlarged prostate glands. It is usually sold under the brand name Proscar. The drug blocks the body's production of male hormones.

Propecia was approved by the U.S. FDA in year 1997 for male pattern baldness. The low-cost dosage of finasteride is only allowed for men. The FDA hasn’t permitted propecia for women or children.

Regarding the interview with New York Times, a senior White House official has informed that Dr. Bornstein wasn’t having President Trump’s permission to talk about his health.

During elections, Dr. Bornstein gave the certificate of good health to President Trump. He said, "If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency."

Regarding the possible side effects of Propecia, pharmaceutical company Merck says, “Patients taking the drug should promptly notify their doctor if they experience changes in their breasts, rash, itching, hives, swelling of the face or hands, or difficulty breathing or swallowing.”

As per reports, “The FDA-approved pill has been called into question, with emerging research and a slew of lawsuits suggesting that finasteride may be more dangerous than previously believed. Users report that its side effects — inability to orgasm, painful erections, chronic depression, insomnia, brain fog, and suicidal thoughts — can last long after patients stop taking the pill.”

Region: United StatesGeneral: FeaturedHealthPeople: Donald Trump
Categories: US News

Doctors, nurses urge Cleveland Clinic system to cut ties to Trump

Fri, 02/03/2017 - 17:52
Doctors, nurses urge Cleveland Clinic system to cut ties to Trump

Hundreds of medical professionals and students have urged the Cleveland Clinic hospital system to cut its ties to President Donald Trump in light of his controversial executive order that has banned people from some Muslim-majority countries from entering the United States.

A large number of physicians, nurses and students signed an open letter yesterday pleading with the hospital system to publicly condemn the executive order that banned immigration from seven countries. They urged the system to use its influence to protect medical professionals from forced banishment.

They also urged the system to cancel a fundraiser scheduled for later this month at President Trump’s Palm Beach, Fla.-based Mar-a-Lago resort.

The open letter reads, “Through this action you are supporting a president who has, in his first ten days in office, reinstated the global gag rule, weakened the Affordable Care Act, fast-tracked construction of both the Keystone XL and Dakota Access Pipelines through legally protected native lands, and banned legal U.S. residents from majority-Muslim countries.”

Cleveland Clinic spokesperson Eileen Sheil said the hospital system is incredibly proud of its highly diverse workforce as well as patient population. But, Sheil indicated that the planned fundraiser could not be cancelled because the sole purpose of the event is to raise funds for important research.

General: HealthResearchCompanies: Cleveland
Categories: US News

Healthy Indiana Plan seeks extension until Jan. 31, 2021

Thu, 02/02/2017 - 17:59
Healthy Indiana Plan seeks extension until Jan. 31, 2021

As U.S. President Donald Trump and Republican Congressmen are pushing ahead with their plan to repeal of the Affordable Care Act (ACA), Vice President Mike Pence’s home state of Indiana on Tuesday sought to extend a regulatory waiver and funding for the healthcare program for the next many years.

Indiana requested the Trump administration to allow it to extend its package of incentives & penalties intended to encourage low-income Medicaid families to adopt healthful behaviors until Jan. 31, 2021.

Under the state program, beneficiaries have to pay premiums for getting health savings accounts. They can lose their benefits in case they miss payments.

V.P. Pence is now in support of the idea to repeal ACA, which is also known as Obamacare, but the Healthy Indiana Plan that he had launched in 2015 as the state’s governor has provided Medicaid coverage to more than 350,000 residents.

In its request, Indiana said continuing the Medicaid expansion would cost it an estimated $1.5 billion but it would bring it $8.6 billion in federal funding from 2018 to 2020.

Gov. Eric Holcomb, a Republican, said, “Indiana has built a program that is delivering real results in a responsible, efficient, and effective way. I look forward to maintaining the flexibility to grow this remarkably successful tool and to preserve our ability to respond to the unique needs of Hoosiers.”

Indiana’s request demonstrates how even Republican-controlled states that expanded their Medicaid health programs under the ACA have become dependant on additional federal dollars to pay for those expansions.

General: HealthPeople: Mike Pence
Categories: US News

Researchers find link between air pollution and Alzheimer’s disease

Wed, 02/01/2017 - 18:40
Researchers find link between air pollution and Alzheimer’s disease

Exposure to diesel soot and other sorts of fine-particle pollutants in the air may significantly increase the risk of dementia and Alzheimer’s disease, according to a new study.

Led by Dr. Jiu-Chiuan Chen of USC, a team of researchers found that elderly women living in parts of the U.S. where fine-particle air pollution surpassed federal health standards were roughly twice as likely to suffer dementia and the Alzheimer’s disease.

Women with high genetic predisposition for the Alzheimer’s disease faced an even higher risk, a 263 per cent higher risk for the devastating disease, than others.

The researchers also warned against the Trump administration’s potential actions against existing environmental regulations, which may soon come under heavy fire.

Speaking on the topic, Chen warned, “If people in the current administration are trying to reduce the cost of treating diseases, including dementia, then they should know that relaxing the Clean Air Act regulations will do the opposite.”

If findings of the new study hold up in the general population, air pollution could be responsible for nearly 21 per cent of overall dementia cases.

The researchers reported their findings in the latest (Jan. 31st) edition of the journal Translational Psychiatry.

General: HealthResearch
Categories: US News

BMA asks medical staff not to use term ‘expectant mother’

Tue, 01/31/2017 - 17:46
BMA asks medical staff not to use term ‘expectant mother’

The British Medical Association (BMA), a prominent group representing medical professionals in Great Britain, has instructed its staff not to use the term “expectant mother” as it may offend transgender and intersex patients.

The BMA asked medical professionals to instead use the term “pregnant people” for transgender and intersex people. The guidelines, published in a fourteen-page booklet titled “A Guide To Effective Communication: Inclusive Language In The Workplace,” is part of the association’s effort to battle stigma and discrimination that often keep transgender and non-binary individuals from receiving health care.

The internal document reads, “Gender inequality is reflected in traditional ideas … large majority of people that have been pregnant or have given birth identified as women. We can include intersex men and transmen who may get pregnant by saying 'pregnant people' instead of 'expectant mothers'.”

Under the new guidelines, medical staff members in the network have also been instructed to call anyone who is biologically male or female as “assigned male or female.”

The workplace guidelines are expected to influence doctors and other medical staff to adopt a more inclusive attitude toward patients as well as one other. Experts have welcomed the move, saying the changing terminology is a positive thing for everyone.

General: HealthCompanies: BMA
Categories: US News

France bans unlimited soda refills to fight obesity

Mon, 01/30/2017 - 17:25
France bans unlimited soda refills to fight obesity

Pushing ahead with their fight against obesity, French authorities have officially banned unlimited refills of sugary drinks across the nation.

Starting Jan. 27th, any restaurant that will offer unlimited soda refills to customers will be prosecuted by government authorities. The new measure against obesity comes nearly five years after the nation slapped a tax on sweetened beverages.

France’s decision is in line with the recommendations of the WHO, which has strongly recommended nations to impose a tax on sugary beverages to fight increasing obesity rates and support its health policy.

The Fiscal Policies for Diet & Prevention of Non-communicable Diseases states, “A meta-review … showed that the evidence was strongest and most consistent for the effectiveness of SSB taxes in the range of 20-50 percent in reducing consumption, and of fruit and vegetable subsidies in the range of 10-30 percent in increasing consumption.”

In 2004, French authorities put a ban on vending machines in school canteens. Earlier in 2011, they restricted the servings of french fries to once per week in schools.

France’s obesity rate was 15.3 per cent in 2014, below the EU average of 15.9 per cent. Among the European nations, Malta has the highest obesity rate at 26 per cent, while Romania has the oldest obesity rate at 9.4 per cent.

General: HealthRegion: France
Categories: US News

Trump administration moves make climate scientists anxious

Sun, 01/29/2017 - 14:35
Trump administration moves make climate scientists anxious

The Trump administration’s moves in the recent past have triggered concerns among climate scientists, who worry that the new federal government could suppress climate change research and conceal facts.

Dr. Georges Benjamin was scheduled to speak at the opening session of the Centers for Disease Control & Prevention’s climate & health conference, which was planned to discuss the health effects of climate change. But, just ahead of the Trump administration’s inauguration, he was informed that the conference had been cancelled.

Like many other federal agencies, employees in the Agricultural Research Service (ARS) were recently asked to keep silent and not to share anything with the public without prior approval.

Sharon Drumm, chief of staff at the agency, “Starting immediately and until further notice, ARS will not release any public-facing documents. This includes, but is not limited to, news releases, photos, fact sheets, news feeds and social media content.”

Republican President Trump is a vocal skeptic of the notion that industrial activity is warming our planet, a position held by 97 per cent of the world’s climate scientists. He has repeatedly called the notion a ‘hoax’ created by China to undermine the Unites States’ economy.

General: HealthPeople: Donald Trump
Categories: US News

FDA urges parents not to use belladonna-containing teething tablets

Sat, 01/28/2017 - 14:45
FDA urges parents not to use belladonna-containing teething tablets

The U.S. Food & Drug Administration (FDA) on Friday advised parents not use Hyland’s homeopathic teething tablets that contain a toxic substance called belladonna.

Belladonna, which commonly known as deadly nightshade, is a potentially dangerous toxic substance that can affect the health of infants.

Los Angeles-based Standard Homeopathic Co., the producer of Hyland’s, has already discontinued the belladonna-containing products.

Discontinuing the products on Oct. 7, the company said, “We discontinued it because we are committed to our moms and our dads who choose to trust us to put medicines in their young infants' mouths, and we didn't want to put them in a place between the FDA warning and us saying the product was safe.”

Homeopathic teething tablets containing belladonna, which provide temporary relief to infants growing their first teeth, have been around in the United States since the early 1900s.

The FDA originally warned against the tablets in 2010 after a study showed that they contained belladonna in inconsistent amounts. Since then, the federal agency has received hundreds of reports of adverse events, such as seizures and some infant deaths, linked to teething products.

General: HealthCompanies: FDA
Categories: US News

Medieval skeleton offers clues to history of leprosy

Fri, 01/27/2017 - 17:15
Medieval skeleton offers clues to history of leprosy

An analysis of a skeleton unearthed from a burial site in the U.K. has revealed clues to the history of infectious disease of leprosy, researchers reported.

The skeleton was unearthed during an excavation of the medieval site of Winchester, England-based St. Mary Magdalen hospital cemetery and chapel. Radiocarbon dating of the skeleton revealed that it was buried sometime during the late 11th or early 12th Century.

Scientific detective work suggested that the remained belonged to a male religious pilgrim who might have caught leprosy during his travels. The analysis also allowed researchers to genotype the disease.

The study also revealed that leprosy-causing bacteria have slightly changed over hundreds of years, probably explaining the decline in the devastating disease after it peaked in medieval Europe and humans gradually developed resistance to it.

However, the 2F strain lineage that was genotyped by the researchers is still linked with some cases in regions like south-central and western Asia. Though the disease continues to occur, it was removed as a public health issue in 2000, which means that it affects less than one case per 10,000 individuals.

Leprosy, which primarily affects the patient’s skin, eyes and nerves, is now totally curable with multidrug therapy, which the World Health Organization (WHO) has been distributing for free since 1995.

Companies: WHOGeneral: HealthRegion: United Kingdom
Categories: US News

Cervical cancer even deadlier to U.S. women than doctors previously thought

Thu, 01/26/2017 - 17:19
Cervical cancer even deadlier to U.S. women than doctors previously thought

The disease of cervical cancer is even deadlier to American women than health experts previously thought, with African-American women being at particularly higher risk, according to a new study.

According to the study, most women get cervical cancer from HPV (human papillomavirus) infection, which is the most common sexually transmitted disease in the United States. As per an estimate by the Centers for Disease Control and Prevention (CDCP), more than 11,000 women in the nation are diagnosed with cervical cancer annually.

Laura Kilpatrick, a cervical cancer survivor, said she was 29 years old and was flying back to her home in Greensboro from her honeymoon when she first realized something went wrong.

Sharing her unpleasant experience, Kilpatrick said, "I was soaked in blood, and a week later, a doctor diagnosed me with cervical caner . I don't think that you can put into words that feeling of what that news is like."

However, there are some ways to avoid the potentially deadly disease, and the Gardasil vaccine is one of them. Doctors recommend boys and girls receive their first three Gardasil shots at age of 11 or 12 years. But, one can receive vaccinate up to age of 26 years.

The alarming findings of the new study were published earlier this week, as January is being observed as the Cervical Cancer Awareness Month.

General: HealthResearch
Categories: US News

FDA grants priority review for Genentech’s Actemra to treat GCA

Wed, 01/25/2017 - 17:50
FDA grants priority review for Genentech’s Actemra to treat GCA

The U.S. Food & Drug Administration (FDA) has reportedly accepted Genentech’s supplemental biologics license application and has granted priority review for Actemra for the treatment of patients with giant cell arteritis (GCA).
GCA is a chronic and potentially life-threatening autoimmune condition, for which there has been no new treatment in more than five decades.

Dr. Sandra Horning, chief medical officer and head of the global product development division at Genentech, said that the positive outcome demonstrated the company’s commitment to helping needy patients.

Announcing the FDA’s decision, Horning said, “This positive outcome in [giant cell arteritis] GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs.

The positive outcome is based on the results of the phase 3 GiACTA research of 251 patients that showed Actemra combined with glucocorticoid led to sustained remission of GCA as compared with a steroid taper regimen alone.

Horning stressed that they would continue to work closely with the federal agency to bring the investigational medicine to individuals with GCA at the earliest possible.

General: HealthCompanies: FDA
Categories: US News




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