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The arm of the agency that handles submissions for medicines began requiring fees in September 2014, while the other unit overseeing cancer drugs took that step in April 2015.
After his spinal cord injury in 2014, Sherown Campbell worked hard to regain as much bodily function as he could. Once a dedicated athlete, Campbell had to learn the new limits of his body. One of them, jarringly, was his body’s inability to sweat.
Universities have also expanded their course offerings, with the number of new students enrolled in accredited midwifery programs growing from 1,006 students in 2014 to 1,214 in 2018 , according to the latest data available. more than doubled from 1991 and 2012 and has continued to grow steadily in the years since. Read the rest…
Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period. ” A Johns Hopkins University study published in 2015 showed that the pharmaceutical industry funds six times more clinical trials than the government. Continue to STAT+ to read the full story…
Editas Medicine, CRISPR Therapeutics, and Intellia Therapeutics were all started in the 2013-2014 time frame with the same goal of turning the nascent CRISPR gene-editing technology into medicines.
The researchers examined Medicare beneficiaries who were diagnosed with cancer and received treatment from 2014 through 2019. Overall, the proportion of patients who were prescribed so-called low-value drugs was higher when their oncologist accepted industry payments, according to the study, published in the BMJ.
A former WHO epidemiologist is applying lessons learned during the Ebola epidemic to her work leading a company at the forefront of women’s health: the reproductive microbiome.
hospitals and then tracked usage of seven antibiotics that were approved by the Food and Drug Administration between 2014 and 2019. They examined data spanning January 2016 through June 2021 at 619 U.S. Continue to STAT+ to read the full story…
Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
The timing of the change is telling: Flovent’s price rose nearly 50% since 2014, according to GoodRx , leaving the drug vulnerable to the new Medicaid penalties going into effect as of this year for medications with price increases that outpace inflation. Prasco, a U.S.
When I left Syria in 2014, I had a dream of becoming a U.S.-trained trained physician. I quickly realized that the American dream is real and that hard work truly pays off.
Amgen filed a lawsuit against the other companies in 2014 for allegedly infringing patents when they sought regulatory approval for their own medication. Continue to STAT+ to read the full story…
The researchers used clinician-level and practice acquisition data to study changes in the makeup of clinician workforces at private equity-acquired versus non-private equity-acquired dermatology, ophthalmology, and gastroenterology practices between 2014 and 2019.
Amgen filed a lawsuit against the other companies in 2014 for allegedly infringing patents when they sought regulatory approval for their own medication. At issue is a long-running battle between Amgen and a pair of rivals — Sanofi and Regeneron Pharmaceuticals — over the market for injectable cholesterol treatments.
But the drug was bought by Leadiant Biosciences which, by 2014, began raising the price in several countries before withdrawing the medicine from the market entirely the following year. At issue is a medicine called CDCA that is used to treat people with a rare genetic metabolic disease known as cerebrotendinous xanthomatosis, or CTX.
But a large-scale clinical trial from Medtronic in 2014 called renal denervation’s efficacy into question, as it did not significantly reduce blood pressure compared to placebo treatments. The therapy, a simple procedure to reduce the blood pressure of millions of Americans , was once seen as a boon for cardiologists and device makers.
When Tamiya Griffin was expecting her first child in 2014, she had what she thought was a straightforward plan: deliver at the hospital down the road, the same place her mother gave birth to her. But when Griffin, then a 22-year-old senior in college, went into labor a few weeks early, she had to undergo an emergency C-section.
When I learned that an outbreak of Ebola was declared in Uganda last fall, I had a flashback to 2014 when I was working at Merck and an outbreak of Ebola disease caused by a different species of the virus emerged in full force in West Africa.
“That she took everything she knew about the pharmaceutical industry, having been part of it, and has really built a powerful advocacy for multiple myeloma patients, is remarkable,” said Tony Coles, who was CEO of Onyx Pharmaceuticals, a myeloma-focused biotech, from 2008 to 2014.
Dispirited, she left in 2014 to work for consulting firm Avalere to build a device recall database. Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. Patients and doctors alike often knew very little about the safety record of their devices.
rival Pfizer in 2014 with an aggressive target of delivering $45 billion in revenue by 2023. The Anglo-Swedish group said it would grow its existing portfolio and launch 20 new medicines before the end of the decade, in areas including cancer care and rare diseases, to raise revenue from $45.8 billion in 2023.
But he was ousted in 2014 after an embarrassingly public conflict with the Sanofi board. At Sanofi, Viehbacher was largely responsible for repositioning the staid drugmaker and for deepening its partnership with Regeneron Pharmaceuticals. But Continue to STAT+ to read the full story…
Soriot fended off a bid by Pfizer in 2014, promising investors he could lead the company to better results on its own. He is largely credited with delivering on his pledges a decade ago, including by bolstering its cancer franchise and turning oncology into its biggest business segment.
million in 2014 to $250,000 in 2016. In New York City, for example, it quickly achieved a large share of the consumer transport business. Its market dominance was so profound that it drove down the cost of taxi medallions from $1.3
The insurer analyzed pharmacy and medical claims of nearly 170,000 people between July 2014 and December 2023 and found 58% did not complete a 12-week course of the medicines. Nearly one-third halted treatment within four weeks, before recommended dosages reached the targeted strength.
Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.
They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The The drugs, Folotyn and Beleodaq, have already been on the market for nearly a decade or more.
In 2014, he became Head of Emerging Markets, overseeing business operations in 80 countries, including Africa, the Middle East, Asia-Pacific, Eastern Europe, the Commonwealth of Independent States (CIS), and Latin America.
This period included the implementation of novel designation types: qualified infectious disease product designation (in 2012), breakthrough therapy (2013), rare pediatric drug designation (2014), and regenerative medicine advanced therapy designation (2017).
FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.
The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.
In the generic filers view, the regulatory review period should have started in January 2014 when the patent was reissued rather than in April 2004, when the IND was opened, because the reissued patent did not exist in April 2004. The plain text of 35 U.S.C.
The Cancer Research UK funded analysis has tracked survey responses since 2014 among more than 28,000 smokers in England. Perceptions of the safety of vaping have worsened considerably over the past decade amongst people who smoke, a UK study has found.
Dr Warner has been the deputy CPhO since 2014, having previously worked […] The post Dr Bruce Warner retires as deputy CPhO appeared first on The Pharmacist.
The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies.
The approval was based on the results of a phase 3 trial that found an improvement in progression-free survival among individuals treated with pembrolizumab.
It is only after 2014, when Prime Minister Narendra Modi took over that our researchers received the right kind of support to explore their potential, said Dr Jitendra Singh. Union Minister Dr Jitendra Singh formally launched the first indigenous antibiotic “Nafithromycin” for resistant infections.
Dr Singh highlighted the impressive growth of Indias bioeconomy, which has surged from $10 billion in 2014 to over $130 billion in 2024, with projections to hit $300 billion by 2030. The Biotech-PRIDE Guidelines introduced in 2021, are a testament to Indias commitment to ethical and secure data sharing.
No medications are currently approved for the treatment of obesity in children under age 12, though Saxenda was approved for adolescents in 2020 and for adults in 2014. The Novo-sponsored study was the first to examine the safety and efficacy of once daily injections of Saxenda, known chemically as liraglutide, in young children.
At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. Dr Se Hwan Yang, PhD, President and Chief Executive Officer, founded NeoImmuneTech in January 2014.
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