FDA Law Blog: Biosimilars

APRIL 8, 2025

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments.

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STAT

MAY 20, 2024

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.

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OCTOBER 25, 2023

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.

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STAT

OCTOBER 24, 2023

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.

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PharmaVoice

JULY 18, 2023

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.

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STAT

APRIL 19, 2024

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…

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STAT

JANUARY 5, 2024

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.

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STAT

DECEMBER 13, 2024

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.

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SEPTEMBER 24, 2022

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…

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JANUARY 9, 2023

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.

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Hospitals 252

STAT

NOVEMBER 8, 2023

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.

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NOVEMBER 4, 2022

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.

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NOVEMBER 4, 2022

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. 

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Hospitals 269

STAT

NOVEMBER 15, 2022

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.

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Drug Pricing 245

STAT

SEPTEMBER 3, 2024

“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.

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Drug Development 361

STAT

OCTOBER 2, 2023

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.

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Hospitals 308

STAT

JUNE 24, 2023

When Dana Lewis built her first artificial pancreas in 2014, she — and millions of other people with type 1 diabetes — didn’t have another option.

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STAT

MARCH 22, 2024

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

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MAY 21, 2024

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.

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JUNE 3, 2024

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.

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MAY 29, 2024

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.

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STAT

NOVEMBER 17, 2023

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.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

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.

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Pharmaceutical Technology

SEPTEMBER 27, 2023

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

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Express Pharma

FEBRUARY 3, 2025

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.

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Pharmaceutical Commerce

JANUARY 15, 2024

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.

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European Pharmaceutical Review

JUNE 19, 2025

Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/2005 Rev1. Guillen E, Ekman N, Barry S, et al.

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Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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ALiEM - Pharm Pearls

APRIL 12, 2023

Hynynen, 10.08 – Ultrasound Therapy, Editor(s): Anders Brahme, Comprehensive Biomedical Physics, Elsevier, 2014, Pages 153-168, ISBN 9780444536334. Egan, Pharmacology and Physiology for Anesthesia (Second Edition), Elsevier, 2019, Pages 390-411, ISBN 9780323481106. DOI: 10.1016/B978-0-323-48110-6.00020-X R. Alerhand S, Singh M, editors.

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The Pharmacist

MARCH 4, 2024

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.

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FDA Law Blog: Biosimilars

MARCH 18, 2025

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.

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The Pharmacist

MAY 31, 2023

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.

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Pharmacy Times

JANUARY 15, 2024

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.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

The panelists referred to other documents that are useful for CCS development: the 2014 Pharmaceutical Healthcare Sciences Society (PHSS) Technical Monograph No 20 Bio-Contamination 2 as well as the Parenteral Drug Association (PDA) Technical Report 90: Contamination Control Strategy Development, 3 published in February 2023.

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Documentation 128

STAT

SEPTEMBER 11, 2024

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.

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Vaccines 141

FDA Law Blog: Biosimilars

JULY 7, 2025

It’s not clear why there was a delay but better late than never.

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Documentation 52

BioPharma Dive

JANUARY 26, 2024

The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.

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