XTalks

JULY 14, 2022

Register for this free webinar for expert insights and an engaging discussion surrounding the utilization of electronic health record (EHR) data in clinical research and what the future might hold. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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XTalks

AUGUST 19, 2022

In a press release , bluebird said the approval of Zynteglo is “the culmination of nearly ten years of clinical research of gene therapy in patients with transfusion-dependent beta-thalassemia.”. Bluebird’s announcement of the FDA approval for Zynteglo led bluebird bio’s shares to jump seven percent this week.

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Gene Therapy FDA Approval Gene Clinical Trials 95

pharmaphorum

DECEMBER 22, 2022

Historically, digital therapeutics (DTx) companies have directed about 95% of their effort into gaining FDA approval and 5% into market access strategy. In 2023, this will shift to a 60%/40% split, with DTx companies having an earlier focus on the commercialisation process, while simultaneously working toward earning FDA approval.

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XTalks

MAY 25, 2022

On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia. This approval is significant because prior to Quell, there were no FDA-approved medical devices for fibromyalgia treatment.

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Velocity Clinical Research

AUGUST 15, 2024

Another milestone for patients with primary biliary cholangitis (PBC) — Gilead’s Livdelzi® (seladelpar) has received accelerated FDA approval as a second-line treatment for PBC. Congratulations to Gilead, Dr. Kowdley, the team in Seattle, and the patients who supported the Phase 3 trial and ongoing research on seladelpar and PBC.

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Velocity Clinical Research

SEPTEMBER 17, 2024

Velocity sites and investigators have now supported research for 12 products that received U.S. FDA approval in 2024! This year’s groundbreaking approvals include: Ebglyss (lebrikizumab-lbkz) by Eli Lilly, a new treatment for moderate to severe atopic dermatitis (eczema).

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Velocity Clinical Research

JULY 30, 2024

Velocity sites and investigators have supported research for nine products that have received U.S. FDA approval in 2024. These include, but are not limited to: Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), the first FDA-approved #MASH drug.

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XTalks

APRIL 13, 2022

The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinical research. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.

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XTalks

AUGUST 18, 2020

The study was funded by a clinical research agreement with the NBA and the players’ union – the National Basketball Players Association (NDG) – which together, contributed over $500,000 to fund the Yale study. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. It’s sensitive.

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XTalks

OCTOBER 24, 2024

Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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XTalks

NOVEMBER 15, 2024

In June, Geron’s telomerase inhibitor Rytelo (imetelstat) won FDA approval for patients with low- to intermediate-risk MDS with transfusion-dependent anemia. This is significant as the therapy can reduce or eliminate the need for frequent blood transfusions.

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Trials HR Immune Response FDA Approval 105

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The FDA approval paves the way for the immunotherapy to undergo review in other countries.

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Insulin FDA Approval Research Development 246

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Khanani, director of clinical research at Sierra Eye Associates, Reno, Nevada, in Iveric Bio’s news release.

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XTalks

OCTOBER 18, 2024

Additionally, the FDA approved FoundationOne Liquid CDx as a companion diagnostic, enabling early detection of PIK3CA mutations through a routine blood test to help identify patients most likely to benefit from Itovebi. Why Target PIK3CA Mutations?

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Pharmaceutical Technology

MARCH 30, 2023

In a 29 March press release, the FDA stated that Lupus ABC will bring voices together in a centralised forum to define challenges in drug development and analyse potential approaches to help advance therapies. Lupus is a difficult to treat – it has a range of symptoms and is poorly understood.

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Development Drugs FDA Approval Clinical Development 162

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

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Scienmag

JUNE 3, 2022

The repurposing of FDA-approved drugs for alternative diseases is a faster way of bringing new treatments into the clinic. Researchers at Karolinska Institutet in Sweden have repurposed a cancer drug for treatment of neuroinflammatory diseases such as multiple sclerosis.

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Drugs Drug Delivery FDA Approval Clinical Research 73

pharmaphorum

SEPTEMBER 1, 2021

This week Teva filed for FDA approval of a new monthly or two-monthly formulation of risperidone that if approved could increase the injectable options for patients further. The FDA approval is based on data showing it is as effective as Invega Trinza formulation, keeping 92.5%

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XTalks

JULY 6, 2023

Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla).

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Hormones FDA Approval Clinical Trials Clinical Trials 98

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

JULY 8, 2021

KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. 1) as determined by an FDA-approved test.

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XTalks

DECEMBER 29, 2023

New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC. In 2020, the FDA approved AstraZeneca’s Imfinzi (durvalumab) for use in combination with etoposide and either carboplatin or cisplatin as a first-line treatment for SCLC.

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Clinical Trials Clinical Trials FDA Approval Trials 119

Find Me Cure

OCTOBER 3, 2019

If you follow our blog, you know that we like to clear confusion about clinical trials. Also called clinical research studies, they don’t just test drugs. There are clinical studies that test new medical devices, diet and lifestyle changes, new procedures and even methods for prevention.

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XTalks

MARCH 18, 2025

Standard treatment strategies include combinations of antibiotics, hormonal therapies and biologic agents most notably adalimumab (Humira), the only FDA-approved biologic for moderate to severe cases while surgery remains an option for advanced disease.

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Trials Clinical Trials Clinical Trials Hormones 59

XTalks

FEBRUARY 12, 2025

Nerandomilast is Boehringers next candidate for PPF and IPF following their FDA-approved treatment, Ofev (nintedanib) one of only two approved therapies for IPF, alongside pirfenidone.

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Clinical Trials Clinical Trials Trials FDA Approval 66

Velocity Clinical Research

SEPTEMBER 24, 2024

Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG , played an integral role in the clinical research that first gained FDA approval in June 2024 , and has now led to the European Union’s approval of Ipsen’s Iqirvo, a groundbreaking therapy for primary biliary cholangitis (PBC), a rare liver condition.

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FDA Approval Clinical Research Medicine Trials 52

Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. A lot of immunotherapies cause side effects in the gastrointestinal tract, says Korman.

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Velocity Clinical Research

JUNE 12, 2024

Kris Kowdley, MD , contributed significantly to the clinical research program that led to accelerated FDA approval of Ipsen’s Iqirvo, a first-in-class treatment for primary biliary cholangitis (PBC), a rare liver disease.

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Research FDA Approval Clinical Research Clinical Trials 52

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Kaeberlein says such research is having a harmful effect on the regulatory side: “The FDA is watching this, and they can see it’s not scientific.”

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XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. Following the announcement, Valnevas stock rose by 1.4%.

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XTalks

JULY 3, 2024

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis.

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Drugs Clinical Trials Clinical Trials FDA Approval 105

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. “For

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FDA Approval Medicine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies.

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pharmaphorum

AUGUST 11, 2021

. “The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” said Dr Scot Ebbinghaus, Merck’s head of clinical research.

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Regulation FDA Approval Drugs Clinical Research 111

Worldwide Clinical Trials

FEBRUARY 26, 2024

From a combined perspective, somewhere along the way, we tend to be able to land at what is the true design of clinical research,” says Perez. The research provides valuable data to sponsors and researchers regarding what is most important to patients with these conditions. And, frankly, none of them are wrong.

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The Pharma Data

DECEMBER 16, 2020

.” In addition to directly funding medical research on lupus nephritis, the Foundation’s public policy initiatives helped secure nearly $2 million to support research on lupus and the kidneys through the U.S. Department of Defense Medical Research Program. About Lupus.

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