XTalks

JUNE 17, 2024

“We are thrilled with the FDA’s approval of Letybo. This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US,” said James Hartman, president of Hugel America in the news release. “As 134 How Does Letybo Work?

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FDA Approval Marketing Botox Clinical Trials 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year.

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XTalks

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals’ liquid version of its epilepsy drug zonisamide (100 mg/5 mL; brand name Zonisade) as an adjunct therapy for the treatment of partial seizures in adults and pediatric patients 16 years of age and older with epilepsy.

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XTalks

DECEMBER 19, 2022

Register for this free webinar to learn about the value of imaging data as a real-world data source, and the power of linking it with clinical data stored in electronic health records (EHRs) to inform research across the drug and device lifecycle for life sciences. The NDA FDA approval is a milestone for the Thea Group.

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Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Fox Foundation gave Sanacora a $2 million grant to study the drug’s use for depression in patients with Parkinson’s disease.

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XTalks

NOVEMBER 1, 2024

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. It is a biologic drug available exclusively as a brand-name medication, with no generic or biosimilar forms available. billion in the US and $4.1

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FDA Approval Drugs Botox Sales 85

XTalks

JANUARY 25, 2021

Cabenuva was actually expected to win FDA approval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time. Since then, Cabenuva received its first global approval in Canada in March 2020, followed by authorization in the EU in December under two separate brand names.

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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Filler FDA Approval Dermatology In-Vivo 92

XTalks

DECEMBER 19, 2022

On December 16, 2022, AbbVie announced in a press release that the US Food and Drug Administration (FDA) approved Vraylar as an adjunctive therapy to antidepressants for the treatment of MDD in adults. This approval positions Vraylar as the first and only dopamine and serotonin partial agonist for the most common forms of depression.

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XTalks

FEBRUARY 8, 2024

Related: Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes Lead Investigator Dr. Genevieve Neal-Perry Discusses New Trial Data for Astellas’ Menopause Drug Fezolinetant (Veozah) – Xtalks Life Science Podcast Ep. Bayer is preparing to file for FDA approval based on strong Phase III data it shared last month.

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XTalks

MAY 22, 2024

is one of the largest global medtech companies with diverse segments ranging from life science solutions to specialty diagnostics, analytical instruments and laboratory products and services. Danaher (Overall Rank 435) Danaher operates in three key areas: Biotechnology, Life Sciences and Diagnostics.

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XTalks

FEBRUARY 16, 2023

However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. billion during the same period.

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FDA Approval Sales Branding Drugs 105

XTalks

SEPTEMBER 28, 2023

In the first half of 2023, pharmaceutical drugs accounted for half of the most viewed new brands by TV ad impressions, according to an iSpot.tv The drug took off quickly after its approval given the growing popularity of GLP-1 agonists like rival Novo Nordisk’s Ozempic for the treatment of diabetes and off-label use for weight loss.

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XTalks

JANUARY 6, 2021

Some include Mind Medicine, Compass Pathways and Champignon Brands. Mind Medicine has multiple FDA-approved trials that are ongoing in multiple jurisdictions and geographies, along with drug developments efforts that include substances such as psilocybin, LSD, MDMA, DMT and their Ibogaine derivative, 18-MC. Champignon Brands.

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XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. In May, Eli Lilly reached a settlement with one of the medical spas.

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Pharmacy Drugs Production Sales 104

XTalks

AUGUST 31, 2023

Related: Non-Stimulant ADHD Drugs: Qelbree Versus Strattera According to the FDA, generics “work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.” The entry of Vyvanse generics into the market will certainly be welcomed by patients as generics are cheaper than the branded version.

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Marketing Branding Drugs Sales 98

XTalks

SEPTEMBER 6, 2024

Novartis is investing $200 million into expanding its Indianapolis, Indiana, site for in-house production of radioisotopes and constructing a brand new one in Carlsbad, California. The facilities are part of the company’s plans to expand its manufacturing and supply chain capabilities.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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XTalks

JUNE 14, 2023

The exact cost of Vevye has not been publicly disclosed; however, it is estimated that the price of Vevye may be in the range of similar cyclosporine ophthalmic emulsions, such as brand-name Restasis that carries a list price of $645.63 One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

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Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.

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XTalks

SEPTEMBER 21, 2023

The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Since the compounded versions of Mounjaro are not FDA approved, Lilly said they may expose patients to potentially serious health risks.

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Pharmacy FDA Approval Drugs Containment 59

pharmaphorum

NOVEMBER 22, 2021

Skip created a virtual classroom to test children with ADHD and is now working with a company that collects data with this application to support the path to FDA approval. Pharma can also utilise VR technology to aid in their research, such as testing new medications for children with ADHD. About the author .

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XTalks

JUNE 8, 2022

Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar. Biosimilars are less expensive than their reference products because of lower R&D costs and a shorter and cheaper path to approval due to reduced clinical trial requirements.

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Generic Pharmaceutical Production Medicine Branding 69

XTalks

MARCH 16, 2022

Exact Sciences and long-time colon cancer screening advocate and award-winning journalist Katie Couric have teamed up for Colon Cancer Awareness Month this March in a TV ad for the company’s at-home screening test Cologuard. The ad is part of Exact Sciences’ “Mission to Screen” campaign that was launched this week.

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DNA FDA Approval Doctors Doctor 98

XTalks

APRIL 5, 2024

The life expectancy after symptoms develop is around two to five years. Relyvrio’s FDA approval was seen as controversial from the get-go as it was based on data from a small Phase II trial that showed a modest slowing of disease progression in patients who received the drug.

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Trials Drugs Marketing FDA Approval 98

XTalks

FEBRUARY 20, 2024

Related: Tarpeyo (Budesonide) Is Transforming IgA Nephropathy Care with FDA’s Full Approval Recently FDA-Approved Drugs for IgA Nephropathy In December of last year, Calliditas Therapeutics announced the FDA approval of its budesonide delayed-release capsules, branded as Tarpeyo , for the treatment of IgA nephropathy.

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Clinical Trials Clinical Trials FDA Approval Antibody 59

XTalks

MAY 31, 2023

As the world’s largest pure-play consumer health company in terms of revenue, Kenvue is renowned for its portfolio of iconic brands, including Aveeno, BAND-AID Brand Adhesive Bandages, Johnson’s, Listerine, Neutrogena, Tylenol and Zyrtec.

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Clinical Trials Clinical Trials Trials Production 97

XTalks

MARCH 13, 2024

Novo’s weight loss version of Ozempic is branded Wegovy (semaglutide). Lilly said it doesn’t endorse use of the medications “outside of a medicine’s FDA-approved indication.” This has sparked criticism as those who need the medicines to manage their type 2 diabetes or obesity are facing challenges in accessing them.

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Medicine Cosmetics FDA Approval Drugs 52

XTalks

SEPTEMBER 12, 2023

Life science podcasts have emerged as an invaluable tool for building connections with audiences in the digital era. Furthermore, we’ll explore the unique advertising opportunities that this platform offers, positioning brands at the forefront of the life science industry. The result?

Life Science 105

Life Science Branding Clinical Trials Clinical Trials 105

XTalks

JUNE 3, 2024

AbbVie has launched another new direct-to-consumer (DTC) TV commercial for Vraylar (cariprazine), a US Food and Drug Administration (FDA)-approved medication used for treating bipolar depression and schizophrenia in adults.

Marketing 52

Marketing Drugs FDA Approval Clinical Trials 52

XTalks

AUGUST 30, 2022

Biogen’s nusinersen (brand name Spinraza) is an antisense oligonucleotide (ASO) therapy that is administered directly into the CNS by intrathecal injection through lumbar puncture. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Nusinersen: A Landmark Therapy.

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Trials Drug Delivery Drugs Gene 83

XTalks

MARCH 19, 2025

This week, were celebrating a significant milestone: the release of our 200th episode of the Xtalks Life Science Podcast ! We’re excited to continue our journey by bringing you more in-depth conversations with industry leaders, highlighting the innovations and trends that shape the future of life sciences.

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Life Science Branding Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Approval Drugs Sales Development 101

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

OCTOBER 1, 2024

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s (BMS) Cobenfy (xanomeline and trospium chloride), formerly KarXT, for the treatment of schizophrenia, the first new class of drug for the disorder to hit the market in over four decades.

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FDA Approval Trials Medicine Sales 97

XTalks

FEBRUARY 9, 2024

For healthcare professionals and stakeholders in the life sciences sector, understanding the top-performing cardiovascular drugs is not just about recognizing their financial success. Marketing in both cardiac and hematological indications has contributed to its success, which continues to grow in emerging markets globally.

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Sales FDA Approval Drugs Marketing 59

XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. Humira Biosimilar Commercialization Agreements.

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