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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

The Pharma Data

JANUARY 21, 2021

Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

JANUARY 25, 2021

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. ATLAS and FLAIR Phase III Trials. Nine out of ten participants in the FLAIR trial preferred the long-acting Cabenuva to their daily oral treatment at week 48.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

DECEMBER 19, 2022

The success of Iyuzeh can be credited to scientists who were able to solubilize and stabilize latanoprost so that it does not require refrigeration at any point during manufacturing, distribution, or storage, like competing brands and generic latanoprost do. The NDA FDA approval is a milestone for the Thea Group.

Clinical Trials 98

Clinical Trials Clinical Trials FDA Approval Life Science 98

XTalks

JANUARY 6, 2021

Some include Mind Medicine, Compass Pathways and Champignon Brands. Scott Freeman said in a statement , “our ability to start this trial on schedule speaks volumes to both the efficiency and high caliber clinical development team Mind Medicine has assembled to develop medicines based on psychedelics. Champignon Brands.

Drugs 97

Drugs Clinical Trials Clinical Trials Medicine 97

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. This initial approval was only for treatment of excessive daytime sleepiness. Wake up and go to sleep.

FDA Approval 116

FDA Approval Marketing Containment Drugs 116

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

FDA Approval 85

FDA Approval Drugs Botox Sales 85

XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. Following the merger, Actavis rebranded itself as Allergan, leveraging the strong recognition of Allergans brand.

Marketing 104

Marketing Botox Life Science Pharma Companies 104

Pharmaceutical Technology

JULY 28, 2022

The therapy received FDA approval in October last year. Avastin, which is currently used as an off-label therapy for wAMD, is also of interest as Outlook Therapeutics is working on developing a branded version for this indication. In addition, as of this month, there are no approved therapies available for GA.

Marketing 130

Marketing Gene Therapy FDA Approval Development 130

XTalks

OCTOBER 27, 2021

Ranibizumab was developed by Genentech and is sold under the brand name Lucentis. It received FDA approval in 2018. In September, the FDA approved Samsung and Biogen’s Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis for the treatment of nAMD and other eye diseases and conditions. Eylea registered $4.95

Drug Delivery Systems 104

Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

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. Still, Funding is not the only issue.

Research 275

Research Trials Drugs Generic Drugs 275

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

Drugs 98

Drugs Hormones FDA Approval Clinical Trials 98

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

FDA Approval 52

FDA Approval Development Production Drugs 52

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.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

Pharmaceutical Technology

FEBRUARY 6, 2023

While norursodeoxycholic acid, a PSC drug is in Phase III of clinical trials, bexotegrast is one of 14 drugs in ongoing Phase II clinical trials. The FDA approved both drugs in 2014. The company said a Phase IIb trial initiation should be expected in mid-2023.

Marketing 147

Marketing Clinical Trials Clinical Trials Drugs 147

pharmaphorum

NOVEMBER 22, 2021

In late 2006, BRAVEMIND was tested in San Diego, California, at the Naval Medical Center and Camp Pendleton, and good clinical data was obtained in the initial open clinical trials. Other groups started to adopt the platform, which led to more research as to its clinical efficacy. VR clinical trials.

Clinical Trials 116

Clinical Trials Clinical Trials Gerontology Trials 116

XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

XTalks

FEBRUARY 8, 2024

From ads for DexCom’s continuous glucose monitor featuring singer Nick Jonas, Bristol-Myers Squibb’s plaque psoriasis drug Sotyktu (deucravacitinib), an unexpected ad for clinical trials and Astellas Pharma’s menopause awareness campaign, there was a notable pharma presence at the Super Bowl last year. billion Japanese yen ($8.8

Life Science 105

Life Science Marketing Branding Drugs 105

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.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

Delveinsight

AUGUST 3, 2021

Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).

FDA Approval 98

FDA Approval Marketing Cardiology Production 98

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.

Generic Pharmaceutical 69

Generic Pharmaceutical Production Medicine Branding 69

Pharma Marketing Network

MARCH 3, 2025

Digital advertising campaigns allow pharmaceutical brands to connect with their audiences at critical moments in the healthcare journey. Omnichannel Engagement : A combination of display, search, video, and programmatic ads ensures brands stay top-of-mind across multiple platforms. Ensure your ads are responsive and load quickly.

Compliance 52

Compliance Branding Doctor Doctors 52

Pharma Marketing Network

MARCH 3, 2025

Digital advertising campaigns allow pharmaceutical brands to connect with their audiences at critical moments in the healthcare journey. Omnichannel Engagement : A combination of display, search, video, and programmatic ads ensures brands stay top-of-mind across multiple platforms. Ensure your ads are responsive and load quickly.

Compliance 52

Compliance Branding Doctor Doctors 52

XTalks

MAY 31, 2023

The success of Acelyrin can be attributed to its industry-leading immunology portfolio and a robust pipeline of clinical and preclinical programs. Izokibep has progressed to Phase II/III clinical trials for multiple indications, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and uveitis.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Production 97

pharmaphorum

OCTOBER 1, 2022

While that may still be enough to secure FDA approval, the latest fail won’t help restore positive sentiment to the OCA programme in NASH, and will reinforce the view that its efficacy is modest. In REVERSE, 11.1%

Trials 59

Trials FDA Approval Clinical Trials Clinical Trials 59

pharmaphorum

AUGUST 20, 2021

The green light was expected after the EMA’s CHMP scientific committee in June, which issued a positive opinion on Evrenzo based on phase 3 trial results which showed the drug helped people with CKD anaemia hit target haemoglobin levels, regardless of dialysis status and prior ESA treatment.

Sales 59

Sales Regulation FDA Approval Drugs 59

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

pharmaphorum

DECEMBER 17, 2020

Clinical & regulatory activity. The company has conducted three Phase 3 clinical trials evaluating the efficacy and safety of Tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis: two monotherapy trials (BLOCK and PHREEDOM) and one dual mechanism trial (AMPLIFY).

Trials 104

Trials FDA Approval Marketing Development 104

XTalks

APRIL 5, 2024

Last month, Amylyx reported results from the global PHOENIX Phase III clinical trial that were unable to confirm the drug’s effectiveness. In Europe, the drug, branded Albrioza, was turned down by the European Medicines Agency (EMA), a decision that Amylyx appealed and lost in October 2023.

Trials 98

Trials Drugs Marketing FDA Approval 98

The Pharma Data

DECEMBER 13, 2020

The company believes the clinical comparability requirement will be met if the time to neutrophil engraftment in patients from the company’s ongoing expanded access program (EAP) using omidubicel produced at Gamida Cell’s planned commercial manufacturing sites is consistent with the results achieved in the Phase 3 clinical trial.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Delveinsight

DECEMBER 27, 2020

NRX-101 is a proprietary, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator; and Lurasidone (Latuda), a 5-HT2a receptor antagonist. It is under phase II clinical trial for Bipolar I depression in the US and Japan, which is being conducted by Sumitomo Dainippon Pharma and Sunovion.

Marketing 52

Marketing Clinical Trials Clinical Trials Trials 52

The Pharma Data

JUNE 18, 2021

Today, the brand is launching ‘ See Yourself’ , a new campaign featuring documentary style shorts that dive deep into the stories of real BOTOX ® Cosmetic patients – people of all shapes, sizes, backgrounds, colors, and origins. Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table.

Botox 52

Botox Cosmetics Doctor Doctors 52

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

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. About Rivaroxaban (Xarelto ) Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto.

Clinical Trials 52

Clinical Trials Clinical Trials Development FDA Approval 52

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. It is sold under the brand name Plaquenil and is available only by prescription.

Marketing 52

Marketing Sales FDA Approval Antibody 52