pharmaphorum

AUGUST 17, 2020

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies.

FDA Approval 66

FDA Approval Antibody Branding Trials 66

World of DTC Marketing

JUNE 2, 2021

One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.” Your physician audience should be segmented by parameters that are important to the success of your brand. They especially like data about clinical trial updates.

Doctors 180

Doctors Doctor Sales Marketing 180

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?

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

pharmaphorum

SEPTEMBER 1, 2021

The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the fewest doses per year of any schizophrenia medicine. of patients relapse-free at 12 months compared to 95% of the comparator group. .

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FDA Approval Sales Compliance Clinical Trials 113

XTalks

APRIL 5, 2024

Amylyx Pharmaceuticals announced yesterday that it will be pulling its ALS (amyotrophic lateral sclerosis) drug Relyvrio from the market after failing in a confirmatory trial. Last month, Amylyx reported results from the global PHOENIX Phase III clinical trial that were unable to confirm the drug’s effectiveness.

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Trials Drugs Marketing FDA Approval 98

Pharmaceutical Technology

NOVEMBER 29, 2022

The company now plans to move this approach into a Phase III trial. 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. PharmaTher is not the only player in this space.

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Research Trials Drugs Generic Drugs 275

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.

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FDA Approval Clinical Trials Clinical Trials Trials 52

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.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Drugs 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. Results from the two trials showed that the extended injectable formulation performed just as well as traditional oral medications to suppress HIV. Updated data from the trial showed 86.6

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

OCTOBER 27, 2021

Ranibizumab was developed by Genentech and is sold under the brand name Lucentis. It received FDA approval in 2018. Some common adverse events in the trial included eye pain, conjunctival hemorrhage, conjunctival hyperemia and iritis, with some cases eye infection. The refillable device is topped up every six months.

Drug Delivery Systems 104

Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

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

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

Pharmaceutical Technology

JUNE 12, 2023

The mechanism is notably faster than popular oral medications such as sildenafil, known by the brand name Viagra and marketed by Pfizer, and tadalafil, which is marketed by Eli Lilly as Cialis. The Guildford, UK-based Futura used data from two clinical studies to enable approval.

FDA Approval 130

FDA Approval Pharmacy Marketing Branding 130

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

pharmaphorum

JULY 20, 2021

The move came despite comprehensive label discussions and the filing of additional data in response to FDA feedback in April, as well as tenapanor meeting its primary and key secondary endpoints in three pivotal trials, he added. “Despite….advantageous “Despite….advantageous

Drugs 98

Drugs FDA Approval Marketing Branding 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

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.

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Marketing Botox Life Science Pharma Companies 104

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.

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Clinical Trials Clinical Trials FDA Approval Life Science 98

The Pharma Data

AUGUST 11, 2020

Photo by FDA/CDC. Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients. The drug would go under the brand name of Veklury. It has not received general approval to treat the virus in the US, but has in several European countries and Japan.

FDA Approval 52

FDA Approval Allergies Branding Drugs 52

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

pharmaphorum

OCTOBER 1, 2022

Intercept Pharma’s hopes of getting its non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA) in the US may have taken another dive, after it flunked a phase 3 trial. The post Intercept hit hard as NASH trial misses the mark appeared first on. In REVERSE, 11.1%

Trials 59

Trials FDA Approval Clinical Trials Clinical Trials 59

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.

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Marketing Gene Therapy FDA Approval Development 130

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

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

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics? Nusinersen: A Landmark Therapy.

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Trials Drug Delivery Drugs Gene 83

Pharmaceutical Technology

FEBRUARY 6, 2023

The company has attributed the success of the follow-on offering to the strength of Phase IIa INTEGRIS-IPF trial data. 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.

Marketing 147

Marketing Clinical Trials Clinical Trials Trials 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. VR clinical trials. In a recent trial, researchers compared exposure therapy using VR to traditional exposure therapy with combat vets.

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Clinical Trials Clinical Trials Gerontology Trials 116

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

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. for a 30-day supply (without insurance coverage).

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

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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Development Manufacturing Marketing Hormones 105

XTalks

FEBRUARY 20, 2024

The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. How Does Sibeprenlimab Work?

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

DECEMBER 17, 2020

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). All trials have met their primary endpoints.

Trials 104

Trials FDA Approval Marketing Development 104

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

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

Clinical Trial Podcast

FEBRUARY 23, 2021

Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. The reason why the project management role is so interesting is because it provides a holistic view of clinical trial management and clinical research. They are accountable of all aspects of a clinical trial.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up.

Drugs 52

Drugs FDA Approval Trials Pharmacy 52