XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration. This will help healthcare providers seamlessly incorporate this ready-to-use solution into their clinical practice.

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Pharmaceutical Technology

MAY 16, 2023

Lecanemab, the brand name of which is LEQEMBI in the US, is indicated to treat mild cognitive impairment caused due to AD and mild AD in people with confirmed presence of amyloid pathology in the brain. In January 2023, the US Food and Drug Administration (FDA) approved lecanemab under the accelerated approval pathway to treat AD.

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Antibody FDA Approval Branding Regulation 130

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.

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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.

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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?

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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

pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. The CONFIRM trial met its primary endpoint of verified HRS reversal, defined as renal function improvement, avoidance of dialysis, and short-term survival.

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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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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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pharmaphorum

AUGUST 2, 2021

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. The post FDA approves AZ’s anifromulab, ending 10-year lupus drug drought appeared first on.

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FDA Approval Drugs Sales 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.

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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

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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.

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Drug Delivery Systems Drug Delivery FDA Approval Drugs 104

XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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FDA Approval Drugs Sales Development 101

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. Another potential lupus nephritis rival is Aurinia Pharma’s voclosporin, which hit the mark last year in the phase 3 AURORA trial.

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FDA Approval Contract Manufacturing Sales Trials 99

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. The medicine is expected to be available on the market in late October.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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FDA Approval Manufacturing Trials Clinical Trials 52

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

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.

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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.

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FDA Approval Marketing Containment Drugs 116

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

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FDA Approval Vaccination Vaccine Containment 52

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

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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.

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XTalks

SEPTEMBER 12, 2023

By fostering a sense of community, addressing pain points and sharing impactful stories, podcasts can strengthen ties with an audience, drive brand loyalty and help life science organizations position themselves for long-term success in an increasingly competitive landscape.

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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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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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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.

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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.

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XTalks

MARCH 27, 2023

The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. The Phase III results support the ongoing development of rezafungin based on efficacy and safety.

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The Pharma Data

DECEMBER 17, 2020

In a pivotal head-to-head Phase III SOPHIA clinical trial, it became the first HER2-targeted therapy to improve progression-free survival (PFS) versus Herceptin® (trastuzumab), when each was combined with chemotherapy. This will be the first branded proprietary product for Athenex, which will be launched in the U.S. Athenex, Inc.

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FDA Approval Genomics Genome Production 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%

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Trials FDA Approval Clinical Trials Clinical Trials 59

pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. The flares can be serious enough to hospitalise patients with complications like heart failure, renal failure and sepsis.

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Drugs Antibody FDA Approval Trials 105

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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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.

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Drugs Hormones FDA Approval Clinical Trials 98