Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Pharmaceutical Technology

NOVEMBER 11, 2022

For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In October, the US Food and Drug Administration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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XTalks

JUNE 26, 2023

Surmodics will manufacture and supply the device and realize revenue from product sales to Abbott as well as a share of profits from Abbott’s third-party sales. SurVeil’s FDA approval was based on 24 months of data from the pivotal, head-to-head TRANSCEND clinical trial that compared it against Medtronic’s IN.PACT.

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XTalks

JUNE 3, 2024

First approved in 2011, Eylea’s market value was estimated to be $8.79 As one of Regeneron’s best-selling drugs, US sales of Eylea were approximately $5.89 First approved in 2022 and winning a subsequent approval in 2023 for macular edema following RVO, Vabysmo exceeded sales expectations earning about $2.7

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XTalks

OCTOBER 4, 2022

Register for this free webinar to learn new ways to operationalize hybrid oncology trials and how virtual sites help reduce patient burden. The featured speakers will discuss where the industry is headed with decentralized clinical trials and oncology. Clinical Trials and Commercialization. How Does Rolvedon Work?

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STAT News

DECEMBER 12, 2022

However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

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XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one.

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Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.

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XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5 BMS had targeted Camzyos in its acquisition of MyoKardia in 2020 for $13.1

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XTalks

JUNE 2, 2021

The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies. The oral treatment was approved for adults with locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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XTalks

DECEMBER 10, 2021

Biohaven’s Nurtec ODT is the first and only FDA-approved CGRP receptor antagonist available in a quick-dissolve ODT formulation. Based on the positive trial data, Biohaven says it plans to file a new drug application (NDA) for Zavegepant with the US Food and Drug Administration (FDA) in the first quarter of 2022.

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World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. It can’t be promotional or sales information and should not be a long document. 100 percent of U.S.

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XTalks

JULY 14, 2022

In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data. There were no new safety signals reported in the trial.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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Pharmaceutical Technology

JUNE 6, 2023

NRx Pharmaceuticals will receive an initial payment of $10m on obtaining successful findings from the ongoing Phase IIb/III clinical trial and on completion of a Type B meeting with the US Food and Drug Administration (FDA).

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XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. Janus kinase one (JAK1) plays a central role in the signaling pathways of several inflammatory cytokines.

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XTalks

JANUARY 29, 2025

This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval. This month, Zepbound won FDA approval for obstructive sleep apnea (OSA) , making it the first approved drug for the condition.

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XTalks

JANUARY 21, 2022

For AbbVie’s Rinvoq, the FDA approval is an expansion of its approval for the treatment of rheumatoid arthritis and psoriatic arthritis. On the other hand, this is the first US approval for Cibinqo. Dupixent has been a market hit since it was first approved by the FDA in 2017. It registered $4.4

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Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is claimed to be the only oral antifungal to receive approval from the US Food and Drug Administration (FDA) to treat VVC, as well as reducing RVVC incidence. Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection.

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XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. billion in revenue by 2024.

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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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Pharmaceutical Technology

JULY 29, 2022

CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.

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pharmaphorum

SEPTEMBER 1, 2021

The six-monthly has also been filed for approval in Europe, with a decision expected within the next few months. J&J’s current daily oral formulation, monthly injectable Invega Sustenna product and three-monthly depot Invega Trinza brought in sales of $1.9 billion in the first six months of this year.

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XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. billion for Calquence. GlobalData is the parent company of Pharmaceutical Technology.

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XTalks

FEBRUARY 9, 2024

As we delve into the top 15 cardiovascular disease drugs in 2023, guided by comprehensive 2022 sales data, we gain valuable insights into the market trends, drug efficacy and the evolving needs of patients worldwide. Read on to learn more about the top 15 cardiovascular disease drugs in 2023, based on 2022 sales statistics.

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World of DTC Marketing

JANUARY 10, 2022

Data were mainly accessible for smaller firms, effects in some therapeutic regions, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period.

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XTalks

NOVEMBER 1, 2024

This year, key players like Roche, AbbVie and Janssen have bolstered their offerings with therapies targeting multiple sclerosis (MS), migraines, schizophrenia and more, each leveraging unique mechanisms of action and clinical benefits that resonate with patient needs and treatment gaps.

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Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. Currently, there are 110 BiTEs in oncology clinical trials, with seven in Phase III and three in pre-registration.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

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pharmaphorum

OCTOBER 21, 2021

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. million in sales for the drug in the second quarter. Biogen reported $1.6

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pharmaphorum

OCTOBER 10, 2021

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. That isn’t approved to treat ANCA vasculitis, but has been tested in small-scale clinical trials alongside Rituxan as a steroid-free option.

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XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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