Pharmaceutical Technology

MAY 25, 2023

It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

Pharmaceutical Technology

MAY 10, 2023

While the government said that Gilead secured its PrEP approvals only after CDC’s research on the topic, the company stated that there already were published materials on the potential use of antiretroviral therapies as PrEP prior to this. Gilead markets both Truvada and its successor Descovy.

Drugs 264

Drugs FDA Approval Containment Licensing 264

XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Voydeya’s FDA approval was based on positive results from the pivotal ALPHA Phase III trial.

FDA Approval 100

FDA Approval Sales Trials Development 100

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus, which currently has 360 approvals, has filed abbreviated new drug applications for more than 440 drugs since 2003-04.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

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.

FDA Approval 105

FDA Approval Sales Clinical Trials Clinical Trials 105

Pharmaceutical Technology

MAY 16, 2023

More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. decline in total aggregate market capitalisation from $3.61 Bayer reported the highest market capitalisation growth of 23.1% Sanofi and Regeneron’s market capitalisation grew by 12.4% This resulted in a 3.4%

Marketing 130

Marketing Sales Generic Drugs Vaccination 130

XTalks

JUNE 26, 2023

The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021. 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.

FDA Approval 95

FDA Approval Drugs Sales In-Vitro 95

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.

Doctors 180

Doctors Doctor Sales Marketing 180

Pharmaceutical Technology

DECEMBER 20, 2022

The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14

Marketing 130

Marketing Vaccination Vaccine Sales 130

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.

FDA Approval 148

FDA Approval Life Science Sales Marketing 148

XTalks

JUNE 21, 2024

While Merck says the vaccine is specifically designed for adults and covers serotypes that cause about 84 percent of IPD in adults 50 years of age and older, it is officially approved for adults 18 years of age and older. Pfizer’s Prevnar 20 was first approved in 2021 for adults 18 years of age and older and has since dominated the market.

FDA Approval 107

FDA Approval Vaccination Vaccine Life Science 107

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The drug generated domestic sales of $200.4 million last year, of which $131.3

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

Pharmaceutical Technology

MAY 19, 2023

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007.

Sales 148

Sales Production Marketing FDA Approval 148

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation. percent of US sales revenue from Niktimvo.

FDA Approval 96

FDA Approval Drugs Gene Trials 96

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

FDA Approval 98

FDA Approval Trials Sales Drugs 98

BioPharma Reporter

APRIL 25, 2024

Back in 2014, AstraZeneca and Merck were the first to receive FDA approval for their PARP inhibitor Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients.

FDA Approval 84

FDA Approval Sales Gene Marketing 84

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list.

FDA Approval 130

FDA Approval Sales Marketing Regulation 130

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.

FDA Approval 79

FDA Approval Vaccination Vaccine Immune Response 79

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

Marketing 130

Marketing Gene Editing Production Sales 130

Pharmaceutical Technology

OCTOBER 26, 2022

The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

World of DTC Marketing

MARCH 10, 2022

market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. Sales of Humira earned AbbVie $20.7 AbbVie won dozens of additional patents — what critics call a “patent thicket” — that extended the exclusive market for the drug. Richard Gonzalez, C.E.O.

FDA Approval 205

FDA Approval Drugs Branding Sales 205

XTalks

NOVEMBER 7, 2024

Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.” Emrosi consists of minocycline, a tetracycline antibiotic, to target bacterial infection that can underlie rosacea.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

XTalks

OCTOBER 4, 2022

Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

OCTOBER 25, 2022

Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo’s approval was based on results from the HIMALAYA Phase III trial , which showed that patients treated with the Imjudo and Imfinzi combination experienced a 22 percent reduction in the risk of death versus sorafenib.

FDA Approval 98

FDA Approval Trials Drugs Immune Response 98

pharmaphorum

NOVEMBER 24, 2020

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

FDA Approval 105

FDA Approval Medicine Licensing Licensing 105

World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Putting it on the market will stress Medicare’s resources.”

FDA Approval 239

FDA Approval Drugs Doctors Doctor 239

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Drugs 93

Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The therapy received FDA approval in October last year.

Marketing 130

Marketing Gene Therapy FDA Approval Development 130

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

FDA Approval 148

FDA Approval Marketing Manufacturing Sales 148

World of DTC Marketing

OCTOBER 21, 2021

Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 That money is gone without any clinical benefit and the executives at those drug companies received compensation because of those sales. This is another example of just how screwed up our healthcare system really is.

Clinical Trials 234

Clinical Trials Clinical Trials FDA Approval Trials 234

World of DTC Marketing

JANUARY 10, 2022

A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period. million (95% CI, $683.6 million $1228.9

Production 213

Production Drugs Development Marketing 213

Pharmaceutical Technology

JUNE 6, 2023

Lotus will purchase global rights for NRX-101 and handle the commercialisation activities of the product in markets outside the US. Lotus and Alvogen will also provide funding for the next registrational trial to support NRX-101’s approval.

Sales 130

Sales FDA Approval Production Clinical Trials 130

XTalks

SEPTEMBER 9, 2024

This blog provides a comprehensive look at the medical device giants, ranked by market capitalization , leading the charge into the future of medicine. Abbott Laboratories (ABT) Market Capitalization : $267.1 Billion Abbott Laboratories leads the medical device industry in market capitalization. In Q2 2024, Intuitive posted $2.01

Marketing 105

Marketing Insulin Sales Big Data 105

pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

Marketing 119

Marketing Insulin HR Production 119

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.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

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

FDA Approval 98

FDA Approval Drugs Sales Trials 98

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97