XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

Sales 52

Sales FDA Approval Pharmacy Production 52

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva made pharma data intelligence firm Evaluate’s list of top ten drug launches this.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

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. billion in 2032.

FDA Approval 81

FDA Approval Clinical Trials Clinical Trials Trials 81

XTalks

FEBRUARY 26, 2024

XTALKS WEBINAR: On-Demand Code-Level Claims Data: Driving Actionable Insights and Efficiencies Live and On-Demand: Wednesday, April 3, 2024, at 1pm EDT (5pm GMT/UK) Register for this free webinar to learn how code-level claims data is a crucial dataset to address various needs across the life sciences and medical device landscape.

Allergies 100

Allergies FDA Approval Drugs Protein 100

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 101

FDA Approval Drugs Sales Development 101

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 89

FDA Approval Vaccination Vaccine Immune Response 89

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

XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

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 Immune Response Drugs 98

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

FEBRUARY 5, 2024

GSK declared Arexvy to be a blockbuster in its first year on the market after higher-than-expected sales. GSK revealed in its 2023 annual and quarterly earnings report last week that sales of Arexvy totaled $1.5 GSK said it has secured about two-thirds share of the US market where nearly all of Arexvy’s sales were recorded.

Vaccination 59

Vaccination Vaccine Marketing Sales 59

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

AUGUST 22, 2022

What sets Auvelity apart from other antidepressants on the market is its ability to act rapidly. Additionally, Axsome says Auvelity is the first oral MDD medication with a new mechanism of action to hit the market in more than 60 years. The med brought in $58 million in sales last year for Jazz.

FDA Approval 98

FDA Approval Production Marketing Drugs 98

XTalks

AUGUST 31, 2023

As Takeda’s blockbuster attention-deficit/hyperactivity (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) reached its patent cliff this month after enjoying 16 years on the market, the US Food and Drug Administration (FDA) gave approval to a slew of generics to coincide with the end of its patent protections.

Marketing 98

Marketing Branding Sales Drugs 98

World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. The amount of money required to gain approval of a new drug has been hotly debated, but it also costs a hell of a lot of money to launch a drug in today’s market.

Life Science 225

Life Science Drugs Genetic Disease Development 225

Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects.

Medicine 147

Medicine Business Development Sales Life Science 147

XTalks

JANUARY 27, 2023

Hyftor became the first FDA-approved topical treatment for facial angiofibroma associated with tuberous sclerosis. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.

Life Science 98

Life Science Genetic Disease FDA Approval Marketing 98

XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

pharmaphorum

DECEMBER 21, 2021

Despite the success tied to the vaccine rollout, analysing data is still a daily challenge for many life sciences and pharmaceutical companies. This makes tools like augmented analytics essential to helping pharmaceutical and life sciences companies dig deeper into their data. Discover patient patterns to improve care .

Life Science 113

Life Science Sales Scientist Vaccination 113

XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

FDA Approval 98

FDA Approval Gene Therapy Antibody Gene 98

XTalks

AUGUST 19, 2021

The flagship version, Xyrem, was first approved and marketed in 2002 as the first treatment for cataplexy and narcolepsy and continues to remain as such. billion in sales. However, the drug will lose its market exclusivity in 2023, at which time Jazz hopes patients will shift to Xywav. In 2020, it garnered $1.74

FDA Approval 64

FDA Approval Drugs Regulation Sales 64

XTalks

NOVEMBER 6, 2023

Phathom Pharmaceuticals received two US Food and Drug Administration (FDA) approvals for its first-in-class heartburn drug Voquenza (vonoprazan) spaced just three days apart for heliobacter pylori ( H. The FDA approval of the drug was based on results from the Phase III PHALCON-EE study that involved 1,024 patients with erosive GERD.

FDA Approval 64

FDA Approval Marketing Drugs Protein 64

XTalks

JULY 6, 2021

As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug. The agreement also includes sales target milestones which, if achieved, could total up to $225 million, Seres outlined in a news release from the company.

Marketing 105

Marketing Drugs Bacteria FDA Approval 105

XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.

Sales 98

Sales FDA Approval Production Insulin 98

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. billion in pharmaceutical sales from 2021. billion, a 42.74

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. More potential patients equal more prescriptions which equals higher sales and bigger profits.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

XTalks

JANUARY 17, 2023

Related: Lung Disease Diagnostic Xenoview Gets FDA Approval for Use with MRI. In light of this, he said the approval “is good news” for this segment of adult asthmatics who make up more than 80 percent of asthma patients in the US. The FDA approval was based on results from the MANDALA, DENALI and TYREE Phase III studies.

FDA Approval 97

FDA Approval Containment Allergies Drugs 97

XTalks

JANUARY 4, 2024

Gene therapy approvals for rare blood disorders like sickle cell disease and beta thalassemia have been gaining traction lately, with two significant approvals in sickle cell disease recently — CRISPR Therapeutics and Vertex Pharmaceuticals’ CRISPR gene editing drug Casgevy (exa-cel) and bluebird bio’s viral vector therapy Lyfgenia (lovo-cel).

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. billion in 2021 to $61.6

Insulin 98

Insulin Hormones FDA Approval Sales 98

XTalks

FEBRUARY 16, 2023

However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. estimating Indorsia spent $6.2

FDA Approval 105

FDA Approval Sales Branding Marketing 105

XTalks

SEPTEMBER 21, 2023

Among the companies Lilly has accused of selling non-US Food and Drug Administration (FDA) approved compounded products “fraudulently claiming to be Mounjaro” are medical spas, wellness centers and compounding pharmacies. Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes.

Pharmacy 59

Pharmacy FDA Approval Drugs Containment 59

XTalks

DECEMBER 5, 2023

Analysts at William Blair estimate that Augtyro’s sales could climb to $258 million by 2027, contingent on its anticipated approval in Europe next year. Other New Treatments for NSCLC on the Market The FDA has recently approved several other medications for various subsets of NSCLC patients.

Protein 115

Protein FDA Approval Medicine Trials 115

XTalks

JULY 10, 2023

“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.

Pharmacy 90

Pharmacy FDA Approval Licensing Licensing 90