XTalks

APRIL 5, 2024

Relyvrio’s FDA approval was seen as controversial from the get-go as it was based on data from a small Phase II trial that showed a modest slowing of disease progression in patients who received the drug. The disease is more common in men than women and is also age-related, with most being diagnosed between 55 and 75 years of age.

Trials 98

Trials Drugs Marketing FDA Approval 98

The Pharma Data

NOVEMBER 8, 2021

Amgen today announced new data from the HER-MES study, the first and only head-to-head study of Aimovig® (erenumab-aooe), a calcitonin gene-related peptide (CGRP) inhibitor, against topiramate for adult patients with episodic and chronic migraine. MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin.

FDA Approval 52

FDA Approval Gene Trials Development 52

XTalks

AUGUST 30, 2022

We know that a lot of different pathologies, especially as we’ve entered the era of molecular medicine and gene therapies, cause many of the same symptoms and work through final common pathways. Viral Vectors for Gene Delivery to the CNS. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

The Pharma Data

NOVEMBER 30, 2020

” Abbreviations used: CGRP – calcitonin gene-related peptide. “Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). GPCR – G protein-coupled receptors. About Sosei Heptares.

Licensing 40

Licensing Licensing Production Development 40

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.

FDA Approval 101

FDA Approval Drugs Sales Development 101

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

Gene Therapy 263

Gene Therapy Marketing Gene Drugs 263

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. Have questions?

Life Science 105

Life Science Branding Clinical Trials Clinical Trials 105

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.

FDA Approval 52

FDA Approval Drugs Sales Development 52

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

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

OCTOBER 15, 2020

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed. For dry AMD, there’s nothing approved by the FDA. As with dry AMD, there is no FDA-approved therapy. “We

Manufacturing 52

Manufacturing Gene Therapy Gene Gene Expression 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. POMC is caused by variants in the POMC or PCSK1 genes, which can lead to severe obesity starting in childhood and insatiable hunger, as well as endocrine abnormalities, and sometimes red hair and light skin pigmentation. with LEPR deficiency obesity.

Licensing 52

Licensing Licensing Drugs Gene 52

XTalks

FEBRUARY 16, 2024

Originally developed by California-based CoTherix, the drug was first approved in 2004 for the treatment of pulmonary arterial hypertension (PAH) under the brand name Ventavis. More often than not, severe frostbite leads to the need for amputation. At the time, it was the only inhaled therapy for PAH in the US. of 100,000 people.

Cardiology 59

Cardiology Gene Therapy Drugs Branding 59

The Pharma Data

JUNE 24, 2021

“The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

DNA 52

DNA Clinical Trials Clinical Trials Trials 52

Eye on FDA

APRIL 15, 2020

Finally, they underscore the innovation of a company that is vital to its brand. Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. Recently in the U.S.

Medicine 55

Medicine Sales Gene Therapy FDA Approval 55

The Pharma Data

AUGUST 3, 2021

Aimovig retains strong payer coverage and remains the segment leader within the preventive calcitonin gene-related peptide (CGRP) class. New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. In the U.S., In May, the U.S.

Sales 52

Sales Production Antibody Development 52

The Pharma Data

DECEMBER 8, 2020

The majority of this revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique New Molecular Entities (NMEs), representing potential best-in-class/first-in-class therapies, and its existing 14 global brands. Food and Drug Administration (FDA). ABOUT TAK-721 and TAK-003.

Containment 52

Containment Engineer FDA Approval Vaccination 52

The Pharma Data

OCTOBER 26, 2020

The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Vaccination 40

Vaccination Vaccine Trials Containment 40

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Gene therapies, some of which are already in market, will see a strong uptick in 2023.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

XTalks

FEBRUARY 21, 2025

This move is designed to extend the companys cash runway through 2026, allowing it to hit key development milestones for its lead gene therapy candidate, ETX101, which is being developed for Dravet syndrome. It said this would lead to a , more efficient company while investing behind growth brands and promising areas of science.

Life Science 66

Life Science Marketing Gene Therapy Research 66

XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. report indicating that they accounted for half of the most viewed new brands. billion ad impressions.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. Sarclisa ® is already approved in the U.S

Sales 52

Sales Vaccine Vaccination Medicine 52

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 Vaccine Vaccination 52

The Pharma Data

MAY 5, 2021

FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ). Affinia Therapeutics raises $110 million for gene therapy treatments ( STAT ). Startup sets out to tackle the gene therapy manufacturing crisis ( Endpoints ). Medtech. Medtech.

Vaccine 52

Vaccine Vaccination Gene Therapy Contract Packaging 52