pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion in sales in 2028.

Sales 111

Sales Medicine Drugs Marketing 111

XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose.

FDA Approval 98

FDA Approval Development Licensing Licensing 98

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

pharmaphorum

MAY 10, 2022

The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA could result in an approval before the end of the year.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

Drug Discovery World

JANUARY 30, 2024

Intellectual property: High patent royalties and licensing fees for key technologies can inflate treatment costs. Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

Druggist

OCTOBER 25, 2020

Nevertheless, calamine lotion is licensed in the UK for symptomatic relief of skin conditions including itchiness. Both products have the same licensed use: symptomatic relief of mild sunburn and relief from other skin conditions. Liquid antihistamine – chlorphenamine (Piriton syrup) is licensed for this indication.

Production 52

Production Pharmacy Licensing Licensing 52

XTalks

JUNE 9, 2021

Aducanumab Controversy and Price Tag. After this, Biogen completed its submission to the FDA in July 2020 for a Biologics License Application for approval of the drug. Evidence for aducanumab’s efficacy has been highly contested. Since then, many in the Alzheimer’s world were awaiting the FDA’s decision on the drug.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. Already a big player in haemophilia treatments, CSL licensed exclusive global rights to Hemgenix from gene therapy developers uniQure back in 2021.

Gene Therapy 246

Gene Therapy Gene Sales Protein 246

XTalks

SEPTEMBER 27, 2022

The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. The price tag reflects “the clinical benefit [it] provides as an urgently needed treatment option to slow the progression of neurologic dysfunction in children impacted by progressive, irreversible and fatal rare disease,” Obenshain added.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

Delveinsight

DECEMBER 3, 2020

It has been speculated that modifications to the epigenome drive cell ageing, especially a process known as DNA methylation, by which methyl groups are tagged onto DNA. Shinya Yamanaka discovered that the factors could alter the epigenome, and in that way modify mature cells back to a stem cell-like state.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

MARCH 22, 2023

New Drug Approvals Are on the Rise In 2002, the FDA approved a combined total of 17 New Molecular Entities (NMEs) and Biologics License Applications (BLAs). In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

Cloudbyz

JUNE 1, 2023

Users can also collaborate on files, add comments, and tag colleagues. Chatter Free Users: Chatter Free licenses allow users to access Chatter without having a full Salesforce license. This includes common file types like PDFs, Microsoft Word documents, and image files.

Compliance 79

Compliance Development Branding Production 79

The Pharma Data

MAY 15, 2021

Web Beacons are tags that can monitor the behavior of a user visiting the Website or sending an e-mail. The Company uses personally identifiable information to undertake such activities as: Like many companies, the Company uses “cookie” and/or “web beacon” technologies on the Website.

Production 52

Production Containment Medicine Vaccination 52

The Pharma Data

MAY 4, 2021

Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) — In February 2021, Pfizer announced that the FDA approved the supplemental Biologics License Application (sBLA) for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

Vaccination 40

Vaccination Vaccine Production Sales 40