XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Zynteglo’s hefty price tag of $2.8

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Gene Therapy FDA Approval Gene Clinical Trials 95

pharmaphorum

JANUARY 5, 2022

Other drugmakers have been looking at Met as a target in cancer, including Novartis, Merck KgAA and Hutchmed, which have all bagged regulatory approvals for oral therapies that target NSCLC harbouring a specific mutation in Met known as exon 14 skipping which affects about 3% to 4% of NSCLC patients.

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Antibody Drugs Protein Gene 110

XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies. The approval of amyloid-beta-targeting therapies like Leqembi and recently discontinued Aduhelm (aducanumab) have come with controversy around their clinical effectiveness.

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Clinical Trials Clinical Trials In-Vitro Protein 52

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. Auvelity is the first drug Axsome has taken through to regulatory approval, but could be the first of a string of new products for the company, according to Tabuteau.

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Drugs FDA Approval Production Marketing 98

pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Antibody 98

Antibody Marketing Drugs Medicine 98

Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. Professor Bigger said: “This is a next generation stem cell gene therapy approach, which allows transit of the IDS enzyme into the brain.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment. The median treatment time is about 23 weeks (or 5.3

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pharmaphorum

DECEMBER 17, 2020

Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval. She told the BBC that her approach on TikTok is “come for the entertainment, but stay for the science.” Dr Austin Chiang.

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Scientist Vaccination Vaccine Medicine 94

pharmaphorum

NOVEMBER 19, 2021

Evrysdi was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in May, a couple of months after the drug also got a green light in the EU. million price tag make it is the most expensive treatment ever approved for NHS funding.

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Drugs Gene Therapy Genetic Disease Gene 98

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

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Branding Marketing Pharma Companies Life Science 120

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval. months of follow-up, 43.5

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

pharmaphorum

NOVEMBER 19, 2020

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

FDA Approval 63

FDA Approval Marketing Drugs Clinical Development 63

Intouch Solutions

APRIL 11, 2024

Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer. In the MagnetisMM-3 trial, elranatamab was associated with an ORR of 60.6%

Antibody 52

Antibody Medicine Drugs Trials 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. The post Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go appeared first on.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

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Sales Medicine Drugs Marketing 110

pharmaphorum

NOVEMBER 24, 2021

reSET-O was the first prescription DTx ever to win a breakthrough device designation from the FDA, according to Pear , allowing it to tap into a programme intended to speed up the development and regulatory review of new therapies so they can reach patients sooner. Photo by thom masat on Unsplash.

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Production Development Trials 58

XTalks

JUNE 9, 2021

Biogen has been working vigorously over the past couple of years to get its potentially disease-modifying drug Aduhelm (aducanumab) approved for Alzheimer’s disease, and it has finally happened. This Monday, the US Food and Drug Administration (FDA) granted accelerated approval to the drug for the treatment of the disease.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

AUGUST 17, 2020

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. Joanna Carlish, managing director, financial services, Tag Americas. Joanna began her career at Tag as an Account Manager with Banco Santander in London.

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Regulation Marketing Sales Branding 93

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

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

JUNE 2, 2021

Evrysdi was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 20 May, almost two months after the drug go the go-ahead in the EU. “NICE’s initial ‘no’ to approving risdiplam for NHS funding is not unexpected,” said SMA UK this morning.

Gene Therapy 52

Gene Therapy Gene Drugs Medicine 52

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. Libtayo has already proved its worth with previous approval in a certain section of the patient pool with advanced cutaneous squamous cell carcinoma.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

The Pharma Data

JANUARY 31, 2021

We will continue to work closely with our collaborators and regulatory authorities worldwide to help make our vaccine accessible to those most in need as quickly as possible.” Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About CpG 1018.

Vaccination 52

Vaccination Vaccine Trials Protein 52

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). Hemgenix is the first and only gene therapy approved for haemophilia B. Despite the limited market, the price tags of haemophilia make it potentially lucrative.

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Gene Therapy Gene Sales Protein 246

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

pharmaphorum

MAY 24, 2021

Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. One of the ways to meet these challenges is to have pre-approved materials and elements lined-up. Robb DeFilippis. Doing more in the digital space. A modular content ecosystem.

Marketing 94

Marketing Branding Sales Life Science 94

FDA Law Blog

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Life Science 81

Life Science FDA Approval Drugs Development 81

pharmaphorum

NOVEMBER 16, 2022

Only a few years later, bluebird bio’s gene therapy, Zynteglo (betibeglogene autotemcel), was approved in the European market for the treatment of the rare blood disorder, beta thalassaemia. However, with a price tag of €1.58 At more than $2.1 The post Advanced therapies and the high-profile pricing dilemma appeared first on.

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Gene Therapy Gene Marketing Development 130

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Over the years, pharmaceutical companies seeking product approvals have submitted increasingly vast amounts of information to regulatory agencies.

Compliance 52

Compliance Life Science Marketing Production 52

Cloudbyz

JUNE 1, 2023

Approval Processes: You can create multi-step approval processes with different levels of approval required for certain actions, like discounts or contract modifications. It offers additional levels of transparency, compliance, and governance to help organizations meet their complex regulatory requirements.

Compliance 82

Compliance Development Branding Production 82

XTalks

AUGUST 17, 2020

In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. IL-2 is not only a validated T cell target, but is also an approved drug for metastatic melanoma and renal cell carcinoma. percent of the T cell immune repertoire) and T regulatory cells (which suppress immune responses).

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

NOVEMBER 15, 2020

In addition, this will meet Clover’s Phase 2/3 clinical production plan and commercial readiness once its vaccine candidate is approved. ” Clover’s COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company’s proprietary Trimer-Tag © technology.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Roots Analysis

SEPTEMBER 13, 2023

These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

Development 40

Development Antibody Protein Drug Delivery Systems 40

Drug Discovery World

NOVEMBER 13, 2023

Fabian Mohr, PhD, Vice President Research & Development, IBA Lifesciences, on: ‘Developing a robust affinity tag platform using engineered streptavidin’. Opher Gileadi, PhD, Head, Protein Science SGC, Karolinska Institute, on: ‘Targeting every human protein: Challenges and prospects’.

Protein 59

Protein Antibody Engineer Scientist 59

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. The FDA action converts the 2018 accelerated approval to full approval. in December 2019; and.

Vaccination 40

Vaccination Vaccine Production Sales 40

The Pharma Data

MAY 5, 2021

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). CureVac says well on track to request vaccine approval as planned ( Reuters ) ( NYT ). Government & Regulatory.

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

Pharmaceutical Technology

NOVEMBER 30, 2022

The drug was approved to treat type 2 diabetes mellitus in May. In the first quarter since its launch as an approved therapy for type 2 diabetes, Mounjaro has proven to be a lucrative drug, making $97.3 However, Novo Nordisk’s anti-obesity therapeutics have had rough rollouts following their approvals. million in Q3.

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264