Drug Discovery World

FEBRUARY 19, 2024

The US Food and Drug Administration has approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of metastatic, unresectable melanoma. Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

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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).

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Drug Discovery World

DECEMBER 21, 2023

In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Other biotechnologies coming to the fore this year were antibody-drug conjugates and CRISPR gene editing. Read the article – Expert view: What’s next for cell and gene therapy?

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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.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. Gene therapy could ‘transform prognosis’ for AADC deficiency patients . FDA approves first disease-modifying therapy for T1D .

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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.

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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.

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XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. XTALKS WEBINAR: Live Cell Metabolic Analysis — Paving the Way for Metabolic Research and Cell & Gene Therapy.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, In July, the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for use in adolescents aged 12 to 15 years.

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The Pharma Data

AUGUST 28, 2020

The top 10 news stories this week are focused on coronavirus vaccines and treatments, as China is set to move ahead with human testing of a potential vaccine that has been created using insect cells, while AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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BioSpace

JUNE 13, 2022

Shares of CRISPR Therapeutics fell more than 11% on Monday as investors react negatively to the endorsement of a rival beta-thalassemia gene therapy developed by bluebird bio.

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XTalks

JANUARY 4, 2024

Pfizer has kickstarted the new year with its first-ever gene therapy approval, awarded by Health Canada to the company’s Beqvez (fidanacogene elaparvovec) for the treatment of hemophilia B. Beqvez is also being reviewed by the US Food and Drug Administration (FDA) with a decision anticipated by mid-2024.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Delveinsight

JANUARY 19, 2021

A Sweet Year For Daiichi/ AZ As Enhertu Gets FDA Approval For Gastric Cancer. Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. The approval is based on the positive results from the randomised Phase 2 trial conducted in Japan and South Korea.

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XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

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Drug Discovery World

JULY 3, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapy for adults with severe haemophilia A. Roctavian was first approved by the European Medicines Agency in August 2022. The post One-time gene therapy for haemophilia A gets FDA green light appeared first on Drug Discovery World (DDW).

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The Pharma Data

OCTOBER 15, 2020

“For cell therapy products to mature into ‘real’ products that deliver on the promises of 10 years ago, they must be scalable – which drives affordability – and they must solve their purity issues.”. Because of the transplant component, cell therapy may enable changes the body never could do alone.”. Source link.

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pharmaphorum

SEPTEMBER 30, 2022

Although the sticker shock that was at first associated with Yervoy (ipilimumab) in 2011 – in the early days of immuno-oncology monoclonal antibodies – has fallen by the wayside, especially in light of CAR-Ts and other “one and done” cell and gene therapies, the field of non-orphan oncology remains a target for cost savings by payers.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. The two types of candidates currently in the pipeline can be categorised as monoclonal antibodies and vaccines. per 100,000.

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pharmaphorum

OCTOBER 31, 2022

The New York biotech said today that the SIERRA trial of Iomab-B – an antibody armed with a radioisotope designed to deliver targeted treatment to tumours and spare healthy tissues – met its primary objective. However, current regimens based on intensive chemo- and radiotherapy are very aggressive so are not suitable for frail patients.

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XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Axovant Gene Therapies. Prevail Therapeutics.

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XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. They’ve also induced lymphomas in humans when delivered directly in the form of gene therapy 17.

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Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

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Drug Discovery World

JANUARY 11, 2023

Supported by landmark clinical data from a Phase III trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab appears poised for full US FDA approval and ex-US launches. Part of a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share held by these therapies. .

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. The deal will provide Biogen the rights to use the technology across their portfolio of gene therapy products.

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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. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Next Steps for Targeted CNS Delivery.

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The Pharma Data

JANUARY 6, 2021

“We are leveraging our strengths in process development and manufacturing for a wide range of biopharmaceuticals such as antibodies, recombinant proteins, gene therapies and vaccines,” said Martin Meeson , chief executive officer at FUJIFILM Diosynth Biotechnologies.

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). If successful, TN-201 would be a first-in-class disease-modifying gene therapy for MYBPC3-associated HCM.

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XTalks

DECEMBER 24, 2020

From rare disease drug approvals to treatments involving immunotherapies and gene therapies and awarding of a Nobel Prize to the inventors of the gene-editing tool CRISPR, 2020 was a year of great activity and productivity despite the backdrop of the pandemic. Drug Approvals.

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The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Embryo-Fetal Toxicity.

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The Pharma Data

AUGUST 11, 2020

In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Embryo-Fetal Toxicity.

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The Pharma Data

MAY 5, 2021

India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines ( Endpoints ). CureVac says well on track to request vaccine approval as planned ( Reuters ) ( NYT ).

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