XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

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FDA Approval Drugs Antibody Medicine 52

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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Development Drugs Clinical Trials Clinical Trials 52

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene.

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XTalks

AUGUST 15, 2023

Approximately 10 to 15 percent of patients with mCRPC have alterations in the BRCA gene — this subset of patients is likely to have aggressive disease, poor outcomes and a shorter survival time, according to information in a press release from Johnson & Johnson announcing Akeega’s FDA approval.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

XTalks

SEPTEMBER 22, 2022

On September 1, 2022, Boehringer Ingelheim Pharmaceuticals announced in a press release that the US Food and Drug Administration (FDA) approved Spevigo (spesolimab-sbzo) intravenous injections for GPP flares in adults. Spevigo is the first approved treatment option for GPP in adults. Clinical Trial Behind Spevigo.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Dermatology 52

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. DMD is a rare genetic disorder that leads to progressive muscle degeneration and weakness.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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.

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FDA Approval Drugs Sales Development 101

XTalks

MARCH 6, 2024

This includes discussions on cutting-edge technologies and methodologies in brain research, such as neuroimaging, genetic engineering and artificial intelligence. Despite the disappointing launch of Aduhelm and questions around Leqembi, companies like Eli Lilly are continuing to pursue their beta-amyloid monoclonal antibody therapies.

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FDA Approval In-Vitro Research Marketing 69

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. The company has partnered with life sciences-focused investors Sixth Street and Royalty Pharma with an aim to bring substantial non-dilutive, low-cost capital to boost innovation and growth.

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Insulin Production Development Genetics 130

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

The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.

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RNA Antibody Life Science Protein 52

XTalks

JUNE 15, 2022

protein that triggers the immune system to generate antibodies against the virus. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. The body creates the protein, triggering the production of antibodies against COVID-19 to protect against future exposure to the virus.

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Vaccination Vaccine Immune Response Protein 59

XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE.

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Drugs Clinical Trials Clinical Trials Antibody 52

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market. months, compared with 6.7 Neurology on the march.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

JUNE 5, 2023

The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease,” said Edward E.

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Vaccination Vaccine FDA Approval Protein 98

XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. Symptoms and Etiology: Characterized by progressive muscle weakness and atrophy, Duchenne muscular dystrophy (DMD) is an X-linked genetic condition that primarily affects males. Novartis’ Signifor (pasireotide) is also indicated in the treatment of the disease.

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Trials Gene Hormones Clinical Trials 98

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The design of the immune biologic puts these elements together on an antibody scaffold. Image from Cue Biopharma.

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Protein Engineer Immune Response In-Vivo 98

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. HER2 is a tyrosine kinase receptor that is overexpressed and genetically amplified in approximately 20 percent of breast cancers.

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FDA Approval HR Hormones Antibody 98

XTalks

NOVEMBER 20, 2023

The newly approved Truqap and Faslodex combo is restricted to patients with a genetic alteration in one or more of the following PI3K/AKT pathway genes: PIK3CA , AKT1 or PTEN. It was also given FDA priority review. Due to the restricted label, analysts at Leerink Partners lowered their estimated peak sales for Truqap from $2.36

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HR FDA Approval Gene Trials 98

XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval.

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Gene Therapy Gene Gene Editing Sales 111

XTalks

JUNE 9, 2022

What happens when the liver is unable to process bad cholesterol due to genetic factors? It is one of the common genetic causes of premature coronary heart disease. Evkeeza — generically known as evinacumab — is a monoclonal antibody. These antibodies bind strongly to their target and provide a robust immune response.

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Trials Antibody Genetics Gene 52

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

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Vaccination Vaccine RNA Manufacturing 105

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. What About Small Proteins and Antibodies Reaching Extracellular CNS Targets? Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

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Trials Drug Delivery Drugs Gene 83

Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. CAR T cells are T cells that have been trained to attack tumours.

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XTalks

APRIL 12, 2021

The gene therapy company was focused on applying adeno-associated virus (AAV) vectors to developing a one-time treatment for patients with Parkinson’s disease who have specific genetic mutations. According to the company’s pipeline page, the antibody drug is still in the drug discovery stage of development. So what about Denali’s ?-synuclein

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Gene Therapy Gene Trials Development 96

XTalks

DECEMBER 24, 2020

The pandemic propelled the life science and healthcare sectors onto center stage, and they rose to the occasion against the most unprecedented health challenge in recent times. While COVID-19 has undoubtedly been the biggest story in the life science industry in 2020, it was a busy and positive year in many other areas.

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pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). It is the first FDA-approved treatment for Zaire ebolavirus. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics. Amgen, Inc.

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Production FDA Approval Antibody Gene 52