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.

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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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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. However, despite this, the FDA did not extend approval to non-PI3K/AKT mutated breast cancer, perhaps based on additional data that they reviewed.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study.

Containment 52

Containment Genetics FDA Approval Marketing 52

Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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Pharmaceutical Technology

DECEMBER 22, 2022

The company is a clinical-stage biopharmaceutical startup that uses its artificial intelligence (AI)-enabled platform to measure brain biomarkers, including electroencephalogram (EEG) activity and behavioural patterns, wearable data, genetics and other factors, to drive targeted drug development in mental health.

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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. When a child born from parents with FH genes, inherits one FH gene from each parent, they might develop homozygous familial hypercholesterolemia (HoFH).

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Roots Analysis

OCTOBER 4, 2023

During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. In fact, six bispecific antibodies have been approved in 2022. I, recently, worked on a market research report, titled Bispecific Antibodies Market , 2023-2035.

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Delveinsight

JULY 20, 2021

for the clinical development and commercialization of infectious disease molecular diagnostic products. Under the terms of the agreement, Seegene will provide diagnostic tests for use on Bio-Rad’s CFX96 Dx Real-Time PCR System for the US market, pending clinical development and approval from the US Food and Drug Administration (FDA).

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

Trials 52

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The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings outside of the US are also planned in 2022.

Genetics 52

Genetics Antibody Medicine Trials 52

Pharmaceutical Technology

APRIL 5, 2023

It will be six years since the US FDA approval of Kymriah in August this year. Bruce Levine [BL]: We now have six approved CAR-T therapies. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

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Gene Therapy Gene Engineer Production 147

Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Regulatory developments There were several noteworthy developments across Pfizer’s pipeline, which were covered by DDW. Chris Boshoff, M.D.,

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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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Delveinsight

AUGUST 4, 2021

Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions. With the advancement in technology, today diagnostics testing such as neurological examination, brain scans, genetic screening, and other tests are available to examine the occurrence of Neurological Conditions.

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XTalks

APRIL 24, 2023

Approximately 72 percent of rare diseases are genetic, and around 70 percent of rare genetic diseases emerge in childhood. Out of over 7,000 rare diseases, only 5 percent (or less) of rare diseases are thought to have approved treatment options, known as “orphan” therapies.

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Gene Therapy Gene Trials Clinical Trials 95

Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia thalassemia in adult and paediatric patients.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

AUGUST 19, 2021

2] These genetic alterations result in hyperactivation of the MET receptor with corresponding cancer cell growth. [3] In the METex14 cohort of the Phase 1 CHRYSALIS study, 19 patients with this genetic alteration received intravenous RYBREVANT TM 1050 mg (for patients who weigh <80 kg) or 1400 mg (for patients who weigh ?80

FDA Approval 52

FDA Approval Dermatology Genetics Development 52

pharmaphorum

DECEMBER 23, 2020

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market. months, compared with 6.7

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XTalks

MARCH 13, 2023

Over 70 percent of rare diseases are genetic, and of those, 70 percent begin in childhood. Since most rare diseases are genetically driven, gene therapies strive to fix the root cause of a disease instead of just treating a patient’s symptoms. There are around 300 million people worldwide living with a rare disease.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

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The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. Both POMC deficiency obesity and LEPR deficiency obesity are ultra-rare genetic disorders. The drug was approved for that indication on November 13. The drug is an investigational melanocortin-4 receptor (MC4R) agonist. with LEPR deficiency obesity.

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The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” Almirall also plans to submit these results this year to the European Medicines Agency (EMA) for authorization.

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The Pharma Data

OCTOBER 30, 2020

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

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Production Antibody Manufacturing Trials 52

The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada. IDHIFA is also approved in Australia and Canada.

Trials 52

Trials FDA Approval Development Clinical Trials 52

XTalks

DECEMBER 24, 2020

However, for virologists like Lori Frappier, PhD, professor in the department of molecular genetics at the University of Toronto, the outbreak of SARS-CoV-2 was less of a surprise and more of an inevitability. Omer maintains that the solution to this challenge is something that’s already in practice by developers of the mRNA vaccines.

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The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

Trials 40

Trials Antibody Genetics Development 40

Worldwide Clinical Trials

MAY 30, 2024

Currently Available Pharmacotherapies in the ALS Treatment Armory The battle against ALS has seen the introduction of a limited number of approved pharmacological treatments combined with other essential areas of multidisciplinary care.

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Gene Clinical Trials Clinical Trials Gene Therapy 203

The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Sigilon Therapeutics

RNA 52

RNA Antibody Life Science Protein 52

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

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 Neuropore’s pipeline page, both UCB0599 and NPT520-34 remain in Phase I clinical development.

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Gene Therapy Gene Trials Development 96

The Pharma Data

OCTOBER 27, 2020

NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. PHILADELPHIA, Oct. 28, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc.

Gene Therapy 40

Gene Therapy Drugs Clinical Trials Clinical Trials 40

pharmaphorum

SEPTEMBER 12, 2022

Everyone’s genetic makeup differs, and each person’s cancer experience is unique to them – how cancer develops, how fast it spreads, which drugs it responds to, and more. Furthermore, each cancer has various gene changes – also referred to as the genetic makeup of cancer. Tailored oncology.

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Genome Genomics Clinical Trials Clinical Trials 104

The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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Antibody Production Trials Medicine 40

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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