Tag: FDA

Translational Regenerative Medicine market is estimated to grow at a CAGR of 24.3% by 2034: Visiongain

Visiongain Reports Ltd Visiongain has published a new report entitled: Translational Regenerative Medicine Market Report 2024-2034: Forecasts by Product (Stem Cell Therapy (Autologous, Allogenic), Tissue Engineering (Scaffold, Hydrogels), Gene Therapy, Others)), by Application (Oncology, Dermatology, Musculoskeletal, Neurology, Cardiovascular, Wound Healing, Ophthalmology, Others) AND Regional and Leading National Market Analysis PLUS…

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Translational Regenerative Medicine market is estimated to

Visiongain has published a new report entitled: Translational Regenerative Medicine Market Report 2024-2034: Forecasts by Product (Stem Cell Therapy (Autologous, Allogenic), Tissue Engineering (Scaffold, Hydrogels), Gene Therapy, Others)), by Application (Oncology, Dermatology, Musculoskeletal, Neurology, Cardiovascular, Wound Healing, Ophthalmology, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading…

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Belantamab Mafodotin Tops Daratumumab in Multiple Myeloma

TOPLINE: Belantamab mafodotin plus a combination of bortezomib and dexamethasone improved median progression-free survival (PFS) by 23 months in patients with relapsed or refractory multiple myeloma compared with daratumumab alongside the same combination. METHODOLOGY: Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for…

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Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open

OSAKA, Japan–(BUSINESS WIRE)– Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the first peer-reviewed publication of the Phase 3 portion of its pivotal, double-blind, randomized, placebo-controlled Phase 2/3 study (SCORPIO-SR) in patients with mild to moderate COVID-19 in Japan, South Korea…

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Pacritinib Shows Transfusion Independence Benefits in Myelofibrosis

Bart Scott, MD Professor, Transplantation Program Clinical Research Division Miklos Kohary and Natalia Zimonyi Kohary Endowed Chair Fred Hutchinson Cancer Center Seattle, WA Targeted Oncology: Could you summarize the approved Janus kinase (JAK) inhibitors for patients with myelofibrosis? BART SCOTT, MD: Ruxolitinib (Jakafi) was approved in 2011, fedratinib (Inrebic) in…

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Shedding Light on BIA-ALCL Risks

In a society that celebrates individuality and self-expression, the journey to aesthetics takes many forms. One such road, taken by countless women seeking empowerment and confidence, is breast augmentation. This blog dives deep into the dark and flip side of breast augmentation- Allergan breast implant lawsuits. Before answering the query…

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Treating the Untreatable with Precision Therapies – A $4 trillion Opportunity?

Precision Therapies For Targeted Results Precision therapies have always been the ultimate goal of medicine. Instead of drugs acting on multiple parts of the body, these therapies would only target one organ, one cell, or even one gene. In theory, not only would this be a lot more efficient, but…

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Can gene therapy be the key to restoring hearing loss?

Gene therapy has had a number of success stories with regards to treating blood disorders like hemophilia and beta-thalassemia, as well as in cancer research. Now, the latest breakthrough in gene therapy has been in restoring hearing loss in an 11-year-old boy.  A team of scientists at the Children’s Hospital…

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This new approach could revolutionize knee osteoarthritis treatment

BioSenic, a clinical-stage Belgian-headquartered company specializing in serious autoimmune and inflammatory diseases and cell therapy, will be sharing data on its late-clinical asset JTA-004 for the treatment of knee osteoarthritis at the Osteoarthritis Research Society International (OARSI) World Congress 2024. The event takes place in Vienna, Austria, from April 18…

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5 hot biotechnology careers skyrocketing in demand

With many exciting discoveries to make and new problems to solve, the biotechnology industry provides many career opportunities that could make a difference in people’s lives. So, if you are searching for a career in the field, we have listed five biotechnology careers that are currently in high demand, and…

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what will therapy look like in 2034?

Drugs like PARP inhibitors and chimeric antigen receptor (CAR) therapies, and advancements in artificial intelligence in drug discovery, have spurred hope for improved cancer care in the past year. Rigorous research has paved the way for a declining cancer death rate – by 33% to be precise – since the…

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Twisted DNA Increases CRISPR Off-target Effects

At the end of 2023, the FDA approved Casgevy for sickle cell disease, its first approval for a therapeutic that used the genome editing tool clustered regulatory interspaced palindromic repeats (CRISPR) to specifically inactivate a human gene as a treatment for a genetic disease. While CRISPR-based gene therapies could potentially…

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16 UK biotech companies you should know about

The UK is home to several biotech hubs, including the famous ‘golden triangle’, made up of Oxford, Cambridge, and London. In fact, after a $700 million surge in funding in the third quarter of 2023, the UK biotech scene is now one of the most vibrant in Europe, laying the…

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Top antibody-drug conjugate (ADC) companies leading the industry

The antibody-drug conjugate (ADC) field is witnessing an expansion in the variety of conjugation techniques, linker chemistry, and payloads being used, moving beyond traditional tubulin inhibitors to include novel mechanisms of action. Investments in ADC research continue to grow, with significant funding rounds and acquisitions. For example, Novo Holdings’ $105…

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The promising horizon of hair loss treatments

There hasn’t been a lot of hair loss treatment progress in the last twenty years. However several biotech companies are hot on the case and are getting tantalizingly close to the breakthrough that many patients hope for. With body dysmorphia magnified by the omnipresent digital world, psychiatrists have increasingly linked…

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Unveiling tomorrow’s cures: insights from Cardinal Health

This week on the podcast, we have a conversation with Fran Gregory, vice president of Emerging Therapies at Cardinal Health.  The discussion covers the company’s role in healthcare, biosimilars, the latest in cell and gene therapies, and Advanced Therapies Week. About Cardinal Health Cardinal Health is a distributor of pharmaceuticals…

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Biotech job market 2024: what to expect?

The past year saw a string of pipeline cuts and downsizing plans strike the biotech job market. Have layoffs spooked young professionals looking for a way into the industry, and does the employment landscape seem to be looking up this year? Employment in the life sciences industry had hit a…

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BioVie Sued By Block & Leviton LLP for Securities Law Violations

BOSTON, Jan. 19, 2024 (GLOBE NEWSWIRE) — Block & Leviton LLP (www.blockleviton.com), a national securities litigation firm, announces that it has filed a class action lawsuit on behalf of shareholders against BioVie, Inc. (NASDAQ: BIVI) and certain of its executives, for securities fraud. The complaint was brought in United States…

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Nanomaterials | Free Full-Text | Tissue Nanotransfection Silicon Chip and Related Electroporation-Based Technologies for In Vivo Tissue Reprogramming

As mentioned above, compared to conventional electrodes, the microneedle-type electrodes exhibit better pain management and lower voltage requirements due to the microscale needle dimensions. To manufacture microneedle-type electrode devices with precise patterning and high yields, sophisticated manufacturing techniques are often utilized. Some of these techniques include laser-cutting, metallization, and semiconductor…

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ADC Therapeutics (ADCT) Rises 43% in a Month: Here’s Why

ADC Therapeutics ADCT is a commercial-stage biotech company focused on developing novel antibody-drug conjugates (ADC) to treat patients with hematologic malignancies and solid tumors. Currently, ADC Therapeutics has only one marketed drug in its portfolio, Zynlonta, which the FDA approves to treat relapsed or refractory (r/r) diffuse large B-cell lymphoma…

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Two Million Cancers; Casgevy OK’d for Thalassemia; Rectal Exams and Prostate Cancer

While cancer mortality continues to decline, the number of new cases is projected to top 2 million in 2024, according to the American Cancer Society’s annual report on cancer statistics. The FDA approved exagamglogene autotemcel (Casgevy) for transfusion-dependent beta thalassemia in patients 12 years and older, maker Vertex announced. This…

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FDA Approves Erdafitinib for FGFR3+ Locally Advanced or Metastatic Urothelial Carcinoma

The FDA has approved erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations, as determined by an FDA-approved test, whose disease has progressed on or following at least 1 prior line of systemic therapy. The agent is not recommended for those who are…

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Path to Safer Genome Engineering: CRISPR Off-Switches?

Using CRISPR, an immune system bacteria use to protect themselves from viruses, scientists have harnessed the power to edit genetic information within cells. In fact, the first CRISPR-based therapeutic was recently approved by the FDA to treat sickle cell disease in December 2023. That therapy is based on a highly…

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A Revolution in Seborrheic Dermatitis and Atopic Dermatitis Treatment

Seborrheic dermatitis, a common skin condition causing redness, itching, and dandruff, often proves challenging to treat, especially in patients who cannot use topical steroids due to contraindications, intolerance, or lack of response. However, a recent subgroup analysis of a phase 3 study brings new hope for such patients with the…

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FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma With FGFR3 Mutations

FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma With FGFR3 Mutations The FDA has approved erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease has progressed on or after previously receiving one line of systemic…

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FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Image credit: Matthieu | stock.adobe.com The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients…

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FDA grants full approval to erdafitinib for FGFR3-positive urothelial carcinoma

The FDA has granted a full approval to erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least 1 line of prior systemic therapy. It is not recommended for patients who,…

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CRISPR off-switches: A path towards safer gen

Using CRISPR, an immune system bacteria use to protect themselves from viruses, scientists have harnessed the power to edit genetic information within cells. In fact, the first CRISPR-based therapeutic was recently approved by the FDA to treat sickle cell disease in December 2023. That therapy is based on a highly…

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Ten NK cell therapy companies to look out for this year

Natural killer (NK) cells are white blood cells that are a part of the body’s defense mechanism. These cells are on the lookout for any kind of disruption in the immune system, and can kill diseased cells like tumor cells. NK cells are being used in clinical applications to treat…

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Could natural killer cells revolutionize Alzheimer’s treatment?

This week on the podcast, we have a conversation with Dr Paul Song, CEO of NKGen Biotech, a company with its sights set on changing the Alzheimer’s disease treatment landscape with natural killer cells. The company’s natural killer (NK) cell Alzheimer’s treatment uses a patient’s cells, collected by a simple…

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The future of diabetes treatment: Is a cure possible?

Diabetes has become an epidemic, sentencing over 537 million people worldwide to lifelong medication. Science is striving to find a diabetes treatment that can cure this chronic disease, but how close are we? Diabetes is the major cause of blindness, kidney failure, heart attack, and stroke. It is estimated that…

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What is new in bladder cancer treatment? The latest breakthroughs

According to the World Health Organisation, 573,278 new cases of bladder cancer were diagnosed in 2020, making it the 10th most common type of cancer. Bladder cancer most commonly starts in the urothelial cells lining the inside of the bladder but can also develop in other areas like the kidneys…

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Highlights of the 2024 JPM Healthcare Conference

Like every year, 2024 kicked off with a bang for the biotech industry, as thousands gathered at the J.P. Morgan Health Conference (JPM) that took place in San Francisco, last week. One of the largest healthcare conventions in the world, JPM recaps the glories as well as the gloom of…

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ALS Agent PrimeC Moves to Phase 3, FDA Clears IND for AB126, APOE Carrier Status Impacts ARIA

WATCH TIME: 3 minutes Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Shortly after positive topline data from the phase 2 PARADIGM study of PrimeC was released, NeuroSense Therapeutics has announced that the FDA has confirmed its development plans for a phase 3 pivotal trial with…

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GLP-1 agonists: what’s the hype about?

Glucagon-like peptide 1 (GLP-1) agonists were on everybody’s mind at the recent JPM healthcare conference in the U.S. as it was one of the major highlights at the event. But all the hype around this class of drugs, which took off when Ozempic was given the go-ahead by the U.S….

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could it be a cure?

When CASGEVY, the first CRISPR-based therapy, was approved by the FDA in December, it gave CRISPR technology the validation it needed. Any promise it had held before that moment was simply investigational. In this case, the approval of CASGEVY was granted for the treatment of two blood disorders – sickle…

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Inotrem Successfully Reaches Agreement with the FDA for a Phase 3 Registration Trial for Nangibotide in Septic Shock

Novel biomarker-guided Phase 3 registration trial in septic shock with an enrichment strategy-based patient selection. Historic paradigm shift in Primary endpoint: from all causes of mortality at Day 29 to proportion of patients alive and free of organ support at Day 29. PARIS, January 08, 2024–(BUSINESS WIRE)–Inotrem, an advanced clinical…

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2 low-priced gene therapy stocks to speculate on

Key Points bluebird bio has three FDA-approved gene therapy treatments that are planning to commercialize after its $150 million secondary offering of common shares priced at $1.50 per share. bluebird bio’s latest FDA approval, LYFGENIA, is a one-time treatment for sickle cell disease, which is priced around $3.1 million per…

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Amid second-largest wave of COVID infections in the US, Florida’s surgeon general calls to halt mRNA vaccines

On Friday, wastewater data from Biobot Analytics and the US Centers for Disease Control and Prevention (CDC) affirmed that the US has now reached its second-highest level of COVID-19 infections of the pandemic. It is anticipated that by midweek, rates of infections will reach 2 million per day with approximately…

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CRISPR Therapeutics Highlights Strategic Priorities and

ZUG, Switzerland and BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) — CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today highlighted its strategic priorities and 2024 outlook as the Company enters its next phase of growth. “We had a landmark year in 2023, marked…

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Can GLP-1 agonists treat cardiovascular diseases?

Glucagon-like peptide 1 (GLP-1) agonists have proven their therapeutic mettle in treating metabolic diseases like diabetes and obesity, and now, researchers are studying their effects on cardiovascular disease.  These drugs mimic glucagon-like peptide 1, a hormone that stimulates insulin production in the body. So, when blood sugar levels are elevated…

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Genetic Technologies and BioVie Interviews to Air on the RedChip Small Stocks Big Money(R) Show on Bloomberg TV

ORLANDO, FL / ACCESSWIRE / December 29, 2023 / RedChip Companies will air interviews with Genetic Technologies Limited (NASDAQ:GENE) and BioVie, Inc. (NASDAQ:BIVI) on The RedChip Small Stocks Big Money® Show, a sponsored program on Bloomberg TV, this Saturday, December 30, at 7 p.m. Eastern Time (ET). Bloomberg TV is…

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Cost and Benefit: Lisocabtagene Maraleucel is Cost Effective as Second-line Treatment for Lymphoma

Lisocabtagene maraleucel (liso-cel; Breyanzi®; Bristol-Myers Squibb), a CD19-directed genetically modified autologous T-cell immunotherapy, also known as chimeric antigen receptor (CAR) T-cell therapy, is a cost effective second line treatment for relapsed and refractory diffuse large B-cell lymphoma (r/r DLBCL). This conclusion is based on results from a study published in…

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Five NASH companies racing to get their treatments approved

NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), where fat builds up on the liver, potentially leading to liver damage or cirrhosis. With no U.S. Food and Drug Administration (FDA)-approved treatments for the disease, many NASH companies are currently attempting to bring their candidates toward approval. In…

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The race for RSV vaccine development and approval in 2023

It has been a bumpy ride for biopharma to develop a vaccine for the potentially deadly respiratory syncytial virus (RSV), since the 1960s. As GSK and Pfizer battled it out earlier this year, with the former’s Arexvy vaccine crowned the first-ever RSV vaccine to hit the market, a mere few…

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2023-12-20 | NDAQ:DRMAW | Press Release

– About 550 patients will be treated once weekly for 12 weeks – – STAR-1 topline results expected in first quarter of 2025 – – Acne affects about 50 million patients in the U.S. – SAN DIEGO, CA / ACCESSWIRE / December 20, 2023 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW)…

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Data manager/Bioinformatics Scientist

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance,…

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FDA approves two gene therapy treatments for sickle cell disease

Two new gene therapies to treat sickle cell disease were approved by the U.S. Food and Drug Administration Dec. 8. The treatments, both produced by Boston-area companies, join 32 other approved gene therapies and are approved to treat the disease in the United States. Experts say the developments are a…

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Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005) All six key secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and dysfunction, fatigue and sleep measures were significantly improved (all p ≤ 0.001) Positive results support planned New Drug Application…

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Tonix Pharmaceuticals Announces Highly Statistically

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005) All six key secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and dysfunction, fatigue and sleep measures were significantly improved (all p ≤ 0.001) Positive results support planned New Drug Application…

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Tonix Pharma (TNXP) Announces Positive Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint in the second of two positive Phase 3…

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FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults

Acceptance based on results from multiple Phase 3 trials If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older, according to CDC data from 2018-2021 RAHWAY,…

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Oculis Announces First Patient First Visit in Phase 3

Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2 topline readout expected before end of 2024 to support NDA submission OCS-01 is also being evaluated as potentially the first topical eye drop treatment for Diabetic Macular…

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Oculis Announces First Patient First Visit In Phase 3 OPTIMIZE-2 Trial Of OCS-01 For The Treatment Of Inflammation And Pain Following Cataract Surgery

(MENAFN– GlobeNewsWire – Nasdaq) Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2 topline readout expected before end of 2024 to support NDA submission OCS-01 is also being evaluated as potentially the first topical eye drop…

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The top biotech breakthroughs that defined 2023

As we look back at 2023 it is clear that the year has been marked by steady progress and notable breackthroughts in the biotech industry. From advancements in Alzheimer’s disease treatments to new approaches in cancer therapy, artificial intelligence (AI) progression, and obesity management, this year has seen important steps…

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Diffuse Large B-Cell Lymphoma (DLBCL) Probe Panel by FISH – Laboratory Test Catalog

Test Name Alias DLBCL by FISH | Double Hit Lymphoma by FISH | Triple Hit Lymphoma by FISH | 9223 Interface Order Alias 11604 Clinical Information This probe panel detects specific structural chromosome abnormalities commonly associated with Diffuse Large B-cell Lymphoma.   Routine chromosome analysis is performed on all diagnostic…

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MedinCell Publishes Its Consolidated Half-year Financial Results

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News: MedinCell (Paris:MEDCL): Commercial launch by Teva of UZEDY™, the first product based on BEPO® technology, in the United States, and collect of first royalties representing €635K (June-September 2023). Christophe Douat, CEO of MedinCell, said: “Commercial revenues will transform MedinCell for the long term, especially as the…

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Researchers look for ways to lower neuroinflammation

Share on PinterestResearchers are looking for more effective ways to deliver a potential therapy against neuroinflammation to the brain. Image credit: Maskot/Getty Images. Small interfering RNAs can silence the machinery that translates certain mRNAs, meaning they can also be used to stop the production of some proteins. Researchers have looked…

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39.5% below its target price, is this the most exciting growth stock?

Image source: Getty Images On 15 November, the UK medicines regulator approved a therapy that uses the CRISPR–Cas9 gene-editing tool, marking a world first. And it sent shares in this growth stock into hyperdrive. And then on 8 December, the US Food and Drug Administration (FDA) also gave the treatment the…

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Charles River’s (CRL) Memphis Site Achieves Crucial Approval

Charles River Laboratories International, Inc. CRL recently achieved an important milestone in its strategic collaboration with Vertex Pharmaceuticals to manufacture CASGEVY (exagamglogene autotemcel [exa-cel]). The company’s Memphis facility has been approved to manufacture Vertex’s CASGEVY — the first-ever gene-edited therapy in the world that targets severe sickle cell disease (SCD)….

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Ascendis Pharma (ASND) Reports TransCon hGH Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial

FREE Breaking News Alerts from StreetInsider.com! StreetInsider.com Top Tickers, 12/19/2023 December 19, 2023 8:30 AM EST Ascendis Pharma A/S (Nasdaq: ASND) today announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with…

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Advances in Anti-CD20 Therapies for Relapsed or Refractory Large B-Cell Lymphoma From ASH 2023

1. FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. News release. US Food and Drug Administration. June 21, 2023. Accessed December 6, 2023. www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-epkinly-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b 2. FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell…

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FDA to Review Omalizumab for Patients With Food Allergies

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to 1 or more foods in adults and pediatric patients aged 1 year and older with food allergy….

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Frontiers Publishing Partnerships | Construction of recombinant adenovirus-5 vector to prevent replication-competent adenovirus occurrence

Introduction In recent years, recombinant adenoviral vectors have been used in different fields of biomedical sciences such as in vitro and in vivo gene transfer, vaccine development, and gene therapy (Russell, 2000; Mitani and Kubo, 2002). Multiple features of recombinant adenoviral vectors such as high packaging capacity for transgene insertion,…

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Merck’s 21-Valent Pneumococcal Conjugate Vaccine Gets FDA’s Priority Review

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for V116, an investigational 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F,…

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The Next Chapter in Genome Editing? Tome Emerges from Stealth with $213M

Rahul Kakkar, MD, Tome Biosciences president and CEO While the CRISPR community celebrates the recent first FDA approval of a CRISPR-Cas9 therapy (Casgevy), new entities are making strides in their efforts to write perhaps the definitive new chapter in programmable genome editing. Last week, Tome Biosciences—a developer of genome editing…

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Casgevy, sickle cell gene-editing therapy, favored for EU approval

A European Medicines Agency committee has issued a positive opinion on the gene-editing therapy Casgevy (exagamglogene autotemcel) in treating sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The Committee for Medicinal Products for Human Use (CHMP) recommendation will be considered by the European Commission in making a final approval decision…

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Start Of Patient Dosing In Early Cardiogenic Shock SEISMiC Extension Study In Preparation For Phase 3 Readiness, Topline Data Expected Mid-2024

WARRINGTON, PA / ACCESSWIRE / December 19, 2023 / Windtree Therapeutics, Inc. (NASDAQ: WINT) has recently enrolled the first subject in its phase 2 SEISMiC Extension Study to evaluate istaroxime in the treatment of early cardiogenic shock. The phase 2 trial builds upon the positive data from the SEISMiC study…

Continue Reading Start Of Patient Dosing In Early Cardiogenic Shock SEISMiC Extension Study In Preparation For Phase 3 Readiness, Topline Data Expected Mid-2024

Nine biotech companies to watch in 2024

As 2024 unfolds, the biotechnology industry is brimming with potential, spearheading scientific innovation. This year is particularly exciting as a diverse range of biotech companies are poised to break new ground to tackle global challenges. Here are nine biotech companies we will follow in 2024. Aiolos Bio Aiolos Bio has…

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HUIADGENE ANNOUNCES RARE PEDIATRIC DRUG DESIGNATION GRANTED TO HG302, A NOVEL CRISPR DNA-EDITING THERAPY, FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

HG302 effectively generates stable genome editing with minimal off-target effects in-vitro and in-vivo A single intravenous injection of HG302 restores functional dystrophin protein expression HG302 demonstrates therapeutic effects by improving muscle functions in humanized DMD mice SHANGHAI and CLINTON, N.J., Dec. 19, 2023 /PRNewswire/ — HuidaGene Therapeutics (辉大基因”HuidaGene”) today announced…

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Non-Hodgkin Lymphoma Market to Register Incremental Growth | AbbVie and Genmab, Roche, AstraZeneca, 4SC AG, Innate Pharma,Teva Pharma, Eli Lilly, and other companies are expected to change the Market scenario by 2032, forecasts DelveInsight.

DelveInsight’s “Non-Hodgkin lymphoma Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of the NHL, historical and forecasted epidemiology as well as the Non-Hodgkin lymphoma market trends in the United States EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. {Delhi, India} To…

Continue Reading Non-Hodgkin Lymphoma Market to Register Incremental Growth | AbbVie and Genmab, Roche, AstraZeneca, 4SC AG, Innate Pharma,Teva Pharma, Eli Lilly, and other companies are expected to change the Market scenario by 2032, forecasts DelveInsight.

FDA approved treatments use gene therapy to help patients with sickle cell disease

By Olivia Trani  The U.S. Food and Drug Administration recently approved two gene therapies, Casgevy and Lyfgenia, to treat sickle cell disease in people ages 12 and older. One of the therapies, Casgevy, use a novel gene-editing technique called CRISPR/Cas9, which can modify a cell’s DNA at a targeted location…

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Eisai files biliary tract cancer drug tasurgratinib in Japan

Eisai has filed for approval in Japan for tasurgratinib, its small-molecule fibroblast growth factor (FGF) receptor inhibitor, as a treatment for biliary tract cancers with FGFR2 gene fusion mutations. The application to the Ministry of Health, Labour and Welfare (MHLW) is set for a priority review, reflecting the relatively high…

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This Antiseizure Medication Is Effective, Safe for Focal Seizures in Asian Patients

Among Asian patients with focal onset seizures, brivaracetam, an antiseizure medication, successfully demonstrated efficacy and tolerability compared to placebo, according to study results presented at the American Epilepsy Society (AES) 2023 annual meeting, held from December 1 to 5 in Orlando, Florida. Brivaracetam is approved by the US Food and…

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Vertex (VRTX), CRISPR Get Positive CHMP Opinion for Gene-Therapy

Vertex Pharmaceuticals Incorporated VRTX announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (“EMA”) had adopted a positive opinion, recommending the conditional approval of Casgevy to treat severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The CHMP’s recommendation, although not legally binding, will…

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Point Bio Prostate Cancer Therapy Meets Phase 3 Goal, But Results Still Disappoint

A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug,…

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3 Biotech Stocks Most Wall Street Analysts Are Bullish About

The scenario for the biotech industry in 2024 looks upbeat after a challenging ride in 2023. New drug approvals, pipeline development, and an increase in mergers & acquisitions (M&A) activity boosted investor sentiment in the last couple of months, even though an uncertain macroeconomic environment was a headwind. Pharma and…

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Clinical Challenges: Using Pola-R-CHP for Diffuse Large B-Cell Lymphoma

Earlier this year, the FDA approved a new frontline option for patients with diffuse large B-cell lymphoma (DLBCL): the antibody-drug conjugate polatuzumab vedotin (Polivy) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP). Combination chemotherapy involving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) — and before that, CHOP alone —…

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Keytruda Plus Padcev Approved for Locally Advanced or Metastatic Urothelial Cancer

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial cancer. Previously, the treatment was approved only for patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-containing chemotherapy. The approval was…

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Alyglo Approved for Patients With Primary Humoral Immunodeficiency

The Food and Drug Administration (FDA) has approved GC Biopharma’s Alyglo™ (immune globulin intravenous, human-stwk) 10% liquid for the treatment of primary humoral immunodeficiency (PI) in adult patients 17 years of age and older. Manufactured from pooled human plasma from US donors, Alyglo supplies a broad spectrum of neutralizing IgG…

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Pembrolizumab/Chemo Receives European Approval in First-Line GI Cancers

The approval was based on data from both the phase 3 KEYNOTE-859 study (NCT03675737) and the phase 3 KEYNOTE-966 study (NCT04003636). The European Commission has granted approval to pembrolizumab (Keytruda) and chemotherapy in 2 gastrointestinal cancer indications, according to a press release from Merck.1 In particular, pembrolizumab is available in…

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Whole Genome Sequencing (WGS) Program

Whole genome sequencing (WGS) is a cutting-edge technology that FDA has put to a novel and public health-promoting use. FDA is laying the foundation for the use of whole genome sequencing to protect consumers from foodborne illness in countries all over the world. On this page: Introduction Whole genome sequencing…

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Promising Biotech Selling Way Under Cash Value

Nkarta is using CRISPR technology for cell therapies for leukemia. The FDA just approved a similar cell therapy treatment for Vertex using the same CRISPR technology. Nkarta is trading well below cash value and has a significant short position sinking underwater. We did very well with Talaris as a takeover…

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Charles River, Vertex Reach Milestone In Cell Therapy Collaboration

Charles River Laboratories reached a milestone in its strategic collaboration to manufacture CASGEVY (exagamglogene autotemcel [exa-cel]). CASGEVY has been approved in some countries for certain eligible patients. The news follows Charles River’s Memphis center of excellence passing back-to-back audits from both the U.S. FDA and the Health Products Regulatory Authority, on…

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FDA Fails to Address DNA Adulteration Concerns

The following article originally appeared on Dr. Robert Malone’s Substack, and is reprinted here verbatim with permission. Robert Malone, MD, MS; Malone Institute December 15, 2023, 2:30 PM EST (Madison VA and Tallahassee FL) The failure of government regulatory authorities to identify and disclose DNA fragment contamination of…

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US neurologists favorably view a BTK inhibitor as an MS treatment

More than one-third of neurologists in the U.S. believe Bruton’s tyrosine kinase (BTK) inhibitors could be of pivotal significance as a future treatment of multiple sclerosis (MS), according to findings of a recent Spherix Global Insights’ survey. “Through Spherix’s quarterly RealTime Dynamix market tracker, neurologists and MS specialists have expressed…

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First Wave BioPharma (FWBI) Enters Term Sheet for Merger with ImmunogenX

First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage biotherapeutics company developing…

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Invivyd Announces Positive Initial Results from Ongoing

VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants Data supportive of an immunobridging approach to the EVADE study of adintrevimab Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to date VYD222 demonstrates continued in-vitro neutralization activity against major…

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Individual Disease Histology and Local Control Are Key Considerations in Endometrial Cancer Care

Systemic therapy and surgery have become mainstays in the treatment of patients with endometrial cancer, although further research is necessary to delineate the optimal use of radiation and later-line immunotherapy in this patient population, according to Hope Cottrill, MD. The phase 3 NRG-GY018 trial (NCT03914612) evaluated the efficacy and safety…

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Illumina, Structure Therapeutics, Point news

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today, we see a small biotech on the verge of ending a rare-disease program thanks to FDA difficulties  — and how that impacts patients. We fete the best of…

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Pharmalittle: FDA found problems at Moderna facility

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of online meetings and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing another cup…

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Adaptimmune Completes BLA for Cell Therapy for Solid Tumors

Adaptimmune Therapeutics has completed its rolling biologics license application (BLA) to the FDA for afamitresgene autoleucel (afami-cel), an engineered T-cell therapy for advanced synovial sarcoma, which are solid tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. Synovial sarcoma accounts for about 5% to…

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Brace yourselves for these trends in clinical research in 2024

There’s an air of cautious optimism about 2024, after a difficult few years following the end of the pandemic when investment in pharma and biotech research dropped substantially. After this significant reset, there’s now hope that in 2024, in line with emerging trends, the funds will be there for the…

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Vertex secures CHMP approval for Casgevy approval in Europe

Casgevy became first FDA-approved medicine to use CRISPR/Cas9 gene-editing technology. Image credit: Shutterstock/Nemes Laszlo. Vertex Pharmaceuticals has gained a positive opinion from the EMA’s CHMP for Casgevy (exa-cel), paving the way for European approval of the sickle cell gene therapy early next year. The CHMP will now send their recommendation…

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First Wave BioPharma Announces Entry into Term Sheet for

Phase 3-ready latiglutenase, a targeted oral biotherapeutic for celiac disease, will expand First Wave BioPharma’s late-stage gastrointestinal (GI) disease clinical pipeline A concurrent institutional investment and a strategic U.S. license agreement with a global pharmaceutical company is anticipated to be completed post-closing BOCA RATON, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE)…

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The Landscape of Agricultural Biotechnology

By 2049, our global population will reach ~9 billion people. Pests, diseases and adverse environmental conditions are impacting crops across the globe, compounding the issue of feeding a growing population. Traditional breeding techniques have enabled scientists and farmers to develop many varieties of plants and livestock tailored for specific agricultural…

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Verrica Pharmaceuticals Announces Positive Results from Phase 3 Trial of TO-208 for Molluscum Treatment in Japan

WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a leading dermatology therapeutics provider, has shared promising top-line results from the Phase 3 trial of TO-208 for molluscum contagiosum (“molluscum”) treatment in Japan. The trial was conducted by Torii Pharmaceutical Co., Ltd., Verrica’s development and commercialization partner. The double-blind, randomized,…

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FDA Suggests Florida Surgeon General Is Spreading “Misinfo” About COVID Vax Safety

Florida Surgeon General Dr. Joseph Ladapo As the federal government renews calls for more COVID-19 vaccines, the Biden administration continues to argue that the jabs are safe and effective, and said suggestions to the contrary, such as those recently expressed by Florida’s top doctor, amount to “misinformation and disinformation” that…

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FDA Fails to Address DNA Adulteration Concerns, Resorting To Gaslighting Instead

Thanks, Jan! Lets get this amplified! Go Joe Ladapo! t.co/kgaIolmKnR — Robert W Malone, MD (@RWMaloneMD) December 16, 2023 Someone said: “If reports I’ve read in the news are correct, that many high level members of the FDA are heavily invested in the covid vaccines, then it make sense that…

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CRISPR Therapeutics Just Made History. So Why Did Its Stock Fall?

On Dec. 8, CRISPR Therapeutics (CRSP -1.37%) and its collaboration partner Vertex Pharmaceuticals (VRTX 1.00%) made history when the Food and Drug Administration (FDA) gave them the green light to commercialize their gene therapy for sickle cell disease (SCD), which is the first medicine to use the much vaunted CRISPR-Cas9…

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