Tag: FDA

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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,…

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…

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…

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…

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…

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…

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…

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…

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….

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

– 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)…

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,…

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…

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…

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…

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…

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,…

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…

(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…

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…

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…

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…

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…

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…

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)….

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…

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…

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….

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,…

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,…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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,…

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…

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 —…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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)…

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…

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,…

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…

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…

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…