Tag: FDA

CRISPR therapeutics made history. So why did its stock fall?

Related investors with two people in the background On 8th December, CRISPR Therapeutics (NASDAQ: CRSP) and its collaboration partners Vertex Pharmaceuticals (NASDAQ:VRTX) made history when the Food and Drug Administration (FDA) gave them the green light to commercialize their gene therapy for sickle cell disease (SCD) using the much-hyped CRISPR-Cas9…

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Caliway Closes Oversubscribed Capital Raise and Secures Over $100M to Advance CBL-514 Pivotal Phase 3 Study in Subcutaneous Fat Reduction

TAIPEI, Dec. 16, 2023 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway) announced that it has closed an oversubscribed capital raise, securing over $100M by issuing 8 million new shares. The new funding will enable Caliway to advance the clinical development of its lead pipeline CBL-514, a small-molecule injectable drug that reduces subcutaneous…

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False claim Moderna admitted mRNA vaccines cause cancer

Scientists win Nobel Prize for mRNA, COVID-19 work Dr. Katalin Karikó and Dr. Drew Weissman won the Nobel Prize in Physiology or Medicine for their work on mRNA vaccines, leading to a COVID vaccine. The claim: Moderna admitted mRNA vaccines cause cancer A Dec. 2 Instagram post (direct link, archive…

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FDA responds to Ladapo letter

In response to a letter in which Florida Surgeon General Joseph Ladapo noted the detection of DNA fragments in mRNA COVID-19 vaccines, Peter Marks, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research, emphasized the FDA’s view that the shots are safe and effective. “I…

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Fatty Acid Metabolism-Related lncRNAs as Biomarkers for SKCM

Introduction Skin cutaneous melanoma (SKCM), as one of the most aggressive types of cancer due to its elevated degree of heterogeneity, has gained increasing attention during the past few decades.1 Also known as “the cancer that rises with the sun”,2 melanoma originates from cancerous melanocytes due to molecular or genetic…

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Readout Newsletter: Amgen, Novartis, Chewy, Bluebird

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hullo! Turns out Jay Bradner is moving from academia and Novartis to serve as Amgen’s new CSO. Also, the FDA has a new registry of trial sponsors and investigators…

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Expert Guidelines Detail Optimal Sequencing of Emerging Therapies for Metastatic Castration-Resistant Prostate Cancer, Journal Club

Read the Full Video Transcript Rashid Sayyid: Hello everyone and thank you for joining us in this UroToday recording. I’m Rashid Sayyid, the Urologic Oncology Fellow at the University of Toronto, and along with Zach Klaassen, Associate Professor Program Director at Wellstar MCG Health, we’ll be discussing the recently amended…

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Enfortumab Vedotin Combo Is Approved by FDA for Advanced Urothelial Cancer

The News Enfortumab vedotin-ejfc (Padcev) plus pembrolizumab (Keytruda) has been approved by the FDA for patients with locally advanced or metastatic urothelial cancer, according to a press release from the organization. Enfortumab Vedotin’s Efficacy The median overall survival (OS) was 31.5 months (95% CI, 24.4-not estimable) in the combination arm…

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FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease | Goodwin

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA.  SCD is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. and inducing a median life…

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FDA official shames FL surgeon general for raising ‘DNA contamination’ concerns in COVID vaccines

Questioning the purity of mRNA COVID-19 vaccines is tantamount to spreading disinformation that kills people, the FDA’s top vaccines official not so subtly implied to Florida Surgeon General Joseph Ladapo this week. Ladapo notified FDA Commissioner Robert Califf and CDC Director Mandy Cohen Dec. 6 of recent research awaiting peer…

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Edesa Biotech Reports Fiscal Year 2023 Results

TORONTO, ON / ACCESSWIRE / December 15, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the fiscal year ended September 30, 2023 and provided an update on its business. During the year, Edesa reported favorable…

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Pharma’s Frontline: 3 Stocks Driving Revolutionary Drug Development

Drug the undrugable, treat the untreatable, the revolution in drug development is happening all around us The pharma stock leaders can at times seem overly risk averse with their approach to developing new medicines and cures. With the difficulty of clinical trials and the uncertainty of Federal Drug Administration (FDA) approval,…

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Torii Shares Positive Data From Japan Trial of TO-208 for Molluscum Contagiosum

Verrica Pharmaceuticals Inc. and its partner, Torii Pharmaceutical Co., Ltd., today shared positive top-line results from the phase 3 trial of TO-208, also known as VP-102, and marketed as YCANTH in the US, for the treatment of molluscum contagiosum in Japan. The confirmatory phase 3 trial, conducted in Japan, utilized…

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CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis

– NDA is supported by data evaluating seladelpar efficacy and safety in over 500 patients –  – Seladelpar is the first New Drug Application from CymaBay in its ongoing mission to help people living with PBC –  NEWARK, Calif., Dec. 15, 2023 /PRNewswire/ — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a…

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Adbry Approval Expanded to Pediatric Patients with Atopic Dermatitis

The Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Previously, the interleukin-13 antagonist…

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Research and Markets: MONJUVI (tafasitamab-cxix) Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM – United States, Germany, France, Italy, Spain, United Kingdom, and Japan

The “MONJUVI Drug Insight and Market Forecast 2032” drug pipelines has been added to ResearchAndMarkets.com‘s offering. This “MONJUVI Drug Insight and Market Forecast 2032” report provides comprehensive insights about MONJUVI for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets. A detailed picture of the MONJUVI for DLBCL in…

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Sickle Cell Disease Gene Therapies Approved by FDA Highlighting Potential of CRISPR/Cas9 Technologies

In a landmark decision last week, the US Food and Drug Administration (FDA) approved two treatments involving cell-based gene therapies.  An agency within the US Department of Health and Human Services, the FDA assures the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for…

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FDA Drug Approval Decisions Expected in January 2024

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after…

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FDA Approves Implant for Glaucoma

The US Food and Drug Administration (FDA) has approved an intracameral implant with 75 mcg of travoprost to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).  The iDose TR (Glaukos Corp) is inserted into a corneal incision on the temple side of the eye….

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Vertex-CRISPR’s Casgevy Gets Positive EMA Panel Opinion, Approval Decision in Q1 2024

Pictured: European Medicines Agency sign on building/iStock, Lubo Ivanko Following in the footsteps of U.K. and U.S. regulators, a European Medicines Agency committee on Thursday endorsed Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, which is intended for the treatment of sickle cell disease and transfusion‑dependent beta thalassemia in Europe.  EMA’s Committee…

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Zanubrutinib Favored Over Bendamustine/Rituximab Combination Across Biomarker Subgroups in CLL/SLL Without del(17p)

Treatment with the BTK inhibitor zanubrutinib (Brukinsa) conferred a progression-free survival (PFS) benefit compared with bendamustine plus rituximab (Rituxan) across most biomarker subgroups of patients with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) without del(17p), according to findings from the phase 3 SEQUOIA trial (NCT03336333) presented as…

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FDA submission signals new era for PTSD treatment

MAPS Public Benefit Corporation (MAPS PBC) has reached a significant milestone in the field of psychedelic medicine by submitting a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) used in combination with psychological intervention. This novel MDMA-assisted therapy, aimed at treating post-traumatic…

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Verrica Pharmaceuticals’ Development and Commercialization

WEST CHESTER, Pa., Dec. 15, 2023 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that its development and commercialization partner, Torii Pharmaceutical Co., Ltd. (“Torii”), reported positive top-line results from its Phase…

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FDA Approves First Pulsed Field Ablation System for AF

The US Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System (Medtronic) for the treatment of both paroxysmal and persistent atrial fibrillation (AF), the manufacturer has announced. The technology uses microsecond-scale pulsed electrical fields for pulmonary vein isolation (PVI) to reduce AF and is the…

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FDA Approves Belzutifan in Advanced RCC

Results from the phase 3 LITESPARK-005 trial led to the approval of belzutifan for patients with advanced renal cell carcinoma, according to the FDA. The FDA has approved belzutifan (Welireg) for patients with advanced renal cell carcinoma (RCC) after a PD-L1/PD-1 inhibitor and VEGF tyrosine kinase inhibitor (TKI) for patients…

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Editas (EDIT) Licenses Cas9 Tool to Vertex, Stock Up 6%

Editas Medicine, Inc. EDIT announced entering into a licensing agreement with Vertex Pharmaceuticals VRTX for the development of the latter’s new sickle cell disease (SCD) gene therapy, Casgevy. Per the terms of the agreement, Vertex will receive a non-exclusive license to utilize Editas’ Cas9 gene editing technology for ex vivo gene editing medicines…

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Biopharma Company Issues New Patent Application; Phase 3 Clinical Trials for Cancer Treatments: RenovoRx (NASDAQ: RNXT)

RenovoRx, Inc. Nasdaq: RNXT NASDAQ: RNXT $RNXT Clinical Sites RenovoTAMP $RNXT Battles Cancer Tumors Direct! RenovoTAMP $RNXT Advancing Cancer Treatments: RenovoRx’s Phase 3 Clinical Trials in Partnership with Imugene RenovoRx, Inc. (NASDAQ:RNXT) LOS ANGELES , CALIFORNIA , UNITED STATES , December 14, 2023 /EINPresswire.com/ — Biopharma Company Issues New Patent…

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FDA Approves Belzutifan for Adult Patients With Advanced RCC

This approval of belzutifan (Welireg) for the treatment of advanced renal cell carcinoma (RCC) is supported by findings from the phase 3 LITESPARK-005 study (NCT04195750). Statistically significant and clinically meaningful improvements in progression-free survival (PFS) were observed with belzutifan. This approval provides adult patients with RCC who progressed on immune…

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Capricor Reports Positive DSMB Review of Phase 3 HOPE-3 Interim Results

Capricor Therapeutics recently reported a positive futility analysis of its phase 3 HOPE-3 study (NCT05126758) assessing its investigational agent CAP-1002 in patients with Duchenne muscular dystrophy (DMD). Conducted by the study’s Data Safety Monitoring Board (DSMB), the results of the interim analysis resulted in a favorable recommendation to continue the…

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RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia. On Dec. 11, 2023, RoslinCT, a UK-based cell and gene therapy contract development and manufacturing organization (CDMO), announced that it will manufacture Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel [exa-cel]), a recently approved…

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Travere Therapeutics Initiates Pivotal Phase 3 Clinical Trial of Pegtibatinase for the Treatment of Classical Homocystinuria (HCU) | Proteins and Peptides

Travere Therapeutics Initiates Pivotal Phase 3 Clinical Trial of Pegtibatinase for the Treatment of Classical Homocystinuria (HCU) Details Category: Proteins and Peptides Published on Thursday, 14 December 2023 14:58 Hits: 136 Potential for pegtibatinase to become first disease-modifying treatment for classical HCU; topline data expected in 2026 SAN DIEGO,…

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FDA approves Abbott laboratory automation system

Abbott’s new laboratory automation system has received U.S. Food and Drug Administration (FDA) approval, the company announced in a statement. The Abbott GLP Systems Track has a self-propelled single-sample carrier called CAR, which allows samples to move independently in self-propelled cars throughout the track without a belt, a feature the…

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Growth Is Still a Better Choice

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) is a leader in the global cystic fibrosis therapeutics market. In addition, the company has an extensive portfolio of experimental medicines aimed at treating common diseases such as type 1 diabetes, sickle cell anemia and APOL1-mediated kidney disease (AMKD). Investment thesis On Dec. 8, the Food…

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Morphogenesis, Inc. Announces Corporate Rebranding to TuHURA Biosciences, Inc. and Provides a Business Overview

Company focused on advancing novel personalized cancer vaccines to overcome tumor resistance to immunotherapies like checkpoint inhibitors; and first-in-class bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to modulate their immunosuppressive effects on the tumor microenvironment Company on track to initiate pivotal Phase 3 study of lead…

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Vertex signs $100m CRISPR deal to use sickle cell treatment

Tada Images / Shutterstock.com More on this story Other related Biotech firm agrees licence deal days after its gene editing treatment gets landmark FDA approval | Patents owned by the Broad Institute protect technology sold via Editas Medicines. Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists…

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STAT Health News: Medication abortion, mifepristone, pregnancy

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. Good morning. Reproductive health is dominating the news and the newsletter this morning. We also have a look at the decade-long battle over a patent for CRISPR. It’s been a rollicking…

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The latest on Moderna, Apellis, and Merck

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, everyone. Damian here with the fallout from Pfizer’s downbeat update, a new entrant in obesity research, and an orthogonal CRISPR business. The need-to-know this morning Apellis Pharmaceuticals said a…

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Vertex licenses Editas’ gene editing technology in $100m deal

Vertex will pay $50m to Editas upfront, with an additional contingent $50m payment. Image credit: Shutterstock/Catalin Rusnac. Vertex Pharmaceuticals has entered a license agreement with Editas Medicine to use the latter company’s Cas9 gene editing technology. Vertex will pay $50m to Editas upfront, with an additional contingent $50m payment, according…

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Capsiplex Trim Reviews – Will It Make You Stronger?

Capsiplex Trim is a supplement designed exclusively for women to enhance the full athletic performance of the female body. Per the company’s official website, Capsiplex Trim is one of the advanced fat-burning formulas for women. You may come across many Capsiplex Trim reviews by now. If you are wondering why…

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Global Next Generation Sequencing Market Share Projections:

Newark, Dec. 14, 2023 (GLOBE NEWSWIRE) — As per the report published by The Brainy Insights, the global Next Generation Sequencing market is expected to grow from USD 8.26 Billion in 2022 to USD 48.01 Billion by 2032, at a CAGR of 19.24% during the forecast period 2023-2032. NGS has completely…

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Seven precision medicine companies worth keeping an eye on

Precision medicine is an approach to tailoring treatments based on people’s genetic makeup, lifestyles and environment. These targeted interventions can tackle diseases like cancer, neurological as well as metabolic diseases. The global market value of the precision medicine industry, encompassing many companies, crossed 70 billion last year, and is expected…

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CDC director visits Orlando to encourage vaccination, combat misinformation

Centers for Disease Control and Prevention Director Dr. Mandy Cohen traveled to Orlando this week as part of a nationwide tour to combat vaccine misinformation during respiratory disease season. Doctors this year are recommending a flu vaccine, an updated COVID-19 booster, and, for those who qualify, the newly available vaccine…

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Gills Onions Salmonella outbreak ends after 80 sick, 18 hospitalized and 1 death

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) collected different types of data to investigate a multistate outbreak of Salmonella Thompson infections. Epidemiologic, laboratory, and traceback data showed that onions processed at Gills Onions were contaminated with Salmonella and made people sick. As of December 4, 2023,…

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Verastem Oncology Announces Initiation of A Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer -December 13, 2023 at 07:01 am EST

Verastem Oncology announced that it has initiated its international confirmatory Phase 3 RAMP 301 trial (GOG- 3097; ENGOT-ov81/NCRI), evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). RAMP 301 is the confirmatory study required by the…

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FDA Weighing New Application to Approve Prescription MDMA

A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD). The MAPS Public Benefit Corporation (MAPS PBC) announced on December 12 that it had submitted the new…

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U.S. Neurologists Eagerly Await Promising Oral Bruton’s Tyrosine Kinase Inhibitors in Multiple Sclerosis Treatment Pipeline, Though Recent Trial Readouts Might Hamper Initial Excitement

Efficacy and safety of pipeline multiple sclerosis assets viewed as increasingly important characteristics, according to Spherix Global Insights. Exton, PA, Dec. 13, 2023 (GLOBE NEWSWIRE) — Several clinical trials are underway for Bruton’s tyrosine kinase inhibitors (BTKi) targeting relapsing and progressive multiple sclerosis (RMS/PPMS). These BTKis, administered orally, possess the…

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Final Analysis of the Phase 2 ELM-2 Study in Patients with DLBCL

Date of Abstract presentation 10th December 2023 Indications Diffuse Large B-cell lymphoma (DLBCL) Abstract Number 436 Abstract type Oral Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. The primary analysis of the…

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Amgen (AMGN) Announces FDA Grants Priority Review to Tarlatamab Application for Advanced Small Cell Lung Cancer

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company’s Biologics License Application (BLA) for tarlatamab. Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients…

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Ocular Therapeutix(TM) Announces Proposed Public Offering of Common Stock

BEDFORD, Mass., Dec. 13, 2023 (GLOBE NEWSWIRE) — Ocular Therapeutix™, Inc. (Nasdaq: OCUL) (the “Company”), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has commenced an underwritten public offering of its common stock. In…

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MAPS Celebrates Submission of New Drug Application to FDA for MDMA-Assisted Therapy for PTSD – Multidisciplinary Association for Psychedelic Studies

FOR IMMEDIATE RELEASE: December 13, 2023 MAPS incubated the program that generated the first NDA submission for any psychedelic-assisted therapy Submission represents 30-plus years of philanthropy-driven clinical research into potential use of MDMA-assisted therapy for PTSD If accepted for review by the FDA, the application could be approved next year  …

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Local sickle cell patient reacts to new treatment options

TAMPA, Fla. — The FDA recently approved two different gene therapies to treat sickle cell disease, and many doctors and patients living with the painful disease say this is a long time coming. What You Need To Know The two newly approved gene therapies each use a different method According to the FDA, in…

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Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

BOSTON–(BUSINESS WIRE)– Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today that it has initiated its international confirmatory Phase 3 RAMP 301 trial (GOG-3097; ENGOT-ov81/NCRI), evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the…

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Non-Hodgkin Lymphoma Pipeline and Clinical Trials Assessment 2023: FDA Approvals, Therapies and Key Companies involved by DelveInsight

PRESS RELEASE Published December 12, 2023 (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Non-Hodgkin Lymphoma pipeline constitutes key companies continuously working towards developing Non-Hodgkin Lymphoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The Non-Hodgkin Lymphoma Pipeline report…

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3 Biotechs With Promising Gene Therapies in the Spotlight

Recently, bluebird bio, Inc. BLUE obtained FDA approval for its third gene therapy, lovotibeglogene autotemcel (lovo-cel), for the treatment of sickle cell disease (“SCD”) in patients aged 12 and older who have a history of vaso-occlusive events (“VOEs”). The FDA approved lovo-cel under the brand name Lyfgenia. Concurrently, it also…

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BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

– BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia –  The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) shared positive feedback that…

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BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia -December 13, 2023 at 07:31 am EST

Official BRIDGEBIO PHARMA, INC. press release – BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia –  The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines…

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From the Desk of Thom Golab: ACSH and Sickle Cell Disease

When I worked for another think tank 40 years ago (dang, I am old), the president used to say books with new ideas are great, but people (by that, he meant journalists and policymakers) don’t have time to read books. So, those potential new policies aren’t discussed. His solution was…

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Reproxalap in Patients with Seasonal Allergic Conjunctivitis

Introduction Reproxalap, a novel chemical entity in late-stage clinical development for the treatment of ocular inflammation, chemically sequesters a class of small molecules known as reactive aldehyde species (RASP). Via covalent binding to amine and thiol residues, RASP modulate the structure and function of proteins in an analog manner1 depending…

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A Majority of Subjects in Jaguar Health s Placebo-Controlled Pivotal Phase 3 OnTarget Trial for Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Therapy Chose to Continue on to Stage II -December 12, 2023 at 06:22 am EST

SAN FRANCISCO – Napo Pharmaceuticals (Napo), a Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar) family company, today announced that a majority of subjects in the company s placebo-controlled pivotal Phase 3 OnTarget trial for prophylaxis (prevention) of diarrhea in adult cancer patients receiving targeted therapy with or without standard chemotherapy chose…

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Biopharma Company Reaches Phase 3 Clinical Trials for Cancer Treatments; 9 Patents Issued; Collaboration with Imugene: RenovoRx (NASDAQ: RNXT)

PRESS RELEASE Published December 12, 2023 Clinical-Stage Biopharma Company Developing Proprietary Targeted Combination Therapies for High Unmet Medical Needs in Oncology.   Trans-Arterial Micro-Perfusion (TAMPTM) Therapy Designed to Directly Target Tumors While Potentially Minimizing Toxicities.  Welcomed Ducreux, M.D., Ph.D., Head of the Gastrointestinal Oncology Unit and Gastrointestinal Oncology Tumor Board at…

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MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD

  Filing marks first NDA submission for any psychedelic-assisted therapy  Submission represents 30 plus years of clinical research into potential use of MDMA-assisted therapy for PTSD NDA includes two Phase 3 trials (MAPP1 and MAPP2) that both met primary and secondary endpoints …

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Caribou Biosciences Shares Rise 4.1% as FDA Approves Lymphoma Trial

By Ben Glickman Shares of Caribou Biosciences rose after the company’s lymphoma trial design was approved by the Food and Drug Administration. The stock was up 4.1% to $5.88 in after-hours trading following a 1.9% drop at Tuesday’s close. Shares are down 10% this year. The Berkeley, Calif.-based gene-editing pharmaceutical…

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RNAi Technology Market is expected to reach US$ 3.6 billion by 2030

The field of RNA interference (RNAi) is witnessing significant growth with the approval of small interfering RNA (siRNA) drugs by the US FDA. These siRNA therapeutics offer a powerful and specific approach to target mRNA, with notable approvals like Patisiran, Givosiran, Lumasiran, Inclisiran, and Vutrisiran. The liver has been a…

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Exclusive interview: Florida Surgeon General Joseph Ladapo asks FDA for data on risks of DNA contaminants in COVID-19 vaccines

Florida Surgeon General Joseph Ladapo | Photo courtesy of FDOH BY JENNIFER CABRERA TALLAHASSEE, Fla. – On December 6, Florida Surgeon General Joseph Ladapo sent a letter to the U.S. Food and Drug Administration (FDA), asking questions about a recent preprint documenting the detection of billions of DNA fragments per…

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Comprehensive Review of Small Interfering RNAs (siRNAs)

Introduction Cancer, also called malignancy, is a group of diseases caused by the rapid multiplication and spread of malignant cells.1,2 According to statistics from the National Cancer Center, more than 100 types of cancer have been identified.3 The ability of malignant tumor cells to metastasize via the blood-lymphatic system and…

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Cholangiocarcinoma Pipeline, FDA Approvals, Clinical Trials Developments and Companies 2023

PRESS RELEASE Published December 11, 2023 DelveInsight’s, “Cholangiocarcinoma Pipeline Insight 2023” report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Cholangiocarcinoma pipeline landscape. It covers the Cholangiocarcinoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cholangiocarcinoma pipeline therapeutics assessment by product type,…

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Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

Caribou Biosciences, Inc. — Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2…

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Cholangiocarcinoma Pipeline Drugs Analysis Report(2023 Updates): FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight

PRESS RELEASE Published December 12, 2023 (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Cholangiocarcinoma pipeline constitutes 55+ key companies continuously working towards developing 60+ Cholangiocarcinoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The Cholangiocarcinoma Pipeline report embraces…

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ADC Therapeutics Announces Initial Results from

Combination demonstrated clinically meaningful benefit in r/r FL patients with 96% overall response rate and 85% complete response rate LAUSANNE, Switzerland, Dec. 12, 2023 (GLOBE NEWSWIRE) — ADC Therapeutics SA (NYSE: ADCT) today announced initial results from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with…

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Biopharma Company Reaches Phase 3 For Cancer Treatments 9 Patents Collaboration With Imugene: Renovorx NASDAQ: RNXT

(MENAFN– EIN Presswire) RenovoRx, Inc. Nasdaq: RNXT NASDAQ: RNXT $RNXT Clinical Sites RenovoTAMP $RNXT Battles Cancer Tumors Direct! RenovoTAMP $RNXT $RXNT is a Clinical-Stage Biopharma Company Developing Proprietary Targeted Combination Therapies for High Unmet Medical Needs in Oncology. RenovoRx, Inc. (NASDAQ: RNXT) LOS ALTOS, CALIFORNIA, UNITED STATES, December 12, 2023…

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Caribou Biosciences Provides Regulatory Update on CB-010

— Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 — —…

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Biopharma Company Reaches Phase 3 for Cancer Treatments; 9 Patents; Collaboration with Imugene: RenovoRx NASDAQ: RNXT

RenovoRx, Inc. Nasdaq: RNXT NASDAQ: RNXT $RNXT Clinical Sites RenovoTAMP $RNXT Battles Cancer Tumors Direct! RenovoTAMP $RNXT $RXNT is a Clinical-Stage Biopharma Company Developing Proprietary Targeted Combination Therapies for High Unmet Medical Needs in Oncology. RenovoRx, Inc. (NASDAQ: RNXT) LOS ALTOS, CALIFORNIA, UNITED STATES, December 12, 2023 /EINPresswire.com/ — Biopharma…

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Diffuse Large B-cell Lymphoma Therapeutics Market Size, Share, Value and Report 2023-2030

The forecasted growth in the treatment of Diffuse Large B-cell Lymphoma (DLBCL) is driven by the increasing preference for targeted therapies. Targeted therapies, such as monoclonal antibodies and kinase inhibitors, offer a less toxic alternative to chemotherapy by focusing on specific molecular targets associated with cancer. Notable examples include rituximab…

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CRISPR Therapies Pipeline Review | Latest FDA, EMA, and PMDA Approvals, Novel and Emerging Therapies, and Treatment Outlook

PRESS RELEASE Published December 12, 2023 (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, CRISPR Therapies pipeline constitutes 25+ key companies continuously working towards developing 30+ CRISPR Therapies treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. The CRISPR Therapies…

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Bluebird Bio gets gene therapy approval but no business boost

The dual approvals have linked the two drugs, inviting comparisons while positioning the gene-editing drug, called Casgevy, to come out on top, analysts said. Casgevy, developed by Boston-based Vertex Pharmaceuticals and its Swiss partner CRISPR Therapeutics, costs nearly $1 million less than Lyfgenia and has a better safety profile. Bluebird,…

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Supreme Court Throws Out Cases On Covid Shot Mandates For Troops

The federal employee vaccine requirement was rescinded by President Joe Biden in May, and the Pentagon similarly withdrew a mandate for troops, but cases challenging the mandate for executive branch employees and military service members had rumbled on. CNN: Covid-19 Vaccine Mandates For Executive Branch Employees And Troops Thrown Out…

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Child PGI: Child PGI to get 33 docs by month end | Noida News

Noida: Child PGI will hire 33 specialists for its ophthalmology, transfusion medicine, orthopaedic, genetic disease, neurology, nephrology and cardiology departments by the end of the month. The move is set to benefit more than 3,000 children who are under treatment or consultation at the hospital.According to the hospital administration, the…

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Capricor Therapeutics (CAPR) Announces Continuation of Phase 3 HOPE-3 Trial of CAP-1002 Based on Completion of Interim Futility Analysis

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced a positive outcome of the interim futility analysis for HOPE-3, the pivotal Phase 3 trial evaluating CAP-1002 in patients with…

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Iptacopan: A New Milestone in Rare Disease Treatment

The pharmaceutical industry has reached a new milestone with the advent of a promising drug, Iptacopan (also known as Fabhalta), developed by Novartis. The company has recently reported positive topline results from a phase 3 trial of this drug, which is designed to treat a rare kidney disease known as…

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Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma

First-in-class and best-in-class potential in NRAS-mutated melanoma and other RAS/MAPK pathway-altered solid tumors Naporafenib has been dosed in more than 500 patients to date, establishing its safety, tolerability, and preliminary proof-of-concept in multiple indications Pivotal Phase 3 SEACRAFT-2 trial initiation in NRAS-mutated melanoma on track for H1 2024 SAN DIEGO,…

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Regeneron announces new, updated data for odronextamabn in R/R DLBCL

Regeneron Pharmaceuticals announced new and updated data for odronextamab in patients with relapsed/refractory diffuse large B-cell lymphoma, or DLBCL. The data from the pivotal Phase 2 trial and Phase 1 trial were shared in several presentations – including two orals – at the 65th American Society of Hematology Annual Meeting…

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NGS Sample Preparation Market Size is Worth USD 10,342.23 Million by 2032

Emergen Research The increased advancements in NGS platforms, a decrease in the price of sequencing, and improving the NGS-based diagnostic test reimbursement scenario are driving the demand for the Next Generation Sequencing (NGS) Sample Preparation market Vancouver, Dec. 11, 2023 (GLOBE NEWSWIRE) — The global next generation sequencing (NGS) sample…

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Gene-Editing Drug: Gaya Man in Research Team Produces First Gene-Editing Drug | Patna News

Patna: The world’s first gene-editing drug approved recently by the USA’s Food and Drug Administration (FDA) and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for therapeutic use owes much to Dr Atul Kumar Verma, a native of Gaya, who headed the analytical group of the research team. Dr Verma,…

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MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study

Pelabresib and ruxolitinib combination significantly reduced spleen size, with an SVR35 response rate nearly double that of placebo plus ruxolitinib Showed a strong positive trend in reducing symptom burden and a twofold increase in patients achieving both SVR35 and TSS50 versus placebo plus ruxolitinib Improved measures of anemia, including higher…

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Marker Therapeutics (MRKR) Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse

Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell…

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Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes | Antibodies

Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes Details Category: Antibodies Published on Monday, 11 December 2023 10:18 Hits: 243 Updated results presented at ASH demonstrated an 80% objective response rate and a 73% complete response (CR), with a 23-month median duration…

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Regeneron Presents Positive Phase II Results for its Lymphoma Drug

Pictured: Regeneron logo on a light brown building/Shutterstock, Lev Radin Regeneron has lifted the curtain on Phase II data for odronextamab, which it is investigating in patients with relapsed/refractory follicular lymphoma. Regeneron’s investigational CD20xCD3 bispecific antibody results were announced Sunday at the American Society of Hematology annual meeting. Regeneron said…

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Novartis reports success in phase 3 trial of drug for rare kidney disease

Pharmaceutical maker and biotechnology company Novartis is reporting positive topline results from a phase 3 trial of a drug to treat a rare kidney disease. Patients with the kidney disease, C3 glomerulopathy, who were taking 200 mg of iptacopan — also called Fabhalta — twice daily for six months were…

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Actinium Announces Iomab-B Produces High Response Rates and Significant Improvement in Overall Survival in Relapsed Refractory AML Patients with Active Disease Overcoming TP53 Mutation

  Relapsed or refractory AML patients with TP53 mutation known to have dismal outcomes due to limited effective treatment options   Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66…

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Metagenomics Market Surges as Genomic Insights Pave the Way for Breakthroughs in Microbial Exploration

PRESS RELEASE Published December 11, 2023 Market Overview Metagenomics involves the study of genetic material recovered directly from environmental samples, providing insights into the structure and function of microbial communities. The application of metagenomics spans diverse fields, including environmental microbiology, agriculture, biotechnology, and human health. Market Size and Growth Trends:…

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A Closer Look at the Approval of CRISPR/Cas9 Gene Therapy for Sickle Cell Disease

Brooks is a rare diseases researcher. Pritchett Clay is a researcher and chemist, and advocate for diversity in STEM. On Friday, the FDA approved two gene therapies to treat patients with sickle cell disease (SCD). One of the therapies, called exagamglogene autotemcel (Casgevy), is the first FDA-approved gene therapy utilizing…

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FDA approves gene therapies for sickle cell disease patients

The U.S. Food and Drug Administration (FDA) has given the green light to two new gene therapies, Casgevy and Lyfgenia, to treat sickle cell disease in patients 12 years old and older. Sickle cell disease is a genetic blood disorder that affects about 100,000 people in the U.S., mainly African-Americans…

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Fla. Surgeon General Seeks Answers on DNA Contamination of Covid Shots

bymuratdeniz/iStock/Getty Images Plus Florida’s Surgeon General, Dr. Joseph Ladapo, is seeking an explanation from federal health authorities on the undisclosed presence of potentially dangerous DNA fragments in mRNA Covid-19 injections. Ladapo sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf and the U.S. Centers…

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Florida Official Raises Alarms That COVID-19 Vaccines Can Cause Cancer

Florida Surgeon General Joseph Ladapo is raising alarms about what he sees as the risk of cancer posed by COVID vaccines. Ladapo, who rose to national prominence during the pandemic for spreading misinformation about the virus and promoting vaccination hesitancy, is asking the Food and Drug Administration (FDA) and the…

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Promising Fabhalta data for C3 glomerulopathy indication

Novartis released promising data on Fabhalta (iptacopan), its recently approved drug for paroxysmal nocturnal hemoglobinuria, this time for a new indication — a rare disease called C3 glomerulopathy (C3G). Topline results from a Phase 3 study released Monday morning showed that iptacopan met its primary endpoint and was effective in…

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Interactions between Vicks Formula 44 Cough Oral and selected-cyp2d6-substrates-desvenlafaxine-400-mg

Drugs & MedicationsVicks Formula 44 Cough Liquid Selected CYP2D6 Substrates/Desvenlafaxine (Greater Than or Equal To 400 Interactions This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Medical warning: Serious. These medicines may…

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DNA Contamination of COVID Vaccines Explored in Journal of American Physicians and Surgeons

DNA Contamination of COVID Vaccines Explored in Journal of American Physicians and Surgeons TUCSON, Ariz., Dec. 11, 2023 (GLOBE NEWSWIRE) — The current controversy over the alleged DNA contamination of COVID-19 vaccines involves complex issues, and also shows the difficulties in arriving at truth in today’s polarized and politicized atmosphere,…

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FDA approves Crispr in gene-editing milestone

Scientist pipetting sample into a vial for DNA testing. Shutterstock/ Cavan-Images The US Food and Drug Administration (FDA) approved the groundbreaking CRISPR gene-editing technology on Friday (8 Dec), heralding a new era in the fight against genetic diseases. Vertex Pharmaceuticals and CRISPR Therapeutics, the pioneering companies behind the innovation, are…

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FDA approves “milestone” sickle cell disease treatments

In what it calls a “milestone” development, the U.S. Food and Drug Administration (FDA) announced it has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients age 12 and older. One of the therapies, Casgevy, is the first FDA-approved treatment to use a…

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ncRNA | Free Full-Text | Regulation of Macrophage Polarization in Allergy by Noncoding RNAs

1. Introduction Allergies affect millions of people worldwide and are characterized by an excessive type 2 immune response to normally harmless substances, generally known as antigens or allergens, specifically [1,2]. Consequently, this response leads to the development of various allergic symptoms, including asthma, allergic rhinitis, and atopic dermatitis. In the…

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