XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development.

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FDA Approval Vaccine Vaccination In-Vitro 59

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). In 2020, the FDA ordered Novo to pause clinical trials of the drug following reports of blood clots in three patients.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. Approval in Brazil would mark the vaccines first use in a region where chikungunya is widespread.

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

XTalks

SEPTEMBER 4, 2024

Dr. Gudeman helped continue the clinical development of Lumryz (sodium oxybate) through to its approval, which was approved last May and is the first and only FDA approved once-at-bedtime oxybate for individuals living with narcolepsy. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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Life Science Clinical Development FDA Approval Regulation 52

XTalks

JULY 25, 2024

The company is developing innovative therapies for these indications that are based on innovative partial epigenetic reprogramming and chaperone-mediated autophagy technologies. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 59

Life Science Gene Therapy FDA Approval Clinical Development 59

XTalks

JULY 3, 2023

XTALKS WEBINAR: Intelligent Drug Development: A New Service Paradigm for Small Pharma Live and On-Demand: Thursday, July 27, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to discover a new paradigm, intelligent drug development, designed to support small pharma in efficiently navigating early clinical development.

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FDA Approval Compliance Clinical Trials Clinical Trials 97

pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

Medicine 122

Medicine Life Science FDA Approval Development 122

The Pharma Data

JANUARY 6, 2021

As the compound was already approved by the FDA for its original indication, the companies are expecting significant savings in cost and time associated with its pre- or clinical development for the new indication. SK Chemicals is a leading company in the fields of chemistry and life science.

FDA Approval 52

FDA Approval Life Science Drugs In-Vivo 52

XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.

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Drug Delivery Drugs Immune Response Allergies 111

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK).

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Vaccine Vaccination FDA Approval Development 105

XTalks

DECEMBER 5, 2023

Other New Treatments for NSCLC on the Market The FDA has recently approved several other medications for various subsets of NSCLC patients. In October 2023, the combination of Braftovi (encorafenib) and Mektovi (binimetinib) received FDA approval for treating adult patients with metastatic NSCLC that exhibits a BRAF V600E mutation.

Protein 115

Protein FDA Approval Medicine Trials 115

XTalks

OCTOBER 31, 2023

GSK hopes to ramp up uptake of its newly minted RSV vaccine, which received approval from Health Canada in August this year after its US Food and Drug Administration (FDA) approval in May. The ad was launched right on the heels of the FDA approval of Arexvy.

Vaccine 97

Vaccine Vaccination FDA Approval Development 97

XTalks

OCTOBER 23, 2024

Related: The National Kidney Foundation’s Role in Advancing Clinical Trials in Nephrology Sibeprenlimab’s progress comes amid growing options for IgAN treatment.

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Trials Clinical Trials Clinical Trials Antibody 101

XTalks

NOVEMBER 20, 2023

However, despite this, the FDA did not extend approval to non-PI3K/AKT mutated breast cancer, perhaps based on additional data that they reviewed. The FDA has also been placing greater emphasis on overall survival, longer follow-up of studies and life expectancy in their review of oncology drugs. billion to $1.28

HR 98

HR FDA Approval Gene Trials 98

XTalks

JUNE 14, 2023

More Drugs for Dry Eye Disease Are on the Way Several other drugs have recently gained FDA approval or are currently in advanced stages of clinical development for the treatment of dry eye disease. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

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Gene Silencing Drug Delivery FDA Approval RNA 97

XTalks

JULY 31, 2024

“An oral JAK that delivers proven results will be impactful for the alopecia areata community,” added Dr. Natasha Mesinkovska, associate professor and vice chair for Clinical Research of Dermatology, University of California, Irvine and investigator in the Leqselvi clinical development program.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). In 2020, the FDA ordered Novo to pause clinical trials of the drug following reports of blood clots in three patients.

FDA Approval 52

FDA Approval Antibody Drugs Clinical Trials 52

pharmaphorum

SEPTEMBER 12, 2022

Reddy says one of LabCorp’s groundbreaking tests, OmniSeq INSIGHT, is an “all-in-one test that includes comprehensive genomics and immune profiling from a single tissue sample to identify all FDA-approved therapeutics, confirm immunotherapy eligibility for a patient, and identify appropriate nearby clinical trials.”.

Genome 105

Genome Genomics Clinical Trials Clinical Trials 105

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. But there was some considerable progress in other fields of medicine even though research efforts were diverted away, reports Richard Staines. months, compared with 6.7

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Marketing Gene Gene Silencing Drugs 96

XTalks

AUGUST 15, 2023

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

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FDA Approval Gene Hormones Drugs 52

XTalks

FEBRUARY 24, 2023

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

Drugs 52

Drugs FDA Approval Antibody Medicine 52

XTalks

JANUARY 6, 2021

The drug is in Phase II trials and Mind Medicine’s chief medical officer, Dr. Scott Freeman said in a statement , “our ability to start this trial on schedule speaks volumes to both the efficiency and high caliber clinical development team Mind Medicine has assembled to develop medicines based on psychedelics.

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Drugs Clinical Trials Clinical Trials Medicine 97

Pharmaceutical Technology

DECEMBER 22, 2022

The company has partnered with life sciences-focused investors Sixth Street and Royalty Pharma with an aim to bring substantial non-dilutive, low-cost capital to boost innovation and growth. Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals.

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Insulin Production Development Genetics 130

XTalks

AUGUST 5, 2022

ChemoCentryx made its way into news in October 2021 when it clenched its first ever US Food and Drug Administration (FDA) approval in 24 years for the drug Tavneos (avacopan) for patients with serious autoimmune disease. The sale of Tavneos has been approved in the US, European Union, Canada and Japan.

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Development FDA Approval Sales Drugs 52

XTalks

JUNE 20, 2023

As part of the accelerated approval, Roche will have to conduct confirmatory trials for Columvi. Roche revealed it has an ongoing clinical development program for Columvi to investigate it as a monotherapy and in combination with other drugs for the treatment of B-cell non-Hodgkin lymphomas, including DLBCL and other blood cancers.

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Antibody Trials Drugs FDA Approval 98

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Ozempic was approved in 2017 and Wegovy in 2021.

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FDA Approval Manufacturing Drugs Pharmacy 59

XTalks

AUGUST 9, 2023

According to information shared by brain health disorders-focused biotech Sage in a press release announcing Zurzuvae’s FDA approval, approximately half of all PPD cases may go undiagnosed without appropriate screening. PPD symptoms can last beyond the postpartum period and can lead to prolonged maternal morbidity.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Delveinsight

AUGUST 4, 2021

In June 2021, Aducanumab by Biogen received FDA approval to treat patients with Alzheimer’s disease. Similarly, other companies in the domain such as Eisai/ BioArctic AB, Hoffmann-La Roche/Chugai Pharmaceuticals, Anavex Life Sciences Corp., and Neurimmune are actively working in the Alzheimer’s Therapeutics Market.

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Marketing Genetics Development Clinical Development 98

XTalks

APRIL 12, 2021

The last update on the clinical development of inzomelid came in December when a pharmacokinetic (PK) study initiated by Inflazome in early April was withdrawn by Roche, who attributed it to a “strategic decision by sponsor.”. According to Neuropore’s pipeline page, both UCB0599 and NPT520-34 remain in Phase I clinical development.

Gene Therapy 96

Gene Therapy Gene Trials Development 96

XTalks

OCTOBER 26, 2023

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

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Vaccine Vaccination RNA Manufacturing 105

XTalks

NOVEMBER 28, 2023

Featuring Ilsun Hong, VP and Product Evaluation Team Leader, and Thomas Newcomer, VP and Head of US Market Access at Samsung Bioepis, the discussion revolves around key developments, challenges and future trends in biosimilars. Read on to learn more about Samsung Bioepis’ pivotal role in the biosimilar industry from these two experts.

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Production Marketing Development Pharmacy 98

XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

DECEMBER 8, 2020

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

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RNA Antibody Life Science Protein 52

Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Some of these approved products contain nicotine as an active ingredient, while others do not. Smoking Cessation: What are the drugs available in the market? Quitting smoking is an arduous, exhausting process.

Marketing 52

Marketing FDA Approval Branding Production 52

XTalks

MAY 31, 2023

Of particular significance is CytoMed Therapeutics’ leading CAR-γδ T cell technology known as CTM-N2D therapy, which is poised to enter Phase I clinical trials. If tecarfarin receives FDA approval, the company anticipates annual revenues of approximately $1 billion in the US market.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Production 97

Roots Analysis

DECEMBER 18, 2023

Subsequently, in mid-October 2018, Novartis acquired Endocyte, leveraging their prostate cancer product for further development. Pluvicto® received the FDA approval in March 2022 and the EMA approval in December 2022. This drug candidate has been developed using the oligonucleotide technology.

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Drugs FDA Approval Antibody Development 40