XTalks

FEBRUARY 24, 2023

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

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XTalks

NOVEMBER 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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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.

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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.

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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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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

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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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 Vaccination Vaccine In-Vitro 59

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

Drug Discovery World

DECEMBER 13, 2023

This article is sponsored by Fortis Life Sciences. In the ever-evolving landscape of therapeutic development, the role of antibodies has become increasingly apparent. Fortis Life Sciences offers custom antibody discovery and manufacturing services for antibodies and single-domain antibodies, supporting the drug discovery market.

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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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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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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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XTalks

MAY 9, 2024

We also invented four proprietary antibody technologies, including our DuoBody® bispecific technology which is the backbone of four FDA-approved bispecifics and over ten in development.

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Antibody Clinical Trials Clinical Trials Medicine 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.

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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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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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The Pharma Data

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. LONDON and BOSTON, Jan. Notes for Editors: About OKYO.

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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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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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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.

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Clinical Trials Clinical Trials Trials Production 97

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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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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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.

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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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Drug Discovery World

AUGUST 10, 2023

Achieve Life Sciences is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialisation of cytisinicline.

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Drugs FDA Approval Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

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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

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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.”.

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XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

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DNA Radiology FDA Approval Development 66

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.

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Gene Therapy Gene Trials Development 96

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . BioMed Realty, a prominent life sciences real estate provider, acquired a 7.5-acre Key comment US . “We

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Gene Therapy Gene Manufacturing Medicine 52

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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XTalks

JUNE 9, 2022

It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. Lomitapide is currently FDA-approved for use in adults with HoFH alongside a low-fat diet.

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XTalks

MARCH 13, 2023

For this reason, rare disease patient communities are hopeful for a new gene therapy that may result in long-term benefits to their quality of life and survival. Dr. Blank emphasized the importance of starting a natural history study early while the gene therapy clinical development program is still in the planning stages.

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XTalks

DECEMBER 24, 2020

The pandemic propelled the life science and healthcare sectors onto center stage, and they rose to the occasion against the most unprecedented health challenge in recent times. While COVID-19 has undoubtedly been the biggest story in the life science industry in 2020, it was a busy and positive year in many other areas.

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XTalks

OCTOBER 26, 2022

The US Food and Drug Administration (FDA) approved a label change for Biktarvy on October 14, 2022, updating the prescribing information to include clinical trial efficacy data from 144 weeks and safety data from 240 weeks in adults with HIV who began the treatment in Study 1489 and Study 1490.

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