XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

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pharmaphorum

NOVEMBER 24, 2020

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

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XTalks

APRIL 3, 2024

Approximately ten to 20 percent of patients with PNH may develop extravascular hemolysis (EVH), a condition that causes RBC destruction outside of blood vessels. Voydeya is the first-in-class, oral, factor D inhibitor developed specifically as an add-on to ravulizumab or eculizumab for patients who develop EVH.

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XTalks

JULY 25, 2023

“The approval of Cyfendus vaccine is symbolic of Emergent’s longstanding partnership with the US government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. What Is Anthrax? How Does Cyfendus Work?

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XTalks

OCTOBER 22, 2024

The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. At the end of May, the FDA accepted the Japanese company’s resubmission of its biologics license application (BLA) for the drug.

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XTalks

JULY 14, 2022

Uncontrolled gout is defined as gout that is unmanageable and/or develops resistance to conventional therapies. Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

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pharmaphorum

DECEMBER 4, 2020

That said, they often go undetected, so J&J will have to develop ways to identify suitable patients if amivantamab is to make headway in the market. In the summer, the drugmaker signed partnered with Guardant Health to seek regulatory approval of a companion diagnostic for amivantamab that will be used to identify suitable patients.

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Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. SNBL has also signed a definitive agreement to acquire Satsuma Pharmaceuticals. in cash per share.

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BioTech 365

MARCH 16, 2021

FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases in Dogs and Cats FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases … Continue reading →

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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. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

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XTalks

FEBRUARY 4, 2025

Related: FDA Approves New Use for Ozempic to Reduce the Risks of Kidney Disease Maze stands out in the biotech space with its Compass platform, which analyzes genetic data to identify disease-linked variants. To further expand its research, Maze has entered several strategic partnerships and licensing agreements.

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Clinical Trials Clinical Trials Trials Genetics 66

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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Fierce Pharma

NOVEMBER 9, 2023

AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for Hutchmed-developed colorectal cancer drug Fruzaqla.

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Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). If approved, ONS-5010 (bevacizumab-vikg) will meet the robust FDA requirements for use as an ophthalmic injectable.

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Pharmaceutical Technology

MARCH 31, 2023

GSK has signed an exclusive licence agreement with Scynexis to commercialise and further develop Brexafemme (ibrexafungerp tablets) to treat fungal infection. in specific development, regulatory and commercial milestones related to IC indications. Brexafemme has a wide spectrum of activity, including against emerging resistant threats.

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XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis. billion in revenue by 2024.

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BioTech 365

JANUARY 25, 2022

Ignis Therapeutics Licenses NeuroSigma eTNS Technology for ADHD in a Significant China Licensing Transaction Ignis Therapeutics Licenses NeuroSigma eTNS Technology for ADHD in a Significant China Licensing Transaction Ignis obtains rights to develop and commercialize NeuroSigma’s FDA-approved Monarch eTNS System in China … Continue reading → (..)

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Pharmaceutical Technology

MARCH 27, 2023

Iovance Bioterapeutics announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for Lifileucel. The San Carlos, California-based company is developing novel T cell-based cancer immunotherapies.

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pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.

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XTalks

DECEMBER 7, 2022

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). The median time to complete remission was 1.9 billion deal.

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XTalks

AUGUST 10, 2022

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The approval makes Enhertu the first approved drug for this indication.

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Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending.

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Pharmaceutical Technology

NOVEMBER 1, 2022

The companies signed an exclusive licensing agreement in December 2021. Our clinical plans remain on track, and we look forward to the continued development of selinexor in MF.”. In July 2019, the FDA approved Xpovio for treating relapsed or refractory multiple myeloma in adult patients.

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XTalks

MARCH 21, 2023

Related: Gene Therapy Clinical Trials for Rare Diseases: 5 Key Takeaways from FDA’s Recent Town Hall Rett syndrome is typically caused by a genetic mutation on the MECP2 gene. Significant development regression associated with the disease occurs after a period of normal development from six to 18 months of age.

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XTalks

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). Last year, the FDA approved the first generic version of Restasis.

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Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. Previously, Takeda had licensed the two Finch treatments FIN-524 and FIN-525 for their development in IBD.

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Bacteria Trials Research Medicine 278

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. The antibody is developed using the company’s VelocImmune technology.

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Pharmaceutical Technology

MARCH 6, 2023

The case of Tuoyi presents a very interesting case in global development and commercialisation efforts. Coherus Biosciences subsequently acquired the rights to commercialise Tuoyi in the US and Canada, and a revised biologics license application (BLA) was submitted to the FDA in July 2022 under priority review.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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XTalks

JANUARY 16, 2025

It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDA approval in 2020. Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

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Trials Clinical Trials Clinical Trials Insulin 59

pharmaphorum

SEPTEMBER 29, 2021

The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud. The finalists are: AIVA , a startup that has developed a voice operating system for patient care.

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Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez. After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8 million at the time). million price tag.

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pharmaphorum

APRIL 23, 2021

After a string of disappointments including the failure of bintrafusp alfa , a drug developed with Germany’s Merck KGaA in lung cancer, any approval is welcome news. The post FDA approves under-pressure GSK’s Jemperli for endometrial cancer appeared first on.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer chairman and CEO Albert Bourla said: “The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech Covid-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed. 5-adapted bivalent vaccine.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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