Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials.

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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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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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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

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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Pharmaceutical Technology

MAY 10, 2023

This marks a significant development in a tumultuous dispute between the pharmaceutical company and the US government. According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC).

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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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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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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. Co-Authors: Ken Phelps. President and Founder.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Premarket Approval (PMA) process (CBER). Regulatory Considerations for Biologics. BLA process (CBER). NDA process (CBER).

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XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore was granted the approval for Kimmtrak several weeks ahead of the scheduled PDUFA date of February 23.

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XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia.

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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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Pharmaceutical Technology

APRIL 25, 2023

Cidara Therapeutics announced the receipt of a $20m milestone payment from Melinta Therapeutics following the US Food and Drug Administration (FDA) approval of its antifungal treatment Rezzayo. In July 2022, Cidara gave Melinta US licensing rights for rezafungin following submission to the FDA.

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The Pharma Data

JANUARY 17, 2021

. In particular, two new drugs developed by Hanmi Pharmaceutical Co., are expected to be approved by the U.S. FDA this year. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. U.S. . U.S.

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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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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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Drug Discovery World

FEBRUARY 23, 2024

In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space. News round-up for 19-23 February by DDW Digital Content Editor Diana Spencer.

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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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Drug Discovery World

NOVEMBER 14, 2023

The Antibody Society’s data confirmed that 3.63% of the approved mAbs were for the treatment of Covid-19, which is significant when considering that it has overtaken diseases such as Alzheimer’s, which has been studied for much longer. The work is continuous for this disease target.

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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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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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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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Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Jazz Pharmaceuticals announced the U.S.

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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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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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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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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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pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

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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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Camargo

FEBRUARY 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication. Emphasis added). Co-Authors: Robb Lawrence.

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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 27, 2023

Faced with such a disappointing approval number last year, manufacturers hope for more NMEs to enter the market in 2023. GlobalData’s Catalyst Calendar provides insight into upcoming events that have the potential to influence the overall drug development and approval process.

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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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Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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