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.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

XTalks

JULY 14, 2022

Krystexxa’s expanded approval was based on data from the randomized, controlled MIRROR trial involving adults with uncontrolled gout. Results from the trial showed “significant improvement and sustained response” to Krystexxa with methotrexate (a chemotherapy drug and immune suppressant) compared to Krystexxa alone.

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FDA Approval Antibody Trials Drugs 105

BioSpace

JULY 28, 2021

Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.

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FDA Approval Clinical Trials Clinical Trials Licensing 98

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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Life Science FDA Approval Drugs Licensing 52

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody DNA 105

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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. This was done to allow for more time for the application’s review.

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Hormones FDA Approval Licensing Licensing 244

Pharmaceutical Technology

MAY 30, 2023

Medsenic reached licensing, marketing and supply agreements with Phebra for OATO in May 2021. Biotechnology company BioSenic’s affiliate Medsenic has amended its licence agreement with Australia-based pharmaceutical company Phebra for the oral formulation of arsenic trioxide (OATO).

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Clinical Supply FDA Approval Licensing Licensing 130

XTalks

JUNE 20, 2022

Amvuttra’s FDA approval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. The condition has very limited treatment options.

FDA Approval 98

FDA Approval Protein Genetics RNA 98

XTalks

JANUARY 28, 2022

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. Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore.

FDA Approval 98

FDA Approval Development Licensing Licensing 98

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. .

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Licensing Licensing Sales FDA Approval 63

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. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

FDA Approval 130

FDA Approval Licensing Licensing Trials 130

pharmaphorum

DECEMBER 4, 2020

CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC. The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

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FDA Approval Sales Antibody Marketing 93

Drug Discovery World

OCTOBER 11, 2023

Boehringer Ingelheim and CDR-Life entered a licensing agreement in May 2020 and announced the selection of an antibody fragment-based therapeutic candidate in September 2021.

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Clinical Trials Clinical Trials Antibody Trials 52

The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

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Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 17, 2021

. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. FDA approval this year. Belvarafenib (HM95573, solid tumor) , which was licensed to Genentech, Inc., U.S.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MARCH 27, 2023

Since its publication on 21 December 2022, it has predicted the following events correctly: The FDA approved GlaxoSmithKline’s (Brentford, UK) Jesduvroq (daprodustat) on 1 February 2023, for the once-daily treatment of anaemia caused by chronic kidney disease in adults administered dialysis for at least four months.

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Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is claimed to be the only oral antifungal to receive approval from the US Food and Drug Administration (FDA) to treat VVC, as well as reducing RVVC incidence. Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection.

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Sales FDA Approval Clinical Trials Clinical Trials 130

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.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

pharmaphorum

APRIL 23, 2021

The FDA has granted an accelerated approval based on data from the ongoing phase 1 GARNET trial, meaning that GSK will have to produce survival data for the drug to remain on the market in the long term. The post FDA approves under-pressure GSK’s Jemperli for endometrial cancer appeared first on.

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FDA Approval Marketing Drugs Licensing 52

Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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Development Clinical Trials Clinical Trials FDA Approval 130

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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Licensing Licensing Drugs Sales 52

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. in 1-15 year olds and 98.7-100%

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FDA Approval Vaccination Vaccine Licensing 52

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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FDA Approval Gene Therapy Gene Marketing 98

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 post US FDA accepts Regeneron’s pozelimab BLA for priority review appeared first on Pharmaceutical Technology.

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Antibody FDA Approval Licensing Licensing 130

Pharmaceutical Technology

MARCH 6, 2023

JUPITER-02 is a Phase III randomised trial with sites in China, Singapore and Taiwan that randomised 289 patients with NPC to receive either Tuoyi + cisplatin/gemcitabine or cisplatin/gemcitabine only. Tuoyi also enjoys an FDA breakthrough therapy designation. Tuoyi has generated the majority of the data in NPC with Asian patients.

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HR FDA Approval Licensing Licensing 130

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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XTalks

MARCH 21, 2023

It is estimated that Rett syndrome affects 6,000 to 9,000 patients in the US, with a diagnosed population of approximately 4,500 patients, according to a press release from Acadia announcing Daybue’s approval. However, in animal studies, trofinetide has been shown to increase dendritic branching and synaptic plasticity signals.

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FDA Approval Gene Therapy Gene Genetics 94

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

DECEMBER 13, 2020

During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 20, 2024

The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. How Does Sibeprenlimab Work?

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

Drug Discovery World

JUNE 1, 2023

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. Under the terms of the licensing agreement, AstraZeneca will be granted an exclusive global license to research, develop, and commercialize LM-305.

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Antibody Marketing Drugs Licensing 98

Pharmaceutical Technology

JANUARY 19, 2023

While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinical trials.

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XTalks

FEBRUARY 29, 2024

After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. The journey of Aduhelm from its accelerated approval and predicted blockbuster status to discontinuation has been fraught with controversy, debate and ultimately, disappointment.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

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FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland. About CNS Pharmaceuticals, Inc.

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