Fierce Pharma

OCTOBER 24, 2023

The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent. . | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

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FDA Approval Vaccination Vaccine Licensing 112

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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FDA Approval Clinical Trials Clinical Trials Contamination 98

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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FDA Approval Licensing Licensing Drugs 91

BioTech 365

APRIL 21, 2021

KemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS™ Per License Agreement with Affiliate of Gurnet Point Capital KemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS™ Per License Agreement with Affiliate … Continue reading →

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FDA Approval Licensing Licensing 40

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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FDA Approval Licensing Licensing Development 52

BioSpace

DECEMBER 12, 2023

The deal follows the FDA approval of Vertex’s gene-editing sickle cell treatment and Editas’ earlier legal battle over rights to the technology.

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Gene Editing Licensing Licensing FDA Approval 60

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

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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FDA Approval Production Insulin Antibody 98

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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FDA Approval Drugs Licensing Licensing 52

pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

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Licensing Licensing FDA Approval Trials 52

BioSpace

JUNE 5, 2022

GSK's MMR vaccine is only the second to be approved in the United States for protection against measles, mumps and rubella. The first, licensed to Merck, was approved in 1971.

FDA Approval 98

FDA Approval Vaccination Vaccine Licensing 98

Pharmaceutical Commerce

DECEMBER 20, 2023

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

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Allergies Licensing Licensing FDA Approval 52

Scienmag

AUGUST 5, 2020

Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink.

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FDA Approval Licensing Licensing Engineer 55

Pharma Times

AUGUST 24, 2021

Biologics License Application approved to prevent COVID-19 in individuals 16 years of age and older

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FDA Approval Licensing Licensing Vaccination 122

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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FDA Approval Gene Expression Cosmetics Trials 97

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. AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer.

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Life Science FDA Approval Drugs Licensing 52

XTalks

JULY 14, 2022

In March, Horizon received FDA priority review for its supplemental Biologics License Application (sBLA) for the expanded labelling of Krystexxa. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. XTALKS WEBINAR: Beyond the EHR: Clinical Trials in the Age of Abundant Data.

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FDA Approval Antibody Trials Drugs 105

Fierce Pharma

NOVEMBER 30, 2023

22, 2025, pending an FDA approval. As Johnson & Johnson’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med. Samsung Bioepis' biosimilar, which Sandoz has agreed to commercialize, can launch on Feb.

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Pharmaceutical Commerce

JANUARY 24, 2024

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.

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FDA Approval Licensing Licensing Genetics 52

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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Licensing 98

Drug Discovery World

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). . The company also offers financial assistance options to eligible patients for out-of-pocket costs. . .

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FDA Approval Antibody Licensing Licensing 52

Pharmaceutical Technology

MAY 10, 2023

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). Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020.

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FDA Approval Drugs Containment Licensing 264

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

BioTech 365

APRIL 28, 2021

Orthofix Announces Exclusive US License for IGEA’s Bone and Joint Stimulation Devices Orthofix Announces Exclusive US License for IGEA’s Bone and Joint Stimulation Devices Orthofix to pursue FDA approval of IGEA’s solutions to expand the Company’s US Bone Growth Therapy … Continue reading →

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Licensing Licensing FDA Approval 52

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

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

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

Fierce Pharma

NOVEMBER 2, 2023

Merck KGaA is in-licensing a PARP1 inhibitor from Hengrui. Merck KGaA is in-licensing a PARP1 inhibitor from Hengrui. The FDA approved Coherus and Junshi's China-made PD-1 inhibitor toripalimab. Novartis said an ex-employee who recently jumped to Takeda took sensitive files.

FDA Approval 52

FDA Approval Licensing Licensing 52

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. However, the use of hormone replacement therapy comes with its set of challenges.

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Hormones FDA Approval Licensing Licensing 244

pharmaphorum

NOVEMBER 24, 2020

Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year. Alnylam licensed inclisiran to The Medicines Company, which was bought last year by Novartis for $9.7

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FDA Approval Gene Silencing Drugs RNA 52

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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Licensing Licensing Sales FDA Approval 64

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 75

Scienmag

MARCH 28, 2021

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. March 29, 2021) – The U.S.

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Production FDA Approval Licensing Licensing 76

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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FDA Approval Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. The ROFN is exercisable by Sanofi until 30 June next year.

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FDA Approval Licensing Licensing Antibody 299

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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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., .

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