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

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Licensing Licensing FDA Approval Clinical Trials 111

XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy. AstraZeneca is also venturing into cell therapy and genetic medicine.

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FDA Approval Sales Trials Development 102

XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. Crenessity marks the third approved drug for Neurocrine.

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Genetics Hormones Trials Drugs 116

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. months, compared to 8.7

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FDA Approval Drugs Licensing Licensing 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.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Licensing 98

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

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

JULY 25, 2023

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Additionally, 533 participants received at least one dose of the comparator-licensed anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed). Overall, 66.3

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FDA Approval Vaccination Vaccine Antibody 98

pharmaphorum

OCTOBER 31, 2022

Actinium Pharma is on course to submit its targeted radiotherapy for acute myeloid leukaemia (AML) patients needing a bone marrow transplant in the US, buoyed by top-line data from a pivotal trial. The post Actinium eyes filing as conditioning drug for AML aces trial appeared first on.

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Trials Gene Therapy Drugs Antibody 124

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 Drugs 93

pharmaphorum

FEBRUARY 11, 2022

Data from the first patients enrolled into Regenxbio’s trial of its gene therapy for rare inherited disease mucopolysaccharidosis type I (MPS I) – also known as Hurler syndrome – has shown the first signs of clinical activity. The post Regenxbio expands MPS I gene therapy trial after first look at data appeared first on.

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Gene Therapy Gene Trials FDA Approval 111

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).

Clinical Supply 130

Clinical Supply FDA Approval Licensing Licensing 130

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. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Pharmaceutical Technology

FEBRUARY 26, 2023

Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold.

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Bacteria Trials Research Medicine 278

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.

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FDA Approval Licensing Licensing Trials 130

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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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

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

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.

FDA Approval 52

FDA Approval Drugs Licensing Licensing 52

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.

Antibody 130

Antibody FDA Approval Licensing Licensing 130

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 64

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

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

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Development Bioequivalency Generic Drugs Production 242

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

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

Pharmaceutical Technology

SEPTEMBER 13, 2022

While Trodelvy is expected to be the first ADC approved in the HR+/HER2-negative breast cancer setting, Daiichi / AstraZeneca’s Enhertu (trastuzumab deruxtecan) received US Food and Drug Administration (FDA) approval just last month for patients with HER2-low expressing breast cancers.

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HR Marketing Hormones FDA Approval 162

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

Pharmaceutical Technology

AUGUST 23, 2022

A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month. In July, the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for use in adolescents aged 12 to 15 years.

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Vaccination Vaccine Gene Therapy Protein 130

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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Marketing Gene Editing Production Sales 130

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 Drugs Marketing Licensing 52

Pharmaceutical Technology

OCTOBER 28, 2022

In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDA approval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.

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Vaccination Vaccine Marketing Bacteria 162

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Use of PK and PD similarity data can remove the need for a comparative efficacy study for a biosimilar approval and lead to a more efficient, streamlined program.

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Development Production Immune Response Licensing 161

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. What Is a Surrogate Endpoint?

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Trials Gene Hormones Clinical Trials 98

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.

Licensing 52

Licensing Licensing Drugs Sales 52

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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FDA Approval Production Clinical Trials Clinical Trials 52