The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved in the U.S.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.

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The Pharma Data

JANUARY 17, 2021

Syngeneic tumor animal models play a critical role because they use standard inbred mice that have a competent immune system, which is required to evaluate immune-modulating therapies. Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. About Taconic Biosciences, Inc.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

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Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

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The Pharma Data

AUGUST 19, 2021

3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] The most common Grade 3 or 4 laboratory abnormalities (?2%) 4] , [5] , [6].

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The Pharma Data

DECEMBER 17, 2020

If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. , Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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The Pharma Data

NOVEMBER 19, 2020

Therapy Selection. Licensed-in the Myriad myChoice® test into China on an exclusive basis for collaborative drug development studies and clinics. Revenue generated from central laboratory business was RMB89.9 Revenue generated from central laboratory business was RMB89.9 Revenues were RMB123.9

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Agency IQ

MAY 28, 2024

Representatives on both sides of the aisle took full advantage of their floor time to probe FDA leadership on its spending, performance and specific regulatory policies – including its recent Laboratory Developed Test final rule. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

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The Pharma Data

OCTOBER 28, 2020

As in the earlier analysis, patients with higher viral load at baseline and/or no detectable antibodies at baseline (suggesting their bodies had not yet mounted an effective immune response), derived greater benefit from REGN-COV2 therapy. combined dose groups; 6.5% placebo; p=0.024).

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Broad Institute

OCTOBER 29, 2024

Previous clinical and laboratory studies on other MCL1 inhibitors have suggested that these molecules can impair heart cells, likely because of prolonged exposure to the compounds. Tags: Center for the Development of Therapeutics Licensing data, tools, and technologies Cancer Drug discovery Nature Cancer. Online August 23, 2024.

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The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. Additionally, the capital will be used to further expand the existing laboratory capacities.

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Drug Target Review

OCTOBER 10, 2024

Developing cell therapies exclusively with healthy donor material introduces substantial risks that can hinder clinical translation and jeopardise the entire program. Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

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Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read A one-time gene therapy injection for spinal muscular atrophy. Gene Therapy. “David Liu’s lab shows new base editing SMA therapy could lead to a one-time therapy.”

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The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. 50 c/mL, meeting noninferiority criteria.

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The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. who require oxygen therapy due to COVID-19, OR.

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The Pharma Data

AUGUST 17, 2021

Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Grade 3 or 4 laboratory abnormalities (?2%) JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014.

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The Pharma Data

NOVEMBER 17, 2020

They are Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track designation. Breakthrough Therapy designation is designed to expedite the development and review of drugs that may have substantial improvement over current available therapies. Sanofi’s Avalglucosidase Alfa for Pompe Disease.

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The Pharma Data

NOVEMBER 22, 2020

The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. Revance Therapeutics has a target action date of November 25 for its Biologics License Application (BLA) for DAXI to treat moderate to severe glabellar (frown) lines.

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The Pharma Data

DECEMBER 27, 2020

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. QARZIBA ® ? BRUKINSA was approved by the U.S.

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The Pharma Data

NOVEMBER 20, 2020

Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Many Progeria patients have received continuous Zokinvy therapy for more than 10 years. PALO ALTO, Calif., 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc.

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The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

APRIL 8, 2021

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Abnormal Laboratory Values: ?Evaluate

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. The deal will provide Biogen the rights to use the technology across their portfolio of gene therapy products.

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The Pharma Data

APRIL 26, 2022

The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability and efficacy profile of this therapy, which has remained the foundational antiviral for COVID-19 treatment,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. About Gilead Sciences. Gilead Sciences, Inc.

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The Pharma Data

MARCH 11, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

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The Pharma Data

APRIL 4, 2022

FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. In September 2020, the U.S.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Patients were randomized to receive the antibody cocktail (either 8,000 mg high dose or 2,400 mg low dose) or placebo, in addition to standard-of-care therapies, with 67% receiving remdesivir and 74% receiving systemic corticosteroids.

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA).

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

FEBRUARY 13, 2022

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). The target action date for the FDA decision on this investigational use is June 9, 2022.

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