The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases.

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The Pharma Data

NOVEMBER 18, 2020

Presentations to highlight the OBI-833 Phase 1 clinical study results in non-small cell lung cancer (NSCLC) and the dose escalation cohort. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” Presentation number: 397P / Poster: ID 680.

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The Pharma Data

APRIL 20, 2023

These data will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Boston and virtually on April 22-27, 2023. A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified 2.

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FDA Law Blog: Biosimilars

OCTOBER 14, 2024

Facts Defendants in this case are two licensed physicians and the stem cell clinics they founded. a), such as being “minimally manipulated,” and that do not meet the SSP exception fall in the middle of the hierarchy and are regulated solely under section 361 of the PHSA, aimed at preventing the spread of infectious disease.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD). Dementia due to Alzheimer’s disease is the most common form of dementia, accounting for 60 to 80 percent of all cases 1.

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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Drug Target Review

APRIL 9, 2024

How has nucleolar stress (NS) been linked to age-related diseases, and what approach did researchers use to investigate its toxicity? The nucleolus (and nucleolar stress) had been previously linked to aging and age-related diseases such as cancer or degeneration.

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Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? There are a lot of drug development challenges that are, in some cases, unique to neuroscience, including neurological diseases, psychiatric disorders, and rare diseases affecting the nervous system.

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The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). About Krabbe Disease. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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Drug Target Review

MAY 17, 2024

COMPASS is Pepper’s ML-driven transomics platform that unlocks a functional understanding of disease and drugs transcending traditional expression-based approaches. This holistic approach offers a full-picture understanding of biological systems and how those processes impact untreatable diseases like cancer.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

JANUARY 18, 2021

Potential first-in-class disease-modifying biologic in late-stage clinical studies. a clinical-stage biotechnology company focused on developing treatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP.

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Drug Target Review

JULY 19, 2023

Most vaccines cannot be self-administered, so distribution requires access to trained healthcare services – a big problem in developing countries, which is where infectious disease burdens are highest. A leading company in this field, Seattle’s Lumen Bioscience, is best known for its orally delivered antibodies targeting diseases such as C.

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DrugBank

AUGUST 15, 2024

An example is the collaboration between Novartis and the University of Oxford to develop a gene therapy for spinal muscular atrophy, a rare genetic disease. This is particularly important in the context of neurodegenerative diseases, where the burden on healthcare systems is significant and growing.

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Drug Hunter

APRIL 20, 2023

The development of a commercial manufacturing process involving deuterated building blocks is notable given the fact that the non-deuterated species has different pharmacology (lower selectivity due to an active metabolite), presenting a significant CMC challenge that needed to be overcome.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

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The Pharma Data

JANUARY 14, 2021

Trial results were presented in a late-breaking oral presentation today by UCLA Health’s Zev Wainberg, M.D., The ASCO GI presentation slides are available on the company’s website. ORR (measurable disease at baseline). Wainberg, M.D., . 33.

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SugarCone Biotech

JUNE 10, 2024

4-1BB enhances the response of activated T-cells to “foreign antigens”: protein fragments derived from infected, diseased or cancerous cells that are presented to T cells by antigen-presenting cells (APC). The NIMBY problem I think the “Cancer Immunity Cycle” as originally presented by Chen and Mellman ( 10.1016/j.immuni.2013.07.012

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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DrugBank

FEBRUARY 9, 2023

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. retrieved the drug targets from DrugBank , which they used to establish the relationship with the disease modules, finally predicting drugs that can target these modules effectively.

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Olympian Clinical Research

JANUARY 5, 2022

When a loved one is diagnosed with Alzheimer’s disease , it can be challenging to know what to do or how to cope. You may first want to understand this degenerative disease so that you can best support your loved one after their Alzheimer’s diagnosis. What is Alzheimer’s Disease? . Learn More About Alzheimer’s Disease.

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The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline.

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The Pharma Data

OCTOBER 18, 2021

under a cooperative development and license agreement. Tofersen is also being studied in the Phase 3 ATLAS study, which is designed to estimate the capability of tofersen to delay clinical onset when initiated in presymptomatic individualities with a SOD1 inheritable mutation and biomarker substantiation of complaint exertion.

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The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. About Ridgeback Biotherapeutics.

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The Pharma Data

JANUARY 14, 2021

“Buprenorphine is the most important medication in our arsenal for treating opioid use disorder, which is currently one of the most lethal diseases for Americans.” The X-waiver presents a major obstacle to “legitimate” patient access to buprenorphine and other MAT.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. The outcome of this review is expected to be reported around the time of the Company’s full year results presentation in February 2021. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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Policy Prescription

MAY 28, 2021

One audience member asks about their loved one who is prescribed the drug Dexilant, a drug that treats gastroesophageal reflux disease. They have been getting it from Canada and are now wondering with this presentation, if that is dangerous.”. and licensed by your state board of pharmacy.” Emphasis added).

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The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. SUZHOU, China and ROCKVILLE, Md. , 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), About Ascentage Pharma.

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The Pharma Data

NOVEMBER 23, 2020

NYSE American: SYN) is a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. . ROCKVILLE, Md. , 24, 2020 /PRNewswire/ — Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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The Pharma Data

JUNE 7, 2023

2] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. [3][4] 5] Chemotherapy used alone is the current standard of care for primary advanced or recurrent endometrial cancer, and many patients eventually experience disease progression. [6] Find out more at gsk.com.

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The Pharma Data

JULY 22, 2021

The estrogen receptor is a well-known disease driver in most breast cancers. Together with Pfizer, we will deploy our PROTAC technology in an effort to help people with this devastating disease.”. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The company anticipates submitting study results for presentation at an upcoming medical congress.

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The Pharma Data

JUNE 7, 2022

80% of lebrikizumab responders maintained improvements in skin clearance and disease severity at 52 weeks; lasting improvements in itch were also observed. “Atopic dermatitis is a complex disease that requires personalized treatment approaches, including flexible dosing options for patients. Almirall S.A.’s

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The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

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