The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO.

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Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3.

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Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

FDA 52

FDA Licensing Licensing Trials 52

The Pharma Data

JULY 22, 2021

The estrogen receptor is a well-known disease driver in most breast cancers. We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. Founder and CEO of Asieris. ” About Photocure ASA. About Asieris.

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The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

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The Pharma Data

APRIL 23, 2021

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. and a disease control rate of 55.6% (95% CI; 45.7-65.1). Issued: London UK.

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Therapies Treatment Licensing Licensing 52

LifeSciVC

JANUARY 25, 2024

Getting funding and publishing papers in these two controversial fields was difficult, but the research teams I led there persevered for 15 years and succeeded in discovering new drugs that were licensed to pharma and biotech companies. Importantly, we were also able to publish the underlying work in high-quality journals.

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Science Clinical Trials Trials Medical Schools 70

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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Therapies Engineering Molecular Biology Immune Response 105

The Pharma Data

NOVEMBER 8, 2020

Bristol Myers Squibb has a target action date of November 16 for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy for adults with r/r large B-cell lymphoma after at least two previous therapies. Bristol Myers Squibb picked up liso-cel when it acquired Celgene.

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The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. . STOCKHOLM , Nov. in the brain.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. How are disease targets selected for challenge trials?

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Vaccine Trials Disease Virus 111

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time). before any other country.

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FDA Drugs Production Licensing 40

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. and a disease control rate (DCR) of 86.2% SHANGHAI, China, Jan.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline.

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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] In 2018, Janssen Biotech, Inc. Interstitial Lung Disease/Pneumonitis 7. 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JANUARY 14, 2021

NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. ORR (measurable disease at baseline). Wainberg, M.D.,

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Trials Treatment Therapies Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. 1 Lederman, S. International Immunol. (11):1583

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The Pharma Data

NOVEMBER 2, 2020

If approved, 1st Therapy in U.S. Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups.

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Drugs FDA Pharmaceuticals Treatment 40

The Pharma Data

JANUARY 13, 2021

Lung cancer is the leading cause of cancer-related death in China, and with NSCLC comprising the most common form of the disease, there is significant patient need. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Accessed December 2020. v Zhang, T., Tang, Z., … Li, K.

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Production Trials Clinical Trials Treatment 52

Codon

JULY 14, 2024

While this departs from the reductionist, single-component therapies that have dominated transfusion medicine since World War II, emerging data underscores that whole blood transfusions—blood with all its parts—yield better outcomes following severe blood loss than transfusions involving discrete blood components. Always free.

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The Pharma Data

NOVEMBER 4, 2020

Previously they had recommended use of VASCEPA for treating patients with established cardiovascular disease. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 million and $8.9 million and $5.7 million and $1.1 million and $346.5

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Production FDA Trials Licensing 40

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Clinical Development Disease Treatment Licensing 40

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. “Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, M.D.,

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FDA Trials Therapies Treatment 52

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab received Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype in September 2018.

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Treatment FDA Clinical Trials Trials 52

Agency IQ

JULY 12, 2024

Intended use includes such things as the condition or disease which the product is meant to treat, the population for whom it is intended, and the route, frequency of administration, and duration of use for the product. Promotional labeling information must be submitted to the FDA “at the time of initial dissemination.”

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The Pharma Data

DECEMBER 2, 2020

Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. The new “pathoblocker” treatment aims to disarm pathogens and suppress the disease-causing properties of P.

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Licensing Licensing DNA Vaccine 52

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. 2018 for patients with severe asthma, without an eosinophilic phenotype. 1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.

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Trials Production Clinical Trials Government 52

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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FDA Biosimilars Science Production 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. Last updated: November 2018. Last updated: November 2018. References.

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The Pharma Data

DECEMBER 21, 2020

Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. 2,3 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.

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The Pharma Data

NOVEMBER 17, 2020

They are Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track designation. Fast Track Designation (FTD) is an FDA process meant to facilitate the development and review of drugs for serious disease and to fill unmet medical need. Sanofi’s Avalglucosidase Alfa for Pompe Disease.

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FDA Licensing Licensing Therapies 52

The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the U.S. STRASBOURG, France and PHILADELPHIA , Jan. ” The U.S.

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Treatment Pharmaceuticals Disease FDA 52

The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Net sales (€ million). Cerdelga ®.

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