Fierce Pharma

NOVEMBER 14, 2024

AstraZeneca's CEO argued that the company did not lose compliance oversight in China amid local authorities' investigations into the drugmaker's senior executives. AZ and Daiichi Sankyo have refiled their TROP2 antibody-drug conjugate with the FDA. And more.

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Compliance Antibody Drugs 52

The Pharma Data

DECEMBER 11, 2020

The test has been designed to quantitatively measure of immunoglobulin G (IgG) antibodies to aid clinicians in identifying patients with an immune Covid-19 response pre- and post-vaccination. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

Antibody 52

Antibody Production Regulation Marketing 52

pharmaphorum

JANUARY 12, 2021

They also offer the potential for self-administration at home rather than in a health setting, making compliance with booster dosage potentially higher.”. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

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Licensing Licensing Vaccination Vaccine 119

Pharmaceutical Technology

OCTOBER 5, 2022

The US government has recently prioritized the pursuit of cases such as Biogen’s as a warning to the industry to remain in compliance of the law. “I At the same time, companies need to prioritize their compliance programs. BIIB107 is a monoclonal antibody that targets ?4 4 integrins, which play a key role in MS pathology.

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Sales Compliance Marketing Drugs 147

The Pharma Data

NOVEMBER 1, 2020

Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

Antibody 52

Antibody Compliance Trials Regulation 52

pharmaphorum

APRIL 28, 2022

In the US market, it is competing against rival oral CGRPs, namely AbbVie’s Qulipta (atogepant) for prevention and acute treatment Ubrelvy (ubrogepant), as well as several CGRP-targeting antibodies delivered by injection or infusion from Amgen, Eli Lilly, Teva and Lundbeck that are used to prevent attacks.

Drugs 98

Drugs Marketing Compliance Licensing 98

XTalks

JULY 11, 2024

Susvimo addresses this issue by offering a less invasive, long-acting treatment option that could improve patient compliance and quality of life. In October 2023, the bispecific antibody got a label expansion to retinal vein occlusion. Clinical trials have demonstrated the efficacy and safety of Susvimo in treating wet AMD.

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Sales 104

The Pharma Data

NOVEMBER 11, 2020

Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

Antibody 40

Antibody Drugs Compliance Regulation 40

XTalks

JULY 27, 2021

The anti-amyloid beta monoclonal antibody was initially handed a broad label approval by the US Food and Drug Administration (FDA) in June. Anti-Amyloid Beta Monoclonal Antibodies and Aduhelm Controversy. This is in light of conflicting results from trials over the past couple of years.

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Antibody Drugs Trials Clinical Trials 98

The Pharma Data

DECEMBER 7, 2020

Use your energy where it’s needed most — ensuring that your products are in compliance and getting to market as quickly as possible. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

Antibody 40

Antibody Compliance Regulation Drugs 40

Worldwide Clinical Trials

JULY 8, 2024

Radiolabeled Antibodies : Various antibodies are being radiolabeled to target specific cancer antigens, enhancing both diagnostic accuracy and therapeutic efficacy. Similar to the FDA, the EMA evaluates radiopharmaceuticals for safety, efficacy, quality, and GMP regulation compliance before granting marketing authorization.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

Pharmaceutical Technology

DECEMBER 15, 2022

In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. Full compliance to both monographs and general notices and chapters is recommended. When choosing an antimicrobial API, it is very likely that local regulations will demand a cGMP ingredient.

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pharmaphorum

JULY 27, 2021

For example, delivering step-by-step best practice guidance to mobile devices can strengthen confidence, compliance and consistency. They cover up the cracks in the system, using huge amounts of time and energy to smooth over the bumps, repeat lost processes, generate paperwork and backdate signatures to satisfy compliance audits.

Compliance 66

Compliance Manufacturing Genome Genomics 66

Cloudbyz

AUGUST 2, 2024

Antibody-Drug Conjugates (ADCs) Antibody-drug conjugates (ADCs) have emerged as a promising approach in cancer treatment, combining the targeting ability of monoclonal antibodies with the cytotoxic effects of chemotherapeutic agents.

Clinical Research 52

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The Pharma Data

AUGUST 7, 2020

NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera . The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells. In a statement, NIH claimed LY-CoV555 was identified in a blood sample from a recovered Covid-19 patient. Source link.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

The Pharma Data

OCTOBER 25, 2020

GMA 301 is the first antibody drug for PAH treatment. “Also, its long-lasting half-life makes monthly dosing possible and this will substantially improve convenience and compliance of drug use for patients.” It’s a global company focusing on R&D, production and commercialization of antibody drugs targeting GPCRs.

Trials 40

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The Pharma Data

JULY 27, 2021

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

Production 52

Production Antibody Sales Development 52

Roots Analysis

SEPTEMBER 13, 2023

Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

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Development Antibody Protein Drug Delivery Systems 40

Advarra

MARCH 21, 2023

Here are some ways to decide if clinical trials are necessary and navigate the compliance intricacies of a complex medical device category. Function Dictates Regulation It’s essential to understand how the product interacts with a patient, as well as what level of importance it holds to the patient’s health.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Crohn’s Disease Therapeutics Market Size $4.7 Billion by 2025. NEW YORK and LONDON, Nov. Shailubhai, K.,

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

The Pharma Data

APRIL 19, 2022

Enhertu is a HER2 – directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Medicine 52

Medicine Trials Antibody Development 52

The Pharma Data

DECEMBER 27, 2020

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures. Cowen served as the sole placement agent for each of the PIPE financings.

Sales 52

Sales Development Life Science Manufacturing 52

The Pharma Data

DECEMBER 30, 2020

The OvPENS platform team supported our manufacturing partner to scale and meet regulatory compliance such that production for all pre-clinical and clinical requirements ahead are secured. .” “Our platform and corporate development also made great progress in the second half of 2020. .

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The Pharma Data

NOVEMBER 23, 2020

Ltd with Alvotech is aiming to build a global standard antibody drug producing and manufacturing platform. Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world.

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Manufacturing Medicine Marketing Containment 40

The Pharma Data

FEBRUARY 18, 2022

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

Manufacturing 40

Manufacturing Vaccination Vaccine Production 40

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

The Pharma Data

DECEMBER 3, 2020

where he served as chief financial officer, chief compliance officer and corporate secretary. Prior to Arrowhead, Bradshaw was president and CSO of Tollnine, a company he co-founded to develop novel antibody conjugates for immuno-oncology. Pfreundschuh joins Frequency from UroGen Pharma Ltd., He was also CFO of Immunomedics Inc.,

Development 52

Development Business Development Manufacturing Clinical Development 52

Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

The Pharma Data

DECEMBER 12, 2020

Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen.

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Development Regulation Medicine Containment 75

The Pharma Data

SEPTEMBER 16, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

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Production Sales Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 20, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

Medicine 52

Medicine Production Sales Clinical Trials 52

The Pharma Data

NOVEMBER 17, 2020

These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws.

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The Pharma Data

NOVEMBER 9, 2020

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,

Trials 52

Trials Production Sales Manufacturing 52

FDA Law Blog

FEBRUARY 29, 2024

Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R. Moreover, Eisai should explain how PTE application for a withdrawn “revoked” of active ingredient BELVIQ® (lorcaserin hydrochloride) is in compliance with requirements of 37 C.F.R.

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Production Drugs FDA Approval Compliance 59

Roots Analysis

MAY 24, 2024

Improved Patience Compliance: The integration of advanced features like Bluetooth connectivity, and audio and visual indicator and convenience provided by connected autoinjector has increased the patient acceptance towards self-injection devices.

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Drug Delivery Containment Contamination Production 40