Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. The Appeal of In-Licensing In-licensing has emerged as a strategic approach for pharmaceutical companies to expand their product offerings without incurring the high costs and risks associated with drug development.

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Licensing Licensing Branding Drugs 96

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Development Production Immune Response Licensing 161

Camargo

DECEMBER 22, 2021

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Fine-Tuning Strategic Assessment.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. that could arise from that same population.

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Production Bioavailability In-Vivo In-Vitro 133

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance. Comments may be submitted by September 30, 2024.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

Bioequivalency 52

Bioequivalency Drugs Production Manufacturing 52

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

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Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. J Neurol Sci. 2003;206(2):165–71.

Trials 52

Trials Medicine Production Containment 52

XTalks

NOVEMBER 6, 2024

To address growing demand, Gelteq is expanding production capacity with a Good Manufacturing Practice (GMP)-certified facility, aiming for scalable, reliable output by 2025. This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 8, 2021

Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.

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Production Insulin Branding Generic Drugs 78

World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Reportedly, the cost of production for molnupiravir stands at about $17.74. Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply.

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Regulation Drugs Bioequivalency Vaccination 218

Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

Bioequivalency 81

Bioequivalency Generic Drugs Drugs Branding 81

Drug Patent Watch

DECEMBER 11, 2024

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). Food and Drug Administration (FDA) that provide detailed recommendations for developing generic drug products. ” – Dr.

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Generic Drugs Production Development Bioequivalency 95

The Pharma Data

MAY 3, 2021

India’s vaccine shortage will last months, biggest manufacturer warns ( FT ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine ( Press ).

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Gene Therapy Vaccination Vaccine Bioequivalency 52