Drug Patent Watch

JUNE 17, 2024

Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs.

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Bioavailability Drugs Development 105

Roots Analysis

FEBRUARY 15, 2023

A study conducted on terminated drug development projects revealed that majority of the drug candidates fail in early drug development phases, due to the problems associated with their pharmacokinetic profiles, ADME ( distribution, metabolism, absorption and excretion ) properties and toxicity-related issues.

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Bioavailability In-Vivo Marketing Drugs 52

Outsourcing Pharma

JUNE 14, 2021

With bioavailability challenges a frequent frustration for drug developers, one research outfit suggests a technique that could reduce the headaches.

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Bioavailability Development Drugs Research 57

XTalks

DECEMBER 4, 2024

Jotrol overcomes these barriers using patented micellar technology, enhancing bioavailability and enabling therapeutically effective doses. The company has secured Orphan Drug designations for Friedreich’s ataxia, offering benefits like market exclusivity and eligibility for Priority Review vouchers.

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XTalks

JANUARY 30, 2025

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients.

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Camargo

JULY 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs.

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Development Bioequivalency Gene Expression Drugs 130

Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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Development Drugs Immune Response Manufacturing 97

Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.

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Pharma Mirror

APRIL 8, 2022

Both have stellar experience and track records in oncology research and development. CellCentric is developing inobrodib, an orally bioavailable drug that is transitioning into Phase II clinical trials in multiple indications.

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Pharmaceutical Technology

FEBRUARY 13, 2023

The continued high level of interest in small molecules presents multiple opportunities to select a candidate that is ‘developable’, with subsequent rapid progression toward first-in-human (FIH) clinical testing. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

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Development In-Vivo Drugs Clinical Trials 130

Pharmaceutical Technology

JANUARY 17, 2023

Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). SF-1 is an important transcription factor for adrenal gland growth and development.

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Bioavailability Clinical Trials Clinical Trials Clinical Development 147

XTalks

FEBRUARY 5, 2025

a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 Despite this, the drug remains under watch for further development.

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Hormones Bioavailability Clinical Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 26, 2022

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage. Polymorphic form issues.

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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. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. that could arise from that same population.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. ADME studies require the use of a radiolabeled version of the investigational drug. ADME studies require the use of a radiolabeled version of the investigational drug.

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Bioavailability Manufacturing Drugs Production 130

Pharmaceutical Technology

JUNE 13, 2023

The company stated that the family of drug candidates of SERCA2a activators has similar mechanisms of action to those of istaroxime, a first-in-class dual mechanism therapy. It might therefore lead to the development of new therapies to treat heart failure.

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Bioavailability Protein Drugs Development 130

Pharmaceutical Technology

AUGUST 10, 2022

Catale n t has signed an agreement for the acquisition of full-service specialty Contract Development and Manufacturing Organization (CDMO) Metrics Contract Services for $475m from Mayne Pharma. It also has two packaging lines that can accommodate a wide range of development and commercial supply programmes.

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Packaging Packaging Bioavailability Manufacturing 147

FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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Drug Delivery Drugs Bioequivalency Production 105

Pharmaceutical Technology

FEBRUARY 13, 2023

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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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. Why Conduct a Portfolio Analysis?

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XTalks

DECEMBER 5, 2022

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2

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Bioavailability FDA Approval Trials Drugs 97

Pharmaceutical Technology

MAY 2, 2023

Erasca has received the US Food and Drug Administration’s (FDA) fast track designation (FTD) for ERAS-801 to treat adults with glioblastoma (GBM) with epidermal growth factor receptor (EGFR) gene alterations. A team of three cancer researchers, Michael Jung, Timothy Cloughesy and David Nathanson, designed and developed ERAS-801.

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Pharmaceutical Technology

APRIL 20, 2023

It also aims to contribute to the pharmaceutical sector by facilitating cross-industry partnerships and research-based product development. The centre will primarily offer expert training and troubleshooting. It also has granulation, blending and coating equipment and high-performance liquid chromatography analysis capabilities.

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pharmaphorum

MARCH 16, 2021

million ($2 million) to develop its artificial intelligence-based platform for discovering therapeutic antibodies. The Cardiff, Wales startup is combining machine learning and phage display techniques to model antibody-antigen binding and says it can cut the time it takes to develop a drug candidate. He added. “In

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Antibody Bioavailability Engineer Drugs 101

XTalks

JUNE 27, 2024

Oral drugs are the most convenient and sought-after form of drug administration. This means they must be digested completely so the active pharmaceutical ingredients (APIs) in the drug can be absorbed by the body. Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand.

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Bioavailability Manufacturing Drugs Development 59

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

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XTalks

AUGUST 8, 2024

Antibody-drug conjugates (ADCs) are at the forefront of targeted cancer therapy. They combine the precision of monoclonal antibodies (mAbs) with the potency of cytotoxic drugs to destroy cancer cells, without harming healthy tissue. Abzena is a leader in bioconjugation and ADC development.

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pharmaphorum

FEBRUARY 25, 2021

Chiesi and Protalix have built the case for their long-acting enzyme replacement therapy (ERT) for Fabry disease PRX-102, as the FDA’s review of the drug continues towards a decision due by 27 April. . The post Switch data back Chiesi/Protalix long-acting Fabry drug appeared first on.

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Pharmaceutical Technology

JANUARY 25, 2023

Development of PROTACs (PROteolysis TArgeting Chimeras) has advanced fairly rapidly as excitement grows over their potential to selectively degrade proteins that are involved in various diseases, including cancer. PROTACs are a type of heterobifunctional degrader that offers multiple advantages over traditional small molecules.

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Protein Bioavailability Development Scientist 130

Roots Analysis

MARCH 2, 2022

Interestingly, recent advances in this domain have led to the development of several treatment strategies that, according to developers, exhibit the necessary capabilities to overcome challenges posed by traditional oral protein formulations and peptide-based therapies. Oral Protein / Peptide-based Drugs.

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Roots Analysis

MAY 21, 2024

Over the last decade, one of the major challenges faced by pharmaceutical companies across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility.

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Drug Delivery Drugs Gene Therapy Bioavailability 40

Roots Analysis

MARCH 1, 2022

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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Drug Delivery Systems Drug Delivery Drugs Bioavailability 52

Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. 3.1.1: Bioavailability Study Reports. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.

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The Pharma Data

JANUARY 7, 2021

Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs). The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs.

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XTalks

JUNE 14, 2023

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Sheppard, MD, MMSc, FACS, professor of ophthalmology at Eastern Virginia Medical School, and mid-atlantic medical director for Eye Care Partners and investigator in the development program. What Is Dry Eye Disease?

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pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. The post Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3 appeared first on.

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Drugs Bioavailability Trials Clinical Development 52

pharmaphorum

JANUARY 16, 2023

The bi-weekly intramuscular shot – which was also approved in China in 2021 – will enter a crowded market for long-acing injectable (LAI) schizophrenia therapies in the US and have to take on heavyweight competition, including drugs that require less frequent dosing.

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