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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Bioavailability Genetic Disease Marketing RNA 111

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

Pharmaceutical Technology

APRIL 7, 2023

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B.

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In-Vitro Bioavailability Development Drugs 276

Pharmaceutical Technology

AUGUST 30, 2022

Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.

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Development Drugs Bioavailability Production 130

BioTech 365

JANUARY 26, 2022

Global Drug Bioavailability Enhancement Summit 2022: Two Day Online Program – May 16-17, 2022 – ResearchAndMarkets.com Global Drug Bioavailability Enhancement Summit 2022: Two Day Online Program – May 16-17, 2022 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “2022 Global Drug Bioavailability Enhancement (..)

Bioavailability 40

Bioavailability Drugs 40

Pharma Mirror

APRIL 8, 2022

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

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Bioavailability Clinical Trials Clinical Trials Development 130

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Development Drugs Clinical Trials Clinical Trials 147

BioTech 365

OCTOBER 5, 2021

Global Peptide Therapeutics Markets, 2021-2026 – Increase Bioavailability of Drugs and Broaden Application of Peptides Therapeutics – ResearchAndMarkets.com Global Peptide Therapeutics Markets, 2021-2026 – Increase Bioavailability of Drugs and Broaden Application of Peptides Therapeutics – ResearchAndMarkets.com DUBLIN–(BUSINESS (..)

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Bioavailability Marketing Drugs 40

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.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

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). The SF-1 antagonist is also being developed to treat other cancers, which are known to express increased SF-1 levels.

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Bioavailability Clinical Trials Clinical Trials Clinical Development 147

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.

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Production Bioavailability In-Vivo In-Vitro 133

XTalks

FEBRUARY 5, 2025

XTALKS WEBINAR: GLP-1 Agonist Development: Endpoint Strategies to Help Differentiate Your Drug Live and On-Demand: Tuesday, February 25, 2025, at 11am EST (4pm GMT/UK) Register for this free webinar to learn how innovative digital and imaging endpoints can maximize the value of GLP-1 clinical trials. billion in 2024 to $37.94

Hormones 59

Hormones Bioavailability Clinical Trials Clinical Trials 59

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. In April 2023, the dual mechanism SERCA2a activator class of drug candidates received a patent from the European Patent Office.

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Bioavailability Protein Drugs Development 130

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

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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Manufacturing Drugs Production Development 130

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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Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 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 10, 2022

The network comprises sites for the production of large-scale and controlled release oral solids in Winchester, Kentucky, development and manufacturing of softgel in St Petersburg, Florida, as well as other facilities with bioavailability enhancement technologies and platforms for oral solids production.

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Packaging Packaging Bioavailability Manufacturing 147

Pharmaceutical Technology

MAY 8, 2023

The approvals were granted for two Supplemental Applications to covert conditional approval to regular approval, and two Supplemental New Drug Applications to treat Waldenström’s macroglobulinemia (WM), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients.

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Bioavailability Clinical Trials Clinical Trials Protein 130

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.

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Bioavailability Clinical Development Gene Trials 130

Outsourcing Pharma

AUGUST 8, 2022

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products.

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Bioavailability Branding Medicine Production 52

Pharmaceutical Technology

APRIL 20, 2023

In the first phase of its training workshops, the Pharmaceutical Innovation Center plans to develop a range of excipients [inactive substances that serve as the vehicle or medium for a drug or other active substance] for controlled release dosage forms, improving their bioavailability, along with formulating orally dispersible and chewable tablets.

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Bioavailability Manufacturing Scientist Development 130

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. Dosing flexibility is another prominent advantage provided by PDFs.

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Manufacturing Development Compliance Production 52

pharmaphorum

JULY 22, 2021

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. billion in backloaded milestone payments.

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Protein Hormones Bioavailability Drugs 116

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. Incentive Programs. Biowaiver Eligibility.

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Bioequivalency Production Genotoxicity In-Vivo 169

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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Drugs Bioavailability Antibody Marketing 80

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

pharmaphorum

MARCH 16, 2021

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. It’s one of the few AI drug discovery companies operating in the antibody category, as most are focused on small molecules. He added. “In

Antibody 101

Antibody Bioavailability Engineer Drugs 101

Camargo

JULY 8, 2021

At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe.

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Development Bioequivalency Gene Expression Drugs 130

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.

Drug Delivery 40

Drug Delivery Drugs Gene Therapy Bioavailability 40

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. One size (never) fits all.

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Development Production Manufacturing Bioavailability 130

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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Manufacturing Production Packaging Packaging 130

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

Roots Analysis

MARCH 2, 2022

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].

Protein 52

Protein Drugs Drug Delivery Drug Delivery Systems 52

Pharmaceutical Technology

FEBRUARY 13, 2023

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

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Development In-Vivo Drugs Clinical Trials 130

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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FDA Approval Drugs Bioavailability Marketing 52

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