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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Pharmaceutical Technology

DECEMBER 19, 2022

The second is the “top-down” approach during which an initial micrometre-sized product is processed to reduce its size down into the nano-range using bead milling. For most grinding processes, lower size limits are above the nanoscale, so grinding products for the nano-range face problems such as clogging of sieves.

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Pharmaceutical Technology

MARCH 7, 2023

But cost-effectiveness in drug-loading and production speed relies on dosing accuracy. For poor-flowing powders, however, operators can face extra challenges in precision, due to the unpredictable nature of these products. Recent analysis valued the market [i] at USD 8.5 billion in 2021, which is expected to reach $15.77

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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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Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

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Pharmaceutical Technology

AUGUST 10, 2022

The takeover of Metrics will bolster the expertise of Catalent in the development of integrated oral solid formulation, production and packaging to aid customers in streamlining and expediting their programmes. It will also aid in expanding the capacity of Catalent to manage highly potent compounds.

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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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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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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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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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Pharmaceutical Technology

MARCH 21, 2023

So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i]. Just before the Covid-19 pandemic, there were 60 ongoing clinical trials with cannabis-based products, with the majority being tested for pain or psychosis.

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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. Windtree Therapeutics noted that these product candidates are intended to be both oral and IV therapies.

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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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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. More FDC products flowing into pharma pipelines.

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Pharmaceutical Technology

MAY 8, 2023

The China National Medical Products Administration (NMPA) has granted approval for BeiGene’s four applications for Brukinsa (zanubrutinib). The small molecule Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been specially designed for delivering sustained BTK protein inhibition by optimising bioavailability, half-life, and selectivity.

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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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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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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.

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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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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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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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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Pharmaceutical Technology

JUNE 14, 2023

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.

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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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Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. 3.1.1: Bioavailability Study Reports. 2.3.2: Repeat-Dose Toxicity.

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Pharmaceutical Technology

AUGUST 22, 2022

When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. They also offer enhanced bioavailability, exact dosing and an extended shelf life.

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The Pharma Data

JANUARY 7, 2021

. The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. The number of biopharmaceutical products show a considerable growth accounting for nearly a quarter of the new molecular entities approved in 2017.

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XTalks

JUNE 14, 2023

Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. As a water-free product, it does not have an associated pH value or osmolarity.

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Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

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Roots Analysis

MARCH 2, 2022

One of the key objectives behind the aforementioned developments is to overcome issues related to high costs associated with the design and production of such pharmacological interventions. Over 40 oral drug delivery technologies have been designed so far. Over 40 oral drug delivery technologies have been designed so far.

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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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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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Roots Analysis

FEBRUARY 20, 2022

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Nanoparticles Contract Manufacturing. Web: [link].

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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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The Pharma Data

JANUARY 27, 2021

Construction of commercial drug manufacturing facility in Germany. Psychedelic transdermal and sublingual drug formulation development. Vektor will position itself for commercial manufacturing, pipeline development and drug formulations for critical mental health conditions.

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Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Alternatively, they can come as a product component of formulations such as cleaning agents and polymers.

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The Pharma Data

DECEMBER 3, 2020

(TWO: 4162) announced today that it has entered into a Collaboration and License Agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578 , a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578. ” About SOL-578.

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