Pharmaceutical Technology

MAY 31, 2023

It is expected to accelerate the development of CFT8919 in important international markets. CFT8919 is an orally bioavailable BiDAC degrader designed to exhibit potent and selective activity against EGFR L858R in patients with non-small cell lung cancer (NSCLC).

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Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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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

SEPTEMBER 23, 2022

Current treatment options for DES are dominated by a mix of prescription and over-the-counter (OTC) products. While Restasis and Xiidra have been in use in the US market for a long time, both treatments have been associated with patient satisfaction issues such as a non-favorable tolerability profile and a slow onset of action.

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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. One of the most significant benefits of PDFs is their ease of administration.

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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. Meanwhile, net product sales of Epidiolex grew by 22 percent to $196.2

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Pharmaceutical Technology

NOVEMBER 24, 2022

We asked them to explain how the company has integrated its isotopic labeling and human ADME testing services to help streamline the drug development process and accelerate the time it takes to get drugs to market. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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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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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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Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. Effective supply chain management is essential for OSD manufacturers that are operating in such a competitive market.

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Pharmaceutical Technology

AUGUST 3, 2022

Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market. During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production.

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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. billion by 2028, at a CAGR of 12.6%.

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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. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

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XTalks

JUNE 27, 2024

Therefore, techniques and technologies that promote drug solubility and bioavailability are in high demand. Their focus is on improving drug solubility and bioavailability with powerful amorphous dispersion technologies, such as KinetiSol for poorly soluble compounds.

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Bioavailability Manufacturing Drugs Development 59

Pharmaceutical Technology

JUNE 26, 2022

Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply. Streamlined processes to reduce time to market for drugs. Polymorphic form issues.

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Manufacturing Drugs Production Development 130

Pharmaceutical Technology

APRIL 12, 2023

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production. After that, the risks to product quality can be identified, quantified, and rated.

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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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Cloudbyz

MARCH 5, 2024

The difference between biologics vs small molecules in pharma drug development In pharmaceutical drug development, biologics and small molecules represent two distinct categories of medicinal products, each with their own unique characteristics, development processes, and mechanisms of action.

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Delveinsight

FEBRUARY 16, 2021

Numerous immunotherapy-based combinations are already trying in the old game of gleek to stake up some share in previously untreated, metastatic kidney cancer; however, the market seems to expand as the new entrants continue to make their entry. Takeda wins big in cytomegalovirus infection market.

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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. The Oral Protein and Peptides Market is anticipated to grow at a CAGR of over 20%, during 2022-2032. Oral Protein / Peptide-based Drugs.

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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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pharmaphorum

AUGUST 19, 2022

If all goes well, the aim is to bring resiniferatoxin to market in 2025. ” Grünenthal already sells a topical capsaicin product called Qutenza for post-shingles nerve pain and diabetic nerve pain affecting the feet, and recently started a phase 3 trial that aims to extend its indications to include post-surgical neuropathic pain. .

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The Pharma Data

JANUARY 27, 2021

As a bioscience accelerator at the leading-edge of the life science industry, XPhyto targets growth through commercialization of its product pipeline and focused investment in impact driven innovation with the potential for meaningful value creation. . VANCOUVER, BC / ACCESSWIRE / January 28, 2021 / XPhyto Therapeutics Corp.

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Roots Analysis

SEPTEMBER 1, 2023

By charting new waters and creating uncontested market spaces, companies can differentiate themselves and unlock unprecedented growth opportunities. In this blog post, I’ll explore how pharma / biotech companies can leverage the blue ocean and red ocean strategy to make waves in the market.

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Delveinsight

JULY 30, 2020

The global Adrenoleukodystrophy market size for the forecast period 2020-30, which was estimated to be USD 922.43 In patients with CALD, Adrenoleukodystrophy market offers two therapies, namely Lorenzo’s oil and haematopoietic stem cell transplantation (HSCT) , using either umbilical cord stem cells or bone marrow stem cells.

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Delveinsight

JANUARY 7, 2021

The startup recently raised USD 87 million to propel itself in a competitive market. Ribometrix will also be eligible to obtain potential milestone payments exceeding USD 1 billion and tiered royalties on future global net sales of products that ensue from the collaboration. Terns raises USD 87 Million for NASH drugs.

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The Pharma Data

NOVEMBER 26, 2020

This novel nanoparticle formation technology provides hope for improving the possibilities and probabilities of developing better medicines for patients and it expands Nanoform’s reach into the growing biological market. ” Prof. Finnish time. About Nanoform. Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.

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The Pharma Data

NOVEMBER 17, 2020

LYT-100 is PureTech’s wholly-owned product candidate that is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. LYT-100 is PureTech’s most advanced wholly-owned product candidate. This press release features multimedia. Photo: Business Wire). About LYT-100.

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The Pharma Data

JANUARY 20, 2021

Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. It also showed that Nefecon was generally well-tolerated.

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The Pharma Data

JANUARY 3, 2021

to have in place 25 operating production lines of which 5 to 10 are expected to be GMP production lines. The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. over 90 percent gross margin. to be cash flow positive.

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Delveinsight

AUGUST 10, 2020

Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Boehringer Ingelheim is worth mentioning here, as it is presenting key posters and studies on Ofev’s SENSCIS Trial and INBUILD Trial. Ofev (Nintedanib) Facts. Ofev (Nintedanib) Approval History.

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The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

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The Pharma Data

DECEMBER 1, 2020

The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14.

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The Pharma Data

APRIL 11, 2023

Notably, these presentations include new data from dose proportionality and bioequivalence studies, which supported the FDA approval of once-daily AUSTEDO XR extended-release tablets – demonstrating AUSTEDO XR is therapeutically equivalent to the currently marketed twice-daily AUSTEDO. Source link: [link]

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The Pharma Data

MARCH 11, 2021

Presentation Title: Preclinical characterization of LY3484356, a novel, potent and orally bioavailable selective estrogen receptor degrader (SERD). Sintilimab injection is not an approved product in the United States. Session Date and Time: Monday, April 12, 2021 1:30 PM – 3:15 PM ET. Abstract Number: 1236. About Sintilimab.

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XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Consider targeting your therapies that fail to be orally bioavailable and brain penetrant. Why is it Difficult to Develop CNS Therapeutics? The patients are waiting!

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Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. Recent analysis valued the market [i] at USD 8.5 But cost-effectiveness in drug-loading and production speed relies on dosing accuracy.

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