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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Camargo

DECEMBER 22, 2021

In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. This is a key factor in designing Phase 2 and 3 trials. It can also help identify which of these factors are most critical to commercial success. Clinical Pharmacology.

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XTalks

FEBRUARY 3, 2023

Aditya Bardia, MD, MPH, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the Medicine Department at Harvard Medical School and principal investigator for the EMERALD trial, in the same press release statement. ER+, HER2- Breast Cancer ER+, HER2- cancers account for about 75 percent of breast cancers.

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The Pharma Data

MARCH 8, 2021

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. About Molnupiravir. About Ridgeback Biotherapeutics.

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Trials In-Vivo Genotoxicity RNA 69

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. If all goes well, the aim is to bring resiniferatoxin to market in 2025.

Drugs 52

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Cloudbyz

MARCH 5, 2024

Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics. Oral Bioavailability: Developing small molecules that are effectively absorbed when administered orally, while also being stable in the digestive system, can be complex.

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XTalks

MAY 23, 2024

XTALKS WEBINAR: Enhancing Efficiency in Early-Phase Oncology Trials: Strategies for Accelerating Data Flow Live and On-Demand: June 24, 2024, at 11am EDT (4pm BST/UK) Register for this webinar today to gain insights into how you can navigate and overcome data flow challenges in early-phase oncology clinical trials. 10), AbbVie Inc. (#11)

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Pharmaceutical Technology

JANUARY 25, 2023

According to Atul Tiwari , Head-Discovery Service Solutions at Syngene “Realising the scientific and market potential of this area, we made proactive and early efforts to establish new models, platforms, identifying new ligases, ligands and establishing the ADME-PK correlations of the PROTACs.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. About Molnupiravir.

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Clinical Trials Clinical Trials Bioavailability Trials 52

The Pharma Data

DECEMBER 1, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). AXS-05 was well tolerated in the COMET trial.

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Trials Clinical Trials Clinical Trials Production 52

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.

Hormones 52

Hormones Marketing Gene Trials 52

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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Drug Delivery Marketing Drug Delivery Systems Drugs 52

Roots Analysis

JANUARY 28, 2024

Pharmaceutical Research: Big data analytics can be applied in various areas of pharmaceutical research, including drug discovery and development, precision medicine , clinical trial optimization, pharmacovigilance and drug safety, supply chain optimization, and real-time monitoring and surveillance.

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Big Data Medicine Marketing Clinical Trials 40

Delveinsight

JANUARY 7, 2021

The immunotherapy pipeline is led by an in-licensed EP4 antagonist that Ikena is testing combined with Keytruda in phase 1b/2 colorectal and non-small cell lung cancer clinical trials. Eli Lilly backed Terns Pharmaceuticals now has two NASH candidates in clinical trials. IND-enabling studies are underway.

RNA 52

RNA Clinical Trials Clinical Trials Bioavailability 52

Delveinsight

AUGUST 10, 2020

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

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XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.

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The Pharma Data

JANUARY 3, 2021

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services. . +46 7686 650 11. 2 Proof of Concept.

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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. Finnish time. About Nanoform. Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806.

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Containment Medicine Bioavailability Clinical Trials 52

Drug Discovery World

JULY 25, 2023

The final section provides practical and pragmatic approaches to clinical study design in paediatric patients including important considerations regarding dose formulation and selection, sample size, sample collection and analysis, relative bioavailability, food interactions and drug-drug interactions (DDIs), amongst others.

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Development Drugs Medicine Production 52

The Pharma Data

DECEMBER 8, 2020

Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma.

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Bioavailability Containment Sales Medicine 52

Delveinsight

SEPTEMBER 8, 2021

As per DelveInsight’s report on Benlysta (Belimumab) market forecast , the sale of Belimumab has kept on increasing year after year. There are several SLE therapies in the pipeline that are under investigation in different phases of clinical trials for the treatment of Systemic Lupus Erythematosus. Anifrolumab (MEDI-546).

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Marketing Sales FDA Approval Antibody 52

Roots Analysis

MAY 21, 2024

In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.

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Drug Delivery Drugs Gene Therapy Bioavailability 40

The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., About Maribavir.

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Drugs Medicine Trials Containment 52

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. Several compounds are being further optimized for preclinical studies. Details can be found at this link.

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Development Bioavailability Production Drugs 40

Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. This has proved to be an extremely effective option for molecules where an understanding of absolute bioavailability is required.

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pharmaphorum

NOVEMBER 22, 2021

Gilead Sciences has submitted its marketing application for bulevirtide, its antiviral therapy for rare hepatitis delta virus (HDV) infections, to the FDA. Eiger’s drug – called lonafarnib – is in a phase 3 trial (D-LIVR) that is now fully recruited and due to generate results by the end of next year.

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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. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing. No single machine comes close to being a process solution for all size reduction applications.

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pharmaphorum

FEBRUARY 25, 2021

Earlier this month Chiesi and Protalix reported results from another trial called BRIDGE which showed a decrease in patients with moderately or fast progressing kidney disease following the switch from Replagal. The post Switch data back Chiesi/Protalix long-acting Fabry drug appeared first on.

Drugs 60

Drugs Bioavailability Antibody Marketing 60

Camargo

SEPTEMBER 30, 2021

Drug product formulation should be as simple as possible, but carefully executed to account for the characteristics of the intended administration route and dosing regimen and to facilitate successful manufacturing, storage, shipping, and compliance in the clinic and eventually on the market. Trial Master File plan. Species Selection.

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Pharmaceutical Technology

OCTOBER 25, 2022

As the number of FDC products in development and coming to the market increase, the pharmaceutical industry is looking to FDCs as a promising strategy to repurpose, repackage, and expand indications for existing and novel therapeutic agents. As a result, FDC products may help prevent medication errors and enable better control of dosing.

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Drug Discovery World

JANUARY 24, 2024

Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. He has been responsible for all aspects of drug discovery, preclinical research, CM&C, Phase I and Phase II clinical trials.

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Research Gene Expression Drugs Development 59

Drug Discovery World

FEBRUARY 2, 2023

ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As reported by DDW , the system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.

Drugs 52

Drugs Clinical Trials Clinical Trials Cosmetics 52

The Pharma Data

NOVEMBER 17, 2020

LYT-100 is a deuterated, oral small molecule designed to overcome the challenges associated with pirfenidone, an approved and marketed anti-inflammatory and anti-fibrotic drug. Photo: Business Wire). Multiple ascending dose and food effect study results.

Production 52

Production Trials Bioavailability Drugs 52

The Pharma Data

MAY 14, 2021

Because after many years of personal trials and experiments, I believe that I have finally discovered a special blend of ingredients which may help anyone support healthy prostate. Frank Neal is a pen name used for marketing purposes and to protect the author’s identity. Trust me, this is the last thing you’d want to do!

Packaging 52

Packaging Packaging Production Bioavailability 52

Pharmaceutical Technology

APRIL 12, 2023

This new market focus shines a spotlight on small molecule API manufacturers and their capacity for handling innovative NME sponsor requirements as well as the value-add services and technical and regulatory expertise they can offer as strategic production partners. The sampling device is suitable for operation in a vacuum environment.

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Pharmaceutical Technology

FEBRUARY 23, 2023

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. The Translational Pharmaceutics approach of testing multiple formulations within a clinical trial can also be applied to FIH studies.

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