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. The report is a useful read to keep current on a topic of interest at the FDA and in drug development as a whole.

Development 130

Development Bioequivalency Gene Expression Drugs 130

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.

Bioavailability 130

Bioavailability Clinical Trials Clinical Trials Development 130

Pharmaceutical Technology

JUNE 9, 2023

VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

Drug Discovery World

JANUARY 18, 2023

The system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models. . We are working hard to evidence how our technology can tackle these critical drug development bottlenecks and lead the way towards inclusion of OOC/MPS data within IND submissions.” .

Bioavailability 52

Bioavailability In-Vitro Research Drugs 52

Pharmaceutical Technology

APRIL 7, 2023

Furthermore, EDP-323 claims to have a favourable oral bioavailability with good plasma exposure in preclinical species and pharmacokinetic properties and supports once-a-day, oral dosage in humans. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”

In-Vitro 276

In-Vitro Bioavailability Development Drugs 276

Pharmaceutical Technology

JANUARY 17, 2023

OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1). SF-1 is an important transcription factor for adrenal gland growth and development. The company is developing OR-449 to treat ACC in adult and paediatric patients.

Bioavailability 147

Bioavailability Clinical Trials Clinical Trials Clinical Development 147

Pharmaceutical Technology

JUNE 13, 2023

It might therefore lead to the development of new therapies to treat heart failure. 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.

Bioavailability 130

Bioavailability Protein Drugs Development 130

Pharmaceutical Technology

MAY 2, 2023

The orally bioavailable small molecule EGFR inhibitor ERAS-801 demonstrated significant central nervous system (CNS) penetration in animal trials. This newly granted status helps Erasca to facilitate the development and review of ERAS-801, thereby accelerating the therapy’s reach to patients.

Bioavailability 130

Bioavailability Clinical Development Gene Trials 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

Bioavailability 97

Bioavailability FDA Approval Trials Drugs 97

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.

Bioavailability 130

Bioavailability Manufacturing Scientist 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.

Packaging 147

Packaging Packaging Bioavailability Manufacturing 147

Pharmaceutical Technology

FEBRUARY 13, 2023

It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility. Elyxyb is claimed to be the only FDA-approved first-line treatment, ready-to-use solution of celecoxib developed for the indication.

Drug Delivery Systems 130

Drug Delivery Systems FDA Approval Bioavailability Drug Delivery 130

Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The guidance mentions PBPK four times regarding renal function and DDIs.

Development 52

Development Drugs Medicine Production 52

Outsourcing Pharma

JANUARY 24, 2023

Evidence shows that animal models currently dominating bioavailability estimates are poor predictors and human, cell-based multi-organ microphysiological systems (MPS) should be investigated, CN Bio says.

Bioavailability 52

Bioavailability Research Clinical Development Development 52

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. Proper planning of PK assessments can accelerate the development of both novel drugs and new formulations of previously approved drugs developed via the 505(b)(2) pathway.

Production 133

Production Bioavailability In-Vivo Bioequivalency 133

Drug Discovery World

DECEMBER 22, 2023

Positive Phase I results for a new solid dose prescription cannabidiol (CBD) demonstrate the tolerability and bioavailability of the drug. We now look forward to the next stage of clinical development.”

Medicine 52

Medicine Bioavailability Clinical Development Trials 52

Drug Discovery World

APRIL 8, 2024

In response to the pressing need of effective treatments for these metabolic disorders, researchers led by Professor Jin Hee Ahn from Gwangju Institute of Science and Technology (GIST) meticulously developed compound 11c, a novel peripheral 5HT2A antagonist.

Drugs 52

Drugs Bioavailability Clinical Trials Clinical Trials 52

BioTech 365

MARCH 25, 2021

NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced … Continue reading → –(BUSINESS WIRE)–Edgewise Therapeutics, Inc.

Bioavailability 52

Bioavailability Development 52

Drug Discovery World

MARCH 3, 2023

To overcome this, oral chemically modified analogs of allopregnanolone have been developed, though these may not capture the full therapeutic potential of natural allopregnanolone. PureTech’s unique model includes moving resources toward the programs with the most promise. Chief Medical Officer at PureTech.

Bioavailability 52

Bioavailability Trials Clinical Trials Clinical Trials 52

Drug Discovery World

JULY 27, 2022

Recursion’s therapy REC-4881 is an orally bioavailable non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients. . FAP is a rare tumour syndrome in which hundreds or thousands of precancerous colorectal polyps grow in the body.

Bioavailability 52

Bioavailability Clinical Trials Clinical Trials Drugs 52

Drug Discovery World

DECEMBER 16, 2022

The investment allows the company to focus on discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases. . Clinical biotechnology company Storm Therapeutics has successfully completed a USD $30 million Series B financing round. . UTokyo IPC). .

RNA 52

RNA Immune Response Bioavailability Development 52

Drug Discovery World

NOVEMBER 27, 2023

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. It works by inhibiting the aberrant activation of the HGF/c-Met axis, a key pathway involved in tumour growth, proliferation, and the development of resistance to certain targeted therapies.

Bioavailability 52

Bioavailability Clinical Trials Clinical Trials Trials 52

Roots Analysis

FEBRUARY 20, 2022

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

Contract Manufacturing 52

Contract Manufacturing Bioavailability Manufacturing Drug Delivery Systems 52

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.

Bioavailability 52

Bioavailability Production Manufacturing Drugs 52

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. Biowaiver Eligibility.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

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.

Protein 130

Protein Bioavailability Development Scientist 130

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

Antibody 101

Antibody Bioavailability Engineer Drugs 101

The Pharma Data

NOVEMBER 19, 2020

Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

Development 40

Development Bioavailability Production Drugs 40

The Pharma Data

DECEMBER 1, 2020

Artificial intelligence holds immense promise to catalyze the development of the next generation of highly selective, orally bioavailable molecules, with reduced side effects, for the most impactful drug targets,” said Evan N. We are united in our view that drug discovery and development must raise its success rate.

Development 40

Development Drugs Engineer FDA Approval 40

Roots Analysis

OCTOBER 2, 2023

Additionally, it increases the bioavailability and solubility of the attached molecule. It is worth noting that in case of oncological disorders, nanoparticles are being developed to increase the permeability and stability of chemotherapeutics agents through the delivery of both diagnostic and therapeutic agents.

Drug Delivery 40

Drug Delivery Drugs Bioavailability Marketing 40

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. Pipeline Overview of Oral Peptide and Protein-based Therapeutics.

Protein 52

Protein Drug Delivery Drugs Drug Delivery Systems 52

The Pharma Data

APRIL 7, 2023

CycPeptMPDB, a novel database – created by Tokyo Tech researchers – focused on the membrane permeability of cyclic peptides, could accelerate the development of drugs based on these promising compounds. We expect it will become a valuable tool to support membrane permeability research on cyclic peptides,” remarks Prof.

Drugs 40

Drugs Bioavailability Protein Research 40

pharmaphorum

AUGUST 19, 2022

Development of TRPV1 agonists for pain isn’t a new concept, but many first-generation drugs were beset by safety issues – notably Amgen’s AMG517 and Merck & Co’s MK2295 – while AstraZeneca’s candidate AZD1386 made it into phase 2 in osteoarthritis but failed to show efficacy.

Drugs 52

Drugs Bioavailability Trials Clinical Development 52

pharmaphorum

JANUARY 16, 2023

They include a once-monthly form of paliperidone called LY03010 that has shown comparable bioavailability with Johnson & Johnson’s Invega Sustenna in a pivotal trial and has a slightly simpler regimen in the induction therapy stage.

FDA Approval 52

FDA Approval Drugs Bioavailability Marketing 52

XTalks

JUNE 14, 2023

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. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.

Gene Silencing 97

Gene Silencing Drug Delivery FDA Approval RNA 97

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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Bioavailability 52

Pharmaceutical Technology

AUGUST 22, 2022

They also offer enhanced bioavailability, exact dosing and an extended shelf life. Procaps’ deep knowledge of gelatine formulation and scientific expertise in softgel technologies has enabled the development of a range of innovative formulations. The best formulation for the job.

Compliance 130

Compliance Bioavailability Containment Branding 130