Clinical Development, Pharmaceuticals and Pharmacokinetics

GSK expands respiratory pipeline with Aiolos Bio acquisition

Drug Discovery World

JANUARY 10, 2024

The acquisition includes Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter Phase II clinical development for asthma, with potential for additional indications.

Pharmacokinetics

Pharmacokinetics Licensing Licensing Clinical Development

Form and Formulation

Sygnature Discovery

JANUARY 26, 2024

Leveraging years of experience, we efficiently advance your compounds through preclinical studies and reduce risks as you move into clinical development. Our talented team of scientists can assist you in crafting robust pre-clinical development strategies.

Process Chemistry

Process Chemistry Pharmacokinetics Clinical Development Laboratories

Drug discovery gets $9.75m boost for MedChem Australia

Drug Discovery World

JUNE 27, 2023

It will be headquartered at the Monash Institute of Pharmaceutical Sciences (MIPS). The Drug Discovery Initiative at the University of Sydney is thrilled to collaborate with the Monash Institute of Pharmaceutical Sciences and WEHI to create this much needed national framework. MedChem Australia will fill this gap.

Drugs

Drugs Medical Chemistry Pharmacokinetics Science

Top 10 Life Science Resources

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Watch it now.

Science

Science Clinical Trials Pharmacokinetics Pharmacy

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. 5, 2020 11:00 UTC. LEXINGTON, Mass.–(

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Small Molecule

Improving Drug Safety Through Cardiotoxicity Assessment

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved.

Drugs

Drugs Pharmacokinetics FDA Approval Drug Development

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan. Zai Lab is leading clinical development in its territory. “We Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”.

FDA

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals’ SPN-812 for ADHD. Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Adamis Pharmaceuticals’ Zimhi for Opioid Overdose. Food and Drug Administration (FDA) in terms of PDUFA dates.

FDA

FDA Trials Pharmaceuticals Pharmacokinetics

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Phase I clinical trial for first-in-class bispecific antibody for cancer treatment

Drug Discovery World

JANUARY 31, 2024

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress. manufacture, preclinical pharmacology and toxicology studies, as well as clinical development and regulatory application of OT-A201 rapidly and efficiently.

Clinical Trials

Clinical Trials Trials Treatment Pharmacokinetics

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment

Treatment Disease Pharmaceuticals Therapies

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. About Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. View original content: [link].

Production

Production Trials Treatment Pharmaceuticals

Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

The Pharma Data

JULY 21, 2021

As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”.

Clinical Trials

Clinical Trials Pharmacokinetics Trials International

Novo Nordisk: positivity for haemophilia treatment

Drug Discovery World

AUGUST 8, 2022

Earlier this year, pharmaceutical company Novo Nordisk announced positive results from Phase I & II clinical trials investigating its antibody treatment for haemophilia A. . We look forward to moving into phase 3 clinical development, which is due to commence in Q4 2022. Available at: [link] Accessed: July 2022.

Treatment

Treatment Clinical Trials International Disease

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. The primary endpoint of the trial will be NASH resolution with no worsening of fibrosis assessed on histology.

Trials

Trials Disease Treatment Pharmacokinetics

Everest Medicines Announces Amended Agreement with Spero Therapeutics

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan.

Clinical Trials

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Minton. Presentation Number: P1133. Presentation Topic: Reproductive Aspects and Pregnancy.

Clinical Trials

Clinical Trials Treatment Trials Disease

Positive Phase 1 results in high-dose setanaxib trial

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials

Trials Clinical Trials Pharmacokinetics Small Molecule

Can Your CRO Add Value During a Recession?

PPD

JUNE 20, 2023

Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy? A strong CRO partner will also talk through your holistic data strategy early, pinpointing milestones at which data could expedite development and approval. Make sure your CRO stays ahead of the curve.

Clinical Trials

Clinical Trials Drug Development Trials Biosimilars

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. In general, regulatory nonclinical studies conducted in animals should mirror the conduct of clinical trials as closely as possible.

FDA

FDA Science Small Molecule Immune Response

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. . ?. ?. .

Clinical Trials

Clinical Trials Clinical Development Small Molecule Trials

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Any CMC changes (e.g.,

Biosimilars

Biosimilars Science FDA Licensing

The evolution of assays for immuno-oncology research

Drug Discovery World

FEBRUARY 15, 2023

Another widely available commercial model is the cell-line derived xenograft (CDX) 9 that involves inoculation of fast-growing tumour cell lines into immunodeficient mice for various applications including pharmacokinetics, efficacy of cell killing, and studying tumour metastasis by in vivo imaging.

Research

Research Therapies Immune Response Clinical Trials

Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. INDICATION.

Trials

Trials Therapies Treatment Pharmacokinetics

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors. Oral, Small Molecules.

Disease

Disease Clinical Trials Small Molecule Trials

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials

Clinical Trials Trials Treatment Production

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises. BNT162 mRNA-based Vaccine Program. and -50.4%

Vaccine

Vaccine Therapies Trials Clinical Trials

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Galactosidase-A enzyme.

Clinical Trials

Clinical Trials Disease Treatment Trials

BioSpace Global Roundup, Oct. 15

The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. Talking Medicine uses advanced AI to provide pharmaceutical companies with real-time data intelligence. All jobs have been maintained and the workforce has grown from about 220 to 350.

Clinical Trials

Clinical Trials Trials Pharmaceuticals Pharmaceutical Companies

New four year data for Roche’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

The Pharma Data

MARCH 20, 2023

“The longer-term results of this study add to the robust body of findings from our broad clinical trial programme evaluating Evrysdi across a variety of ages, disease severities and treatment histories.” Roche is the majority shareholder in Chugai Pharmaceutical, Japan. The study met its primary endpoint. Source link: [link]

Pharmacokinetics

Pharmacokinetics Treatment Clinical Trials Trials

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

The Pharma Data

SEPTEMBER 27, 2020

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Pharmacokinetics

Pharmacokinetics FDA Approval Treatment Clinical Trials

Drug Discovery Digest

GSK expands respiratory pipeline with Aiolos Bio acquisition

Form and Formulation

Trending Sources

Drug discovery gets $9.75m boost for MedChem Australia

Top 10 Life Science Resources

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Improving Drug Safety Through Cardiotoxicity Assessment

FDA Action Alert: MacroGenics and Amgen

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Phase I clinical trial for first-in-class bispecific antibody for cancer treatment

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

Novo Nordisk: positivity for haemophilia treatment

Poxel Announces Additional Positive Phase 2a Results, and Phase 2b Plan for PXL770, an Oral First-in-Class AMPK Activator, in NASH

Everest Medicines Announces Amended Agreement with Spero Therapeutics

Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

Positive Phase 1 results in high-dose setanaxib trial

Can Your CRO Add Value During a Recession?

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

The evolution of assays for immuno-oncology research

Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

Advances in the Battle Against Autoimmune Disease

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

BioSpace Global Roundup, Oct. 15

New four year data for Roche’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

Roche presents new 2-year data for Evrysdi (risdiplam) in infants with Type 1 spinal muscular atrophy (SMA)

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