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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

FDA Approval

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

Drug Target Review

APRIL 25, 2025

19 Multi-organ CIVMs provide several new opportunities in ADME including in vitro bioavailability predictions, assessment of the effect of gut microbiome on hepatic drug metabolism, and prediction of the pharmacokinetic (PK) profile in humans in early pre-clinical stage. Organs-on-chips: a decade of innovation.

Clinical Development

Drug Target Review

MAY 8, 2025

However, their complex structures comprising monoclonal antibodies, linkers and cytotoxic payloads require advanced bioanalytical strategies to assess pharmacokinetics (PK), drug-to-antibody ratios (DAR), stability and metabolite profiling. The most effective strategies for ADC characterisation include: Ligand-binding assays (LBA).

Pharmacokinetics

New Drug Approvals

MAY 27, 2025

Milestone Pharmaceuticals Announces USAN Approval of Generic Name Etripamil for its Phase 2 Clinical Development Product for the Treatment of Paroxysmal Supraventricular Tachycardia. [3]. Cardiovascular and Pharmacokinetic Profiles of Intravenous Etripamil in Conscious Telemetered Cynomolgus Monkeys. J Am Coll Cardiol.

Pharmaceuticals

New Drug Approvals

MAY 11, 2025

11] History Omaveloxolone is a second generation member of the synthetic oleanane triterpenoid compounds and in clinical development by Reata Pharmaceuticals. 2] [5] It is taken by mouth. [2] 3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 9] SYNTHESIS PATENT Sheikh, AY et al.

FDA