Alta Sciences

MAY 28, 2024

Altasciences’ integrated, full-service solutions include preclinical safety testing , clinical pharmacology and proof of concept , bioanalysis , program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements.

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Clinical Pharmacology Drug Development Science Clinical Research 40

Alta Sciences

SEPTEMBER 22, 2023

You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology. png Tags Preclinical Research Weight 10

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Clinical Pharmacology Drugs International Pharmaceuticals 40

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Alta Sciences

SEPTEMBER 20, 2023

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc.

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Alta Sciences

AUGUST 28, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology.

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Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Drug Target Review

JULY 4, 2023

Author bios: Dr Petra Dieterich Petra has 30 years’ experience of drug development in the Pharmaceutical industry with a focus on supporting CMC activities. Translational and Clinical Pharmacology [Internet]. Clinical Pharmacology & Therapeutics. 2022 [cited 2023 Feb 10];30(2):71. 2021 Jul 8;110(5):1216–30.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Sygnature Discovery

JANUARY 13, 2022

We’ve appointed the highly experienced pharmaceutical executive Dr Charles Woler as Chairman. In a broad career, Charles has held multiple key roles in the sector, including CEO at Roche France, Executive Chairman for Europe at SmithKline Beecham PLC, and CEO at Cadus Pharmaceutical in the US.

Clinical Pharmacology 52

Clinical Pharmacology Pharmaceuticals Laboratories Drugs 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Pharma Companies Licensing Licensing Disease 111

New Drug Approvals

SEPTEMBER 10, 2024

“A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1 Hz, 1 H), 5.09 (s, 2 H), 7.33 (d, J=7.8 PMC 9544063.

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

Eye on FDA

JANUARY 5, 2022

Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.

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FDA Clinical Pharmacology Vaccine Production 76

Eye on FDA

AUGUST 4, 2021

The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee. Also the vacancies on the Peripheral and Central Nervous System Drugs Advisory Committee largely reflect the protest of the FDA approval decision in Alzheimer’s.

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FDA Clinical Pharmacology FDA Approval Therapies 122

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. Advances in artificial intelligence, machine learning, large datasets, and CM&S technologies are assisting the pharmaceutical industry in the drug development process.

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Drug Development Disease Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 40

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

Additional product-specific considerations include clinical pharmacology considerations, such as whether the product is thought to penetrate the CNS; clinical experience with the product in other populations; the route of administration (such as the impact of pain from repeated injections on neurodevelopment); and the nature of product components, (..)

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Production FDA Therapies Clinical Pharmacology 64

The Premier Consulting Blog

NOVEMBER 4, 2023

For the drug product, the critical review items during the IND review revolve around the dose uniformity, stability, and the amount of active pharmaceutical ingredient (API) released from the dosage form. The justification is suitable for discussion at the pre-IND meeting. Control of these parameters can be discussed at the pre-IND meeting.

Clinical Pharmacology 52

Clinical Pharmacology Production FDA Packaging 52

The Pharma Data

OCTOBER 15, 2020

formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. Prior to that role, Hanna served as CEO at ORIC Pharmaceuticals and before that, Hanna was head of Commercial and Medical Affairs Finance at Genentech and CFO of the Genentech Foundation.

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Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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FDA Biosimilars Science Production 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder.

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology 40

Agency IQ

MAY 3, 2024

and the E.C.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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FDA Science Regulations Production 40

The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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Clinical Trials Drugs Trials Treatment 40

Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Learn more at www.janssen.com.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

JUNE 2, 2023

Start Date End Date Event Event Type Center 06/05/2023 06/09/2023 Regulatory Education for Industry (REdI) Annual Conference 2023 Virtual CDER 06/07/2023 06/08/2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Public CDER 06/07/2023 06/08/2023 RDEA Pilot Program 2023 Public Workshop Workshop (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

and the E.C.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The FDA DSUR is intended to be consistent with the format and content for IND annual reporting supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is more comprehensive, and informative than the IND annual report currently required by FDA.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Alta Sciences

OCTOBER 30, 2023

35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

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Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. and the E.C.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JULY 12, 2024

and the E.C.

Regulations 40

Regulations FDA Science Production 40