Alta Sciences

SEPTEMBER 22, 2023

Mastering Drug Safety: Your Passport to Successful Pharmacology tchichekian Fri, 09/22/2023 - 13:36 HTML Navigating the Depths of Safety Pharmacology Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin. png Tags Preclinical Research Weight 10

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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Alta Sciences

MAY 28, 2024

This marks the ninth year that Altasciences, a fully integrated drug development solution company, has been deemed a top performer. Clinical Leader and Life Science Leader teamed up with ISR Reports to assess 42 CROs on more than 20 performance metrics in ISR’s annual CRO Quality Benchmarking survey.

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Drug Discovery World

JULY 15, 2024

Dr Alexandra Sapetschnig, Group Leader at STORM Therapeutics, described the event as one that “really set the agenda for oncology research in 2024” through the display of new approaches and methods that are expanding opportunities in drug development. This bodes well for potential future research and therapies,” she adds.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study. Expert Review of Clinical Pharmacology. References Wong MCS, et al. Montazeri K & Bellmunt J.

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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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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. . - Electronic security access to the pharmacy and video monitoring. - 24/7 monitoring of temperature and humidity.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 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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New Drug Approvals

SEPTEMBER 10, 2024

“In Vitro Metabolism of Slowly Cleared G Protein–Coupled Receptor 139 Agonist TAK-041 Using Rat, Dog, Monkey, and Human Hepatocyte Models (HepatoPac): Correlation with In Vivo Metabolism” Drug Metabolism and Disposition. 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); ESI-MS m/z [M+H] + 393.9.

Clinical Pharmacology 62

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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

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Eye on FDA

JANUARY 5, 2022

One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. FDA Adcomms have been declining in number even as the agency approves more drugs. FDA has scheduled the first advisory committee meetings of 2022.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. ” Prof. XPhyto Therapeutics Corp.

Drug Development 40

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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. Listen here. Read or listen now.

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The Premier Consulting Blog

NOVEMBER 4, 2023

Key to the IND opening studies is that the CMC information is sufficient to support the safety of the drug substance and drug product and establish the phase-appropriate quality of the drug product. Other safety considerations for the drug substance include potential impurities, such as process impurities and degradants.

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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.,

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Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

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Agency IQ

MARCH 1, 2024

On March 26, the Supreme Court will hear the case of Alliance for Hippocratic Medicine vs. FDA , a case which calls into question FDA’s authority to make regulatory changes, to be free from unreasonable scrutiny, and to ensure that the abortion drug mifepristone remains both approved and widely available.

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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.

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Drug Discovery World

AUGUST 15, 2023

Can potentially lethal arrhythmias induced by novel drugs be better predicted by using more relevant and sophisticated electrophysiological screening methods? Such techniques, if routinely deployed in drug discovery, may enable improved decision making in predicting serious adverse cardiovascular events.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Drug Discovery World

NOVEMBER 8, 2023

Antibody-based cancer therapies The second track of PEGS Europe 2023 is ‘Antibody-based cancer therapies’, which will feature a range of sessions made up of presentations, talks and posters which cover antibody drug conjugates (ADCs), intracellular, bispecific, and logic-gated antibodies, and conditionally active biologics.

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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. Altasciences helps sponsors get better drugs to the people who need them, faster.

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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. A similar draft guidance document for drug development is in process.

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Drug Discovery World

NOVEMBER 9, 2023

The first three include: Sungjin Park, PhD, CEO, Onegene Biotechnology, on: ‘UniStac: Enzyme-mediated conjugation technology for accelerated development of tetraspecific NASH drug’. Klaus Wagenbauer, PhD, Founder & CEO, Plectonic, on: ‘Programmable DNA-origami-based T cell engagers: PTE’.

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Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. Importantly, the Principal Investigator determined that few adverse events were drug-related.” is a privately held drug development company based in Grafton, MA.

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Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. As a reminder, the U.S.

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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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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

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Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? Within those focused on human drugs , there are 17 committees organized under therapeutic categories (Arthritis, Cardiovascular and Renal, Gastrointestinal, e.g.). Fewer meetings – more approvals. If they did want to hold more, are they ready?

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The Anticancer Fund

JUNE 7, 2022

10 June 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Below, we have listed recent findings about the repurposing of generic drugs in oncology. It is one of the focus areas of the Anticancer Fund.

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Patient enrollment of EXCELLENCE pivotal trial reaches 98%.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted. DRUG INTERACTIONS. Drug Interactions – Based on in vitro data, ZYTIGA ® is a substrate of CYP3A4.

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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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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