Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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H1 Blog

AUGUST 17, 2023

An HCP Digital Engagement Strategy Case Study In this case study , H1 partnered with a top global pharma company to enable them to expand their digital engagement strategies beyond traditional KOLs to deliver effective messaging related to patient care while also staying compliant with healthcare regulations – making it easier than ever before to keep (..)

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H1 Blog

DECEMBER 11, 2024

In 2025, I predict that there will be global regulations requiring comprehensive diversity plans for all major markets, including the EU and EMEA. As these standards take shape, pharma companies will adopt tools and models to reach broader and more diverse participants.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,

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The Pharma Data

DECEMBER 17, 2020

AB2 Bio – Swiss pharma company AB2 Bio Ltd. holding positions of increasing responsibility in Merck Research Laboratories before joining the company’s executive committee as CSO. Immune Regulation – U.K.-based based Immune Regulation Ltd. named Djordje Filipovic as its new chief commercial officer.

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Altus Drug Development

JUNE 28, 2022

For instance, European pediatric regulation places certain requirements to support the safety and efficacy of drugs destined to be used on children ( source ). In an effort to reduce regulatory risk and reach the market faster, pharma companies might decide to pursue the approval of medicines with a simple lead formulation.

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The Pharma Data

NOVEMBER 5, 2020

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 CET on November 6, 2020.

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Drug Target Review

MAY 26, 2025

“Regulators are also much more interested in the manufacturing process, especially when it comes to stability.” Because analytical questions from both manufacturers and regulators are increasing, we have to think smarter with novel technologies. We can combine multiple biologically active molecules to create hybrid drugs.

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Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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The Pharma Data

MAY 14, 2021

First, most are on the payroll of the big pharma companies earning lucrative commissions for pushing their drugs…. While most of the focus is on the pancreas, as that’s the organ that produces insulin and plays a major role in regulating erratic blood levels…. The second reason is even more common….

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The Anticancer Fund

JUNE 7, 2022

Also notable is that the majority of the new use patents are held by pharma companies, and that they maintain (pay to renew) their portfolio. Clinical investigation of this approach, particularly with respect to the sequencing of chemotherapy and immunotherapy, is warranted.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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Drug Patent Watch

APRIL 8, 2025

"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. Patent Portfolio Strength : A strong patent portfolio can significantly impact a company's valuation.

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The Pharma Data

MAY 13, 2021

Unfortunately, I learned the hard way that the “Big Pharma” companies don’t care about their patients. Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. It’s all about the bottom line, at any cost.

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Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. Techbio companies have initiated this approach. FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

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The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. One of the reasons they expect VC spending in biopharma to expand is that during 2020, particularly from March through about July, many pharma companies, if able, paused their clinical trials.

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The Pharma Data

DECEMBER 16, 2020

Recombinant monoclonal antibodies are designed to enhance the immune system’s ability to regulate cell functions. and will leverage a major COVID-19 vaccine partnership the company struck with the U.K. Defense Advanced Research Projects Agency (DARPA), as well as previous funding from the Bill and Melinda Gates Foundation.

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Drug & Device Law

APRIL 7, 2023

The company lodged a request under the Freedom of Information Act (“FOIA”), which the FDA refused. So the company sued, and the district judge ruled that the FDA had no valid basis to withhold the requested information. The company therefore submitted a supplemental New Drug Application, or sNDA, seeking approval for that use.

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