Pharmaceutical Technology

JULY 30, 2025

The future of DMD drug development now hinges on who steps into the role and how the FDA navigates this high-profile therapeutic area.” ” The public playout of DMD treatment developers with the FDA is not only impacting biopharma share prices but also raising concerns about the agency’s internal operations.

Insurance Coverage and Processing

Pharmaceutical Technology

JUNE 25, 2025

In September 2024, Medera entered a definitive merger agreement with Keen Vision Acquisition Corporation. By generating patient-specific 3D human heart models from a simple blood draw, we aim to uncover the biological mechanisms driving disease in each child — and ultimately tailor treatments that improve their chances of survival.”

Mayo Clinic

Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

Drug Development

Pulses

AUGUST 31, 2023

Despite the increasing popularity, definitive classifications of these terms remain elusive, and too often, are used interchangeably. Understanding the differences can assist educators in developing curricula aligned with the available resources, space requirements, and learning context (see Table 1).

Medication Dispensing

European Pharmaceutical Review

FEBRUARY 7, 2023

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023.

Packaging

European Pharmaceutical Review

JANUARY 13, 2025

3 Encouragingly, there are many examples of the life sciences sector seeking to embrace sustainable drug development; reconciling the drive for innovation with the need to reduce waste and emissions produced during the R&D process, as well as throughout the product lifecycle.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging

European Pharmaceutical Review

DECEMBER 21, 2022

All traditional small molecule pharmaceuticals include carbon building blocks – by definition, organic materials – which are then transformed via modern synthetic chemistry to assemble the complex and highly variable skeletons that the final target structures demand. in South San Francisco, CA, USA.

Compounding

Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

Communication

pharmaphorum

APRIL 11, 2022

Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. The answer to this question comes back to our definition of value. And it all fuels the debate: are medicines a cost or an investment?

Pharmaceutical Companies

PharmaTech

JUNE 12, 2025

The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.

Dosage