European Pharmaceutical Review

MAY 11, 2023

Sitra joined Eli Lilly and Company in 2004 and held roles first in Pharmacovigilance for two years and then for nine years in CNS drug development across various indications, including a dual role as Medical and Project Leader accountable for a portfolio of metabotropic Glutamate receptor modulators at various stages of development.

Drug Development 95

Drug Development 95

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. J Clin Oncol, 2004; 22(14): 2849-2855.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

Safe Biologics

OCTOBER 10, 2023

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. – View clip. Clip 4: Panel Discussion – View clip.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Pharmaceutical Technology

APRIL 12, 2023

This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. These include guidelines on good primate housing systems, minimising non-human primate use in drug development, and generating evidence in areas to refine non-human primate vaccine studies.

Vaccines 98

Vaccines Biosimilars Communication Pharmaceutical Companies 98

European Pharmaceutical Review

FEBRUARY 7, 2023

Key changes are expected to be proposed in relation to the Community Code on medicinal products, the EMA Regulation 726/2004 (the EU’s general pharmaceuticals legislation), the Orphan Regulation 141/2000 and the Pediatric Regulation 1901/2006.

Packaging 117

Packaging Drug Development 117

PharmaShots

FEBRUARY 20, 2023

According to a survey, a majority from a cohort of pharmaceutical leaders expressed that the drug development plans, which ideally takes years of research, when asked to prepare in haste, may cause serious implications on the health of the population.

Vaccines 40

Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 40

PharmaShots

FEBRUARY 21, 2023

This year, Novartis has secured the top position with a market cap of $207.65B, followed by Bayer and Lantheus Medical Imaging PharmaShots has compiled a list of the Top 20 Radiopharma Companies developing products as a treatment option, ranked based on their market cap.

Dosage 56

Dosage Labelling Immunity Immunization 56

Express Pharma

JANUARY 2, 2025

Its new brand name reflects the evolution from a generics-focused Contract Research Organization (CRO) to a drug development services enterprise for different modalities of drugs including generics and novel chemical and biological entities.

Drug Development 105

Drug Development 105

FDA Law Blog: Biosimilars

JANUARY 12, 2025

The new draft guidance , Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics , is intended to replace much of the 2014 Guidances discussion of the topic. While examples of this approach are uncommon, it stands out to us that FDA included this example in its guidance.

Drug Development 64

Drug Development Communication Labelling 64