Pharmaceutical Technology

NOVEMBER 30, 2022

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. Like all drugs, biologics are regulated by the FDA. They are different from small molecules in terms of their size and complexity.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis.

FDA Approval 82

FDA Approval Contract Manufacturing Sales Trials 82

pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.

Vaccination 52

Vaccination Vaccine Contract Manufacturing Production 52

Pharmaceutical Technology

JULY 4, 2022

Companies that own Russian pharma contract manufacturing or supply chain sites include Novo Nordisk (Bagsvaerd, Denmark); UPS (Atlanta, Georgia, US) subsidiary Marken (London, UK); Thermo Fisher Scientific (Waltham, Massachusetts) subsidiary Patheon (Durham, North Carolina); Servier (Paris, France); and Takeda (Tokyo, Japan).

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. and agonism of 5HT-1A, which regulate food intake, metabolism, weight control, and anxiety.

Manufacturing 52

Manufacturing FDA Approval Trials Development 52