Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. 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.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Camargo

JANUARY 19, 2021

On the other hand, an NDA for a drug improvement product utilizing the 505(b)(2) pathway typically has a Phase 1 bridging study, for which the drug product and API generally need to be at the to-be-manufactured stage. CMOs are subject to cGMP regulations, so they have standard operating procedures they must follow.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305