Features

Led by increased product development of biologics, including new modalities, biomanufacturing continues to be an active area of investment by CDMOs/CMOs. A roundup of the latest expansions.

In May (May 2022), the FDA issued draft guidance to spell out the types of drugs that are vulnerable to shortages and should be subject to risk-management plan reporting. What does the industry think?

A measure of innovation in the bio/pharma industry is to look at “first-in-class” new drug approvals, referring to drugs with new mechanisms of actions than existing therapies. A look at key trends, the companies, and products for first-in-class drugs.

Novartis’ decision to spin out Sandoz, its generics and biosimilars business, into a separate, stand-alone company is the latest move in the highly cost-competitive generics market. What was behind Novartis’ decision, and how does it fit with other recent deals?

How have the bio/pharmaceutical majors performed thus far in 2022? Which companies and products are on the upside, and which companies and products are not meeting expectations? An analysis of first-half 2022 results and key pipeline progress of the top companies.

The industry is moving to meet a deadline of November 27, 2023, for implementing interoperability requirements under the Drug Supply Chain Security Act, which outlines the steps to build an electronic, interoperable system to identify and trace Rx drugs through the supply chain.

What are noteworthy trends in drug delivery and drug-product development in key dosage forms: solid dosage and parenteral drugs? A look at key technology advances and recent new drug approvals.

Rx drug pricing reform in the US took a major step this week with the passage of a Senate bill, which now goes to the House of Representatives, where it is likely to pass. What is in the plan?

The FDA has issued draft guidance to lay out its current thinking on remote regulatory assessments, an approach it took when onsite inspections were not possible due to the COVID-19 pandemic. What’s in the plan?

Emerging Pharma companies are important as drug-development partners with larger bio/pharma companies and represent an important customer base for CDMOs/CMOs. Which companies and their deals have stood out this far in 2022?