DARK SECRETS: Ema | Vintage Vibes

Three charts show boutique firms are telling agencies how to spend money

Agencies are now getting more advice on how to outsource work.

The Canberra Times · Sep 24

Biocon arm gets positive EMA panel recommendation for breast cancerbiosimilar Pebrilzo

Biocon Biologics has received a positive recommendation from the European Medicines Agency’s CHMP for its Pertuzumab biosimilar, Pebrilzo, for HER2-positive breast cancer. The European Commission will take the final decision on marketing authorisation across the EU.

The Economic Times · Sep 21

From Gujarat to Rio: How India's pollution solution could offer lessons for Delhi-NCR’s dirty air crisis

An Indian emissions trading scheme developed in Gujarat is now being explored internationally. This market-based approach encourages industries to reduce pollution through economic incentives. The successful pilot in Surat demonstrated significant emission reductions and cost savings for factories. This innovative model is now being considered for adoption in Rio de…

The Economic Times · Sep 14

Greece: Only one in five new medicines reaches patients – the 'legacy' of the bailouts

Greeks wait almost two years for access to new treatments, while pharmaceutical companies increasingly say they do not intend to launch new products in the country.

Euronews · May 28

Where do Europeans wait longest for new medicines?

Access to new medicines still varies sharply across Europe, with waits ranging from months to more than three years, according to the European Federation of Pharmaceutical Industries and Associations.

Euronews · May 20

Capricor Therapeutics Q1 Earnings Call Highlights

Capricor Therapeutics (NASDAQ:CAPR) said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku. On t

MarketBeat · May 12

Anavex Life Sciences Stock Is Deeply Oversold. Should You Buy the Dip?

Anavex shares crash as the EMA indicates it won’t issue a positive opinion on its candidate Alzheimer’s drug. Here’s why long-term investors may still consider loading up on AVXL stock today.

Barchart · Mar 26

Blame U.S. Regulations for China's Dominance in Rare-Earth Minerals

America once dominated the rare-earth market, but permitting requirements are holding the industry back.

Reason · Mar 21

Why drug approval in Canada should not rely on foreign regulators

Without much fanfare, Health Canada announced in the Canada Gazette Part 1 on Dec. 22, 2025 that it was beginning a 70-day consultation period on using the decisions of foreign drug regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve new…

The Conversation · Jan 29

Why Requirements Management Is Critical in Regulated Device Development

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

inkl · Dec 8, 2025