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GMO Regulations in Europe Are “Not Fit for Purpose”

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Regulations on Genetic Data Could Threaten Genomics Innovation

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To avoid stagnation, the EU must refine its ATMP regulation

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News and Trends 11 Sep 2024

Can Europe revive its biopharma innovation leadership?

Find out if the biotech runner-up, Europe, can step up to boost research and revive its innovation leadership.

September 11, 2024 - 9 minutesmins - By Jules Adam

The crucial role of rapid toxicology material delivery

Accelerating the path to clinical filing applications with rapid toxicology material delivery

Pre-clinical toxicology studies and prompt material delivery are essential for IND and CTA approvals, crucial for advancing drug candidates to clinical trials.

September 10, 2024 - 8 minutesmins - By Alexander Burik

News and Trends 4 Sep 2024

2024: a year of breakthroughs for endometrial cancer?

New treatments have been approved by regulators for endometrial cancer, which are regarded as major therapeutic breakthroughs.

September 4, 2024 - 7 minutesmins - By Roohi Mariam Peter

Mastering regulations and supply chain for advanced therapies

Navigating your path to globalization: Untangling the regulatory maze of the Advanced Therapies supply chain

Discover how Cryoport Systems can help you navigate EMEA regulations and manage the supply chain complexities for advanced therapies.

August 27, 2024 - 6 minutesmins - By External Contributor

News and Trends 13 Aug 2024

Biologics vs. drugs: What does Ipsen’s lost case against the FDA mean for the industry?

Ipsen has lost a court case against U.S. regulators to have its blockbuster cancer medication Somatuline Depot regarded as a biologic instead of a drug.

August 13, 2024 - 4 minutesmins - By Roohi Mariam Peter

News and Trends 1 Aug 2024

European regulators reject Alzheimer’s drug Leqembi: is it downhill from here?

European regulators have now refused to market the Alzheimer’s drug Leqembi after it was approved by the FDA last year.

August 1, 2024 - 6 minutesmins - By Roohi Mariam Peter

More News! 23 Jul 2024

First AKT-targeting drug capivasertib to hit the market, could it open the door for more?

As AstraZeneca and Astex’s capivasertib gains market presence in breast cancer, could it be the time for AKT inhibitors? Let’s find out!

July 23, 2024 - 7 minutesmins - By Jules Adam

In Depth 27 Jun 2024

The 2024 drug approval list: Eight new treatments you should know about

In this article, we take a look at eight much-anticipated drugs that have been approved by regulators so far this year.

June 27, 2024 - 9 minutesmins - By Roohi Mariam Peter

In Depth 19 Jun 2024

MASH candidates make a splash after first drug approval

The first drug to treat MASH, a potentially life-threatening liver disease, was approved this year. More recent advancements bring hope to patients.

June 19, 2024 - 9 minutesmins - By Roohi Mariam Peter

Expert Advice 14 Jun 2024

Biotech valuation multiples: how to value a biotech company?

How do biotech valuations based on multiples work? Experts share their most reliable methods to find the right price for a company’s stocks.

June 14, 2024 - 12 minutesmins - By Carlos de Rojas

In Depth 5 Jun 2024

Evolving standards of care: new treatments for cervical cancer

New treatments for cervical cancer aim to broaden therapeutic options, and improve current standards of care for patients.

June 5, 2024 - 7 minutesmins - By Roohi Mariam Peter

In Depth 15 Apr 2024

Does the FDA need to tighten its grip on drug trials in the U.S.?

Studies suggest that the FDA has been less rigorous with its drug approval standards. We looked at the current state of the approval process.

April 15, 2024 - 8 minutesmins - By Roohi Mariam Peter

Swiss biotech going strong in 2024: 18 companies to put on your radar

The ABC of biotech startup funding

Bridge RNA: A new gene editing technique that could overcome the limitations of CRISPR

Special Olympics: How is biotechnology revolutionizing sports performance worldwide?

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Swiss biotech going strong in 2024: 18 companies to put on your radar

The ABC of biotech startup funding

Bridge RNA: A new gene editing technique that could overcome the limitations of CRISPR

Special Olympics: How is biotechnology revolutionizing sports performance worldwide?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Editor's Picks for Regulatory approval