FDA Head, Company CEOs Cheer Bumper Haul of New Drugs

Pharmaceutical industry productivity is improving as a more targeted approach to drug development yields dividends and regulators offer speedier decisions on medicines that make a real difference to patients.

That is the view of both the head of the U.S. Food and Drug Administration and drug company CEOs meeting in Davos this week at the World Economic Forum.

"The products that we have approved in the last two years do give us real cause for optimism," FDA Commissioner Margaret Hamburg told Reuters.

A total of 39 new drugs won approval last year - a record only beaten in 1996 - up from 30 in 2011, which itself was a marked improvement on the 21 cleared in 2010.

The industry badly needs a winning streak after delivering poor returns for several years due to a wave of patent expiries on older products and a notable failure to bring enough new drugs to market to replace them.

The advance reflects progress in understanding the basic science of many diseases - notably some types of cancer - as well as smarter use of tests to target treatments to specific patient groups based on genetic profile.

"Not only have we been able to approve more new drugs that have real benefits for patients but also classes of drugs that signal where we are going in areas like personalised medicine, where we've been able to use diagnostics to target sub-populations of responders," Hamburg said.

The attitude of the FDA has also helped, according to Novartis CEO Joe Jimenez.

"The FDA has really shifted back to a very disciplined scientific approach to drug approvals, so we are starting to see more drug approvals come through," he said.

These days, however, winning approval for a new medicine is not the whole story. Drug manufacturers also have to fight hard to win a place for their usually pricey new products on lists of treatments covered by insurers or state health services.

The rigour of having to prove the value, as well as clinical effectiveness, of new medicines is helping to make companies more targeted in developing drugs that have a clear edge - even is this involves zeroing in on small, niche markets, said Sanofi Chris Viehbacher.

Discovering new medicines and progressing them through the three required stages of clinical development remains, however, a complex business with a fair dose of serendipity.

"It's not like engineering where the iPhone 5 follows on from the iPhone 4. Coming up with a new drug requires skill, insight and luck," said Merck & Co Ken Frazier.

"But we are on the verge, potentially, of a new wave of pharmaceutical innovation - and I think Merck stands to be at the forefront of that new wave."

 

Interview

Fostering Innovation and Collaboration
Specialty Chemicals Distributor IMCD’s Strategy

Fostering Innovation and Collaboration

Valerie Diele-Braun, CEO of IMCD, shares her vision for sustainability, global expansions, and strategic direction in an exclusive CHEManager International interview.

Innovation Pitch

The Start-up Platform for Chemistry & Life Sciences
Discover Tomorrow’s Innovators

The Start-up Platform for Chemistry & Life Sciences

CHEManager Innovation Pitch supports innovation in the chemistry and life sciences start-up scene. The platform allows founders, young entrepreneurs, and start-ups to present their companies to the industry.

most read

Photo
24.01.2025 • News

And the Winners are: Cynio, EnaDyne and Green Li-ion

The CHEManager Innovation Pitch, the start-up promotion initiative of CHEManager and CHEManager International, has given more than 100 start-ups from over 15 countries the opportunity to present their innovative ideas, products and technologies to a broad target group since its launch in 2019.

Photo
08.11.2024 • News

Future Prospects in Green Chemistry

The Discourse on Green Chemistry Interactive Pitch Competition, held on November 5, 2024, at Wiley's Berlin office as part of Berlin Science Week, showcased a range of innovative projects aimed at addressing critical environmental challenges.

Photo
19.03.2025 • NewsInnovation

Data-Driven Enzyme Immobilization

Inseit, based in Bern, develops biocatalysts for industrial setups using enzyme immobilization and biocomputation. Addressing biotech and sustainability challenges, Inseit was selected for Venture Leaders Biotech and won two Nucleate accelerator prizes.