Posts Tagged “R&D”

Failures in pharma R&D may pave the way for medical breakthroughs of the future.

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Failures in pharma R&D may pave the way for medical breakthroughs of the future.

Nobody wants to experience failure, but everybody does occasionally. Some experience failure more than others. This is the case for those who work in medical research, as failure is so often a part of the job while on the road to scientific discovery. While many consider failure to be a completely negative experience, that’s not always the case, as every failure is still a lesson learned. Occasionally, these failures can even lead to some of the biggest breakthroughs in medical history.

Turning failure into innovation

In a recent article, the former president of Pfizer Global Research and Development details just how failures in the pharmaceutical industry can actually lead to innovations later down the line. In his article, he talks about how the study of a drug that was designed to raise HDL-cholesterol ended up failing to show that the drug was able to help prevent heart attacks and stroke. But this failure turned out to be a pretty big breakthrough for the pharmaceutical industry, as it ended up proving that elevating levels of HDL-cholesterol through medication had little to no impact on heart attacks and strokes, thus ending the theory that increasing one’s amount of “good cholesterol” could help prevent such…

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Novartis reduces it’s drug development program by 20% to 340, amid other comparable R&D consolidations

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Novartis reduces it’s drug development program by 20% to 340, amid other comparable R&D consolidations

Novartis has dropped about a fifth of its research projects as the drugmaker narrows its focus on the most cutting-edge medicines.

The pharmaceutical giant has reduced its drug programs to 340 from 430 after completing a review of its portfolio, Jay Bradner, president of the Novartis Institutes for Biomedical Research, said in an interview Monday. Among the research projects it’s no longer pursuing are medicines for infectious diseases.

“The sadness about these 90 projects is there’s some great science there,” Bradner said. “These are not bad ideas. Many of them have momentum, but they either are not likely to be transformative for patients, or are ill-suited to the focused business ambitions of Novartis.”

The decisions are a sign of Chief Executive Officer Vas Narasimhan’s effort to make the Swiss drugmaker more competitive as development costs climb and big pharma’s returns on investments decline. They also come amid broader scrutiny of the industry’s pipelines. Drugmakers including GlaxoSmithKline Plc have pruned their portfolios in a bid to boost efficiency and deliver medicines that significantly improve patients’ health.

“Society should expect Novartis to bring forward truly impactful, truly differentiated, truly important medicines for patients with life-threatening diseases,” said Bradner, who joined Novartis in…

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New FDA guidance will support R&D on Complex Generics and Combination Products

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New FDA guidance will support R&D on Complex Generics and Combination Products

To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.

A main strategy for challenging the high prices of innovator therapies is to support the development and production of more competitive generic drugs and biosimilars, as outlined in FDA’s Drug Competition Action Plan, issued in June 2017. One sign of success is the agency’s approval of a record 971 new generic drugs this past fiscal year, largely due to devising a more streamlined and efficient review process and providing added advice and assistance on product development to manufacturers.

FDA is applying a similar approach to spurring development of more complex generic drugs and combination products, such as injectables, topicals, and patches that act locally on the skin, inhaled drugs affecting the lungs directly, or eye drops that act on the surface of the eye. These all raise challenging issues for production, formulation, and demonstrating equivalence to a brand reference listed drug (RLD). One result is that competition is limited for complex and combination products that involve complex and expensive product development and production methods, permitting brands to retain high prices even years after losing exclusivity. To achieve…

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Pharma R&D productivity: Discovering new medicines

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Pharma R&D productivity: Discovering new medicines

CEO of Medicines Discovery Catapult, Chris Molloy provides a compelling analysis of pharma R&D productivity and the discovery of new medicines and the role that the SME sector can play in this

Despite the greatest explosion in ‘new’ biology in 50 years, pharma R&D productivity has been falling for a decade. According to an annual survey by Deloitte, the top 10 global pharma companies now have a return on their R&D investment of only 3.4% and spiralling R&D costs. Stand up the SME sector. Traditionally the agile, risk-taking tester of new ideas, primed to be bought, incorporated into a bigger firm or to see their product developed by others, the SME now has a new opportunity to grow.

The Medicines Discovery Catapult has been established in Cheshire as a national collaborative R&D centre to help SMEs overcome barriers to growth. Our insightful sector analysis, The State of the Discovery Nation, shines a light into their world and shows how they can be helped to go beyond the next acquisition, to become the next generation of [UK] pharma.

A model in need of retooling

Discovering new medicines is hard. Every successful medicine has to do the biological equivalent of threading the…

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