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Pharmaceutics_R&D
Pharmaceutical companies R&D specifically in neuroscience, CNS disease, pain and electrophysiology
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PharmaGossip: Lilly depression drug fails late-stage trial

Eli Lilly and Co on Thursday said its experimental drug to treat major depression failed to meet it primary goal in three late-stage trials and the drugmaker will not seek approval of the medicine for that condition.

The drug edivoxetine, a member of a family of medicines called norepinephrine reuptake inhibitors, was tested in combination with a member of a widely used class of depression treatments called selective serotonin reuptake inhibitors (SSRIs) in each of the three trials.

But after eight weeks of treatment, the combination of drugs that included edivoxetine did not prove superior to the SSRIs alone, thereby failing the main goal of the study. - PharmaGossip, December 5, 2013

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Novartis CEO: The Age Of Massive Blockbuster Drugs Is Over

Novartis CEO: The Age Of Massive Blockbuster Drugs Is Over | Pharmaceutics_R&D | Scoop.it

Big pharma needs to change its whole business model.


The business model for large pharmaceutical companies hasn't changed for decades.


You target a huge population, like people with heart disease, find and patent a drug that's at least marginally better than current treatments, and make billions. It's worked pretty well for a long time. (..) - by Max Nisen, Business Insider, Mar. 4, 2013

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Will "Robust Pipeline" Yield More New Drugs?

Will "Robust Pipeline" Yield More New Drugs? | Pharmaceutics_R&D | Scoop.it

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in the pipeline globally, many for untreated diseases and life-threatening conditions. The promise is that this more robust pipeline will lead to more new critical therapies for patients.

Yet, the data also reveals that most of these therapies are in early stages of development:  less than 1000 of the 5400 products in clinical development have reached stage III, and only 82 are headed for market following approval by the Food and Drug Administration. The attrition from phase II to phase III remains very high despite a range of scientific advances and regulatory improvements. Of nearly 3000 new molecular entities (NMEs) to treat cancer, only 288 have reached stage III clinical trials, and only  a handful make it to market. Therapies for infectious diseases seem to have a higher success rate, with about 700 investigational projects yielding 22 recent approvals. Certainly a higher “early kill” rate may be a sign of progress in the  risky world of pharma R&D, where a key goal is to avoid costly phase III studies that won’t pass muster with FDA. The current study doesn’t provide the historical data that could tell more about whether pharma R&D is becoming more productive, but there doesn’t seem to much evidence of progress.

A more telling sign is the recent rise in FDA’s approval numbers for NMEs, reaching almost 40 in 2012 and still providing steady good news for sponsors. The promise is that more INDs eventually will yield more new approved medicines. “There are no guarantees” from a stronger and more diverse pipeline, but the study reveals the “depth of possibilities,” observed Genia  Long of the Analysis Group in a PhRMA webinar. However, it also is important for pharma to reduce the overall cost of developing new drugs, and that will require more informative early stage research strategies that efficiently separate potential winners from likely losers. Researchers are making progress in developing treatments for Alzheimer’s disease, pointed out Eli Lilly CEO John Lechleiter, acknowledging that success “will require longer, more expensive studies to show benefit for patients.”

The PhRMA report aims to demonstrate to the public and policymakers the high value of biopharmaceutical R&D and the importance of continuing government support for FDA programs and research funded by the National Institutes of Health. It also highlights the value – and the need to pay for – new therapies to treat rare diseases and conditions that currently lack effective treatment. Ultimately, these new, costly research endeavors could lead to cures and preventives for cancer, Alzheimer’s and other devastating illnesses that affect millions. But the costs for individual patients may be enormous, and it remains to be seen if public and private health programs will pay for them.

 


Via Lionel Reichardt / le Pharmageek, Chaturika Jayadewa
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Indian pharmaceutical industry to grow 19% in 2013 | pharmaphorum

Indian pharmaceutical industry to grow 19% in 2013 | pharmaphorum | Pharmaceutics_R&D | Scoop.it

This is a pharma news story about the Indian pharmaceutical industry which is expected by analysts to grow 19% in 2013. (...) - pharmaphorum, 14th January, 2013

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European Court Wants Drug Data Kept Secret

 A court has ordered the European Medicines Agency (EMA) to keep data from two drug companies confidential, running counter to EMA's recent push to share clinical and nonclinical information as widely as possible. The temporary injunction from the General Court of the European Union backs two drug firms on the U.S. side of the pond: AbbVie, headquartered in North Chicago, Illinois, and InterMune in Brisbane, California. (...) - ScienceInsider, by Jennifer Couzin-Frankel on 30 April 2013

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Europe bets on drug discovery

Europe bets on drug discovery | Pharmaceutics_R&D | Scoop.it

Proponents hope consortium will revive flagging industry.


Two sites shuttered by the pharmaceutical giant Merck, one in Scotland and one in the Netherlands, will soon be humming again with the work of drug discovery. But the hum will not be business as usual. It will be the sound of a public–private consortium placing a high-stakes wager: a nearly €200-million (US$271-million) bet that it can boost a languishing pharmaceutical sector by fusing academic innovation with industrial-scale screening, using robots to test chemicals for biological activity. (...) - by Monya Baker, Nature07 February 2013

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James A Smith MCIM's curator insight, February 25, 2013 7:17 AM

Some big money investment here and interesting to see from a business model perspective

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Rhenovia invente le patch anti-Alzheimer

Rhenovia invente le patch anti-Alzheimer | Pharmaceutics_R&D | Scoop.it

Spécialiste de la biosimulation pour la recherche pharmaceutique, Rhenovia Pharma, basé à Mulhouse et implanté aux Etats-Unis depuis un an, vient de breveter un patch électronique pour l'administration contrôlée de médicaments. (...) - Les Echos, par CHRISTIAN LIENHARDT | 23/01/2013

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New cures sought from old drugs

New cures sought from old drugs | Pharmaceutics_R&D | Scoop.it
Researchers to re-examine compounds shelved by industry.


Progeria is a rare, lethal disease that ages children so rapidly that they seem to be 80 years old when they are just 10. So patients and families celebrated the news last week of the first therapeutic success against the disease — as did advocates of the notion that abandoned drugs can rise again. A clinical trial has shown improved symptoms in children with the disease who used lonafarnib (L. B. Gordon Proc. Natl Acad. Sci. USA http://doi.org/jfz; 2012), a drug developed by Merck in the 1990s that failed against its original target, head and neck cancer. (...) - by Meredith Wadman, Nature News, 3 October, 2012

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