BrainBlog

Investors ready to craft new biotechs out of Pfizer's discards February 9, 2011 — 8:47am ET By John Carroll FierceBiotech Read the article

From FierceBiotech , an interesting report: Full article: Top 10 Phase III Failures of 2010

A very readable piece from Gina Kolata of the New York Times: Doubt on Tactic in Alzheimer’s Battle By GINA KOLATA The New York Times Published: August 18, 2010 "The failure of a promising Alzheimer’s drug highlights the gap between diagnosis and treatment." Read the full article

From FierceBiotech FDA panel backs new epilepsy drug from GSK, Valeant August 12, 2010 — 7:41am ET By John Carroll "GlaxoSmithKline and Valeant got a solid endorsement for their new epilepsy drug Potiga (ezogabine) from the FDA's panel of experts, putting them on track to a likely approval. The experts unanimously agreed that the drug would benefit epilepsy patients whose meds couldn't stop seizures. And they agreed that careful monitoring would flag patients who experience an inability to urinate while taking the drug." Read the full article

From The New York Times : Hopes for Alzheimer’s Drug Are Dashed By ANDREW POLLACK Published: March 4, 2010 "The drug, called Dimebon, failed in its first late-stage clinical trial, dealing a blow to patients with Alzheimer’s and the companies developing the treatment, Medivation and Pfizer." Read the full article

A press release from earlier today by Pfizer: Pfizer And Medivation Announce Results From Two Phase 3 Studies In Dimebon (latrepirdine) Alzheimer’s Disease Clinical Development Program [snip] "About the CONNECTION Study "CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment. "No statistically significant improvements for the 20 mg TID group relative to ...

Today's recommended article to read; abstract from PubMed : Bergmans BA & De Strooper B. gamma-secretases: From cell biology to therapeutic strategies. Lancet Neurology . 2010 Feb; 9(2 ): 215-226. Department of Molecular and Developmental Genetics, VIB, Leuven, Belgium; Center for Human Genetics , Katholieke Universiteit Leuven, Leuven, Belgium. Presenilins form the catalytic part of the gamma-secretases , protein complexes that are responsible for the intramembranous cleavage of transmembrane proteins. The presenilins are involved in several biological functions, but are best known for their role in the generation of the beta-amyloid (Abeta) peptide in Alzheimer's disease and are therefore thought to be important drug targets for this disorder. Mutations in the presenilin genes cause early-onset familial Alzheimer's disease, but mutation carriers have substantial phenotypic heterogeneity. Recent evidence implicating presenilin mutations in non-Alzheimer's dementia...

From Fierce Biotech : UCSF enters drug discovery agreement with Genentech Posted February 19, 2010 "The University of California, San Francisco has signed a partnership agreement with Genentech, Inc., a wholly owned member of the Roche Group, to discover and develop drug candidates for neurodegenerative diseases. "Through the agreement, Genentech will provide funding and its research acumen in neuroscience and will collaborate with UCSF to identify small molecules." Read the full article

From FierceBiotech : GSK launches new specialist unit to research and develop medicines for rare diseases Issued: Thursday 4 February 2010, London UK Read the full article

From FierceBiotech : FDA approves Acorda's new MS drug January 22, 2010 — 4:49pm ET By John Carroll [snip] The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with multiple sclerosis. In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with a placebo. This is the first drug approved for this use. [snip] Read the FierceBiotech full article

An Associated Press report this evening outlines changes at a number of Wyeth and Pfizer research facilities: Read article

The Mobile Healthcare Industry Summit takes place this 1st and 2nd of December at the Thistle Marble Arch Hotel in London, England. According to the conference website, topics include: - Using Mobile Healthcare Partnership to Transform a Health System From Responsive Into Preventative - Using Mobile Healthcare to Improve Precision in the Diagnosis and Cure of Patient Illness - Freeing the Patient and the System with Intelligent Biometric Diagnostics - Defining the Data Management of Digital Healthcare - What Are The Technical Platforms For Mobile Healthcare Success? - SMS, Devices, Intelligent M2M - Globalising Mobile Healthcare: Regional Case Studies and Uniting the Service – South Korea, North America, Japan Visit the conference website for detailed information.

This week, the Twitter sidebar will scroll #ClinicalTrials.

The Genesis 2009 Conference will take place on the 10th and 11th of December at the Queen Elizabeth II Conference Centre (London). From the website: " Welcome to Genesis 2009 – “Back in focus!” The challenges of the economic downturn stimulated us to build innovative new partnerships at Genesis last year. The resultant exciting mix of business and science is something many have only dreamed of. This will be retained for 2009 with a streamlined approach for delegates to maximise the return on your investment in participating." For details, please see the conference website

Early next year: Third Annual Patient Recruitment in Clinical Trials conference, to be held 08th-09th March, 2010 in Philadelphia, PA. From the conference webpage: "Patient recruitment and retention are critical to drug development programs. Patient recruitment if not adequately planned for can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan. This conference is intended to cover the topics one should consider when drafting and strategically implementing a patient recruitment and retention plan for a clinical development program." Please see conference webpage for details.

From The New York Times : Biotech Tries to Shrug Off Setbacks By JAMES FLANIGAN Published: September 17, 2009 "While some investors are pulling back, life sciences companies continue to innovate, and hope the capital to expand will come." Read the piece

FierceBiotech reported today about a failed Phase III trial of Acadia's Pimavanserin in a study of Parkinson's Disease Psychosis (sometimes abbreviated as "PDP"): ACADIA Pharmaceuticals Announces Results from Phase III Trial of Pimavanserin in Parkinson's Disease Psychosis Pimavanserin Misses Primary Endpoint of Antipsychotic Efficacy; Meets Key Secondary Endpoint of Motoric Tolerability [snip] SAN DIEGO -- Sep. 1, 2009-- ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the first pivotal Phase III trial with pimavanserin in patients with Parkinson's disease psychosis, or PDP. The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Pimavanserin met the key secondary endpoint of motoric tolerability as measured using the Unified Parkinson's Disease Rating Scale , or UPDRS. Pimavanserin was safe and well tolerated, with the frequency of...

A report from BusinessWeek from 27 August 2009: Drug, Biotech Research Spending Hangs Tough Overall U.S. corporate R&D spending is down 4% since the end of 2007, but some companies have chosen to buck the trend By Emily Thornton and Frederick Jespersen [snip] Corporate America's research spending shrank 4% overall, or $1.9 billion, from the fourth quarter of 2007 through the second quarter of this year, according to data compiled by Capital IQ on 961 U.S. companies. But many health-care companies have boosted their research outlays. BusinessWeek sought out 25 companies that most aggressively increased their research budgets during the first six months of 2009. Thirteen members of the group, which collectively boosted its spending by $2 billion, were pharmaceutical and biotech companies. Only eight were high-tech outfits, such as Apple (AAPL) and Microsoft (MSFT). [snip] Read the full article

From today's Guardian : Major drug trial highlights a new approach in stroke prevention The success of Pradaxa in a 44-country trial indicates a possible end to the use of the rat poison warfarin as a primary treatment to prevent stroke Press Association guardian.co.uk Sunday 30 August 2009 23.27 BST Read the full article Boehringer Ingelheim's (BI) corporate website information about their clinical trial programmes: click here

The September 2009 issue of Wired has a nifty little article on the impact of placebo effects on pharmaceutical clinical trials and pharma company decision making: "Real. Fake. Both Can Cure Depression." by Steve Silberman. === Addendum on 28th August: As you will see from the comments, this piece is available on Wired magazine's website. You can access it here ===