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David M. Goldstein, Head of Inflammation Chemistry at Hoffmann-La Roche, to give featured presentation at 5th Annual Protein Kinases in Drug D...GTCbio ...
AngioScore Announces Favorable Results from the MASCOT Trial
AngioScore Announces Favorable Results from the MASCOT TrialAngioScore, Inc., a developer of novel angioplasty catheters for u...AngioScore Inc. ...
Enzo Biochem Reports Results for Second Fiscal Quarter
Enzo Biochem Reports Results for Second Fiscal Quarter Enzo Biochem, Inc. (NYSE:ENZ), a vertically integrated biotechnology co...Enzo Biochem Inc. ...
ZOLL Reports Establishment of 10b5-1 Sales Plan by Chief Financial Officer
ZOLL Reports Establishment of 10b5-1 Sales Plan by Chief Financial Officer ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufac...ZOLL Medical Corporation ...
FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy...Medtronic Inc. ...
FDA Allows IND for Bio-Path Holdings’ Liposomal Grb-2
FDA Allows IND for Bio-Path Holdings’ Liposomal Grb-2 Bio-Path Holdings, Inc. (OTCBB: BPTH), a publicly traded biotechnology c...Bio-Path Holdings Inc. ...
Drugs.com - New Drug Applications
NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12
Sophia Antipolis, France, March 8, 2010. -NicOx S.A. today announces that on Wednesday, May 12, 2010, the US Food and Drug Administration (FDA) plans to hold a meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk... ...
InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
BRISBANE, Calif., March 5 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to... ...
FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone
SEATTLE, March 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for... ...
VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity
MOUNTAIN VIEW, Calif., March 1 /PRNewswire-FirstCall/ -- VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa, for the... ...
Adventrx Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530... ...
MELBOURNE, Australia & MENLO PARK, Calif.-- Mar 2, 2010 - ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting... ...
Pharmaceutical Industry | Processing & Engineering: Knowledge, News and Analysis | Pharmaceutical Manufacturing
AstraZeneca Inks First Generic Drugs Deal
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AstraZeneca Job Cuts Reflect New Landscape For Drug Innovation
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Focus on Pharma Podcast: Episode 3: Inside the FDA and the New Transparency Initiative
Accused of being too chummy with the drug industry, FDA has moved to improve transparency. CDER's Helen Winkle discusses the initiative's progress....
From Harmonization to Inspections: An FDA Update
A talk with FDA’s CDER Office of Compliance's Division of Manufacturing and Product Quality about the state of regulatory harmonization, enforcement, and priorities for the future....
Novartis Goes Wireless for Process and Plant Info
Smart Wireless technology aims to improve operator efficiency and plant flexibility for Novartis in France....
Concerns Raised about Tromethamine Contamination
Rx-360 is warning drug manufacturers about possible contamination of Tromethamine....
Monday, 15 March 2010
Quintiles Opens Clinical Research Facility In Kenya
Quintiles, a US-based biopharma services company offering clinical, commercial, consulting and capital solutions, has expanded its clinical research capacity in Africa by opening an office in Nairobi, Kenya....
GSK Receives Marketing Authorisation For Revolade
GlaxoSmithKline (GSK) has received marketing authorisation from European Commission (EC) for its Revolade (eltrombopag), used in the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP)....
Novartis Reports Preliminary Results Of Navigator Trial
Novartis has reported that results from a study involving more than 9,000 people showed that the high blood pressure medicine Valsartan delayed progression to type 2 diabetes in patients with cardiovascular disease or risk factors and impaired glucose tolerance (IGT)....
NHC Group (NHC), an Australian audiology service provider, is set to launch operations in India through its subsidiary NHC Hearing Care (India)....
Medtronic Reports Clinical Results For Endeavor Drug-eluting Stent
Medtronic has presented five-year findings of Endeavor drug-eluting stent (DES) as a treatment for coronary artery disease at the American College of Cardiology’s 59th Scientific Session....
Sigma-Aldrich To Sell Pfizer Bioactive Small Molecule Compounds
Sigma-Aldrich has entered into an agreement with Pfizer to sell approximately 100 Pfizer-developed small molecule compounds to life science researchers for target characterisation, assay development, screening and in-vivo animal model applications....
Pharma QbD -
PAT and QbD for Biopharmaceuticals
Date: 05/25/2010 End: 05/26/2010 Timezone: Developing a secure in-house strategy for PAT and QbD application for biopharmaceutical products. read more...
Design for Six Sigma: A Potent Supplement to QbD
The tools of Design for Six Sigma help development teams to find the “vital few” and build on the strengths of Quality by Design. read more...
2010 PDA/FDA Joint Regulatory Conference
Date: 09/13/2010 End: 09/15/2010 Timezone: The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. read more...
Date: 03/15/2010 End: 03/19/2010 Timezone: Join industry and regulatory peers at this meeting to examine manufacturing best practices and strategies to maximize your company’s efficiency and productivity, while delivering safe and reliable drugs to patients. read more...
Spare Parts: Waters Releases 2010 Supplies Catalog
The catalog includes listings of quality parts, chromatography columns, and other key supplies. read more...
Understanding the Basics of Peptide and Protein Manufacturing
A look at the applications and markets for these fundamentally different large molecules. read more...
PharmaGossip
Pharmaceutical Fraud – Pfizer: Too big to nailDrew Griffin was in with tonight’s “Keepin Them Honest” segment. Pfizer employs 116,000 people and has revenue of $50 billion dollars per year. It is the world’s largest pharmaceutical company and the government has built a case against Pfizer for marketing Bextra for...
Crazy contd. - healthcare premiums
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For all those who have missed the hot 'n sexy drug reps
Fill your boots!...
Introducing The Naked Scientists' Forum
http://www.thenakedscientists.com/forum/...
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Pfizer - Sutent: clinical trials, ain't they a bitch!
Pfizer said two late-stage breast cancer trials involving its cancer drug Sutent failed to meet their goals and it has stopped a pivotal lung cancer trial of an experimental drug. Pfizer said outside monitors concluded that the Phase 3 trial of the lung cancer treatment, figitumumab, in patients with previously...
Drugs.com - Clinical Trials
ASBMR Task Force Reviewing Link Between Fractures and Bisphosphonate Therapy
International Group to Present Findings This Fall; Issues Interim Guidance WASHINGTON--(BUSINESS WIRE)--Mar 11, 2010 - Recent reports suggesting a link between long-term bisphosphonate usage and rare bone fractures have sparked rising concern among... ...
Session on Bacterial Drug Resistance, Superbugs, and the Need for New Antibiotics RADNOR, Pa.--(BUSINESS WIRE)--Mar 11, 2010 - PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to... ...
Baxter Presents Clinical Efficacy Results from Phase III Study of Seasonal Flu Vaccine
PREFLUCEL Influenza Vaccine shows 78 percent rate of prevention against matching influenza strains DEERFIELD, Ill.--(BUSINESS WIRE)--Mar 11, 2010 - Baxter International Inc. (NYSE:BAX), in conjunction with DynPort Vaccine Company LLC (DVC),... ...
Novel stroke treatment passes safety stage of UCI-led clinical trial
Sequential-growth-factor therapy holds promise for improving recovery outcomes Irvine, Calif., March 10, 2010 —A clinical research trial of a new treatment to restore brain cells damaged by stroke has passed an important safety stage,... ...
BioSante Announces Positive Leukemia Vaccine Results
Johns Hopkins Researchers Say Vaccine Appears to “Mop Up” Leukemia Cells Gleevec Leaves Behind LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Mar 11, 2010 - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced positive results of a human... ...
Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Mar 12, 2010 - Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B... ...
Pharma Marketing Blog
Social Media Intern is Here to Help Pharma Avoid Social Media Faux Pas!
Regular readers of Pharma Marketing Blog are familiar with Emily Jameson, aka "FDA Intern" and "PhRMA Intern." Emily has moved on to accept a position with a leading pharma interactive media agency and is now Social Media Intern! We've watched Emily's career progress from her internship at PhRMA, which hired...
Shirley Ledlie, aka "Ann Adams", "Julie Kahn", "Jasper Boon", and who-knows-how-many-more-phony-FB-aliases -- the patient who claims sanofi-aventis (S-A) mislead her about the side effects of cancer drug Taxotere (see "sanofi aventis Feels the Social Media Pain. But Is It Authentic?") -- is laying siege to S-A's VOICES Facebook page. Maybe...
Making Sense Out Pharma DTC Spending Trends
ePharma boosters see the latest direct-to-consumer (DTC) advertising spending numbers as a positive sign that the drug industry is finally increasing its allotment to the Internet in its DTC marketing budget. Nielsen data indicate that "spending on Internet ads, which has doubled over the last five years, hit $117.4 million,...
Use of Patient Testimonials in DTC & Social Media Advertising
This week I was a guest moderator for a graduate class at Johns Hopkins University: “Marketing in a Regulated Environment”. The students are 90% scientists, working at places like NIH, Amgen, Medimmune, etc. They had a few questions they want me to answer, including these:"Recently, companies appear to be using...
sanofi aventis Feels the Social Media Pain. But Is It Authentic?
Simultaneous posts on Pharmalot and Pharma bnet have focused on what seems to be a disgruntled patient who posted photos and comments on sanofi-aventis's (S-A) Facebook page (see "Bald Women Lash Out At Sanofi-Aventis & Taxotere" and "Sanofi's Latest Challenge: Women Who Say Its Chemotherapy Left Them Permanently Bald")."Ann Adams"...
Pharma Should Leave Unmoderated SM Discussions to 3rd Parties
In comments addressed to the FDA, many drug companies and ad hoc industry groups are suggesting ways drug companies can legally "engage" with patients, physicians, and consumers in online social media discussions (see, for example, "A Pharma 'Social Media Working Group' Submits Comments to FDA").The hope is that new FDA...
Pharma 2.0
In the past I have written about drug review sites like iGuard.org. Social/digital pharma blogger extraordinaire Jon Richman recently wrote a post about “The Best Pharma Products According to Patients” on Dose of Digital. He provides deep analysis about iGuard in particular which has over 2 million users...
I do not know Bertalan Mesko, MD personally but this Hungarian physician and PhD-to-be in personalized genomics publishes some of the best content related to Health 2.0 on the Web. His blog is ScienceRoll and he tweets @berci. Bertalan has assembled an incredible list of online/2.0 resources by specialty on his...
My friend and fellow social media evangelist Eileen O’Brien has launched a weekly Tweetchat about social media and pharma. I stumbled upon it on Wednesday night (1/6) and joined in near the end when Eileen mentioned AZ Helps – a sort of help desk offering from AstraZeneca that uses...
Pharma and Healthcare Social Media Wiki
I have no clue when Jonathan Richman has time to sleep or work given all of the information he gathers and publishes on his blog Dose of Digital. One of the best areas on his site is the Pharma and Healthcare Social Media Wiki. It is chock full of real-world...
Facts, figures, data. We all love to use numbers in our PPTs. Great info has trickled out over the past couple of months from one of my favorite sources – Manhattan Research. And thank you to MR for mentioning Pharma 2.0 in its white paper: How Digital is Shaping...
FDA hearings on social media in progress
The day has arrived – the big FDA hearings on social media. People are tweeting and blogging and texting and posting every single word of the testimony. It is surreal and exhausting to follow, which I only do sporadically. There will so many post-mortems on the two days I...
Pharmainfo.net - Pharma Industry News
Three Pfizer Cancer Treatments Fail to Materialize Results (NYSE: PFE)
Three Pfizer Cancer Treatments Fail to Materialize Results (NYSE: PFE) read more...
FDA Approves Watson's TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for
FDA Approves Watson's TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for read more...
ATLANTA, Georgia, March 14, 2010 /PRNewswire/ -- Cardiovascular risk can be reduced by an additional 31 percent in type 2 diabetes patients with atherogenic dyslipidemia, the common combination of elevated triglycerides (TG, 204 mg/dL or 2.3 mmol/L or higher) and low levels of high-density lipop ...
New Data Demonstrates Abbott's Investigational MitraClip® System Has Potential to be a Valuable Treatment Option for Patients with Mitral Regurgitation, the Most Common Heart Valve Condition ...
Siemens Highlights Its Commitment to Excellence in Cardiology at ACC 2010
ATLANTA, March 14 /PRNewswire-FirstCall/ -- Siemens Healthcare addresses the clinical and business needs of cardiology service lines at the 59th Annual Scientific Session of the American College of Cardiology (ACC), March 14-16 in Atlanta, in booth #1018. With a commitment to excellence, Siemens emp ...
Abbott Statement: ACCORD Lipid Results Support Treatment Guidelines for Fibrate Use
Abbott Statement: ACCORD Lipid Results Support Treatment Guidelines for Fibrate Use ...
BioSpace.com Featured News and Stories
WOODCLIFF LAKE, N.J., March 11 /PRNewswire-FirstCall/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood...
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). An independent Data...
Women On Pill 'May Live Longer', Aberdeen University Study
LONDON (Reuters) - One of the world's largest studies of the contraceptive pill has found that women who have taken it can expect longer lives and are less likely to die from any cause, including cancer and heart disease....
Movement Disorder Symptoms Are Lessened by an Antibiotic, University of Alabama at Birmingham Study
EurekAlert! -- TUSCALOOSA, Ala. Discovery of an antibiotic's capacity to improve cell function in laboratory tests is providing movement disorder researchers with leads to more desirable molecules with potentially similar traits, according to University of Alabama scientists co-authoring a paper publishing March 10 in the journal Disease Models &...
ScienceDaily (Mar. 11, 2010) A clinical research trial of a new treatment to restore brain cells damaged by stroke has passed an important safety stage, according to the UC Irvine neurologist who led the effort....
Pfizer Inc. Says Sutent Breast Cancer Trials Fail
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that two Phase 3 studies of Sutent (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did...
Bayer staffing up in India, Vietnam
Bayer Schering Pharma plans to invest heavily in Asia by doubling its sales team in India and tripling its workforce in Vietnam. Report...
Roche, Pfizer cancer meds fail trials
Talk about a double whammy: Two big cancer drugs failed late-stage trials that could have broadened their use considerably. Roche's Avastin didn't make the grade against prostate cancer, failing to improve overall survival in combo with chemotherapy and prednisone. And Pfizer's kidney and gastric cancer drug Sutent flopped against breast...
Daiichi aims to double profits by 2013
Daiichi Sankyo is aiming high: The Japanese drugmaker announced that it aims to almost double profits in three years. To do that, it intends to boost revenue by 20 percent, counting on a.) overseas expansion, b.) the resurgence of its generics subsidiary Ranbaxy Laboratories, and c.) strong sales of Effient,...
Indian pharma eyes $60B in lost patents
While Big Pharma bewails the forthcoming loss of patent protection on many top-selling drugs, the knock-off drug business is rubbing its hands in anticipation. Just witness the Indian pharma industry, which is positioning itself to capture as much of that business as it can. Considering that nearly $60 billion worth of...
Have pharma promos gone too commercial?
Over the past few years, we've seen some drugmakers choose new executives from the ranks of consumer-products companies. Joe Jiminez, Novartis' new chief, says his experience hawking Heinz ketchup helps him manage more effectively in the pharma world. Pfizer CEO Jeff Kindler is famous for his status as a former...
Genzyme: CEO compensation down 25%
Bad news for Genzyme CEO Henri Termeer (photo): The company has declined to give him a bonus this year, citing manufacturing woes at the Allston Landing plant. His total compensation came in at 25 percent below 2008 levels. But that lack of bonus isn't a surprise; Termeer had told the...
myharvardnews.com
FDA On Merck's Fosamax Suggest No Problems
By: Susan HarrisPublished: Mar 12, 2010Updated: Mar 15, 2010FDA reviews recent studies on Merck's Fosamax that suggest it may increase the chance of femur fractures.READ MORE...
FDA requires no new trials for Amylin's Byetta LAR
BOSTON (Reuters) Amylin Pharmaceuticals Inc (AMLN.O) said on Monday that U.S. health regulators did not immediately approve a once-weekly form of its diabetes drug Byetta, but they did not ask for lengthy new clinical trials, a relief to investors who pushed the company's stock up nearly 10 percent...
Ranbaxy to launch anti-diabetic drug Actos by 2012
Economic Times Ranbaxy, majority owned by Japan's Daiichi Sankyo, said it has settled litigation with the country's Takeda Pharmaceutical over a generic equivalent version ...READ MORE ...
FDA issues boxed warning for 'poor metabolisers' of Plavix
Pharma Times - Kevin Grogan How big an impact the black box warning will have on sales of Plavix, which is already suffering from generic competition in Europe and loses patent ...READ MORE ...
Mylan pulls EU application for generic Taxotere
Reuters - Ben Hirschler, David Holmeshas withdrawn its application to market a generic version of Sanofi-Aventis's (SASY.PA) cancer drug in Europe, after adverse feedback from regulators. ...READ MORE ...
Alternative to Statins Shows Promise
Broader study needed to check for possible long-term effects, experts say By Ed EdelsonHealthDay Reporter(HealthDay News) -- A thyroid-derived cholesterol-lowering drug that could be an alternative to the widely used statin medications has done well in a small, early trial, Swedish and American researchers report.READ...