Topic: Regulatory
There is a flurry of activity surrounding the controversial Avandia diabetes pill. The UK #8217;s Medicines and Healthcare products Regulatory Agency says the GlaxoSmithKline drug #8220;no longer has ... moreRosiglitazone: what went wrong? Correspondence to: dcohen@bmj.com Over 10 years after the diabetes drug rosig ... more
Rosiglitazone: what went wrong? Correspondence to: dcohen@bmj.com Over 10 years after the diabetes drug rosig ... more
The Medicines and Healthcare products Regulatory Agency (MHRA) has received encouraging results of UK testing on the silicone gel breast implants manufactured by the French company Poly Implant Prosth ... more
* UK safety experts want Glaxo's Avandia pulled from sale * Regulator's advisory group says risks outweigh benefits * European drugs regulators hold special meeting this week * Glaxo says dru ... more
* UK safety experts want Glaxo's Avandia pulled from sale * Regulator's advisory group says risks outweigh benefits * European drugs regulators hold special meeting this week * Glaxo says dru ... more
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Produ ... more
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we €™ll share with it others. That €™s right. Send us your announcements and w ... more
The speculation earlier this week that Roche was planning a round of cutbacks is, in fact, on the money. After a scheduled managerial meeting, the drugmaker issued a statement using the usual euphemis ... more
The American Society of Consultant Pharmacists (ASCP) has asked the Drug Enforcement Administration (DEA) to consider changes to the Controlled Substances Act regulatory framework to improve timely ac ... more
The recent salmonella outbreak/egg recall is raising questions about whether the FDA is fulfilling its regulatory role, PBS' NewsHour reports. "For the past few years, it's been one food safety scare ... more
For the second time this summer, a Japanese drugmaker has agreed to pay $50 million upfront for the rights to a forthcoming diet pill. This time, Takeda Pharmaceuticals is giving Orexigen Therapeutics ... more
Study using animal model shows stress has impact in the short term causing metabolic changes in the longer term that contribute to obesity Bethesda, MD–Stress can take a daily toll on us that has bro ... more
The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with LytixarTM (LTX-109) treatment of skin infections caused by G ... more
Due to a fairly high percentage (12-13%) of five year revision or secondary hip surgeries DePuy Orthopaedics, Inc. reported based on this year's data from the National Joint Registry (NJR) of England ... more
New research in the FASEB Journal suggests that the #8216;Sprouty #8217; protein could be a therapeutic target for patients with obesity and/or osteoporosis, as well as diabetes, osteoarthritis and h ... more
Contact: Laura Thompson lthomp@mcmaster.ca 905-525-9140 McMaster University The data monitoring committee of the AVERROES study, seeing overwhelming evidence of the success of apixaban in the preventi ... more
Randomized controlled trial For people suffering chronic pain, smoked cannabis reduces pain, improves mood and helps sleep, according to new research published in CMAJ (Canadian Medical Association Jo ... more
Press conference on the occasion of the 23rd ECNP Congress 2010, Amsterdam All humans are synchronised to the rhythmic light-dark changes that occur on a daily basis. Rhythms in physiological and bioc ... more
Genetic variant may increase susceptibility to migraine triggers A world-wide collaboration of researchers has identified the first-ever genetic risk factor associated with common types of migraine. T ... more
The new buzzword in health politics: Comparative Effectiveness. Comparative effectiveness, often seen as CE, is not to be confused with continuing education.I can understand the concern that CE wil ... more
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people that a manufacturer, Abbott Medical Optics (AMO), is recalling two lots of AMO Complete multi-purpose contact lens solu ... more
Roche expects a global regulatory submission mid 2012. Roche today announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company #8 ... more
Study suggests potential for new oncolytic therapies LA JOLLA, CA-A novel mechanism used by adenovirus to sidestep the cell #8217;s suicide program, could go a long way to explain how tumor suppressor ... more
A new study in Pediatrics finds more pediatric trials are going overseas - 65 percent conducted under the pediatric exclusivity provision, which offers drugmakers six months of patent extension for ru ... more
The new buzzword in health politics: Comparative Effectiveness. Comparative effectiveness, often seen as CE, is not to be confused with continuing education.I can understand the concern that CE will ... more
Hello, everyone. Nice to see you again. As promised, we have returned. We trust you had a pleasant and productive week while we were away. And we want to say thanks for the nice send-off notes so many ... more
The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced that it has scheduled a live webcast entitled: "Healthcare Reform I ... more
A key step in understanding the origins of familial breast cancer has been made by two teams of scientists at the University of California, Davis. The researchers have purified, for the first time, th ... more
New studies show that treatments targeting specific viral genes protected monkeys infected with deadly Ebola or Marburg viruses. Furthermore, the animals were protected even when therapeutics were adm ... more
James Brokenshire, UK minister for crime prevention is giving law enforcement authorities additional powers to combat a worryingly growing wave of legal highs, types of new narcotics which are usually ... more
If your body #8217;s autonomic nervous system (ANS) is working properly, you probably won #8217;t notice it. The ANS regulates involuntary functions including blood pressure, breathing, digestion, sle ... more
Montreal, August 19, 2010 – The internationally-renowned scientific journal Immunity, from the Cell Press group, publishes online today, and will publish in its August 27 print issue, the results of ... more
FINDINGS: The genes that are responsible for maintaining each cell type form DNA loops that link control elements for these genes. This surprising genome structure is generated and reinforced by two e ... more
Long research and development cycles. Low success of clinical trials. Slow and unpredictable regulatory reviews. Dependence on out-dated information technology options. It's not just time and mone ... more
Double standard for big pharma bribes By Shelley DuBois, reporterAugust 17, 2010: 11:44 AM ETFORTUNE -- Legally, of course, companies can't bribe anyone to do anything, whether the kickback is takin ... more
Double standard for big pharma bribes By Shelley DuBois, reporterAugust 17, 2010: 11:44 AM ETFORTUNE -- Legally, of course, companies can't bribe anyone to do anything, whether the kickback is takin ... more
A regulatory protein best known for its role in a rare genetic brain disorder also may play a critical role in cocaine addiction, according to a recent study in rats, funded by the National Institute ... more
A regulatory protein best known for its role in a rare genetic brain disorder also may play a critical role in cocaine addiction, according to a recent study in rats, funded by the National Institute ... more
Last Thursday, 12 August, enforcement officers from the Medicines and Healthcare products Regulatory Agency (MHRA) visited six Polish convenience stores in the Hull area. This followed information rec ... more
"As I mentioned in a speech last week to the Pharmaceutical Regulatory and Compliance Congress, one area of focus will be overseas sales in the pharmaceutical industry. In some foreign countries and u ... more
"As I mentioned in a speech last week to the Pharmaceutical Regulatory and Compliance Congress, one area of focus will be overseas sales in the pharmaceutical industry. In some foreign countries and u ... more
Protein linked to mental retardation may be controlling factor in drug #8217;s effect in the brain JUPITER, FL, August 10, 2010 – Scientists from the Florida campus of The Scripps Research Institute ... more
New Rochelle, NY, August 13, 2010—The easy accessibility of the eye and the established link between specific genetic defects and ocular disorders offer hope for using gene therapy to provide long-te ... more
Anavex Life Sciences Corp. ("ANAVEX") (OTCBB: AVXL) today announced that it has signed a definitive master services agreement with Genesis BioPharma Group ("Genesis") and ABX-CRO Advanced Pharmaceutic ... more
Under the €œchange of control €™ €™ agreement currently worth $23 million, Termeer would receive several payments. He would receive a lump sum of $11 million, a figure representing three times his b ... more
Under the €œchange of control €™ €™ agreement currently worth $23 million, Termeer would receive several payments. He would receive a lump sum of $11 million, a figure representing three times his b ... more
Prescribing Advice for GPs » Drug Safety Update €“ August 2010: "The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2010 (PDF).This issue cont ... more
Prescribing Advice for GPs » Drug Safety Update €“ August 2010: "The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2010 (PDF).This issue cont ... more
The Drug Controller General of India has ordered an inquiry into one of the clinical trials that were conducted at Bhopal Memorial Hospital and Research Centre during which three people died. The tria ... more
Eight months after their counterparts in Europe told doctors to stop prescribing the Meridia diet pill, the FDA has finally scheduled an advisory committee meeting to review safety risks. A spokesman ... more
Is Regenerative Sciences a drugmaker or a medical practice that simply uses stem cells to perform procedures? This argument has been at the heart of a simmering dispute between the Broomfield, Colorad ... more
Consumers' Union recently published a report entitled "How Much is Too Much?" I've read the CU report carefully. I think it's much ado about nothing much.The CU report questions the surplus accumulat ... more
GE (NYSE: GE) and Intel Corporation have announced the entry into a definitive agreement to form a 50/50 joint venture to create a new healthcare company focused on telehealth and independent living. ... more
Pharmaceutical companies in the UK will have to declare the amount of money paid to its healthcare professionals who act as €˜consultants €™ or Key Opinion Leaders (KOLs) under proposed new rules.The ... more
Pharmaceutical companies in the UK will have to declare the amount of money paid to its healthcare professionals who act as €˜consultants €™ or Key Opinion Leaders (KOLs) under proposed new rules.The ... more
Here is an interesting dichotomy: At the same time that AstraZeneca is forking out tens of millions of dollars to settle thousands of product-liability lawsuits claiming the risks of its Seroquel anti ... more
Ed has the story ... more
Ed has the story ... more
Glycotope GmbH has received regulatory approval by German and Italian regulatory authorities for a Phase I study of Glycotope´s next generation antibody CetuGEX „¢ (GT-MAB 5.2-GEX) for the treatme ... more
Missouri voters sent Barack Obama and the Democrats in Washington a loud and clear message yesterday by voting no to Obamacare's mandate: About 71 percent of Missouri voters backed a ballot measure, P ... more
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to med ... more
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency €™s public health mission as it relates to m ... more
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency €™s public health mission as it relates to m ... more
Study represents important example of value of genome scanning for identifying potential targets for drug development PHILADELPHIA – Researchers at the University of Pennsylvania School of Medicine, ... more
So what should be done about it? Eighty-nine percent of Americans support legislation that would put new drug safety measures in place, and the support crosses partisan lines. Meanwhile, only 45 perce ... more
Merz Pharmaceuticals has announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Xeomin® (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults w ... more
DURHAM, N.C. – An experimental vaccine based on a virus that causes encephalitis in the wild appears to block tumor growth in some cases of advanced cancer, according to researchers at Duke Universit ... more
An international team of senior experts on nuclear safety regulation completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safe ... more
Last week, the FDA issued one of those surprise product approvals by giving a thumbs up to a generic version of Lovenox, a widely used bloodthinner sold by Sanofi-Aventis, much sooner than most people ... more
Last week, several public interest groups filed a complaint with the United Nations High Commissioner for Human Rights alleging the Obama Administration €™s US trade policy violates international huma ... more
Here #8217;s a radical idea: Congress should amend the Food, Drug, and Cosmetic Act to allow Americans to use new meds once these are approved by the European Medicines Authority. Why? #8220;Congress ... more
WASHINGTON €” Safeguards to protect patients from risky drugs should have less paperwork and more consistency, drugmakers and pharmacy representatives said this week during a U.S. Food and Drug Admi ... more
WASHINGTON €” Safeguards to protect patients from risky drugs should have less paperwork and more consistency, drugmakers and pharmacy representatives said this week during a U.S. Food and Drug Admi ... more
In this day and age where drugmakers are trying harder all the time to outsource work in hopes of cutting expenses, it is worth remembering this approach can have a downside. River #8217;s Edge Pharma ... more
The Royal College of Pathologists welcomes the decision announced in the Report of the Arm's Length Body Review to abolish the Human Tissue Authority. This is a sensible economy. Professor Peter Furn ... more
PITTSBURGH, July 28 – With a single stimulatory molecule, human insulin-producing beta cell replication can be sustained for at least four weeks in a mouse model of diabetes, according to researchers ... more
In an animal model, angiotensin influences the immune system / Heidelberg and Stanford neurologists publish in the Journal of Clinical Investigation Researchers in Heidelberg and Stanford have discove ... more
Unlike any other book about the pharmaceutical industry, Mike Wokasch a 30 year industry veteran, delves into the causes of the industry €™s current state of dysfunction. He provides practical solut ... more
* Lack of U.S. benefit unexplained - FDA staff * FDA reviewer: hard to discount benefit outside U.S. * Panel to review drug on Wednesday * AstraZeneca shares gain nearly 4 pct in New York (New ... more
AstraZeneca Gains After FDA Staff Recommends Brilinta - BusinessWeek: "AstraZeneca Plc gained in London trading after U.S. regulatory staff said the blood-thinner Brilinta is approvable if the drugmak ... more
Unlike any other book about the pharmaceutical industry, Mike Wokasch a 30 year industry veteran, delves into the causes of the industry €™s current state of dysfunction. He provides practical solut ... more
* Lack of U.S. benefit unexplained - FDA staff * FDA reviewer: hard to discount benefit outside U.S. * Panel to review drug on Wednesday * AstraZeneca shares gain nearly 4 pct in New York (New ... more
AstraZeneca Gains After FDA Staff Recommends Brilinta - BusinessWeek: "AstraZeneca Plc gained in London trading after U.S. regulatory staff said the blood-thinner Brilinta is approvable if the drugmak ... more
The American Academy of Ophthalmology has named Michael X. Repka, MD, to the newly created position of Medical Director for Governmental Affairs. The position was created to provide Washington-based p ... more
Be a part of an effort that brings together people with the expertise, experience, and creativity needed to transform the medical research system. Join us at Partnering for Cures to be held December 1 ... more
Scientists at the Virginia Bioinformatics Institute (VBI) at Virginia Tech have constructed a mathematical and computational model of inflammatory bowel disease that allows researchers to simulate the ... more
Two years ago, the FDA approved Avastin to combat breast cancer, even though an advisory panel determined that risks such as high blood pressure and death outweighed the benefit of slowing the spread ... more
The brain undergoes rapid growth and development in the early years of life and then degenerates as we progress into old age, yet little is known about the biological processes that distinguish brain ... more
The American College of Physicians' Medical Laboratory Evaluation (MLE) program recently gained approval to offer certain analytes for use with the College of American Pathologists (CAP) Laboratory Ac ... more
Major turning point in antiepileptic drug testing and development New York University researchers revealed that data from previously completed withdrawal to monotherapy studies for antiepileptic drugs ... more
The brain undergoes rapid growth and development in the early years of life and then degenerates as we progress into old age, yet little is known about the biological processes that distinguish brain ... more
BPA among chemicals used in study COLUMBUS, Ohio – Cancer researchers have discovered a previously unknown type of gene regulation and DNA behavior in breast cancer cells that may lead to better insi ... more
AimThe aim of our study was to evaluate survival outcomes in malignant mixed Mullerian tumors (MMMT) of the uterus with respect to the role of cell cycle and apoptotic regulatory proteins in the carci ... more
Personalized medicine is about to get a much-needed kick start: The FDA has agreed to produce draft guidance documents that clarify and revise the standards by which companion diagnostics and biomarke ... more
Information security and privacy in the health care sector is an issue of growing importance but much remains to be done to address the various issues raised by health care consumers regarding privacy ... more
The US FDA has become the latest regulatory agency to say it will investigate a possible link between angiotensin-receptor blockers and cancer. Heartwire ... more
SPOKANE, Wash.—Washington State University researchers have discovered a way to help cancer cells age and die, creating a promising avenue for slowing and even stopping the growth of tumors. #8220;H ... more
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we €™ll share with it others. That €™s right. Send us your announcements and w ... more
The healthcare giant submitted its long-awaited remediation plan to the FDA today - you know, the plan that is supposed to help Johnson #038; Johnson #8217;s McNeil Consumer Healthcare unit get back ... more
Recordati announces the positive outcome of the Decentralized Procedure for the approval of pitavastatin (Livazo®, Alipza® and other brands) in Europe following the communication from the Reference ... more
Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States a ... more
Part II from Oct 2005. Just as relevant today.My last post attempted to discredit the patient satisfaction survey process that many physical therapy clinics have in place. My belief is simply that ... more
Would it surprise you if 35 percent lie awake fretting over their commercial business models? Or if 24 percent lose sleep over their feeble pipelines? That number actually seems small, don #8217;t you ... more
Analysis: Policy resistance to harm reduction for drug users and potential effect of change Strict laws on the criminalisation of drug use and drug users are fuelling the spread of HIV and other serio ... more
Mike Ward, a pharmaceuticals analyst at Ambrian in London, said that as safety risks had hit its popularity, Avandia's US sales had dwindled to barely 1.5% of Glaxo's turnover. But Avandia also faces ... more
Mike Ward, a pharmaceuticals analyst at Ambrian in London, said that as safety risks had hit its popularity, Avandia's US sales had dwindled to barely 1.5% of Glaxo's turnover. But Avandia also faces ... more
OneMedPlace has announced that the first OneMedForum New York 2010 successfully brought together a promising group of 70 private and microcap companies in 25 different healthcare sectors with a promin ... more
Johns Hopkins Berman Institute of Bioethics plays prominent role Amid growing concerns about clinical trials for drugs that have been approved by the F.D.A. but are later linked to serious health risk ... more
At the 52nd meeting of the American Association of Physicists in MedicineAmerican Association of Physicists in Medicine (AAPM), which convenes from July 18 - 22, 2010 in Philadelphia, PA, thousands of ... more
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, announced that its licensee, Alimera S ... more
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, announced that its licensee, Alimera S ... more
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood announced that Sara Radcliffe, formerly Vice President of Science and Regulatory Affairs at BIO, has been promoted to Executiv ... more
Thousands of scientists and health professionals from the field of medical physics will meet at the 52nd meeting of the American Association of Physicists in Medicine (AAPM) from July 18 - 22, 2010 in ... more
Optics Express publishes special focus issue highlighting lung cancer imaging research WASHINGTON, July 7—Advanced imaging technologies that promise to improve the development of effective drugs to t ... more
€œThe point is to make them realize that there €™s no sense from a business perspective in counterfeiting our products, because if we find you, we €™re taking your money away, € says John P. Clark, ... more
€œThe point is to make them realize that there €™s no sense from a business perspective in counterfeiting our products, because if we find you, we €™re taking your money away, € says John P. Clark, ... more
The Los Angeles Times explores the "deep divide" between President Barack Obama's administration and the Supreme Court under Chief Justice John Roberts. "The president and congressional Democrats hav ... more
Politico: Some state insurance commissioners are not happy with a proposal that would give the federal government the authority to centralize premium rate reviews of health insurance. The commissioner ... more
Novartis AG's cancer drug Afinitor (everolimus) has been rejected for patients with kidney cancer by Britain's health costs watchdog, which says it is too pricey for the country's taxpayer-funded Nati ... more
Patient groups and politicians are demanding that Merck move faster to end an ongoing shortage of Sinemet, a widely used Parkinson #8217;s treatment that the drugmaker says may not become available ag ... more
Using ever-growing genome data, scientists with the Department of Energy's (DOE) Oak Ridge National Laboratory and the University of Tennessee are tracing the evolution of the bacterial regulatory sys ... more
Using ever-growing genome data, scientists are tracing the evolution of the bacterial regulatory system that controls cellular motility, potentially giving researchers a method for predicting importan ... more
There is benefit to make a law ambiguous-at least to the bureaucrats whose rule making will give that law operational meaning. There is benefit to a law which delegates to federal agencies the power ... more
Endo Pharmaceuticals (Nasdaq: ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 relat ... more
PASADENA, Calif.—When does a cell decide its particular identity? According to biologists at the California Institute of Technology (Caltech), in the case of T cells—immune system cells that help de ... more
by Josh Herigon, MPH Nicholas Kristof in the New York Times writes about a new report from the President €™s Cancer Panel calling attention to the role common chemicals may play in ... more
A letter to Agriculture Secretary Tom Vilsack from Senators Blanche Lincoln (D-Ark) and Saxby Chambliss (R-Ga.) expresses concern that recent court cases dealing with biotech crops are hampering the U ... more
Mirna Therapeutics announced publication of new results in the journal Cancer Research demonstrating proof of concept that the systemic delivery of tumor suppressor microRNAs (miRNA) inhibits tumor gr ... more
Following two decades of intensive research and development efforts, MagForce Nanotechnologies AG, a Berlin-based medical technology company founded in 1997, has received European regulatory approval ... more
Steve Churton was re-elected as the President of the Royal Pharmaceutical Society of Great Britain at today's Council meeting. Prof Nick Barber was elected as Vice President and John Gentle was re-e ... more
The U.S. Food Drug Administration (FDA) has granted Investigational New Drug (IND) regulatory clearance to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in type 1 diabeti ... more
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Appointments Commission are pleased to announce the appointment of two new members to the Commission on Human Medicines (CHM). T ... more
The U.S. Food Drug Administration (FDA) has granted Investigational New Drug (IND) regulatory clearance to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in type 1 diabet ... more
The US Supreme Court has rejected an appeal by Pfizer to overturn a ruling that reinstated lawsuits filed by Nigerian families, who say the drugmaker tested an experimental antibiotic on their childre ... more
In what may be a new get-tough program at the FDA, the agency issued a so-called untitled letter to CSL, a big maker of flu vaccines based in Australia, for flunking an April inspection that found sev ... more
Researchers from the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany, and the Max-Planck Institute of Immunobiology Freiburg have identified a novel protein complex that regulates ... more
The last several days there has been several news items impacting physical therapists: -we had over a drop of 21% in Medicare with claims withheld and then another temporary fix thru Nov which resulte ... more
Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant digestive tumor with a very poor prognosis. Hypoxia-inducible transcription factor-1α (HIF-1α) is involved in malignant progression ... more
Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant digestive tumor with a very poor prognosis. Hypoxia-inducible transcription factor-1α (HIF-1α) is involved in malignant progression ... more
The Healthcare Association of New York State (HANYS) presented its 2010 Distinguished Service Award to Raymond D. Sweeney, HANYS' Executive Vice President. Mr. Sweeney has been a driving force behind ... more
OneMedPlace announced today that its #8220;2010 New York OneMedForum #8221;Â finance conference, which will be held next week #8212; June 29-30, 2010, at New York #8217;s historic Roosevelt Hotel # ... more
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced guidance regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed ... more
The growing number of clinical trials conducted overseas, which drugmakers are pursuing to hold down costs, has increasingly raised concerns about proper regulatory oversight and the welfare of enroll ... more
Each day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, t ... more
The first symptom relief drug specifically for people with multiple sclerosis (MS) has been licensed by the MHRA (Medicines and Healthcare products Regulatory Agency). 'Sativex' is an oral spray made ... more
Global Health Ventures Inc. (OTCBB:GHLV) (the "Company"), a specialty pharma company focused on life style products is pleased to announce that it has signed a binding letter of intent ("LOI") with Pa ... more
Each day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, t ... more
Each day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, t ... more
Are stem cells ready for prime time? The therapeutic potential of embryonic stem cells has been an intense focus of study and discussion in biomedical research and has resulted in technologies to prod ... more
Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. announced that they are resuming their Stimuvax® (BLP25 liposome vaccine)* clinical program in patients with non-smal ... more
Scientists recently investigated the expression of key members of the Nodal embryonic signaling pathway, critical to maintaining pluripotency, in hiPSC and hESC cell lines. Nodal is an important morph ... more
Amid ongoing quality control problems at its manufacturing facilities, Ranbaxy Laboratories will close one of its biggest global bulk drug production units in Mohali, India, and is now relying on loca ... more
"The Future of the Nuclear Industry" will be the Plenary Session topic of the 55th Annual Meeting of the Health Physics Society (HPS) taking place June 28-July 1, 2010, at the Salt Palace Convention C ... more
AUGUSTA, Ga. – One way obese people become salt sensitive and hypertensive has been identified by Medical College of Georgia researchers. They #8217;ve documented a chain of events in which excess in ... more
(Boston) – Researchers from Boston University School of Medicine (BUSM) have discovered that Sfrp5, which refers to secreted frizzled-related protein 5, is an anti-inflammatory adipokine whose expres ... more
LONDON - At just 28, Duncan Casey has already been from the university science bench to the world of Big Pharma research and back again. Now working in an Imperial College lab tucked behind London €™s ... more
LONDON - At just 28, Duncan Casey has already been from the university science bench to the world of Big Pharma research and back again. Now working in an Imperial College lab tucked behind London €™s ... more
In an editorial published Tuesday in the Washington Examiner, Paul Howard, Director of the Center for Medical Progress at the Manhattan Institute, decried what he sees as the sluggish and inefficient ... more
The outcome of tuberculosis infection in mice depends in part on how quickly bacteria-fighting T cells can get to the lungs. According to a new study online on June 14th in the Journal of Experimental ... more
STANFORD, Calif. #8212; Oncogenes are like friends who #8217;ve gone off the deep end. Normally steady, reliable members of the cellular workforce, these genes become very bad influences when mutated ... more
An international research consortium identifies more than 800 genes that appear to play a role in the male zebra finch's ability to learn elaborate songs from his father. The researchers also found ev ... more
Nutcasis: In Which the Distant Footfalls of Hucksters Can Be HeardLast week I posted the video clip above. It showed some of the research going on at the California-based laboratories of Nutcasis ... more
Nutcasis: In Which the Distant Footfalls of Hucksters Can Be HeardLast week I posted the video clip above. It showed some of the research going on at the California-based laboratories of Nutcasis ... more
Five makers of genetic tests have been told by the US FDA (Food and Drug Administration) that they have to obtain federal approval before selling and/or marketing their genetic tests to the general pu ... more
UroToday.com - Research examining the impact of chronic illness has consistently shown that individuals often demonstrate large variations in adaptation, and objective measures of illness severity can ... more
A guest column by the American Medical Association, exclusive to KevinMD.com. by J. James Rohack, MD Unbelievable as it is, for the third time this year the Senate failed to act on time to stop th ... more
The long-running and expensive quest by Alfred Mann, a Los Angeles billionaire and philanthropist, to develop an inhaled insulin device took another odd turn this week. His company, which has the not- ... more
FT.com / Companies / Pharmaceuticals - Health study deals further blow to GSK €™s AvandiaDavid Graham, a researcher at the US regulatory agency, concluded that among 227,000 diabetics aged over 65 in ... more
FT.com / Companies / Pharmaceuticals - Health study deals further blow to GSK €™s AvandiaDavid Graham, a researcher at the US regulatory agency, concluded that among 227,000 diabetics aged over 65 in ... more
As the National Institutes of Health grappled last year with an ongoing Senate probe into financial conflicts of interest involving academic researchers who accept federal grants and industry funding, ... more
In a stinging, 12-page letter, the FDA has scolded Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camp ... more
The Canadian Food Inspection Agency (CFIA) has extended the application deadline for compensation related to Phytophthora ramorum to December 31, 2012. The amendment to the P. ramorum Compensation Re ... more
Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p Phase III trials studying the eff ... more
New device may provide safer way to treat the third leading cause of death in the US When someone suffers a stroke, time is critical #8211;more than a million brain cells die each minute, starved of n ... more
This will be a two-day meeting for clinical pharmacologists, scientists and pediatricians to discuss overcoming the scientific challenges using tools such as models simulations and PK PD studies t ... more
This will be a two-day meeting for clinical pharmacologists, scientists and pediatricians to discuss overcoming the scientific challenges using tools such as models simulations and PK PD studies t ... more
Contact: Christine Stencel news@nas.edu 202-334-2138 National Academy of Sciences WASHINGTON #8212; The U.S. Food and Drug Administration #8217;s abilities to discover potential threats to food safet ... more
Nothing like invoking the fate of thousands of babies to draw attention to a problem. That #8217;s the tactic taken this week by Unitaid, the United Nations affiliate, to convince Bristol-Myers Squibb ... more
In the wake of the Johnson #038; Johnson recall scandal, almost as many questions were raised about the conduct of the FDA as there were about the behavior of the healthcare giant. During a May 27 co ... more
At this week's Society of Nuclear Medicine (SNM) Annual Meeting in Salt Lake City, Cardinal Health is introducing new, real-time data integration tools to help imaging centers and nuclear medicine fac ... more
via nj.com ohnson Johnson €™s epilepsy drug Topamax was approaching $1 billion in annual sales in 2003 when the company began a campaign to persuade doctors to use the medicine as a treatment for ... more
via nj.com ohnson Johnson €™s epilepsy drug Topamax was approaching $1 billion in annual sales in 2003 when the company began a campaign to persuade doctors to use the medicine as a treatment for ... more
A recent publication in the publication "Health Affairs" has evoked comments and some concern from advocates of comparative effectiveness research and admirers of the Dartmouth Atlas. See here for f ... more
A big star of the American Society of Clinical Oncology meeting this past weekend was ipilumumab, a drug that was designed to enhance the immune system and Bristol-Myers Squibb presented data showing ... more
For the past two years, the National Institutes of Health has been pressured by Congress to do a better job of monitoring conflicts of interest in which academic researchers accept funding from the ag ... more
by John Schumann, MD Time to turn our attention to an unpleasant topic: Lawsuits. Who files them? Why? And what actually happens? There have been oceans of ink spilled about medical malpractice. An ov ... more
Walter and Eliza Hall Institute scientists have made a significant advance in understanding how potassium channels, which permit the flow of electric currents central to many of the body's biological ... more
Roche today provided an overview of the new medicines in early-stage studies that will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place June 4-8 ... more
J J Misled Pennsylvania on Drug €™s Risks, Lawyer Says (Update2) By Jef Feeley and Margaret Cronin Fisk June 3 (Bloomberg ... more
J J Misled Pennsylvania on Drug €™s Risks, Lawyer Says (Update2) By Jef Feeley and Margaret Cronin Fisk June 3 (Bloomberg ... more
By Gillian Parrish, Manager, Alliance Development and Communications Every day, hundreds of thousands of lives are indefinitely on hold €“ patients waiting for effective treatment options to become a ... more
In a closely watched matter, the US Solicitor General has filed a brief suggesting to the US Supreme Court that a lawsuit filed against Pfizer by several Nigerians over the 1996 Trovan scandal should ... more
Any of the commonly used antidepressants was associated with a 68 percent relative increase in the overall risk of a miscarriage, and there were significant associations with the use Pfizer #8217;s Ef ... more
Researchers have now identified the gene regulatory protein NFI-A as a new molecular regulator of nerve cell protection in mice. Such information has implications for developing therapeutics that coul ... more
Contact: Kim Guenther kim.guenther@uphs.upenn.edu 215-200-2312 University of Pennsylvania School of Medicine New trials harness immune system to improve efficacy of therapeutic vaccine, chemotherapy C ... more
Patient safety is a top priority for Pfizer. Pfizer conducts clinical trials globally according to the highest ethical and scientific standards. To ensure compliance with good clinical practice and re ... more
Novartis announced that the US Food and Drug Administration (FDA) has extended by three months, to September 2010, its review period for the regulatory approval of FTY720 (fingolimod). FTY720 once-dai ... more
Novartis announced that patupilone (EPO906) did not show a significant overall survival advantage in a phase III trial of patients with advanced ovarian cancer, refractory or resistant to platinum-bas ... more
"Firing" is really not the right word; the administration says she resigned; but the truth is that former MMS head Liz Birnbaum was in fact a "scapegoat" in order to advance the Obama administration's ... more
via time.com In late April, when the Justice Department announced its deal with AstraZeneca for the pharmaceutical company to pay a $520 million fine, as a result of the off-label marketing of ... more