Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts
Thursday, August 08, 2013
Sunday, August 04, 2013
Tuesday, October 05, 2010
Thursday, April 29, 2010
Thursday, April 08, 2010
Monday, November 16, 2009
More Zetia quotes
Zetia "has been on the market for about seven years and we still haven't proven that it improves clinical outcomes," said Dr. Roger Blumenthal, preventive cardiology chief at Johns Hopkins University.
"It should be better for the arteries and it wasn't," Dr. Allen Taylor said of Zetia. "The drug wasn't operating as you otherwise would expect it to," raising concern that its effects are not fully understood, he said.
Dr. Anthony DeMaria, a past president of the American College of Cardiology from the University of California at San Diego, said the study "doesn't quite put the nail in the coffin" for Zetia, but pushes it way down on the list of things to try.
Another Vytorin Mess For Merck - Matt Herper
via forbes.com
"How is it possible for a drug to have $4 billion in sales without any evidence of benefit?" says Harlan Krumholz, a cardiologist at Yale University. He said that the small size of the two imaging studies mean they couldn't render a clear verdict on Zetia. "But they don't instill any confidence in it either. "
Saturday, November 14, 2009
Tuesday, November 03, 2009
Thursday, October 22, 2009
Attention Neurologists! - look for a Gardasil/ALS association
Oct. 16, 2009 (Baltimore) -- Researchers believe that there may be a link between a vaccine against cervical cancer and a rapidly progressive, fatal disease in two young women.
Both the timing of the symptoms and autopsy results “suggest a link between” the Merck Gardasil vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, says Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center.
With only two confirmed cases, “we don’t know for sure if it’s coincidence or if they’re connected [to the vaccine],” she tells WebMD. “We hope that by raising awareness, we will become aware of any other cases."
Both the timing of the symptoms and autopsy results “suggest a link between” the Merck Gardasil vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, says Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center.
With only two confirmed cases, “we don’t know for sure if it’s coincidence or if they’re connected [to the vaccine],” she tells WebMD. “We hope that by raising awareness, we will become aware of any other cases."
Presumably GSK will be looking at Cervarix as well.
Hat tip: Helen Borel
Friday, September 25, 2009
Pancreatitis - just Januvia?
FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.
Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009.
FDA
Insider's view: what about the other gliptins (Onglyza)?
Also remember Byetta.
Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009.
FDA
Insider's view: what about the other gliptins (Onglyza)?
Also remember Byetta.
Wednesday, September 09, 2009
Monday, March 09, 2009
Merck buy Schering Plough - megamergers a la mode
Bye bye.Merck & Co Inc said on Monday that it would acquire Schering-Plough Corp for $41.1 billion, uniting the makers of cholesterol drugs Zetia and Vytorin, in the second megadeal for Big Pharma in weeks.
Source
Wednesday, November 05, 2008
Merck Schering Plough - Vytorin: DoJ investigating
The U.S. Department of Justice has begun investigating the conduct of Merck and Schering-Plough in the marketing of the cholesterol drug Vytorin, according to a regulatory filing.
Lawsuits against the companies related to Vytorin marketing also are piling up, Merck said in a filing late Monday to the Securities and Exchange Commission.
The Justice Department's Civil Division notified Merck in a Sept. 10 letter that the agency was investigating whether the drugmakers' promotion of Vytorin resulted in false claims to federal health-care programs, Merck noted. If so, federal health programs could seek to recover money they have spent on the drug.
Thirty-five state attorneys general are jointly investigating whether the partners violated state consumer-protection laws in marketing Vytorin, Merck said.
More
Lawsuits against the companies related to Vytorin marketing also are piling up, Merck said in a filing late Monday to the Securities and Exchange Commission.
The Justice Department's Civil Division notified Merck in a Sept. 10 letter that the agency was investigating whether the drugmakers' promotion of Vytorin resulted in false claims to federal health-care programs, Merck noted. If so, federal health programs could seek to recover money they have spent on the drug.
Thirty-five state attorneys general are jointly investigating whether the partners violated state consumer-protection laws in marketing Vytorin, Merck said.
More
Wednesday, October 22, 2008
Merck to slash middle management
Pharmaceutical giant Merck said Wednesday that it will cut 7200 jobs by the end of 2011 to lower costs, with 40% of the reductions coming from the U.S.
Merck also will cut its number of senior and mid-level executives by about 25%.
More
Merck also will cut its number of senior and mid-level executives by about 25%.
More
Thursday, October 02, 2008
Merck pull taranabant
Merck said Thursday it will not seek regulatory approval for taranabant, an investigational medicine to treat obesity (similar to rimonabant).
The North Jersey pharmaceutical company has discontinued its clinical development program for the drug.
“Available phase-III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses,” said Dr. John Amatruda, senior vice president and research head of diabetes and obesity at Merck Research Laboratories.
More
The North Jersey pharmaceutical company has discontinued its clinical development program for the drug.
“Available phase-III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses,” said Dr. John Amatruda, senior vice president and research head of diabetes and obesity at Merck Research Laboratories.
More
Merck - Vioxx: just when they thought it was all behind them
Florida has joined eight other states in suing drug manufacturer Merck over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.
In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.
Florida's Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.
The lawsuit alleges that "Merck's costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment," according to a statement from the attorney general.
The suit also seeks civil penalties of up to $10,000 for each time that Merck's advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.
"The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx," the statement adds.
Thursday, September 25, 2008
Let there be light
Amid a national debate over the influence of industry money on medical research and practice, two pharmaceutical giants say they will begin publicly reporting payments they make to outside doctors.
John C. Lechleiter, chief executive of Eli Lilly & Company, announced on Wednesday that starting next year it intended to post in an online database all its payments to doctors for speaking and consulting services. The postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments, the company said.
In the wake of Lilly’s announcement, Merck & Company said later Wednesday that it would disclose speaking fees it pays to doctors, also beginning in 2009.
More at NYT
John C. Lechleiter, chief executive of Eli Lilly & Company, announced on Wednesday that starting next year it intended to post in an online database all its payments to doctors for speaking and consulting services. The postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments, the company said.
In the wake of Lilly’s announcement, Merck & Company said later Wednesday that it would disclose speaking fees it pays to doctors, also beginning in 2009.
More at NYT
Thursday, September 18, 2008
Wednesday, September 17, 2008
Schering Plough - ENHANCE: dear oh dear oh dear
I do hope Fred Hassan is sitting down!
258. To reduce the possibility of the results being biased, clinical trials are often “double-blinded,” meaning that neither the patient nor the doctor (nor, with most trials, the pharmaceutical company sponsor) knows whether the patient is in the experimental group (i.e., the group taking the drug under study) or the control group (i.e., the group taking placebo or another drug with known effects in the study population). Despite the obvious (and intended) limitations of blinding a clinical trial, if certain data about the population in the trial are made available, it is possible to discern useful information about the trial’s results, even while the treatment assignments remain blinded. Recognizing this, on February 11, 2008, in the Second Senate Letter, Senator Grassley wrote to Hassan that ENHANCE statisticians would not have needed to unblind the ENHANCE data to know that the study was not likely to show a statistically-significant difference between treatment arms:
It has come to my attention that Schering Plough and Merck would not need to unblind the data to understand that Vytorin performed no better than generic simvastatin. . . . These studies try to detect a statistically significant difference between treatment groups on the primary endpoint. Once the results are recorded, the study is then unblinded to determine which drug is the better performer. However, if the drugs performed the same, meaning there is no statistically significant difference in the treatments, then this information is apparent before the study has been unblinded.
259. Dr. Allen Taylor of Walter Reed reached the same conclusion. Dr. Taylor told Heartwire that, “Somebody had looked at the end-point examination, the IMT results, and, irrespective of group assignment, could know that a groupwise comparison of CIMT changes showed no statistically significant difference. . . . In my view, once that is known, the trial is functionally unblinded.”
258. To reduce the possibility of the results being biased, clinical trials are often “double-blinded,” meaning that neither the patient nor the doctor (nor, with most trials, the pharmaceutical company sponsor) knows whether the patient is in the experimental group (i.e., the group taking the drug under study) or the control group (i.e., the group taking placebo or another drug with known effects in the study population). Despite the obvious (and intended) limitations of blinding a clinical trial, if certain data about the population in the trial are made available, it is possible to discern useful information about the trial’s results, even while the treatment assignments remain blinded. Recognizing this, on February 11, 2008, in the Second Senate Letter, Senator Grassley wrote to Hassan that ENHANCE statisticians would not have needed to unblind the ENHANCE data to know that the study was not likely to show a statistically-significant difference between treatment arms:
It has come to my attention that Schering Plough and Merck would not need to unblind the data to understand that Vytorin performed no better than generic simvastatin. . . . These studies try to detect a statistically significant difference between treatment groups on the primary endpoint. Once the results are recorded, the study is then unblinded to determine which drug is the better performer. However, if the drugs performed the same, meaning there is no statistically significant difference in the treatments, then this information is apparent before the study has been unblinded.
259. Dr. Allen Taylor of Walter Reed reached the same conclusion. Dr. Taylor told Heartwire that, “Somebody had looked at the end-point examination, the IMT results, and, irrespective of group assignment, could know that a groupwise comparison of CIMT changes showed no statistically significant difference. . . . In my view, once that is known, the trial is functionally unblinded.”
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