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A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug MORE
Alzheimer's Disease Drugs (Pharmaceuticals) Clinical Trials Elderly Memory Brain Aducanumab (drug) Biogen Inc Food and Drug Administration Alzheimer's Assn your-feed-science your-feed-healthcare MORE
SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. They research the drug online and ask their physician about it if they decide it’s a treatment option. 2wo: DTC marketing is one of the reasons prescription drugs cost so much. MORE
Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear MORE
This translates to longer development times for cancer drugs which means that cancer patients could suffer. It’s essential that drug companies get creative and find new ways to reach patients when incomes to cancer drug screening and clinical trials. MORE
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients. your-feed-science Alzheimer's Disease Drugs (Pharmaceuticals) Clinical Trials Aduhelm (Drug) Elderly Biogen Inc MORE
SUMMARY: Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry. We’re just not sure when,” said one drug industry lobbying source. The drug industry has had a large target on its back for a long time. MORE
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. ” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science? MORE
Another TED talk on the evils of prescription drug marketing was filled with misinformation as usual. The disconnect between consumers and prescription drug marketing has grown quite a bit. The post Prescription drug marketing misconceptions appeared first on World of DTC Marketing.com. MORE
The offering is the latest step in the rapid emergence of Adagio, which raised nearly $400 million and brought a drug to pivotal testing in less than a year MORE
SUMMARY: One area where Republicans and Democrats agree is that drug pricing is out of control. Retail price increases for widely used brand name prescription drugs consistently exceeded the rate of general inflation between 2006 and 2020. AARP Drug Pricing. Drug costs MORE
online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Food and Drug Administration to make sure those drugs will work as directed by their prescribers. MORE
SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Drug Prices MORE
QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. The post <strong>Social media and prescription drugs:</strong> A study. MORE
The acquisition is the third Amgen has made since March and broadens its ability to develop bispecific antibodies, a drug class of intense interest to big biotech MORE
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. MORE
CMS announced it would begin an official process to determine whether a national policy is necessary for Aduhelm and other drugs in development like it, responding to calls from insurers and patient advocates MORE
The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. Aduhelm (Drug) Alzheimer's Disease Drugs (Pharmaceuticals) Inspectors General Biogen Inc Food and Drug Administration Woodcock, Janet MORE
The new label recommends that the drug be given only to patients with mild symptoms. Alzheimer's Disease Labeling and Labels (Product) Aduhelm (Drug) Drugs (Pharmaceuticals) Clinical Trials Food and Drug Administration Biogen Inc MORE
QUICK READ : Prescribers are reviewing some of their favorite prescribed drugs and are open to learning about new drugs in terms of efficacy and patient outcomes but you had better be ready to talk about patients beyond the science. MORE
The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's MORE
AstraZeneca aims to help the biotech make a drug based on its findings After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. MORE
s approval of the Alzheimer's drug aducanumab is inexplicable. . Drugs (Pharmaceuticals) Aduhelm (Drug) Alzheimer's Disease Food and Drug Administration Biogen IncThe F.D.A.'s MORE
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals MORE
The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients. MORE
This includes about one in five who report that they have not filled a prescription or took an over-the counter drug instead, and about one in ten who say they have cut pills in half or skipped a dose. Drug prices in the United States are extreme. Drug Prices MORE
The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease MORE
Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research MORE
Aduhelm (Drug) Alzheimer's Disease Food and Drug Administration Drugs (Pharmaceuticals) Labeling and Labels (Product) Clinical Trials Elderly Science and Technology Regulation and Deregulation of Industry Research Brain Biogen Inc your-feed-science your-feed-healthcare MORE
In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb MORE
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval MORE
Lumakras is the first drug proven effective For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. MORE
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech MORE
The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time MORE
Yet the media has led with “diabetes drug leads to major weight loss” Will doctors inform patients? The drug carries a potential risk for a type of thyroid tumor and has a boxed warning. This drug can be effective if patients follow the directions for weight loss. MORE
Second quarter sales of Nurtec ODT, which recently became the first migraine drug cleared for acute and preventive treatment, were nearly twice what analysts on Wall Street had predicted MORE
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs MORE
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look MORE
New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts. MORE
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year MORE
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb MORE
SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. MORE
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena MORE
The rejection of the new Alzheimer’s drug by the two major medical centers is one of the starkest signs of concern over its approval by the F.D.A. MORE
Drugs Related Topics 
World of DTC Marketing
JULY 13, 2021
SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.
World of DTC Marketing
JUNE 16, 2021
This includes about one in five who report that they have not filled a prescription or took an over-the counter drug instead, and about one in ten who say they have cut pills in half or skipped a dose. Drug prices in the United States are extreme. Drug Prices
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
World of DTC Marketing
DECEMBER 10, 2020
SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Drug Prices
World of DTC Marketing
MARCH 23, 2021
SUMMARY: Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry. We’re just not sure when,” said one drug industry lobbying source. The drug industry has had a large target on its back for a long time.
World of DTC Marketing
JUNE 27, 2021
Yet the media has led with “diabetes drug leads to major weight loss” Will doctors inform patients? The drug carries a potential risk for a type of thyroid tumor and has a boxed warning. This drug can be effective if patients follow the directions for weight loss.
World of DTC Marketing
OCTOBER 6, 2020
This translates to longer development times for cancer drugs which means that cancer patients could suffer. It’s essential that drug companies get creative and find new ways to reach patients when incomes to cancer drug screening and clinical trials.
Bio Pharma Dive
JULY 27, 2021
AstraZeneca aims to help the biotech make a drug based on its findings After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight.
World of DTC Marketing
JUNE 1, 2021
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. ” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?
World of DTC Marketing
APRIL 9, 2021
QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. The post <strong>Social media and prescription drugs:</strong> A study.
NY Times
JULY 14, 2021
The rejection of the new Alzheimer’s drug by the two major medical centers is one of the starkest signs of concern over its approval by the F.D.A.
Bio Pharma Dive
JUNE 24, 2021
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena
NY Times
JULY 19, 2021
Aduhelm (Drug) Alzheimer's Disease Food and Drug Administration Drugs (Pharmaceuticals) Labeling and Labels (Product) Clinical Trials Elderly Science and Technology Regulation and Deregulation of Industry Research Brain Biogen Inc your-feed-science your-feed-healthcare
Bio Pharma Dive
JULY 28, 2021
The acquisition is the third Amgen has made since March and broadens its ability to develop bispecific antibodies, a drug class of intense interest to big biotech
World of DTC Marketing
DECEMBER 3, 2020
Another TED talk on the evils of prescription drug marketing was filled with misinformation as usual. The disconnect between consumers and prescription drug marketing has grown quite a bit. The post Prescription drug marketing misconceptions appeared first on World of DTC Marketing.com.
World of DTC Marketing
JULY 21, 2021
SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. They research the drug online and ask their physician about it if they decide it’s a treatment option. 2wo: DTC marketing is one of the reasons prescription drugs cost so much.
Camargo
FEBRUARY 16, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.
Bio Pharma Dive
JULY 19, 2021
The offering is the latest step in the rapid emergence of Adagio, which raised nearly $400 million and brought a drug to pivotal testing in less than a year
World of DTC Marketing
JULY 23, 2020
QUICK READ : Prescribers are reviewing some of their favorite prescribed drugs and are open to learning about new drugs in terms of efficacy and patient outcomes but you had better be ready to talk about patients beyond the science.
NY Times
JULY 9, 2021
The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. Aduhelm (Drug) Alzheimer's Disease Drugs (Pharmaceuticals) Inspectors General Biogen Inc Food and Drug Administration Woodcock, Janet
Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech
Bio Pharma Dive
JULY 26, 2021
New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts.
NY Times
JUNE 5, 2021
Alzheimer's Disease Drugs (Pharmaceuticals) Clinical Trials Elderly Memory Brain Aducanumab (drug) Biogen Inc Food and Drug Administration Alzheimer's Assn your-feed-science your-feed-healthcare
Bio Pharma Dive
JUNE 1, 2021
The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's
NY Times
JUNE 10, 2021
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients. your-feed-science Alzheimer's Disease Drugs (Pharmaceuticals) Clinical Trials Aduhelm (Drug) Elderly Biogen Inc
Bio Pharma Dive
JANUARY 25, 2021
Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year
NY Times
JUNE 15, 2021
s approval of the Alzheimer's drug aducanumab is inexplicable. . Drugs (Pharmaceuticals) Aduhelm (Drug) Alzheimer's Disease Food and Drug Administration Biogen IncThe F.D.A.'s
Bio Pharma Dive
JUNE 22, 2021
A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug
Bio Pharma Dive
JULY 19, 2021
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb
NY Times
JULY 8, 2021
The new label recommends that the drug be given only to patients with mild symptoms. Alzheimer's Disease Labeling and Labels (Product) Aduhelm (Drug) Drugs (Pharmaceuticals) Clinical Trials Food and Drug Administration Biogen Inc
Pharmacy Checkers
SEPTEMBER 10, 2020
online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Food and Drug Administration to make sure those drugs will work as directed by their prescribers.
Bio Pharma Dive
JULY 6, 2021
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs
Bio Pharma Dive
JULY 12, 2021
CMS announced it would begin an official process to determine whether a national policy is necessary for Aduhelm and other drugs in development like it, responding to calls from insurers and patient advocates
Bio Pharma Dive
MARCH 23, 2021
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals
Bio Pharma Dive
JULY 8, 2021
The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients.
Bio Pharma Dive
JULY 30, 2021
The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time
Bio Pharma Dive
JULY 8, 2021
Second quarter sales of Nurtec ODT, which recently became the first migraine drug cleared for acute and preventive treatment, were nearly twice what analysts on Wall Street had predicted
Bio Pharma Dive
MARCH 8, 2021
Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear
Bio Pharma Dive
DECEMBER 22, 2020
In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb
Bio Pharma Dive
JUNE 17, 2021
Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research
Bio Pharma Dive
JUNE 9, 2021
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look
Bio Pharma Dive
JULY 6, 2021
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval
Bio Pharma Dive
JULY 27, 2021
The companies said that patients treated with their experimental drug BIIB080 had reductions in a protein called tau, which research indicates is tied to Alzheimer's but isn't yet proven to impact the course of the disease
World of DTC Marketing
JUNE 7, 2021
SUMMARY: One area where Republicans and Democrats agree is that drug pricing is out of control. Retail price increases for widely used brand name prescription drugs consistently exceeded the rate of general inflation between 2006 and 2020. AARP Drug Pricing. Drug costs
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