Drug companies know how to play the FDA drug approval process

World of DTC Marketing

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.

Drugs 157

Prescription drug prices are out of cotrol

World of DTC Marketing

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

Drugs 153
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Drug pricing increases are disgraceful

World of DTC Marketing

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

Drugs 155

Drug price negotiations on the horizon

World of DTC Marketing

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.

Drugs 157

Um, about that diabetes drug that helped patients lose weight

World of DTC Marketing

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.

Drugs 157

New cancer drug clinical trials struggling

World of DTC Marketing

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.

Regeneron, AstraZeneca team up on targeted drugs for obesity

Bio Pharma Dive

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.

Drugs 208

Biogen’s Alzheimer’s drug: What’s the price tag on hope?

World of DTC Marketing

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?

Drugs 157

Social media and prescription drugs: A study

World of DTC Marketing

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.

Drugs 231

Ohio Clinic Says It Won't Administer Alzheimer's Drug to Patients

NY Times

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.

Drugs 73

With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt

Bio Pharma Dive

The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena

How an Unproven Alzheimer’s Drug Got Approved

NY Times

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

Drugs 68

Amgen pays $900M for Teneobio and bets bigger on next-gen antibody drugs

Bio Pharma Dive

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

Prescription drug marketing misconceptions

World of DTC Marketing

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.

The debate on DTC marketing is going to heat up again

World of DTC Marketing

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.

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

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.

COVID-19 drug developer Adagio plans IPO to cap fast rise

Bio Pharma Dive

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

Launching a drug in a pandemic

World of DTC Marketing

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.

Drugs 130

F.D.A. Requests Investigation of Its Own Alzheimer’s Drug Approval

NY Times

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

Drugs 62

Celldex pins its hopes for a comeback on skin disease drug

Bio Pharma Dive

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

Denali drug for rare brain disease disappoints investors

Bio Pharma Dive

New data from an early-stage study of Denali's drug for Hunter syndrome look "noisy" and even "uninterpretable," according to some analysts.

Drugs 145

Alzheimer’s Drug Poses a Dilemma for the F.D.A.

NY Times

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

Sanofi rare disease drug hits another setback

Bio Pharma Dive

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

Trials 153

Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

NY Times

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

Drugs 91

FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

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

The F.D.A.'s Approval of Biogen's Alzheimer's Drug Is a New Low

NY Times

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

Drugs 64

FDA documents show how controversial Alzheimer's drug decision was reached

Bio Pharma Dive

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

Drugs 182

Cytokinetics heart drug succeeds in mid-stage study, boosting shares

Bio Pharma Dive

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

Trials 149

In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug

NY Times

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

Drugs 66

Valisure Supports Drug Importation

Pharmacy Checkers

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.

As Arrowhead falters, lungs remain a tough target for RNA drugs

Bio Pharma Dive

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

RNA 192

Medicare to weigh nationwide coverage rules for Biogen Alzheimer's drug

Bio Pharma Dive

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

Roche stops giving Huntington's disease drug in closely watched study

Bio Pharma Dive

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

DNA 195

FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment

Bio Pharma Dive

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.

Drugs 205

FDA rejects a biotech's kidney drug, but some analysts still see a 'sliver of hope'

Bio Pharma Dive

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

Trials 153

Biohaven beats expectations with fast sales of migraine drug

Bio Pharma Dive

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

Sales 149

Merck gives an early peek at COVID-19 drug results

Bio Pharma Dive

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

Drugs 193

FDA grants approval to Ebola drug from Ridgeback

Bio Pharma Dive

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

Trials 191

Trial failure dashes Biogen hopes for next Alzheimer's drug

Bio Pharma Dive

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

Trials 145

Biogen Alzheimer's approval could open the door for other similar drugs

Bio Pharma Dive

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

Drugs 180

Lilly, Boehringer say diabetes drug first to succeed in hard-to-treat heart failure

Bio Pharma Dive

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

Drugs 192

Biogen, Ionis tout data from early study of RNA-based Alzheimer's drug

Bio Pharma Dive

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

RNA 153

The perfect storm is coming for pharma

World of DTC Marketing

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