STAT News

APRIL 4, 2023

… People who are overweight are flocking to a drug called Ozempic to slim down, but looming is an even more powerful weight-loss treatment called Mounjaro , The Wall Street Journal says. No anti-obesity drug has ever safely made such a difference. One diabetes doctor called it a “King Kong” of diet drugs.

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STAT News

AUGUST 18, 2022

Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose. But for decades, an archaic web of federal regulations has kept the medication out of reach for countless Americans. Physicians aren’t allowed to prescribe the drug directly to patients.

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Pharmacy Doctors Doctor Regulation 119

The Pharma Data

MAY 15, 2021

Product Name: The Longevity Breakthrough Your Doctor Won't Tell You About. Click here to get The Longevity Breakthrough Your Doctor Won't Tell You About at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

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Drug Discovery World

JULY 12, 2023

Following this investigation and a complaint from doctors and other healthcare professionals to the Care Quality Commission (CQC), the regulator says it has launched a review into the concerns. The post Patient dies after receiving unlicensed drug appeared first on Drug Discovery World (DDW).

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Drugs Medicine Doctors Doctor 52

XTalks

JUNE 16, 2023

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US. The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

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Outsourcing Pharma

JANUARY 16, 2023

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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Drug Trials Doctors Doctor Drugs 59

XTalks

MARCH 25, 2024

The latest phase of Oprah’s weight loss journey brought her to GLP-1 receptor agonist drugs, which have taken Hollywood and social media by storm. GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes, have been found to have significant effects on weight loss. Obesity is a disease.

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STAT News

MARCH 16, 2023

The most basic argument for this, put forth by medical device makers and regulators, is that mimicking an invasive procedure is far more difficult than handing patients a sugar pill. But for most medical devices, placebo trials have never been done. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.

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World of DTC Marketing

JUNE 24, 2021

As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business. To portray patients, mindless people who blindly believe DTC TV ads and rush to their doctor to ask for a product are inaccurate. Prescription drugs are not the same as items found in a grocery store.

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Doctors Doctor Production Drugs 165

World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

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Drugs Doctors Doctor Research 185

XTalks

JANUARY 24, 2024

In a bold move to tackle the high cost of prescription drugs in the US, Senator and Chairman of the Committee on Health, Education, Labor and Pensions (HELP) Bernie Sanders (I-Vt.) Americans consistently pay more for prescription drugs than people in other developed countries.

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pharmaphorum

JANUARY 24, 2022

The UK scientists that ran one of the largest trials of experimental COVID-19 drugs have formed a non-profit company that will apply the methodology to other disease areas – with $6.8 RECOVERY was unusual in that it tested several different therapies and had an adaptive design, so new drug candidates could be added to the protocol as needed.

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Trials Drugs Clinical Trials Clinical Trials 97

STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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World of DTC Marketing

JANUARY 20, 2022

and recent privacy regulations. According to Pew Internet, “two-thirds of all health seekers (64%) have looked for information about prescription drugs. Those who have seen a doctor in the past year are more likely to use the Internet to research a specific drug than those who have not consulted with a doctor.

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pharmaphorum

DECEMBER 21, 2021

However, despite the work still left to be done, there are now a growing number of treatments in the pipeline and 2020 proved to be a remarkable year for orphan drug approvals, with the US FDA approving more orphan designated treatments than non-orphan drugs. Headway being made. The potential to leverage genomic data.

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Development Genome Genomics Drugs 98

XTalks

JUNE 14, 2023

Huma Therapeutics, a leading global digital health company, announced this week that it has received multi-condition US Food and Drug Administration (FDA) 510(k) Class II regulatory clearance for its disease management Software as a Medical Device (SaMD) platform. eSTAR aims to increase regulatory efficiency through digitalization.

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Regulation Compliance Doctors Doctor 97

pharmaphorum

NOVEMBER 24, 2020

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. The disease is also difficult to diagnose and often takes around six years before doctors correctly identify it.

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FDA Approval Gene Silencing Drugs RNA 52

World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA).

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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FDA Law Blog

FEBRUARY 21, 2022

Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987.

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Drugs Cardiology FDA Approval Doctors 40

pharmaphorum

JANUARY 10, 2022

The US regulator has cleared two doses of dual orexin receptor antagonist (DORA) Quviviq (daridorexant) – 25 mg and 50 mg – for the treatment of adults with insomnia characterised by difficulties with falling or staying asleep. The post Dream result for Idorsia as FDA clears its insomnia drug appeared first on.

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Drugs Sales Marketing FDA Approval 52

World of DTC Marketing

MARCH 6, 2022

The excitement about these technologies partially stems from their potential to address health care system challenges that have slightly improved with traditional health care processes, payment models, regulations, guidelines, and innovations such as drugs and devices.

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Production Doctors Doctor Branding 244

FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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FDA Law Blog

JUNE 28, 2022

841) and its implementing regulations (21 C.F.R. Ruan is a consolidation of two cases involving two doctors (Ruan and Kahn) that were found guilty of issuing prescriptions that violated 21 U.S.C. § The following is a brief summary based on an initial review of the case.

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pharmaphorum

SEPTEMBER 9, 2020

Merck & Co is planning to file a drug for unexplained or treatment-resistant cough after supportive results from two phase 3 trials. US-based Merck , known as MSD outside the US and Canada, said results from the phase 3 COUGH-1 and COUGH-2 trials will form the basis of filings with regulators across the world.

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Drugs Trials Doctors Doctor 52

pharmaphorum

FEBRUARY 2, 2021

Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a second indication for the would-be blockbuster. The drug was one of the top 2020 drug launches to watch by Clarivate ahead of the COVID-19 crisis, with a 2024 sales estimate of $1.6

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Drugs Sales FDA Approval Marketing 44

Clinical Trial Podcast

JUNE 30, 2023

At a macro level, private for-profit organizations want to maximize profits (think CROs, biopharmaceutical and medical devices companies), non-profit organizations want to achieve their mission (think large academic sites), or the government (think US Food and Drug Administration) want patients to be safe. We just don’t know.

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Clinical Trials Clinical Trials Trials Regulation 52

Pharmacy Checkers

DECEMBER 10, 2020

These rights are applicable to Americans who can’t afford prescription drugs domestically because the prices are too high. Human rights include access to safe and affordable medicines, such as through importation of a more affordable drug ordered over the Internet. can’t afford a prescription drug that they need to get better.

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XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their caregivers and the doctors that treat them.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

ACRP blog

FEBRUARY 26, 2024

Every drug I have received so far is the result of men and women participating in clinical trials that have shown these drugs are safe and effective in the treatment of breast cancer. The same applies to drugs for other cancers. Food and Drug Administration (FDA) inspections. This The research toward a cure continues.

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Clinical Trials Clinical Trials Trials Nurses 59

pharmaphorum

OCTOBER 3, 2022

Pharma hasn’t fully moved into the experiential content space and is stuck on brand-centric content, which is not as engaging as experiential content that can make one question how a product impacts their life and how it helps doctors treat their patients better, Kapoor reasons. “That can only be done in a Meta world.

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Branding Doctors Doctor Compliance 113

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. Keep it simple.

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Clinical Trials Clinical Trials Trials Clinical Research 109

Drug Discovery World

NOVEMBER 27, 2023

Across the biotherapeutics workflow The landscape of large molecule drug development has evolved significantly in recent decades. Prioritising critical attributes in the upstream workflow is crucial for predicting and preventing challenges downstream, ultimately avoiding high development costs and delays in drug approvals.

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pharmaphorum

AUGUST 13, 2020

Exon-skipping drugs are used to patch the mutations and allow the gene to produce partially functional dystrophin. Viltepso can be used to treat around 8% of DMD patients and previously approved DMD drugs has not been shown to change the course of the disease.

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FDA Approval Drugs Gene Trials 52

Druggist

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., The supply of prescription-only medicines is possible after a prescription (NHS or private prescription) is issued to the patient by a doctor or another qualified prescriber. .

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pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion by 2028.

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