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Archive for the ‘Pharmaceutical’ Category

Pfizer in Hot Water With FDA Over ESTRING Ad

A recent advertisement for Pfizer’s new hormonal therapy for postmenopausal patients, Estring, caught the attention of the FDA’s Office of Prescription Drug Promotion in a bad way. In this direct-to-consumer promotion, spokespeople for Estring, depicted in the ad as doctor and patient, discuss the new treatment, with the patient proclaiming that she had suffered no side effects. Unfortunately for Pfizer, any plausible side effects must be brought to the attention of consumers, even if this particular case showed none. This resulted in a chastising letter for Pfizer.

Though Pfizer might not agree, this story…


Drug Repurposing, Diabetes, Parkinson’s Disease, and Gila Monster Saliva

Exenatide treats Type 2 diabetes, but a recent study has led to positive steps in treating Parkinson’s disease. Derived from the saliva of a Gila monster, this GLP-1 hormone mimicking drug could find success outside of its designated treatment, furthering the discussion of drug repurposing in the pharmaceutical industry.

According to our friends over at FierceBiotech, the researchers observed 60 patients with Parkinson’s disease, who had injected themselves once a week with either a placebo or exenatide, while still taking their current prescriptions for 48 weeks. Afterward, the patients were removed from their treatment regimens so that the researchers could…


FDA Head & Former ExL Speaker, Dr. Scott Gottlieb, Takes to Twitter With Clear Stance on Vaccines

Recently sworn-in commissioner of the Food and Drug Administration (FDA) Dr. Scott Gottlieb has affirmed his stance on the vaccination debate in many instances, but a recent Twitter post is sure to make his intentions on the matter perfectly clear. Unlike the man who appointed him to his position, President Donald Trump, toes the line of anti-vaccine and pro-vaccine, Gottlieb is embracing his new status to spread scientific data and other newsworthy tidbits on the matter.

In a message to his followers, Dr. Gottlieb shared an infographic the country before and…


The Top 10 Diabetes Drugs by Sales

If you’re reading this post, you’re likely involved in the world of diabetes in some way — either as a patient yourself or as a supporter of a loved one that is diabetic. What drugs have you used to treat diabetes in your life? You could have that medicine/treatment in common with others affected by diabetes. Just below, FiercePharma has compiled the 2016 sales rankings of diabetes drugs, based on data from EvaluatePharma. The following graphic breaks down this information by drug class, drug name, pharmaceutical company, and sales, all compiled into an easy-to-understand…


13th Pharmaceutical Meeting Professionals Summit to Be Held November 6–7, 2017 at the Hilton Philadelphia at Penn’s Landing

The 13th Pharmaceutical Meeting Professionals Summit will be held on November 6–7, 2017 at the Hilton Philadelphia at Penn’s Landing. This interactive summit attracts 200+ senior-level meeting professionals working in the pharmaceutical, biotechnology, and medical device industries, and acts as their annual gathering to learn, engage, and network.

With well over 60% of the 2016 audience representing meeting planners and with 57% of them having more than 10 years of experience in the events industry, this is the ideal forum to learn from and meet with industry veterans to understand current trends, innovation and efficient strategies for optimizing medical meeting…


GSK Acquires PRV for ViiV’s Two-Drug HIV Therapy, Beating Gilead to Billion-Dollar Market

Late last week, ViiV Healthcare filed applications with both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) for the world’s first two-drug HIV maintenance therapy. The treatment will also be the first of its kind on the market thanks to a surprising priority review voucher (PRV) acquisition by ViiV’s majority owner, GlaxoSmithKline – capitalizing on the multi-billion-dollar HIV market four months earlier than competitors Gilead’s HIV treatment.

Instead of the usual 10-month application process, this PRV allows ViiV, and therefore GSK, to have it completed in six months. For more information on PRVs, check out…


Top 10 U.S. Pharma Patent Losses of 2017

As we come approach the midway mark of 2017, we can’t help but wonder how the passage of time is affecting the pharmaceutical industry. Regarding U.S. patents on certain drugs, some big-name pharma companies are looking at big-time losses in 2017. Companies like Takeda, Pfizer, Gilead, Eli Lilly, and Bristol-Myers Squibb are doing their best to hold onto these coveted drug patents, but odds are that they won’t have such great luck. According to a recently published content report from FiercePharma, a handful of popular drug patents in the U.S. are expiring.

To give you an idea…


Top 10 Pharma R&D Budgets

Since drug pricing was a noted talking point of the 2016 presidential election, it might not come as a surprise that R&D budgets in the pharmaceutical industry have seen big cuts as a result. And while this comes across as a negative, reduced spending on pharma R&D – though resulting in staff cuts, restructured operations, and more – actually resulted in positive percentage terms in sales. Luckily for us, FierceBiotech has made this information easy to understand in a recently published content report.

R&D spending varied from company to company, but overall,…


Senate Confirms New Head of FDA: Two-Time ExL Speaker Dr. Scott Gottlieb

ExL Events would like to congratulate our speaker alumnus Dr. Scott Gottlieb for the recent United States Senate confirmation, naming him the new Food and Drug Administration commissioner. Dr. Gottlieb was the keynote speaker at ExL’s 2nd Trial Design Innovation Conference and was also a featured speaker at our Private Fee-for-Service event.

President Donald Trump nominated Gottlieb earlier this year, for his previous service as deputy commissioner for the FDA, as well as his experience in the pharmaceutical and health care industries. As the FDA’s newly appointed commissioner, Gottlieb will…


Key Stakeholders Gather This Fall to Discuss Abuse-Deterrent Formulations, Regulations and Policies

Dan Cohen, Forum Chair, Abuse Deterrent Coalition

This guest blog post is written by Dan Cohen, the Forum Chair of the Abuse Deterrent Coalition and speaker at the 3rd Human Abuse Liability & Abuse-Deterrent Formulations conference, which takes place in Arlington, VA this November 2-3. 

The prominence of Abuse Deterrent Formulations (ADF) in the public policy debate has never been greater.  This fall is no exception as we are now at yet another critical juncture for the ADF sector, with…


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