Combating Neurodegenerative & Age-related Diseases

| December 20, 2018

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We recently spoke to Karoly Nikolich, chairman and chief executive officer of Alkahest, a clinical-stage biotechnology company, to learn more about their approach to developing therapeutics for both neurodegenerative and age-related diseases. Karoly touches on the company's mission and highlights the development of GRF6021, which is currently being investigated for the treatment of cognitive impairment and dementia in patients with Parkinson's disease.

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McGee Pharma International, a PharmaLex Com

We are passionate about putting safe and effective products in the hands of patients. We are an award winning pharmaceutical consultancy that combines industry leading EU and FDA quality and technical insight with best-in-class product development and commercialization knowledge.

OTHER ARTICLES

What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

Article | April 11, 2020

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.

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Pricing of drugs – at what cost?

Article | February 27, 2020

We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 26, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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McGee Pharma International, a PharmaLex Com

We are passionate about putting safe and effective products in the hands of patients. We are an award winning pharmaceutical consultancy that combines industry leading EU and FDA quality and technical insight with best-in-class product development and commercialization knowledge.

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