Existing drug may treat triple-negative breast cancer

| October 9, 2018

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The existing drug estradiol can inhibit tumor growth in a subtype of triple-negative breast cancer. The researchers may soon test the repurposed drug in phase II clinical trial. Triple-negative breast cancer is an aggressive form of breast cancer wherein tumors lack expression of three proteins. The three are the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2).

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PharmaDirections

PharmaDirections is a consulting and project management company with a unique approach to managing preclinical, CMC and regulatory affairs programs. We provide strategic planning then oversee and direct pharmaceutical contract research using our own scientific experts and project managers. We are a comprehensive R&D resource for pharmaceutical and biotech companies who need more than just outsourcing of their API or drug product development.

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Advance Your Pharma Supply Chain Planning during a Pandemic

Article | March 20, 2020

One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.

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WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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Top Specialty Pharmacy Therapy Areas

Article | March 16, 2020

Accelerated by advancements in cancer treatments and a growing emphasis on personalized and precision medicine, specialty pharmacy represents a rapidly growing sector within the healthcare industry. In fact, the market is projected to grow to $500 billion by the end of this year—up from $200 billion in total U.S. specialty drug spending in 2017. Industry growth of this magnitude creates challenges for those looking to understand and penetrate the market. It can be difficult, after all, to maintain updated information about high-priority drug therapy areas or facility affiliations in a market that’s constantly changing.

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PharmaDirections

PharmaDirections is a consulting and project management company with a unique approach to managing preclinical, CMC and regulatory affairs programs. We provide strategic planning then oversee and direct pharmaceutical contract research using our own scientific experts and project managers. We are a comprehensive R&D resource for pharmaceutical and biotech companies who need more than just outsourcing of their API or drug product development.

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