Biopharma Manufacturing Trends 2019

| March 14, 2019

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How slow-motion trends are driving biopharma growth, the dangerous impact of unproven stem cell therapies and more. For over two decades, the biopharmaceutical manufacturing industry has created a body of industrial knowledge and institutional experience.

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MedActive Oral Pharmaceuticals, LLC

Home MedActive Oral Pharmaceuticals, LLC MedActive Oral Care & Relief, Providing Relief from Oral Discomfort associated with Dry Mouth (Xerostomia), Sjögren's Syndrome, Oral Thrush (Candidiasis), Burning Mouth & Tongue, Oncology Oral Side Effects, Medication Oral Side Effects, and more.

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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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WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | March 26, 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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What do you have to lose taking hydroxychloroquine for coronavirus? Potentially your life

Article | March 26, 2020

The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 26, 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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Spotlight

MedActive Oral Pharmaceuticals, LLC

Home MedActive Oral Pharmaceuticals, LLC MedActive Oral Care & Relief, Providing Relief from Oral Discomfort associated with Dry Mouth (Xerostomia), Sjögren's Syndrome, Oral Thrush (Candidiasis), Burning Mouth & Tongue, Oncology Oral Side Effects, Medication Oral Side Effects, and more.

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