WELCOME TO The PHARMACEUTICAL REPORT
Does Lactic Acid Really Cause Muscle Pain?
| January 26, 2019
Regulatory Affairs Specialists with clients ranging from start-up biotechs to multinational pharmaceutical companies.
Cambridge Regulatory Services has expertise and.
Article | March 6, 2020
Pharma has deep roots in human history with centuries of folk pharmaceutical knowledge offering a hit-and-miss range of natural remedies. But the industry as we know it today actually emerged in the second half of the 19th century when the world’s first factory for the sole production of medicines was found. By the late 19th and early 20th century, some chemical companies had already begun using research labs to explore the medical applications for their products. Fast forward to today and the pharmaceutical sector is a global trillion-dollar industry. However, to ensure the safety and efficacy of drugs, the process of drug discovery and development is under extensive scrutiny and control on both national and global levels.
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.
Article | April 10, 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.
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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