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pharmaceutical companies 19 articles

New testosterone replacement capsule fares well in clinical trials

Clinical trials for Clarus Therapeutic’s new testosterone replacement treatment Rextoro show the drug is comparable to other testosterone therapies and, if approved by the Food and Drug Administration (FDA), could provide patients with yet another treatment option to boost the amount of the male hormone in their systems. Rextoro is a softgel capsule that contains a testosterone prodrug, testosterone undecanoate, or TU. It is formulated to foster absorption via the intestinal lymphatic pathway. After oral TU is absorbed, natural enzymes in the body cause testosterone to be released from the prodrug. “This proprietary formulation enables us to increase the amount ... Read More

North Carolina senate supports measure to shield drug makers from personal injury claims

The North Carolina Senate has approved an amendment to a bill that would give pharmaceutical companies protection against litigation regarding adverse effects from their drugs if they have previously warned of specific side effects and followed all Food and Drug Administration (FDA) rules. If the legislation becomes law, North Carolina consumers would likely have a more difficult time suing drug companies for injuries caused by their products. Supporters say the measure will put drug companies on equal footing with consumers. Opponents disagree, saying the move could hurt people who hare harmed by side effects that emerge after a drug is ... Read More

Was the FDA’s approval of the controversial painkiller Zohydro influenced by drug companies?

Two senators are pushing for an investigation into reports that pharmaceutical companies paid to attend private meetings between Food and Drug Administration (FDA) officials and medical professionals in an effort to influence the approval of the controversial new opioid painkiller Zohydro ER. These so-called “pay-to-play” meetings, during which drug companies allegedly paid between $25,000 and $35,000 to the University of Rochester Medical Center to participate, demonstrate a clear, illegal conflict of interest that put consumer safety at risk, Sen. David Vitter said in a statement issued earlier this week. Vitter and Sen. Mike Lee are urging the U.S. Department of ... Read More

Supreme Court considers legality of drug companies’ pay-for-delay deals

An attorney for the Federal Trade Commission (FTC) urged the Supreme Court to stop so-called pay-for-delay deals among pharmaceutical companies that keep generic drugs off the market longer and keep costs to consumers high. “It’s unlawful to buy off the competition,” said Malcolm Stewart, an attorney for the FTC and the Justice Department, arguing that the practice among drug companies is “presumptively illegal.” The hearing will determine whether there is a violation of antitrust laws when brand name drug companies pay generic drug makers of the same drug to postpone launch of their products. New brand-name drugs to hit the market ... Read More

Drug companies ignoring FDA’s requirement to warn about drug side effects

Pharmaceutical companies have largely ignored recent federal requirements to compile data and warn doctors and patients of possible side effects caused by their drugs, according to a report from the Department of Health and Human Services’ (HHS) Office of Inspector General. The report is the first independent report into requirements put in place in 2008 allowing the Food and Drug Administration (FDA) to require drug makers to develop risk-management plans for new drugs. These Risk Evaluation and Mitigation Strategies (REMS) require drug companies to produce patient brochures warning about drug side effects, provide specialized training for doctors who prescribe some ... Read More

Alabama court rules that makers of brand name drugs can be sued by generic drug users

Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled. The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the ... Read More

Drug companies get creative with social media marketing

Social media has become a wildly successful way for people to stay in touch, and it has become a great tool for organizations to educate and raise awareness about conditions such as diabetes. It is also a great venue for businesses to promote their products. Of course, it didn’t take long for drug companies to find a way to push their products under the guise of providing a platform for people to share experiences and treatment information. It’s an easy leap for drug companies to make, providing a patient forum full of people who make up their target audience. The Food ... Read More

Appeals court says free speech applies to drug company reps, too

Pharmaceuticals are cleared by the Food and Drug Administration (FDA) for specific uses only after studies have shown that the drug is both safe and effective for the conditions for which it is approved. Doctors have the discretion to prescribe medication for conditions other that what is on the drug’s label. However, by law, drug companies are forbidden to promote their drugs for these off-label uses. But leave it to the pharmaceutical companies to find a loophole. A U.S. appeals court has just determined that free speech applies to drug company sales reps while on the job, too. If they ... Read More

Lawsuit filed against drug maker for violating consumer protection laws

Arizona has filed a lawsuit against McKesson Corp, the nation’s largest drug wholesaler, claiming the company violated state consumer protection laws by artificially inflating the prices of more than 400 brand-name prescription drugs, including Allegra, Celebrex, Coumadin, Flonase, Lipitor and Valium. The lawsuit claims McKesson raised the cost between the published average wholesale price (AWP) and the actual acquisition costs to increase profits for its pharmacy customers which, in turn, were passed on to third-party customers and consumers. “Since this claim alleges markup irregularities on more than 400 drugs over multiple years, the consumer damages were enormous,” said Attorney General ... Read More

Group petitions FDA to change labels of common prescription painkillers

A team of doctors, researchers and public health officials are lobbying the Food and Drug Administration (FDA) to change the safety labels on prescription painkillers known as opioids to prevent more people from abusing the drugs. Opioids are powerful pain relievers such as fentanyl, morphine and oxycodone. They work by suppressing the perception of pain and calming the emotional response to pain. They are generally prescribed to treat moderate to severe chronic pain. The medical and public health officials are asking the FDA to revise the drugs’ safety labels to add a maximum daily dose and only allow patients to ... Read More