Extra Strength Tylenol bottles will soon have a new warning about the potentially fatal risks of taking too much of the pain reliever, whose active ingredient is acetaminophen. Tylenol is an over-the-counter product, meaning a prescription is not required for most dosages.
Faced with dozens of lawsuits by patients claiming liver damage, Johnson & Johnson and its McNeil Consumer Healthcare division announced the changes Thursday. A link to the company's page is here.
The McNeil Consumer Healthcare unit's headquarters is in Fort Washington, Montgomery County. The company has a manufacturing facility on that property, though it has not produced medicine since April of 2010 because of problem with contaminated medicine. A federal judge and the U.S. Food and Drug Administration has allowed McNeil plants in Lancaster and Puerto Rico to operate under greater restrictions.
Teva Pharmaceuticals shareholders met in Tel Aviv this week and voted to approve the compensation package for chief executive officer Jeremy Levin - despite increasing pressure on the company from Wall Street analysts.
Teva is based in Israel and has operations in the Philadelphia area. Its Americas headquarters is in Montgomery County. Teva sells more generic medicine than any other pharmaceutical company and is trying to increase revenue with higher-profit, brand-name drugs.
Teva did not say in its filing with the Securities and Exchange Commission (link here) what the vote totals were, but the result means that Levin will get the cash payment of $1,203,125 for his work in 2012. The shareholders also approved the compensation package for 2013, under which Levin gets a base salary of $1.5 million and a bonus of up to $3 million. Eighty five percent of the bonus is based on the company hitting certain performance targets and 15 percent on an assessment of Levin's performance.
Endo Health Solutions said Wednesday morning it will pay $225 million in cash for the private company Boca Pharmacal, which makes specialty generic medicine.
Endo already had a brand-name drug division and a generic component, both of which produced medicines that included opioid painkillers. Such painkillers are controlled substances, regulated in the United States by both the Food and Drug Administration and the Drug Enforcement Administration.
Endo's generic division is called Qualitest and this deal will add to Qualitest's pipeline of products. Endo described Boca Pharmacal's focus as being on "niche areas, commercializing and developing products in categories that include: controlled substances, semisolids, and solutions."
Amgen's $10.4 billion purchase of Onyx Pharmaceuticals for the sake of cancer drugs prompted much of Monday's discussion in the pharmaceutical world, but AstraZeneca was also buying medicine in that category.
AstraZeneca agreed to pay $225 million up front and perhaps $275 million more for Amplimmune, a privately-held, biologics company that focuses on developing drugs in cancer immunology. The second amount depends on whether the drugs meet certain development and sales milestones.
Cancer cells can be crafty and try to avoid detection while attacking the body. Cancer immunology medications are supposed to help counter those tactics.
PhillyPharma will return Aug. 27. Be well.
Moody's Investor Service said in a report this week that generic drug companies are facing increasing challenges about the prices they want to charge and regulatory oversight of the drugs they make and sell.
The continued push by people and organizations paying for drugs - patients, private insurance companies, employers, governments - will make meeting revenue expectations more difficult.
Supreme Court decisions in June will impact in several ways, all of them raising regulatory, legal and competitive costs for generic companies.
The multiple problems that prompted Malvern-based Endo Health Solutions to cut 15 percent of its workforce in June have not abated - indeed, they might worsen - but chief executive officer Rajiv De Silva said Tuesday that there are no immediate plans for more layoffs.
"We don't need to make further employee reductions to meet our cost savings projections," De Silva said of the promise to financial markets that it would cut $150 million from yearly operating expenses by the end of 2013 and $325 million by the end of 2014.
Endo makes brand-name, patent-protected drugs, but also has a generics division and a device unit.
Johnson & Johnson said in a filing with the Securities and Exchange Commission that federal investigators in Atlanta are examining the company's sales tactics, including payments to health-care providers, for its opioid painkillers, Nucynta IR and Nucynta ER.
J&J filed its second quarter financial report (10-Q, here) on Friday. The item on the subpoena is on page 34. J&J's Janssen Pharmaceuticals makes Nucynta and got the subpoena from the Atlanta regional Office of the Department of Health and Human Services, Office of Inspector General.
The OIG is "seeking production of documents and information regarding: (1) the sales, marketing and promotional practices, including the remuneration of healthcare providers, related to Nucynta IR and Nucynta ER; and (2) any studies, reports and/or complaints regarding the safety and/or actual or potential side effects of Nucynta IR and Nucynta ER."