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."
Legal bills lead to Teva's second-quarter loss, including possible settlement of Cephalon pay-to-delay case
Teva Pharmaceutical Industries, Ltd., reported a net loss of $452 million in the second quarter of 2013 because of slightly lower revenue for the period but mostly because of legal bills that amounted to $1.4 billion.
Part of that legal bill is coming due now because of the Supreme Court's June ruling in an antitrust case, in which the Court found in favor of the Federal Trade Commission and against drug companies that engaged in so-called "reverse payments" or pay-to-delay deals.
Teva said Thursday it had an "agreement in principle" to settle a lawsuit and would take a charge of $485 million against second quarter earnings.
Drugmaker Merck & Co., said Tuesday its second quarter revenue declined from $12.3 billion to $11 billion and its net income fell from $1.8 billion to $906 million compared with the same period in 2012.
Merck, which is based in Whitehouse Station, N.J., has a big operation in West Point, Montgomery County, but also has other facilities in Pennsylvania and New Jersey.
Earlier in the year, Merck changed leaders of its research and development department.
Drugmaker Pfizer reported a quarterly revenue decline of seven percent on Tuesday after earlier this week saying that it would reorganize its existing businesses over the next few years.
The company had previously sold its infant nutrition business to Nestle and, in the second quarter, completed the spin off its animal health unit into a standalone company called Zoetis.
The new structure will have two units that concentrate on developing and selling medicine with patent expirations beyond 2015. Such products usually bring higher profits than those whose patents have expired and, thus, face generic competition. A third unit will handle the older products. The restructuring will begin in 2014 but might not be completed until 2017.
Trevena chief executive officer Maxine Gowen leads a 30-person pharmaceutical company, whose lead product is in phase 2b of development and, thus, years from generating revenue. But she also worked at a giant drugmaker, GlaxoSmithKline, which had 103,000 employees when she departed at the end of 2007, according to GSK's annual report.
Gowen shared her thoughts on running a small business in Monday's Inquirer. Trevena is in King of Prussia, just outside of Philadelphia. A link is to the story is here and the Inquirer's Tom Gralish has a video report, too.
Gowen had plenty of interesting thoughts on a range of health-care issues that didn't fit in the print edition, so we'll share them here. She grew up in the United Kingdom with its National Health Service and but has lived in the United States for most of 20 years. She and her husband, Brian, have three sons, one of whom is a scientist at Trevena.
Teva Pharmaceuticals and the Lonza Group AG said Thursday they are ending their joint venture, which was supposed to help each drug company develop biosimilar medication.
However, part of the impetus to cancel the deal is that Lonza was struggling with a different part of its operation: wood treatment.
Yes, wood and pharmaceutical products both involve biology, but apparently there was not enough profitable synergy past that connection.