Ranbaxy Laboratories, Ltd., is an India-based pharmaceutical company with a U.S. subsidiary, Ranbaxy USA Inc., headquartered in Parsippany, N.J.
Ranbaxy provided another example this week that drug companies the world over are sometimes willing to skirt rules and laws, while ignoring public and patient safety.
The Justice Department said Monday that it had reached the largest drug safety settlement to date with a generic drug manufacturer. Ranbaxy agreed to pay $500 million and plead guilty to criminal charges relating to the manufacture and distribution of certain drugs made at two of Ranbaxy’s facilities in India. The Justice Department statement is here.
Movie star Angelina Jolie's revelation Tuesday of having had a double mastectomy to help avoid breast cancer had business and legal angles.
Myriad Genetics, the Utah-based company at the center of a legal debate about the acceptability of gene patenting, has a monopoly on the testing Jolie had before opting for surgery. With the news of Jolie breaking in the morning, the company's stock rose to a three-year high of $34.70 during trading on the NASDAQ market on Tuesday. The trading volume was also much higher, with 2.6 million shares exchanged, more than double the three-month daily average of 1.1 million shares.
Jolie explained her decision in an Op-Ed piece in the New York Times, a link to which is here.
Indiana farmer Vaughn Hugh Bowman got shut out at the Supreme Court and some of the cheering from the stands was the biotech industry.
A soybean farmer from Indiana, Bowman took on a giant in the industrialized agriculture world, Monsanto, and lost badly. All nine justices ruled in favor of Monsanto. The case was Bowman v. Monsanto et al., and a link to the opinion is here.
The court will decide several cases this spring that involve patent law and drug companies. Still to come is a decision on human gene patenting and whether generic and brand-name companies violated antitrust laws in settling litigation about patent infringement.
Malvern-based Endo Health Solutions will be a stock to watch Monday when the stock market opens because of Friday evening's news that the FDA had rejected the company's request to stop generic competitors to Endo's Opana ER opioid painkiller.
The FDA announcement came after the trading closed Friday. But word of the pending announcement leaked out enough that trading was halted Friday before the market closed.
Federal judge gives go-ahead to sale of over-the-counter, morning-after contraception for women of all ages
A New York federal judge on Friday gave the go-ahead for women of any age to buy over-the-counter, morning-after oral contraceptives. Plan B is made by Teva Pharmaceutical Industries Ltd., which is based in Israel but has its Americas headquarters in North Wales, Montgomery County. There are also generic versions.
The Associated Press story is below:
By Larry Neumeister
In a stinging rebuke that will cause financial pain, the U.S. Food and Drug Administration late Friday rejected Malvern-based Endo Health Solutions' request that the agency deny approval to generic versions of its opioid painkiller Opana ER.
Last year, Endo took the unusual step of asking the agency in a citizens petition to withdraw approval of its own drug on safety grounds. Overdose deaths from opioid painkillers now exceed those by cocaine or heroin. Besides swallowing too many pills, abusers crush, liquefy, inject and smoke the drug to get high.
Endo sought approval of a new form of the drug that Endo said was tamper resistant and wanted generics blocked from entering the market. But the FDA dismissed Endo's suggestion that its request was made on safety grounds, viewing it as a way to deter generic competitors.
Justin Forsyth changed his mind about GlaxoSmithKline.
Forsyth is the chief executive officer of Save the Children, which announced a five-year, $23 million agreement with GSK to work on improving health care and vaccination in the developing world. One aim is to combat basic-but-deadly problems such as diarrhea, pneumonia and malnutrition for children.
"I used to protest against GSK and campaign against GSK," Forsyth said during a conference call with reporters on from Nairobi. "That was years ago before Andrew Witty took over and it was because the high prices that they were charging for HIV medicine."
Drugmakers Merck and GlaxoSmithKline joined the GAVI Alliance in a new agreement to supply HPV vaccine at lower prices to developing countries to help girls and women in those nations avoid cervical cancer.
GAVI stands for the Global Alliance for Vaccines and Immunization and is based in Geneva. It is a public-private partnership, funded by governments and non-profit organizations, with for-profit drug companies contributing medicine at lower prices than they charge in developed countries.
Human papillomavirus can contribute to cancer of the cervix, anus and other parts of the pelvis. Both girls and boys have begun to be treated with the vaccine in the United States and other developed countries.
Drug pricing is among the many mysteries of the U.S. pharmaceutical industry. Critics suggest the opaque nature allows drug companies to unduly profit from a system in which taxpayers often end up with the bill.
Pennsylvania taxpayers, theoretically, will be represented Tuesday when the Commonwealth's Supreme Court is scheduled to hear arguments in Harrisburg in two separate but similar cases involving Big Pharma companies. Johnson & Johnson and Bristol-Myers Squibb, among other companies, were accused of improperly reporting the so-called "average wholesale price," for drugs that were reimbursed through Medicaid. Medicaid is the government health insurance program for low income citizens that is funded by the federal government and states.
The J&J discussed the Pennsylvania case briefly amid a batch of other such litigation in its quarterly report filed May 3 with the Securities and Exchange Commission. A link to the report is here. Under the category of "Average Wholesale Price (AWP) Litigation," was this passage:
Drugmaker Pfizer said Monday that it would begin selling its iconic erectile dysfunction drug Viagra online - a prescription is still required - in hopes of boosting profits and thwarting counterfeit online pharmacies.
As noted in Linda Johnson's Associated Press story, the pharmaceutical industry will watch this closely because it could change the dynamics of how drugs are delivered through the many layers of the current system.
Pfizer will market the drug through viagra.com, but CVSCaremark will handle the online processing. Patients must still get a doctor's prescription and the web site walks patients through the paperwork (insurance, billing information) required.