A packaging problem has led Merck to recall 276,000 bottles of a cancer med because the child-proof feature can fail, allowing children to get their hands on the chemo drug.
Merck & Co.'s plant in Pennsylvania has been impacted by the drugmaker's drastic job cuts in the last 5 years, losing hundreds of manufacturing jobs. Now, in an email exchange made public by one of the unions there, a labor official has lashed out at CEO Ken Frazier, saying workers are now forced to work 16-hours shifts, the fatigue from which puts themselves and others in danger.
Hemispherx Biopharma has had a somewhat rocky relationship with both the FDA and the Street. But with a manufacturing upgrade complete and a distribution agreement in hand, it expects to return to the market its only approved product after a 7-year hiatus.
Mylan's recent recall of injected cancer drugs, was a hint that all was not well at some of the plants Mylan got two years ago in its $1.75 billion deal for Indian sterile injectables producer Agila Specialties. But just how deep those problems are came to light today when the FDA posted a warning letter for three of those Indian facilities, including one that was cited shortly before Mylan bought it.
The weeklong production hiatus at a GlaxoSmithKline plant in the U.S. is over. The British drugmaker has resumed making products at its plant in North Carolina that it closed a week ago after routine testing detected the bacteria for Legionnaires' disease in two cooling towers at the site.
The job cuts at Merck have been massive ever since its 2009 merger with Schering-Plough, 36,000 in 5 years. They have almost run their course, but manufacturing will make up most of what is left as it continues to shed manufacturing plants.
Denmark's Novo Nordisk has filling, packaging and a device manufacturing in the U.S., but when it comes to its insulin API production, it has kept that close to home. But CEO Lars Rebien Sørensen says it looks like it might be time to open its first plant in the U.S.
A pharma industry group in Australia has warned the government that it needs to do something to relieve the high costs of drug manufacturing in the country or continue to lose exports.
Denmark-based Xellia Pharmaceuticals bought a manufacturing facility from Fresenius Kabi last year and kicked off a $100 million expansion project on the Raleigh, NC, plant. Now the specialist in anti-infective treatments says it has decided it makes sense to have its U.S. commercial operations in the same locale.
GlaxoSmithKline expects to miss another couple of days of production at a plant in Zebulon, NC, while it disinfects cooling towers where the bacteria for Legionnaires' disease was detected. But the company said late Wednesday that the products were unaffected by the episode and that the 800 employees or so who have been biding their time since the plant was cleared Tuesday will be recalled once the facility returns to normal operating conditions.
Chinese drugmaker Jinan Jida has turned to a U.S. company to help it resolve plant issues that led the EU to suspend its certificate of suitability for the antibiotic nitrofurantoin last month.
India's Claris Lifesciences won FDA approval of its generic version of Lasix for sale in the U.S. last year, at which point, furosemide had been on the FDA shortage list for 18 months and there was big demand. But this year Claris ran into supply issues of its own, which it has now gotten on top of.
Sun Pharmaceutical Managing Director Dilip Shanghvi warned that the cost of fixing up the plants that it got in its Ranbaxy buyout was going to weigh on earnings, and indeed it has. But it actually was one of Sun's original facilities, one which the FDA has had issues with, that Sun named this week as the culprit for falling sales in the U.S.
The FDA has been doggedly pursuing Canada Drugs and its affiliates after it tied counterfeits of Roche's cancer drug Avastin to the online pharmacy and wholesaler. Now the feds have fired off an indictment with a host of charges that include money laundering and conspiracy in addition to selling illegal and counterfeit drugs.
Inhalers can be tricky devices to manufacture and for the second time in two weeks a drugmaker is having to recall inhalers because the devices may not deliver any drugs. Following last week's recall by AstraZeneca of asthma inhalers in Denmark, Boehringer Ingelheim is recalling in the U.S. tens of thousands of inhalers used to treat chronic obstructive pulmonary disease.
It was announced on the Bing blog that the search engine will push to consumers a warning message when they are about to land on a site that the FDA has tagged as fake.
Daiichi Sankyo has some new vaccines in the pipeline and is getting prepared for their production with the soon-to-be-completed expansion of a plant in Tokyo.
The FDA found itself several times in the last few years warning doctors to be on the alert for counterfeit Botox. But the agency said the two men at the top of the drug smuggling food chain have been sentenced after pleading guilty to charges they ran an illegal wholesale operation that distributed counterfeit, misbranded, and adulterated versions of Allergan's Botox in the U.S.
A Taiwan FDA plant inspector has been charged with taking more than $150,000 in bribes to pass on to Chinese drugmakers info on upcoming pharmaceutical inspections. The yearlong probe by Taiwan's Agency Against Corruption has also swept up the inspector's wife and executives and owners of 8 drug companies believed to have made payoffs in a scheme that some believe is much more widespread.
India has lashed out at the European Union, miffed over the EU ban of more than 700 drugs after finding issues in the clinical trials conducted by India's GVK BioSciences.