HHS OPDP Letter Rips Kadmon Pharmaceuticals for Marketing Claims
The Office Of Prescription Drug Promotion has sent a nasty warning letter to Kadmon Pharmaceuticals this month. The Department of Health and Human Services agency, which must ensure that drugmakers’ claims do not go too far, sent a stern warning letter to Kadmon regarding a letter that it sends out with the Ribasphere RibaPak. OPDP […]
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Layoffs Continue in Pharma in November
Earlier in 2013, Merck, Astrazeneca and Eli Lilly announced restructuring that has led to disappearing jobs. Much of the cuts were related to poor clinical trial results and revenues that were dropping because of generic competition. This week, Novartis, Bristol Myers Squibb and Ariad have announced that they also are cutting jobs. At Novartis, the […]
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J&J to Pay $2.5 Billion to Settle Hip Replacement Lawsuit
Johnson & Johnson this week stated that it will agree to pay out $2.5 billion to settle tens of thousands of suits from hip replacement patients who say that they were sold implants that were faulty that caused injuries and more surgeries. The agreement will bring to an end about 8000 cases of patients who […]
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Merck Ends API Production at Plant in Puerto Rico
Merck announced last week that it was ending API production at one of its key plants in Puerto Rico. This is a major blow to the city of Barceloneta, which was once considered a major pharmaceutical hub there. Merck stated that the production at the plant will be ended in 2014, as part of a […]
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Chicago Government Issues Subpoena to J&J in Investigation
The Rahm Emmanuel administration is conducting an investigation into a branch of Johnson & Johnson for allegedly engaging in deceptive marketing of painkillers to employees of the City of Chicago. This information is according to a petition that was filed in Cook County Circuit Court, which is trying to force the company to divulge six […]
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House of Representatives To Grill FDA on FDASIA
A year has passed since Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) act. Now, legislators are wondering how the law is doing, and an upcoming hearing this week answer some questions that Congress has. FDASIA was passed in 2012, and has provisions that include both user fee programs and reforms. […]
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Another Nasty 483 for Hospira
Hospira this week got another 483, this time for three cGMP violations for its plant in Kansas. Most of the focus on Hospira has been with the Rock Mount NC plant and all of the problems and warning letters it has gotten from FDA. But CEO Michael Ball also told stakeholders last week about a […]
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What You Must Know About New Cholesterol Guidelines
The American Heart Assn. and the American College of Cardiology this week came out with new cholesterol guidelines that are designed to cut down on cardiovascular risks. They are a marked change from the last guidelines, which were last updated 9 years ago. Here are the most important things that people must know: 1. The […]
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Shire Cutting More UK R&D Jobs – CEO Overhauls Operations
Shire Pharmaceuticals Plc is cutting UK research jobs and is going to move its Swiss operations as one part of a large reorganization that is being spearheaded by CEO Flemming Ornskov. About 200 employees at Shire’s HQ in the UK in Basingstoke may lose their jobs. The company also is planning to move its Swiss […]
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FDA Trying to Increase Placement of Auditors in China
FDA has reported this week that getting visas approved for new FDA inspectors in China is taking longer than they hoped. The idea was for FDA to double its presence in that country. The delays are continuing as FDA has only eight auditors based in China. It asked the government there in 2012 about being […]
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