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Rise and shine, everyone, another busy day is on the way. And this is shaping up to be another cloudy one here at the Pharmalot campus. Nonetheless, our spirits our sunny. You know why. The Morning Mayor taught us long ago that every brand new day should be unwrapped like a precious gift. So while you contemplate the possibilities, here are some tidbits to help you along. Hope you conquer the world today and, of course, do stay in touch …

Warding off syphilis may be more difficult for awhile, because Pfizer is experiencing a shortage of Bicillin L-A, an antibiotic that is the recommended treatment. The drug maker blames a “manufacturing delay” and will only be able to provide one-third of the usual monthly demand until July, according to this letter. The medication is the only one available for pregnant women who are infected with or exposed to syphilis.

A lab at the Massachusetts Institute of Technology has developed a prototype machine that produces 1,000 pills in 24 hours, which is faster than it takes to produce some batches in a real factory, NPR tells us. “If there was an emergency you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed,” says MIT professor of chemical engineering Allan Myerson.


GlaxoSmithKline received a boost thanks to a study showing its Breo inhaled drug for treating chronic obstructive pulmonary disease was significantly better than standard care, Reuters says. The findings may help blunt the failure of a trial reported last year in which the product failed to prolong life. Glaxo is relying on Breo, which was approved in 2013, to help defend its respiratory drug business as its older blockbuster Advair faces generic competition.

An FDA preliminary review ahead of an advisory panel meeting Tuesday expressed doubts about study findings and practical use of Novo Nordisk’s diabetes drug IDegLira, BioCentury says. A separate meeting will be held Wednesday to review a pair of Sanofi diabetes drugs, and MedPage Today points out that FDA staffers have reservations about a combination treatment.


Samsung says its biosimilar version of Johnson & Johnson’s Remicade has been accepted for review by the US Food and Drug Administration, the Wall Street Journal writes.

Allergan chief executive Brent Saunders says the drug maker is “weeks away” from closing the $40.5 billion sale of its generic medicines portfolio to Teva Pharmaceutical, Reuters informs us.

Valeant Pharmaceuticals chief executive Joe Papa would consider selling some assets but believes the Bausch & Lomb ophthalmic division is a “core franchise” worth keeping, the Rochester Business Journal says.

Johnson & Johnson’s Darzalex received a condition approval in Europe for treating multiple myeloma, according to Pharma Times.

A federal court dismissed a lawsuit filed by Takeda Pharmaceutical, which sought to prevent Hikma Pharmaceutical from selling a version of its Colcrys gout drug, Reuters reports.

  • This statement from the NPR article is a bit misleading. “MIT researchers say continuous monitoring would be built into the continuous production process. The Food and Drug Administration is working on how to oversee this type of process.” Yes, FDA is supporting PAT (Process Analytical Technology) and they are supporting continuous manufacturing. The concept of a ‘turn it on right now make any product line’ is not in keeping with the current regulatory framework.

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