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STAT+: Pharmalittle: We’re reading about a generic HIV prevention shot, Lonza buying U.S. facilities, and more

By · Via STAT Health · Published by Everything Blog

In short

The U.S. Food and Drug Administration granted tentative approval to Dr. Reddy’s Laboratories for a generic HIV prevention drug, paving the way for broader global access. Priced at just $40 per person annually, shipments of the preventative shot will begin next month with the backing of international health groups. On the manufacturing side, Lonza is acquiring five U.S. production facilities from Merck KGaA, which is divesting the sites to concentrate on drug development. This major acquisition broadens Lonza's footprint across four states to support advanced cancer and gene therapy output.

Key points

  • Tentative regulatory clearance will expand affordable preventative HIV options to dozens…: Tentative regulatory clearance will expand affordable preventative HIV options to dozens of low- and middle-income countries.
  • The multi-site acquisition more than doubles Lonza's manufacturing presence in the United…: The multi-site acquisition more than doubles Lonza's manufacturing presence in the United States to nine total facilities.
  • The facility transfer allows Merck KGaA to focus resources on drug development while boos…: The facility transfer allows Merck KGaA to focus resources on drug development while boosting Lonza's gene and cancer therapy production.

Sources checked by our analysis pipeline: 1

Top of the morning to you. And a fine one it is here at the Pharmalot campus, where the official mascots are snoozing away and a breathtaking autumn landscape is visible in all directions. Moreover, a warm and shiny sun is making a welcome appearance. To celebrate, yes, we are downing a cup of stimulation — hot buttered rum is our preference today. Feel free to join us. As always, here are your tidbits. Hope your day goes well and you conquer the world. …

After months of anticipation, the U.S. Food and Drug Administration gave tentative approval to Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine, a key step in widening access for dozens of low- and middle-income countries, STAT says. The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible. The annual cost per person will be $40, comparable…

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