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Alcon Snags Aerie Pharmaceuticals and Its Prescription Eyedrop Portfolio

  • Post author:PacConAdmin
  • Post published:August 23, 2022
  • Post category:Drug Industry Daily

Novartis spin-off Alcon will pick up Aerie Pharmaceuticals, expanding Alcon’s eye care products focus into the prescription pharmaceuticals arena. Source: Drug Industry Daily

Continue ReadingAlcon Snags Aerie Pharmaceuticals and Its Prescription Eyedrop Portfolio

Endo Loses Contested Patent Suit Just Days After Bankruptcy Filing

  • Post author:PacConAdmin
  • Post published:August 23, 2022
  • Post category:Drug Industry Daily

Days after announcing a bankruptcy filing to restructure more than $8 billion in debt, Endo International has lost a long-contested patent lawsuit, piling more woes on the beleaguered company. Source:…

Continue ReadingEndo Loses Contested Patent Suit Just Days After Bankruptcy Filing

Reforms Needed in FDA Advisory Committee Process, Says Former AdComm Member

  • Post author:PacConAdmin
  • Post published:August 23, 2022
  • Post category:Drug Industry Daily

The role of FDA advisory committees is “malleable” and the public would trust the FDA more if the agency aligned its decisions on drug approvals with the decisions by the…

Continue ReadingReforms Needed in FDA Advisory Committee Process, Says Former AdComm Member

Wockhardt Manufacturing Division Ordered by DOJ to Shut Down

  • Post author:PacConAdmin
  • Post published:August 23, 2022
  • Post category:Drug Industry Daily

Morton Grove Pharmaceuticals (MGP), a division of Mumbai, India-based generics maker Wockhardt, is shutting down operations at its plant in a suburb of Chicago after receiving a court order from…

Continue ReadingWockhardt Manufacturing Division Ordered by DOJ to Shut Down

Vifor Wins Patent Case Against Teva Over Phosphate-Controlling Velphoro

  • Post author:PacConAdmin
  • Post published:August 22, 2022
  • Post category:Drug Industry Daily

A Delaware federal judge has ruled that a planned generic from Teva Pharmaceuticals infringes on a patent on Vifor Fresenius Medical Care Renal Pharma’s Velphoro (sucroferric oxyhydroxide), a chewable tablet…

Continue ReadingVifor Wins Patent Case Against Teva Over Phosphate-Controlling Velphoro

FDA Slaps Sun Pharma With Form 483 for Allegedly Falsifying Documents

  • Post author:PacConAdmin
  • Post published:August 22, 2022
  • Post category:Drug Industry Daily

Indian generic drugmaker Sun Pharmaceuticals drew an FDA Form 483 for allegedly falsifying internal documents covering batch records, among other deficiencies, following an agency inspection of the company’s plant in…

Continue ReadingFDA Slaps Sun Pharma With Form 483 for Allegedly Falsifying Documents

FDA Updates Draft Guidance on Charging for Investigational Drugs With Additional Advice

  • Post author:PacConAdmin
  • Post published:August 22, 2022
  • Post category:Drug Industry Daily

The FDA has revised its 2016 draft guidance on charging patients for drugs under investigational new drug applications (IND) in clinical trials or expanded access programs. The updates, which pertain…

Continue ReadingFDA Updates Draft Guidance on Charging for Investigational Drugs With Additional Advice

Less Than 40 Percent of Drugs With Accelerated Approval are of High Therapeutic Value

  • Post author:PacConAdmin
  • Post published:August 22, 2022
  • Post category:Drug Industry Daily

The FDA’s accelerated approval program has come under fire again, this time from a group of researchers that found only 38.9 percent of new drugs green-lighted via accelerated approval demonstrated…

Continue ReadingLess Than 40 Percent of Drugs With Accelerated Approval are of High Therapeutic Value

Australian Biotech Will Seek Approval for Anti-Edema Drug

  • Post author:PacConAdmin
  • Post published:August 19, 2022
  • Post category:Drug Industry Daily

CSL has posted positive phase 3 topline results for garadacimab, a drug designed to prevent potentially dangerous attacks of swelling related to a rare genetic disorder called hereditary angioedema. Source:…

Continue ReadingAustralian Biotech Will Seek Approval for Anti-Edema Drug

Colorado Names Private-Sector Partners for Canadian Drugs Imports

  • Post author:PacConAdmin
  • Post published:August 19, 2022
  • Post category:Drug Industry Daily

Colorado has chosen three supply chain partners to help the state import lower-cost medications from Canada, in anticipation of getting the FDA’s approval to launch the program. Source: Drug Industry…

Continue ReadingColorado Names Private-Sector Partners for Canadian Drugs Imports
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