1. Pink Sheet
  2. >>Geography
  3. >>Europe

Pressure For Bexsero: Fate Of Novartis Vaccines Unit Hangs On Success

 
• By Jessica Merrill

The EU CHMP’s recommendation in favor of Novartis’ Meningitis B vaccine Bexsero is a positive turn for the company’s vaccines business, but with the division’s sales and profits languishing, some investors are wondering if Novartis should cut its losses and get out of the space.

Novartis AG will soon have a new vaccine on the market in Europe, Bexsero (meningococcal group B) for meningitis B, if the European Commission follows through with approval of the product as expected. The commission’s advisory group, the Committee for Medicinal Products for Human Use (CHMP), issued a positive recommendation in favor of approving the vaccine Nov. 15, paving the way for approval of the product within three months.

Novartis hopes Bexsero will breathe life into its languishing vaccines business. The vaccine could be Novartis’ last chance to prove...

More from Europe

More from Geography

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."