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Novartis/Chiron: Validating the Value of Vaccine R&D

 
• By Cole Werble

Nothing solidifies the emergence of a hot investment sector like a big investment of cash, and Novartis AG provided that with its two-stage $5.7 billion close out of the remaining shares of Chiron Corp. that it did not already own (W#200510159). Novartis bought $300 million worth of Chiron's stock in December 2005 and then closed out the deal with $5.4 billion in April 2006.

Nothing solidifies the emergence of a hot investment sector like a big investment of cash, and Novartis AG provided that with its two-stage $5.7 billion close out of the remaining shares of Chiron Corp. that it did not already own [See Deal]. Novartis bought $300 million worth of Chiron’s stock in December 2005 and then closed out the deal with $5.4 billion in April 2006. That’s a noteworthy price, representing a direct investment to purchase one company in the vaccines sector for a price equal to almost 60% of the total current sales of the whole segment (estimated at about $10 billion currently).

Almost as important as Novartis’ dollars in validating the value of the vaccine business is the rhetoric that the Swiss...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from Pink Sheet

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.