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GSK And HGS Face Off Over Buyout

 
• By Lisa LaMotta

Human Genome Sciences says the long-term blockbuster opportunity in Benlysta and the potential of its pipeline products are under-valued by GlaxoSmithKline’s takeover offer. Management at GSK, however, plays down any talk of increasing its bid.

GlaxoSmithKline Inc. and Human Genome Sciences Inc. made their case to investors regarding GSK’s proposed buyout of HGSI in back-to-back sales and earnings calls. HGS said the $13-per-share offer undervalues the company and played up the market opportunity for jointly owned pipeline drug darapladib during its April 24 first quarter sales and earnings call. Meanwhile, GSK defended its offer in a next-day conference call and pointed to the significant pipeline risks associated with darapladib.

“As far as HGS is concerned, we think we've made a very full offer for HGS,” said GSK CEO Andrew...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 
• By Francesca Bruce

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.

Global Pharma Guidance Tracker - July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.