EMA

EMA’s CHMP Greenlights Omicron-1 Vaccines

The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and Moderna, combining protection against the original Omicron variant as well as the wild type that emerged in China in early 2020.

EMA Opens in Amsterdam

France and Germany plan for hard Brexit

Amsterdam Beats Milan to Host EMA

EMA Gets Ready for Relocation Decision

EU and US Mutual Recognition Pact Begins

EU and USA in Medicines Inspections Pact

Journalists Unhappy with Drugmaker Communications

Pharma Chiefs Call for Decision on EMA

Union Wants Germany to Apply for EMA

Denmark Joins Crowd Offering EMA Post-Brexit Base

Report Warns Brexit Could Delay Access to Drugs

EMA to Review Merck KGaA’s MS Tablets MAA

Novartis Sticking With UK, Sees Lower US Prices

UK Drugs Industry Forms Brexit Steering Group

Biogen Alzheimer’s Drug Accepted for EMA PRIME

Discovering the Future of Pharma

Eli Lilly Copy of $8 Billion Sanofi Insulin Wins EU Approval

GDUFA’s Impact on the API Industry – an Update

GSK Combined Melanoma Treatment Delayed in Europe

EU Looks to Speed Drug Access With Staggered Approval

GDUFA’s Impact on the API Industry

Europe Backs New Dual-Action Novartis Lung Drug

Sanofi’s Chris Viehbacher: EU’s Drug Data Stance Threatens Investment

Court Stops EU Regulator Releasing Drug Company Data

AbbVie Delivers on Scorching Humira Drug Sales Growth

Biogen Wins EU Backing for Big New MS Drug Hope

Antibiotics Crisis Prompts Rethink on Risks, Rewards

Switzerland's Roche Pledges to Open Up Access to Drug Data

GSK Vaccine Ingredient Scrutinized for Narcolepsy Clues

US FDA New Drug Approvals Hit 16-Year High in 2012

Number of New Drugs Picks Up in Europe and U.S.

Lundbeck's Alcohol Dependency Drug Gets EU Green Light

EU Agency Rejects Sanofi, Isis Cholesterol Drug

Roche Offers Compromise in Flu Drug Row