European Medicines Agency (EMA)

The Success Story of Biosimilars

With their triumphant advance, biosimilars are also setting in motion the usual market mechanisms. Biopharma interest groups warn against the automatic substitution of originator drugs.

EMA Reviewing Approval of Novartis’ Adakveo

The European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) has begun reviewing its marketing authorization for Novartis’ Adakveo, a medicine to prevent vaso-occlusive pain crises in patients with sickle cell disease.

AstraZeneca Withdraws US Vaxzevria Launch Plan

AstraZeneca (AZ) has announced it is permanently backing away from any plans to sell its Vaxzevria-branded Covid-19 vaccine in the US.

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 Gets Ready for Relocation Decision

EMA Approves AstraZeneca’s Lung Cancer Drug

US Gives Merck’s Antitoxin Priority Review

FDA Accepts Valeant-AstraZeneca Psoriasis Application

US Approves AstraZeneca’s Zurampic Gout Drug

Baxalta Gets EU Nod for Hemophilia Treatment

EU Commissions Backs New GSK Asthma Drug

Sanofi to Streamline Global Organization From 2016

EU Approves Sales of Sanofi’s New Diabetes Drug

European Price Wars Seen Shaping up Over Hepatitis C Drugs

Discovering the Future of Pharma

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

Ending Drug Trial Secrecy Is a Boon for R&D, Says EU Agency

Enzymes as a Catalytic All Rounder

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

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

Roche May Face Fines for Lax Drug-Safety Reporting

EU Agency Lifts Lid on Drug Data Secrets