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Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
One of the leading manufacturers of painkillers is calling for leniency from the Drug Enforcement Administration (DEA) if it decides to adopt new restrictions for hydrocodone combination products. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
Pfizer has confirmed it made an aggressive bid to merge with AstraZeneca in an apparent attempt to gain a lower tax rate and shore up its pipeline in the face of costly patent expirations. Read More
Drugmakers must now give Brazil’s Anvisa a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
The EU Parliament advanced major data privacy legislation, but not before amending two provisions that pharma companies had said would cripple clinical research. Read More
GlaxoSmithKline says it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More