Pharma Intelligence

Pharma Intelligence
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Pharma Intelligence

 •  April 18

Executive Summary Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these...

Pharma Intelligence

 •  April 18

Executive Summary The EU’s centralized drug approval process will not be disrupted regardless of the number of employees the European Medicines Agency might lose when it relocates from London to Amsterdam, Guido Rasi pledged yesterday at the the DIA Europe 2018 conference.

Pharma Intelligence

 •  April 18

Executive Summary Kuwait is the latest market in the Middle East to introduce a new regulatory procedure for speeding up market entry of innovative new drugs. However, industry experts would like to see it go further.

Pharma Intelligence

 •  April 18

Executive Summary The need to update the European Pharmacopoeia text on gene therapy products (GTPs) has prompted the reactivation of the GTP working party, which has been dormant until now.

Pharma Intelligence

 •  April 18

Executive Summary The message is unmistakably clear: new policies are putting China first to make drugs more accessible and affordable, including widely prescribed products for cancer. Tactics including compulsory licensing, tax incentives, and substitution to support the use of domestic generics should ring alarm bells for multinationals,...

Pharma Intelligence

 •  April 16

Executive Summary Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  April 16

Executive Summary The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.

Pharma Intelligence

 •  April 12

Executive Summary The European Commission’s strategy on Pharmaceuticals in the Environment is expected to be published by the summer. The pharmaceutical industry has concerns about what it is likely to include. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  April 10

Executive Summary As a simmering trade dispute between the US and China looks set to continue worsening, many companies in the pharma sector are closely watching what's coming and getting ready for any disruption. But what is the actual and predicted impact on exporters and producers in China, India and the US?

Pharma Intelligence

 •  April 6

Executive Summary US FDA has issued at least 10 GMP warning letters in February and March to drug and API manufacturers in China, India, France, South Korea, Hong Kong, the Dominican Republic and the US. Common problems seen are failure to validate manufacturing processes, inadequate testing to conform that products meet specifications, and...