Breaking News on Biopharmaceutical Development & Manufacturing

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Finnish Medicines Agency: No evidence of adverse events from biosimilar switches

There is no evidence for adverse effects due to a switch from a reference product to an approved biosimilar and the “theoretical basis of such adverse effects is weak,” according to the latest statement on biosimilars from the Finnish Medicines Agency Fimea.

Novartis to assess biologics with micro-sugar-needle delivery tech

Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.

Remsima's US FDA review held back by contradictory demands, says Celltrion

Contradictory requests from the US FDA on the statistical analysis of Remsima are one of many regulatory hurdles facing biosimilar developers, according to Celltrion.

Biomay to use VTU's yeast-based tech for its allergen pipeline

Biomay has licensed a yeast-based expression system from fellow Austrian biotech VTU Technologies to use for the commercial production of its recombinant allergens.

CROs look to buttress research models businesses with CRISPR/Cas tech

As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’ research models.

Draft guidance stresses need for quality in development of gene therapies

The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.

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