Outsourcing-Pharma presents its weekly round-up of the latest happenings in the world of pharmaceutical employment, including news from Genzyme, Catalent and Futura.
Changes to manufacturing practices at Genzyme’s plant have led to further shortages of Fabrazyme (agalsidase beta), with production expected to remain below 30 per cent of demand until after June 30.
Genzyme has reported a small dip in preliminary fourth quarter and full year revenues, driven by declining sales of Cerezyme and Fabrazyme which have been affected by manufacturing problems.
The EMEA has issued US biotech firm Genzyme with a letter detailing “one major observation and several other observations” following an inspection of its Allston, Massachusetts manufacturing plant last month.
Shareholders have filed an $8bn (€5.7bn) lawsuit against Genzyme alleging that the company’s CEO “issued a series of materially false and misleading statements” about its manufacturing problems.
The FDA has found “significant objectionable conditions” at the Genzyme manufacturing facility that makes Lumizyme, creating another issue in the product’s approval process.
The problems facing companies trying to bring 'biosimilar' versions
of biologic drugs to market were thrown into stark relief yesterday
when the US Food and Drug Administration (FDA) refused to approve
Genzyme's genetic...
A major shareholder in Bioenvision could seriously compromise the
biotech company's proposed $345m (€242m) takeover by Genzyme as it
is preparing to vote against the merger arguing the offer is too
low.
Genzyme is expanding its manufacturing capabilities of
thymoglobulin in France as it moves to meet the growing demand and
future potential of the rabbit serum derivative.
Dyax announced that it has reached a mutual agreement with Genzyme
to terminate their joint venture for the development and
commercialization of DX-88 for hereditary angioedema (HAE).
With two acquisitions in two months, US biotechnology major Genzyme
has strengthened and diversified its ability to develop gene
therapy products that use either adenovirus or adeno-associated
virus vectors.
