The FDA has followed the EMA in approving the Framingham, MA plant that Genzyme hopes will cut production bottlenecks.
News from Genzyme, Catalent and Futura – People on the move
Outsourcing-Pharma presents its weekly round-up of the latest happenings in the world of pharmaceutical employment, including news from Genzyme, Catalent and Futura.
Sanofi still suffering fall-out from Genzyme supply chain disruption
The fall-out from Genzyme’s supply disruptions is still hindering Sanofi, more than five months after taking over the business.
EMA OK for second Shire Replagal plant
Shire has received European Medicines Agency (EMA) approval for a new US plant, doubling purification capacity for its Fabry disease drug Replagal.
Bilfinger Berger wins €30m deal for work on Genzyme plant
Bilfinger Berger has won a €30m ($43m) contract to help Genzyme add 8,000L of production capacity at its site in Geel, Belgium.
Genzyme manufacturing issue causes Thyrogen shortage
Genzyme will be unable to meet demand for Thyrogen until July 2011 because of a manufacturing issue.
CEO: Sanofi may provide Genzyme with fill/finish long term
Sanofi Aventis’ CEO, Chris Veibacher, said the French drugmaker may look at providing some fill/finish capacity for Genzyme in the long term.
Genzyme lowers guidance after Fabrazyme production delay
Genzyme has lowered 2011 financial projections after delaying the date it expects Fabrazyme production to return to normal.
Genzyme sells genetics lab; amid talk of staff cuts
Genzyme has confirmed plans to sell genetic testing unit to LabCorp for $925m amid media rumours that 1,000 employees face redundancy.
US patients call for Fabrazyme patent break; Are you watching Sanofi?
Calls for US government to break Genzyme’s Fabrazyme patents accompany more speculation that French drugmaker Sanofi Aventis is in takeover talks.
EU majors reported to be looking at Genzyme
European drugmakers Sanofi-Aventis and GlaxoSmithKline (GSK) are rumoured to be looking at a possible acquisition of US biotechnology group Genzyme.
Genzyme inks expanded fill & finish deal with Hospira
Genzyme has entered into an expanded fill and finish manufacturing deal with Hospira as it works to move operations out of its Allston Landing plant.
Manufacturing changes extend Genzyme’s Fabrazyme shortage
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’s preliminary revenues dip
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.
Genzyme receives EMEA letter about Allston plant
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.
Genzyme hit with $8bn lawsuit
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.
Genzyme accused of cGMP deficiencies by FDA
The FDA has found “significant objectionable conditions” at the Genzyme manufacturing facility that makes Lumizyme, creating another issue in the product’s approval process.
Genzyme knockback has implications for biosimilars
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, Bioenvision merger on the rocks
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
Genzyme anticipates demand for thymoglobulin with new plant
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 and Genzyme agrees to terminate DX-88 contract
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).
Genzyme expands manufacturing capacity in Europe
US biotechnology company Genzyme invests heavily in Lyon, boosting
their biotech-production operations in Europe
Genzyme strengthens its gene therapy program
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