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Reinspection lands Alexion with 483 for Soliris plant

Reinspection lands Alexion with 483 for Soliris plant

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

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News in brief

Johnson & Johnson subsidiary Janssen has acquired monoclonal antibody (mAb) platform FynomAb through its purchase of private Swiss biopharma company Covagen.

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.

Between 70-80% of ADC (antibody drug conjugate) manufacturing is performed by CMOs, according to a new report .

Global Industry News

Volunteer drug users: the highs and lows of addiction trials from Outsourcing-Pharma.com

CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.

Recipharm: 'Client investment gives us competitive edge in CDMO space' from Outsourcing-Pharma.com

Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.

DEA approves manufacture of GHB at Patheon Cincinnati plant from Outsourcing-Pharma.com

Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

USP joins campaign against illegal online pharmacies from in-PharmaTechnologist.com

Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Catalent contract secure as Roche buys InterMune for $8.3bn from Outsourcing-Pharma.com

Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).

Argentina to allow Indian drug imports after inspecting five plants from in-PharmaTechnologist.com

Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

Spotlight

Kentucky firm ramps production of plant-based antibodies for Ebola

Kentucky firm ramps production of plant-based antibodies used to treat two Ebola patients

Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment...

Pfizer buys Baxter's vaccine business plus Austrian plant for $635m

Pfizer buys Baxter's vaccine business plus Austrian plant for $635m

Pfizer has agreed to pay $635m (€474m) to Baxter International for its vaccine business, including two marketed...

Where are tomorrow’s biosimilar hotspots?

Where are tomorrow’s biosimilar hotspots?

As the US FDA (Food and Drug Administration)’s biosimilars pathway is tested for the first known time...

GSK files world’s first malaria vaccine

GSK files world’s first malaria vaccine

GSK has submitted an application for the world’s first malaria vaccine to the European Medicines Agency (EMA)....

J&J's Janssen remains confident in Remicade despite biosimilar threat

Biosimilars will not erode sales like generics, says J&J

Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson...