News

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

Insulin has been shown to improve the production of viruses and viral vectors.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

The company announced plans to begin shipping Inflectra to the US market in late November 2016.

A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

The companies will collaborate the manufacture of personalized cancer vaccines.

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

A new study proposes a new way to potentially treat congenital diseases in utero.

The company invested more than CHF 100 million in a new Delaware manufacturing plant.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

Marken announced the opening of a new depot and logistics operations center in Argentina.

The companies entered into a collaboration and license agreement for Crescendo’s Humabody-based therapeutics.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.

Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.