News

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Kangstem Biotech has selected Orgenesis subsidiary, MaSTherCell, as its contract manufacturing partner for the European clinical trial of Furestem-AD.

Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.

The divestiture of the European generic-drug business of Sanofi-Zentiva-to Advent International has been completed.

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.

The companies collaborated to launch a new cell-based profiling service for biochemical assay.

CPhI releases the bio trends portion of its annual report, which predicts an increase in bioconjucation expertise and biopharma productivity over the next five years.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

The agreement now includes 15 European Union (EU) member states.

The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.