News

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).

CDER director plans to start implementation of new review practices by the end of 2018.

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 World Packaging Organization will present a keynote session at CPhI discussing trends affecting pharmaceutical packaging, including user-friendly design.

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.

Nanjing-based PharmaBlock Sciences acquired a GMP-compliant manufacturing facility in Shangyu, China from Porton Pharma Solutions.

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.

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.

Finalists for the CPhI 2018 Pharma Awards, taking place on Oct. 9, 2018 in Madrid, have been announced.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Experts suggest health care providers and policymakers proceed with caution when exposing patients to the digital pill.

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.

A keynote session at CPhI will discuss how the trend to personalized medicine affects pharmaceutical packaging.

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

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 agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.

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

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

The company will be presenting at CPhI Worldwide on Oct. 11, 2018.

The company will showcase its line of connected devices at and its new PureHale portable drug delivery device designed for upper respiratory care.

Omya will showcase Omyapharm 500-OG (calcium carbonate and tribasic calcium phosphate) at CPhI Worldwide in Madrid, Spain, on Oct. 9–11, 2018.