BioPharm International Editors

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

CPhI North America 2018 is hosting a forum for female pharmaceutical professionals to network, collaborate, and share their perspectives at this year’s conference.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.

Shashank Upadhye, Esq., managing partner at Amin Talati Upadhye, will discuss intellectual property/patent issues for active pharmaceutical ingredients and abbreviated new drug applications at CPhI North America in Philadelphia, PA, on Tuesday, April 24, 2018.

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The contract development and manufacturing organization announced the addition of a new building complex that will house its headquarters in Bothell, WA.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.

The contract service provider will invest in a laboratory expansion at its site located in Tredegar, Wales, UK.

A new scientific publication examines analytical processes for the emerging legal cannabis industry.

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

The contract research organization has added a new analytical laboratory in Middleton, WI, to expand its biologics testing capacity.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.

The company’s Krios G3i cryo-electron microscope is a finalist in the 2018 Edison Awards.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.

Takeda is considering approaching Shire with a possible offer.

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.

Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.