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

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

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.

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.

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.

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.

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

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

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

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

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

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

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

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

A new book by Robert Thomas, principal consultant at Scientific Solutions, provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues. Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb.

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

The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.

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.

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

Nik Leist’s keynote address will explore the manufacturing of digital medicines at the CPhI North America 2018 conference in Philadelphia, PA, on Wednesday, April 25, 2018.

Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.

Industry analyst Jim Miller will provide insight into the past, present, and future of the contract services market at the CPhI North America conference on Wednesday, April 25, 2018 in Philadelphia, PA.

The new premises have been built-to-spec to offer efficient, high quality, and environmentally friendly service to customers.

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