
AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.

Catalent Pharma Solutions’ technical project manager, Elanor Pinto-Cocozza, PhD, will present at InformEx 2016.

Systag, a Swiss fine chemicals and process automation company, appeared at InformEx 2016

InformEx, a conference for the fine and specialty chemicals industry, kicked off on Feb. 2, 2016 in New Orleans.

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Suppliers must develop new technologies to drive the bio/pharma innovation engine.

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

The chemical distribution industry has formed an international chemical trade association to address global issues.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

Amgen announces FDA will review the company’s BLA for ABP 501.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Vetter announces completion of multi-functional building for development service and IT functions.

Siemens and ADENTS develop joint solution for drug serialization challenges.

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.