News

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.

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

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.

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

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

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

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

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

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.

The new website, dubbed “Integrated Solutions”, helps clients implement single-use solutions and hybrid biomanufacturing processes.

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

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

GS1 US announces the expansion of its advisory services program to address industry needs.

Austrianova completes facility for GMP cell banking and fill/finish services for cell therapy products.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

SGS Life Sciences expands chemistry and microbiology testing services after acquisition of Quality Compliance Laboratories.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.