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Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.

The assay will provide information on biosimilar comparability.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

International-domestic pharma partnerships will drive next wave of growth in China, according to new CPhI report on China.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

Evonik will acquire Transferra for an undisclosed amount, and the transaction is scheduled to close at the end of July 2016

A study by MilliporeSigma and the Economist Intelligence Unit reviews growth drivers and approaches to mitigate risk.

Califf appointed Richard Pazdur as acting director of the Oncology Center of Excellence under the Cancer Moonshot Initiative.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

Two recently published studies suggest that pre-exposure to the dengue virus (DENV) could predict a person’s reaction to the Zika virus (ZIKV) because of of the antigenic similarity between the viruses. One study was published on June 23, 2016 in Nature Immunology and the other on June 27, 2016 in Proceedings of the National Academy of Sciences of the United States of America (PNAS). Dengue and Zika are both mosquito-borne flaviviruses that are cross-reactive.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

The facility will be built in approximately 18 months using GE Healthcare’s KUBio modular facility solution.

Charles River acquired Blue Stream Laboratories, an analytical contract research organization.

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

A new facility in Marlborough, MA, will house laboratories to support GE Healthcare Life Sciences’ biomanufacturing and development operations.

ICH detailed the highlights of the council’s June 2016 meeting.

The cell lines have the potential to provide new medical applications for patients suffering from Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

Thermo will provide access to its instruments to NIBRT so that the Dublin-based group can generate helpful characterization data.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.