Randi Hernandez

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.

Senators encourage the repatriation of offshore funds in a new report targeting the pharmaceutical industry.

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.

The 12th Annual Report and Survey of Biomanufacturing is now available.

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results-and costs-of popular cancer medications.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

Will biosimilars share a compendial identity like generic drugs do?

New test methods can streamline drug development by bringing safety testing of raw materials directly to the manufacturing floor.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

The rapid testing of biologic raw materials can lead to greater efficiency.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Novartis will make payments to Juno to settle a patent dispute covering chimeric antigen receptor T-cell (CAR-T) therapies.

The system is compatible with a wide range of industrial CHO cell lines.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.