Randi Hernandez

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

BioPharm International sat down with Kevin Isett, PhD, co-founder and CEO of Avitide, to find out why he thinks the company’s tailored approach to purification resins will change the face of biopharmaceutical separation.

FDA should not release naming rules for biosimilars ahead of interchangeability guidelines, says the pharmacy benefit manager.

Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.

The deal to acquire Allergan will cost Pfizer $160 billion, and if the merger does not go through, CNBC reports the break-up fee would be $3.5 billion. The amount of the termination fee was calculated in advance of any further restrictions on tax inversion deals, however.

Pharmaceutical manufacturers should not be protected from antitrust litigation simply because FTC chooses not to pursue a lawsuit, the agency wrote in a recent amicus brief.

Global spending on medications will continue to rise, and it is expected to increase by $349 billion on a constant-dollar basis by 2020-more than $150 billion more than it increased during the past five years, according to a new IMS Institute for Healthcare Informatics report, Global Medicines Use in 2020: Outlook and Implications. Although the spending increase is large, total spending on medicines is expected to increase at a slower rate than it did over the past five years, when spending on medicines increased approximately 35%.

A landmark study by the National Institutes of Health determines that Lucentis is highly effective as a treatment for diabetic retinopathy.

Panelists at the meeting will focus on clinical trial design, immunogenicity, and enhancing implementation plans for administering already-licensed vaccines to this patient population.

AstraZeneca has agreed to acquire ZS Pharma for $2.7 billion, according to a press release from AstraZeneca. 

The company said its DevClin business will continue to be an integral part of its long-term biologics business growth strategy.

The new IVIG products boast improvements in purity, safety, and yield.

The testing laboratory will add capacity to strengthen its early-stage drug research capabilities for its small and large biotech clients.

According to Diplomat’s CEO Phil Hagerman, true specialty pharmacies are “not in the business of toenail fungus and teenage acne.”

According to Bio-Rad executives, the company’s adoption of its ERP system has created a backlog of projects.

All biosimilars for a specific product will be reimbursed with the same J-code under Medicare Part B regardless of manufacturer, according to a CMS rule that was proposed in July 2015 and finalized on Oct. 30, 2015. The rule was finalized prior to any formal guidance from FDA on interchangeable products.  CMS said it did not consider interchangeability into its decision, as there are no currently approved interchangeable biologics on the market.

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.

Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.

The company terminates its relationship with mail-order pharmacy Philidor Rx Services after allegations of improper accounting surface.

In 2016, Amgen will simultaneously fight off biosimilar competitors to its legacy products and prepare to file its own follow-on products with regulators.

The “next-generation” design for the pods will build on Pfizer’s existing modular prototype for oral solid-dose manufacturing.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

Valeant faces increased scrutiny for allegedly using its in-house mail-order pharmacy, Philidor, to keep drug prices artificially high.

Senator McCaskill deemed J. Michael Pearson’s response letter on drug pricing “inadequate.”

Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

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The results from an international study on nivolumumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.

Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.