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South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

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.

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.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

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

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

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

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

Regeneron announced additional investments to its Limerick, Ireland biologics production facility.

The agency gives an update on the regulation of combination medical products.

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

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Merck relaunches brand identity to reflect transformation into a science and technology company.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

Avantor released a packaging platform that allows for the direct dispensing of chemicals-such as salts, buffers, and cell culture ingredients-into processing equipment.

The process provides an alternative to the sterilization of cartridges and vials with ethylene oxide (EtO).

Hiroaki Suzuki will lead Vetter’s business activities in the new Tokyo-based office.