PharmTech Talk

Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA,

Industry, the public sector, and individuals can play an important role in creating solutions.

In attending the exhibitions and conference sessions at Interphex 2012 this week in New York, we gain a pulse on the current and future state of pharmaceutical manufacturing.

Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment.

Abbott Laboratories submitted a Citizen’s Petition to FDA, requesting that the agency not consider any applications for biosimilar versions of its monoclonal antibody therapeutic.

In the last five years, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized counterfeit drugs worth more than £25 million ($41 million), but the war isn’t over yet.

The Obama Administration released last week the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy.

PDA is hosting a few interesting workshops in the coming weeks on key topics facing the industry.

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices.

The past month has seen a lot of news about the pharmaceutical industry’s positive influence in developing countries.

Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients.

Apr. 16, 2012 marked the closing date for submitting comments on FDA’s draft guidance documents clarifying the approval process for biosimilars.

Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management.

Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.

For some time, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been working on developing a European verification system to help combat falsified medicines.

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts.

Here in sunny Arizona, PDA is holding its annual conference, a chance to present data and discuss all aspects of sterile manufacturing. The theme for the first day of sessions was personalized medicine.

Researchers at the Massachusetts Institute of Technology (MIT) recently developed nanoparticles that can be controllably triggered to synthesize proteins.

In February, I wrote that Roche could be in for a lengthy battle if it wants to acquire the gene-sequencing specialist Illumina.

The industry is increasingly adopting continuous processing models as it works to gain better process understanding and control, an approach that is being encouraged by regulators under the QbD paradigm.

In contentious three days of hearing on the Affordable Care Act, the Supreme Court now seems far more likely to overturn the landmark legislation.

Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011.

With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight.

The confluence of science, technology, and regulation can provide path forward.

Historically, the pharmaceutical industry had the luxury of accepting lower manufacturing utilization rates compared to other manufacturing industries given the higher margins for their products.

The 2009 swine flu pandemic (and panic) has been forgotten by most, but regulators, global health organisations and pharmaceutical companies are continuing post-pandemic activities.

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart.

Personalized medicine is gaining traction as scientists gain greater understanding of disease processes.