PharmTech Talk

Guest blog written by Walter Morris, Director of Publishing, Parenteral Drug Association, on behalf of the PDA Quality Metrics Task Force.

CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.

It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past.

Officials from FDA and the National Institutes of Health (NIH) were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week.

US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget.

Public outrage over deaths from contaminated injectibles produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation.

Healthcare spending will rise modestly in the US over the next decade, as economic growth picks up, health reform provides expanded coverage, and the population continues to age, according to an annual analysis from the Centers for Medicare and Medicaid Services (CMS).

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force.

Product quality is of paramount importance to pharmaceutical manufacturers, and implementing a strategy for impurity control is crucial.

With the increasing use of high-potency APIs, it is more important than ever to have an appropriate containment strategy to protect both the quality of your product and the safety of your personnel.

A team of scientists recently reported on the first study of interactions between the antiretroviral drug, amprenavir, and the HIV-1 protease enzyme.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Craig Stobie from Domino Printing Sciences shares on how to prepare for FMD and other emerging legislation.

Guest blog written by Adrian Tombling, partner and patent attorney at Withers & Rogers LLP.

We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market.

The Food and Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the US Court of Appeals for the District of Columbia.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world.

Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week.

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases.

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics.

Quality is of utmost importance in drug development and manufacturing.

Risk and reward. It is a balance that has to be achieved in any business endeavor and is of utmost importance for pharmaceutical and biopharmaceutical companies managing their growth and manufacturing in emerging markets.

It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals.

International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance.

The US Food and Drug Administration and industry have been working to incorporate process validation as an integral component of drug development and production, and to avoid divergent policies in the US and Europe.

The issue of patients not receiving essential medicines because they cannot afford them is becoming a serious problem in the EU as the region battles through its economic crisis.

FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality.

The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain.

Evidence of health outcomes is what payers want to see. As a result, biotech companies are now focussing more on demonstrating economic value, for example, by showing survival benefit of a cancer drug or superiority to branded or generic competitors.

AstraZeneca and Exco InTouch have announced a program to develop and launch interactive mobile phone and internet-based health tools that will help patients in the UK and their healthcare providers to track and manage chronic conditions.