True Pharma Innovation Lies in Quality, not Quantity, of Approvals, say FDA Analysts

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 tally is closely watched as a sign of the state of biopharmaceutical innovation and the health of the pharmaceutical industry and biomedical research enterprise.

But this focus on the quantity of new drug approvals is misleading, according to FDA analysts, because it fails to distinguish between truly innovative new therapies and those that are similar to medicines already on the market, explains Mike Lanthier, operations research analyst on the economics staff of FDA’s Office of Planning. While all NMEs offer some therapeutic advantage, those that are “first-in-class” and “advance-in-class” medicines represent important advances, he explains. Alternatively, “addition-to-class” therapies may provide useful options for patients, but not substantial advances over existing products. And it is this last category that has experienced the much-hyped decline in approvals in recent years, while more vital therapies are holding steady or increasing in number, Lanthier points out in an FDA Voice blog posted Aug. 6, 2013. This “more nuanced and informative” assessment of NME categories thus refutes fears of an “innovation gap” that threatens drug discovery.

One factor may be a rise in small biopharma companies developing more innovative drugs, while large drug companies have focused on refining blockbuster drugs for large patient populations. NMEs from small companies have increased notably since 1996 and now account for 50% of approvals, compared to roughly one-third in the past, Lanthier and colleagues explain more fully in an article in the August 2013 issue of Health Affairs.

FDA initiatives also may support these developments. Most innovative NMEs have benefited from priority review treatment, and the new breakthrough drug program and added incentives for new antibiotics and pediatric treatments promise to expedite the development of innovative therapies. It’s also possible, the authors say, that the increased influence of large pharmacy benefit management firms reduces reimbursement for pricey drugs that lack proven benefits.

Another measure of biopharma innovation may be the number of new drug applications filed with FDA, although the quantity-over-quality measure also may apply here.

Drug Development: To Sue or Not to sue?

Guest blog written by Dr Nicholas Jones, partner and patent attorney at Withers & Rogers LLP.

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. Read more »

Informex Perspectives: Still a Small-Molecule World

Patricia Van Arnum PharmTech editor As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

Will “Robust Pipeline” Yield More New Drugs?

Jill Wechsler Washington EditorBiopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in the pipeline globally, many for untreated diseases and life-threatening conditions. The promise is that this more robust pipeline will lead to more new critical therapies for patients. Read more »

A New Year in Pharma

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.

Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

Non-Profit Research Organization’s Mission Includes Hot-Melt Extrusion Studies

markarian online portraitThe Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion. I recently visited with the PPI researchers and toured their facilities. Read more »

Hot Melt Extrusion Research Continues

markarian online portraitResearch into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week. Read more »

Borders on Intellectual Property

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

Read more »

GlaxoSmithKline: A Rebuffed Suitor for the Moment

Patricia Van Arnum PharmTech editor Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.  Although rejecting GSK’s initial bid, HGS kept the door open for other suitors, including again GSK. Read more »

JOBS Act Passage—A Boost for Biopharma?

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. Read more »

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