India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »
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.
The pharmaceutical industry is shifting away from the blockbuster model towards the development of personalized medicines and niche, individualized therapies and associated companion diagnostics, noted Sam Venugopal, director, healthcare, PricewaterhouseCoopers. These drugs target specific populations and genomic makeups and are known to have greater efficacy. William Botha, Sensei at Interlean, added that there will also be companies moving towards commodity-based, low-margin products. As a result, one can expect to see increased specialization, particularly amongst small and medium companies. Read more »
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.
“Our vision of success is to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research,” stated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom as it unveiled its 2013–2018 corporate plan on 11 April. The agency announced its aims to be a leading regulator on the world stage in supporting science and research as part of its five-year corporate plan, which was developed using responses from a public consultation launched last December. Read more »
Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »
Janssen is partnering with the UK National Health Service (NHS) on a new programme that seeks to inspire innovative ideas that will help reshape and improve the way dementia care is delivered. The company recently launched the inaugural NHS innovation challenge prize for dementia, which is designed to harness the expertise of those working at the frontline of dementia care in the UK. Janssen is offering a prize of up to £150 000 for solutions that can make a real and sustained difference to the lives of those affected by dementia, both directly and indirectly. Read more »
President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation. So how has the pharmaceutical industry responded?
In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »
Consultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialise new innovations. The company has been published the index for three years and uses publicly available data to reach its conclusions. Read more »
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!