Industry news

Early-stage biotech funding at risk from drying well

Ben Adams / FierceBiotech

Funding streams for early-stage biopharma and med tech research dwindled in 2015, as investors shifted their support to bigger companies--potentially cutting off the lifeblood for future life sciences R&D.

European drug regulators report lots of plant issues in first quarter

Eric Sagonowsky / FiercePharmaManufacturing

Not even three months into 2016, the European Compliance Agency says that drug regulators on the continent have taken to task a dozen pharma plants around the world for substandard manufacturing practices.

Partnering deal flow continues its torrid pace to start year

Peter Winter, Karen Carey / BioWorld

Two deals alone contribute about 20 percent of the almost $16.7 billion in total biodollars associated with the deals that revealed financial terms in the first two months of this year – well ahead of the totals raised in the same periods of 2015 (+15 percent) and 2014 (+146 percent). The number of deals tracked by BioWorld, however, remained about the about the same, with 143 so far this year, an increase of about 6 percent over the same period last year.

Japan’s Biopharmas Respond to Price Cuts with Plans for Innovation, Expansion

Richard Smart / Life Sciences Connect

Japanese biopharmaceutical companies are bracing for tough years ahead, as cuts in the costs of medicine at home and issues of getting new drugs to the market begin to bite. For some, the response is to step up development of new drugs.

Scientists create insulin-producing patch made with beta cells to replace insulin injection

Stacy Lawrence / Fierce Medical Devices

In the last few years, researchers have gotten very good at mass-producing pancreatic beta cells that produce sufficient insulin to offer improvement for diabetic patients. But now, they're focused on inventing and testing the means to use these beta cells in a way that effectively introduces insulin into the system--while simultaneously protecting the cells from a patient's immune system.

How Important is Data Integrity to Regulatory Bodies?

Bob McDowall, Joanne Ratcliff / BioPharm International

D3Damon/Getty ImagesData integrity is a major regulatory topic in GMP-regulated laboratories. The problem is widespread, as cases of non-compliance have also been observed in laboratories regulated by good laboratory practice (GLP) and good clinical practice (GCP), not just GMP. Non-compliances from the European Medicines Agency (EMA) or warning letters from FDA show examples from companies in the United States, Canada, the United Kingdom, and Italy, as well as China and India. So, it is not just a problem for Asia—it is a global issue.

How will competition among PE fund managers affect future industry performance disparity?

Garrett James Black / PichBook Blog

Post-recession private equity funds experienced a tightening of IRR spreads across several different vintages, as fund managers of all tiers weathered the economic downturn. 2010 and more recent vintages, however, have seen a widening of the spread.

Tearing down barriers to cooperation with strengthened intellectual property protections

PhRMA

Robert Frost once wrote, “Good fences make good neighbors.” To make good neighbors, Frost suggested that we need to respect the boundaries that exist between us. But what if it’s actually the walls that alienate us from one another? And what if, to truly make good neighbors, we must tear down the barriers in order to promote better cooperation?

No One Likes the Medicare Part B Pilot

Jill Wechsler / BioPharm International

This time, doctors and oncologists agree with pharma companies in opposing the latest proposal from the Centers of Medicare and Medicaid Services (CMS) to revise how it pays for drugs administered in doctors’ offices. Similarly, many patient advocates fear that ceilings on drug prices will curb access to newer therapies, and leading Republicans have rebuked the plan.

Four trends that will transform healthcare in Europe in 2016

Warren Hochfeld, Jenna Riffell and Neil Levinson / Europian Pharmaceutical Review

With 2015 giving some hints of what is to come, the Kaiser Associates European Healthcare team are predicting another year of big disruptions, transformations and innovations as the healthcare industry continues to overhaul outmoded business models.