Who’s got a powerful grip in biopharma?

Posted under Big Pharma, Blog, Companies, Diagnostics, EMEA, FDA, Funding, layoffs, Medical Devices, Medical Supply, NICE, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

In some cases, the most influential people in biopharma appear in these pages every day. They are the CEOs of the largest companies, who control the largest R&D budgets, the fates of thousands of employees and the medicines that impact millions of patients. When one of these company chiefs decides to move like a gangbuster into (or out of) a therapeutic or geographic area, a seismic shift in the industry could be in the offing. That's power.

Health regulators also hold lots of sway over drug approvals, and government bodies have certainly tightened their grips on reimbursements. So we can't forget the obvious influence of bureaucrats. Other times, there are people whose influence in the biopharma world isn't so obvious. Perhaps there's a federal judge in New Jersey or Massachusetts whose rulings have broken big holes in the corporate fortresses of giant drugmakers. Or a well-connected lobbyist on Capitol Hill who knows just what lawmaking levers to pull to determine a legislative outcome to benefit drugmakers. On the other hand, public health advocates can wield some clout, too.

Enough commentary. We want our readers to weigh in on whom should be selected for our list of the 25 most powerful people in biopharma. We expect that we'll receive nominations for the industry's usual suspects ("Calling Monsieur Viehbacher"), but we're also hoping to be surprised by some of the names you send to us. As we've done with previous features, we plan to factor reader submissions for this feature heavily into our decisions on the final list. Please check in with us after the new year to read the special report.

Please take a minute to fill out our online nomination form. - Ryan McBride (twitter | email)

AstraZeneca wins EMA backing for thyroid cancer drug

Posted under AstraZeneca, Blog, Cancer, Companies, Diagnostics, EMEA, European Commission, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vandetanib, Videos by Ryan McBride

AstraZeneca ($AZN) has gained support for its cancer drug vandetanib from European regulators, paving the way for a potential approval of the drug in the EU for advanced forms medullary thyroid cancer. However, the drug--once a blockbuster hopeful that garnered U.S. approval for MTC in April--has been knocked down a few notches.

The European Medicines Agency backed AZ's application for approval of the drug, a kinase inhibitor, for treating patients with aggressive and inoperable cases of MTC, the least common of the four types of thyroid cancer. They threw their support behind vandetanib after reviewing data from a late-stage study of 331 patients with aggressive MTC that had spread to other organs. Patients on the drug had a 54% reduction in risk of the disease getting worse than those in the placebo camp.

However, European regulators recommended the approval come with a caveat that MTC patients whose RET mutation status is negative or unknown might not benefit from the drug as much as those with the mutation. AstraZeneca said clinical trials show the drug benefits the non-RET set of patients, but it's planning another study to provide more evidence of that.

With a U.S. approval already in place, analysts expect annual sales of the drug, marketed as Caprelsa, to hit $112 million in 5 years, Reuters reported. That's a far fall from the earlier blockbuster figures industry watchers were predicting when the drug was still in the running to treat the big non-small cell lung cancer population. The drug failed to succeed in clinical trials involving patients with lung cancer.

The European Commission now gets the final say on whether the drug gains approval for the niche MTC indication in the EU. Europe doesn't have any approved drugs for the advanced MTC cases the drug aims to treat, and outcomes for patients with the cancers have not improved much over the past two decades, according to AstraZeneca.

- here's the release
- check out the Reuters article

Related Articles:
AZ wins tightly-limited FDA OK for new thyroid cancer drug
Panel back's AZ's ($AZN) thyroid cancer drug vandetanib
FDA cites vandetanib toxicity ahead of AZ panel review