�鶹Ů��

Spark Therapeutics Inc., which developed the gene therapy to cure a rare form of childhood blindness called RPE65-mediated inherited retinal disease, is among the first to face this question. Spark’s treatment, voretigene neparvovec, delivers a functioning piece of DNA directly to the eyes to preserve remaining sight and even restore some vision. Other companies, including GlaxoSmithKline Plc and BioMarin Pharmaceutical Inc., have also been grappling with the pricing problem. (Chen, 4/6)

The General Assembly passed a bill that would give the state attorney general powers to sue drug manufacturers that dramatically raise prices, a first-in-the-nation measure aimed at protecting patients from what the measure brands "price gouging." The bill was the top priority for health care advocates during this year's session. (Duncan, 4/10)

No one seems to like drug companies these days, whether because their products are too expensive, their leaders are overpaid, or their marketing is sometimes less than legal...The campaign, and PhRMA by extension, is taking up a difficult task. The explicit message is that the industry’s scientists are dedicated to the time-consuming, difficult, and expensive work of finding new cures. But the public backlash is almost entirely tied to high drug prices, which the industry insists are necessary to fund all that telegenic science. (Garde, 4/6)

Once again, congressional lawmakers have introduced a bill that would end a practice that generic drug makers complain is used by brand-name rivals to thwart competition. Known as the Fair Access for Safe and Timely Generics Act, the bipartisan legislation comes amid ongoing complaints that brand-name drug makers sometimes refuse to provide samples to generic companies. They need samples to prove their copycat versions are equivalent to brand-name drugs in order to win regulatory approval. The issue has also caught the eye of the Federal Trade Commission. (Silverman, 4/7)

More than two years after hedge fund manager Kyle Bass started his quixotic crusade to challenge pharmaceutical patents he said lead to inflated drug prices, he doesn’t have much to show for it. Patents on only three of the 14 medicines Bass’s Coalition for Affordable Drugs targeted at the U.S. patent office were invalidated. None led to lower drug prices. Short-term share drops in companies he petitioned didn’t endure. And late last month a generic-drug company achieved what Bass could not: Patents he unsuccessfully challenged on Acorda Therapeutics Inc.’s multiple sclerosis drug Ampyra were thrown out in a court case, opening the door to cheaper versions as soon as next year. (Decker, 4/10)

Drug manufacturers and the companies that pay for drugs are once again squabbling over why medicines are so expensive. That has the potential to upend the opaque and very profitable three-way relationship among pharma companies, insurers and pharmacy-benefit managers. Shares of all three are vulnerable. (Grant, 4/9)

Greenleaf Health may be the most influential FDA consulting firm you’ve never heard of. Operating out of the Georgetown end of K Street, on Washington Harbour, Greenleaf has built an enormous business advising life science companies how to get their products through FDA review, fend off enforcement actions, and otherwise stay out of trouble. (Kaplan, 4/11)

Hedge fund manager Kyle Bass appears to be wrapping up a generally unsuccessful patent-law assault on drug manufacturers. “In the end, lobbying and special interests pay,” Bass told Bloomberg in a defeatist-sounding email. “Medicare and U.S. consumers pay the ultimate price for the evergreening of bad patents by the pharma cabal.” (Barrett, 4/10)

Don’t believe everything you read on the internet — especially if a small, thinly traded biotech stock is involved. So says the Securities and Exchange Commission, which charged 27 people and companies with misleading investors by pushing promotional articles without disclosing that the authors had been paid for their pumping. (Garde, 4/10)

In November, California voters defeated a ballot proposal that would have given state government more control over drug prices. It was a victory for pharmaceutical companies, which spent more than $100 million campaigning against the measure. Now the industry is fighting new efforts by state lawmakers to impose regulations. Drugmakers are watching Senate Bill 17, in particular. Instead of direct price controls, it calls for price transparency. Drug companies would have to announce large price hikes and give detailed justifications to explain why the prices are going up. (Feibel, 4/11)

Last month, a group of Democratic lawmakers introduced a far-reaching bill designed to combat the rising cost of prescription drugs. One provision would allow Americans to import “qualifying” medicines that are manufactured at FDA-inspected facilities from licensed Canadian sellers and, after two years, from OECD countries that meet standards comparable to US standards. (Silverman, 4/7)

That’s what investors seem to think, as the news that Axovant Sciences hired an industry veteran sent the shares of biotech’s most polarizing company up nearly 30 percent on Monday. But while the market sees potential for a big buyout that would rescue an otherwise tepid year for biotech, Axovant says it’s settling in for the long haul, suggesting investors may have outpaced reality. (Garde, 4/10)