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Intra-Cellular's depression drug goes 1 for 2 in Phase 3 studies

The biotech's stock dropped more than 20% on news of a failed study in bipolar disorder, which company execs attributed to a high placebo rate.

Sangamo backs up early success for hemophilia gene therapy

Updated results show the highest dose of Sangamo's gene therapy boosted blood-clotting protein levels for hemophilia A patients to normal levels.

Roche acknowledges the obvious, extends Spark buyout deadline

"Good things almost always take time," Roche CEO Severin Schwan wrote in a note to Spark employees.

Zolgensma set a new drug pricing bar. Insurers show some signs of pushback

One month after approval, a handful of payers have adopted policies taking a more cautious stance than what the FDA set out in the gene therapy's label.

UPDATED: July 5, 2019 at 4:24 p.m.

BioPharma Dive's 10 biggest stories of the spring

Developments in gene therapy, cancer treatments, drug pricing and dealmaking kept the industry in the headlines.

Gilead firms up path to market for key arthritis drug

Filing filgotinib with the FDA this year, as Gilead now plans to do, would shorten the lead held by competitor AbbVie.

Rival accuses Kaleo of cybersquatting in 'elaborate scheme'

A lawsuit claims Kaleo registered domains containing the brand name of a competitor's new drug, redirecting traffic to a website for its own product.

Amarin to double sales team again as it boosts Vascepa sales forecast

The drugmaker also plans to start direct-to-consumer advertising in the second quarter of next year, aiming to further grow sales of the fish oil pill.

Deep Dive

Once 'bodies for hire,' CROs are finding a new role as data specialists

Drugmakers and regulators are paying more attention to what real-world data can prove — driving demand for CROs to help keep up.

Array pushed Pfizer for a higher price to get deal done

Array is the third targeted cancer biotech acquired since December for which only one serious bidder emerged. Yet deal details show pharma as still willing to put up a premium.

Bayer backs cell therapy startup with $215M in funding

Created by Versant Ventures, Century Therapeutics aims to develop allogeneic cancer therapies using pluripotent stem cells rather than donor T cells.

Pfizer muscular dystrophy gene therapy stumbles on safety

Study results presented Friday, which were the first significant look at Pfizer's DMD candidate, spurred shares in rival Sarepta to climb higher.

Former FDA head Gottlieb joins Pfizer board

Gottlieb stepped down from his high-profile post just months ago — timing that raises questions about the "revolving door" between regulator and industry. 

Q&A

Digital is bringing the change clinical trials need, DIA head says

Barbara Kunz, DIA's global chief executive, noted that when it comes to new technology, "there's a pretty big mountain that we'll be climbing. Some of the early successes will seem trivial a year from now."

AbbVie deal for Allergan not about the taxes, thanks to 2017 law

AbbVie will stay in the U.S. if its deal goes through — a departure from Pfizer's plan in a failed 2015 attempt to merge with the Ireland-based Allergan.

Amgen bone drug application knocked back in Europe

While both the U.S. and Japan have approved Evenity, the EMA's drugs committee judged its heart risk didn't outweigh its potential benefit.

FDA set for 'exceptionally light month' of generic drug approvals in June

After generic drug approvals by the FDA hit all-time highs last year, one Wall Street analyst wonders if June data shows the start of a slowdown.

ImmunoGen to lay off 220 workers, as it pushes ahead with troubled drug

The Massachusetts-based biotech will reduce its headcount by about 75%, narrow its pipeline and sublease office space to stretch out its cash.

AstraZeneca gets immuno-oncology win in a disease that Merck doesn't rule

Imfinzi's success in small-cell lung cancer pits it against Roche's Tecentriq, as both are now ahead of Merck's Keytruda.

Samsung Bioepis CEO urges patience as US biosimilar market lags

"Market shaping takes time," the head of the Korean drugmaker told BioPharma Dive, as a few experts call to give up on the copycat biologics altogether. 

Zogenix boosted on FDA about-face for seizure drug application

The regulator agreed to permit resubmission of Zogenix's drug with a corrected dataset, while waving off a potentially time-consuming toxicology study.

Aiming for price transparency, Civica Rx hits snag with bundled payments

The payment model, often opaque on specific drug costs, affects many of the medicines the hospital-led group is targeting, according to its commercial chief.

5 reasons AbbVie bought Allergan, and why they may not be enough

The $63 billion deal secures a post-Humira future for AbbVie, its executives argue. But such a massive acquisition isn't a sure thing to play out as expected.

CMS approves Louisiana's 'Netflix model' using Gilead hepatitis C drugs

The subscription model will go into effect Monday, and a similar plan by Washington state is also expected to start next week.

Merck is on top. Investors worry there's only one way to go.

Products like Keytruda and Gardasil have propelled the pharma to new heights. But at its first investor day in five years, concerns about maintaining that success crept through.