News

J&J's IL-23 psoriasis contender scores a PhIIb win in a turbulent race

J&J's IL-23 blocker came through in a Phase IIb psoriasis study, with one of the top doses clearing symptoms of the disease in 86% of patients. Easily beating out the placebo response, the top psoriasis contender--which is facing off against a lineup of competing remedies in late-stage development--also beat out Humira in the study.

Female libido drug lobbying sparks a backlash as FDA decision looms

Five weeks from now, the FDA will face a deadline for making a final marketing decision on flibanserin, a drug designed to treat sexual desire disorder in women. Already a two-time loser at the agency, Sprout Pharmaceuticals--which acquired the treatment from a frustrated Boehringer Ingelheim--managed to make a comeback recently and snag an important 18 to 6 FDA panel vote in its favor. And whatever the FDA officially concludes, the decision will come down as one of the most controversial of the year.

Celgene recommits to Epizyme, adding $620M in cancer drug bonuses

Three years after stepping up with a $250 million deal--with $90 million upfront--Celgene has remapped its partnership with Epizyme, extending their collaboration three more years. Under this new deal, Cambridge, MA-based Epizyme gets $10 million cash with up to $610 million in milestones for three histone methyltransferase inhibitor targets.

KDEV halves its portfolio value as new accounting practices take effect

Karolinska Development has slashed the value of its portfolio after adopting a new way of tallying up what its early-stage biotech investments are worth. The new accounting model and the sale of Pharmanest almost halved the value of its portfolio, but the fall is not over yet. If another deal is revalued as KDEV expects, the value could sink to less than 25% of the tally as of the end of March.

Battle between Chinese investors puts Oramed on the cusp of a $50M deal

Oramed Pharmaceuticals has found itself at the center of a tug of war between Chinese investors. Days after Guangxi Wuzhou Zhongheng Group revealed it was edging toward a $52 million (€47 million) deal, Oramed said a pair of other Chinese financiers are now in the box seat.

Ripple from U.S. biotech boom drives U.K. life sci funding to 10-year high

More evidence has emerged that the ripples emanating out of the U.S. biotech boom are raising boats on the other side of the Atlantic.

FierceBiotech Radio on big approvals for Novartis and Vertex, Mylan's real estate controversy, and @brentlsaunders

FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including Novartis and Vertex Pharmaceuticals scoring big FDA approvals, Mylan's headquarters scandal, and the refreshing approach to Twitter of Allergan's CEO.

AstraZeneca, Ironwood score PhIII success in China

AstraZeneca and Ironwood Pharmaceuticals say their Phase III study for linaclotide, conducted primarily in China among patients with irritable bowel syndrome with constipation, came through on all primary and secondary endpoints.

Sanofi advances a one-shot malaria program as drug resistance spreads

Sanofi has re-upped with its partners at Medicines for Malaria Venture in hopes of developing a single-dose treatment for the infectious disease, advancing a pair of candidates through mid-stage development.

Third Rock startup Afferent lands $55M C round as it preps for PhIII

Back in February, Afferent Pharmaceuticals pronounced itself satisfied with the outcome for a mid-stage study of its lead drug, AF-219, being developed for a range of conditions including pain, persistent coughing and urinary urgency. And today the venture backers behind the San Mateo-based biotech have come up with $55 million in a crossover round to fuel new work on the pipeline.

Gensight scouts a $100M IPO for its ocular gene therapies

Parisian drug developer Gensight Biologics is swinging for a $100 million U.S. IPO to fund its work on potential one-time treatments for serious retinal diseases, angling to take advantage of a bullish market for biotechs.

Merck and Samsung's Humira biosimilar comes through in Phase III

Partners Merck and Samsung Bioepis cleared late-stage trials with their knockoff of Humira, the world's top-selling medicine, setting the stage for global regulatory applications as the reference treatment comes off patent.

UPDATED: FDA OKs Novartis' megablockbuster heart failure drug Entresto

The FDA has approved Novartis' big 2015 blockbuster, the heart failure drug Entresto, better known in development circles as LCZ696.

Galenica plans dealmaking flurry ahead of mooted spinout

Galenica is set to embark on a period of checkbook pipeline building to beef up its drug development unit ahead of a planned spinout. The plan is to build a pipeline of near- and long-term assets to complement its Roche-partnered iron-deficiency drug, Mircera.

Imperial Innovations shopping cystic fibrosis gene therapy asset after posting clinical data

Imperial Innovations is negotiating with pharma companies over its gene therapy that has shown the potential to treat cystic fibrosis. A trial of the gene therapy posted patchy but promising data this week, putting the tech-transfer business in a position to strike a deal for further development.

Another Indian CRO runs afoul of global authorities over trial errors

The World Health Organization has chided one of India's biggest CROs over mishandling clinical trial results, echoing a data scandal that threatens to tarnish the reputation of the country's biopharma contractors.

Essex Woodlands raises $360M for new life sciences fund

Essex Woodlands is making progress with its ninth life sciences fund. The group noted in an SEC filing that it has raised $360 million of a planned $750 million fund, up from the $221 million it had raised and then reported last year.

Listen up! It's time to nominate top biotechs for the Fierce 15

It's time to start getting ready for the 14th annual Fierce 15. And if you have a biotech you'd like to nominate for the award, we've got a quick and easy form for you to fill out.

Esperion's PCSK9 spoiler clears another FDA roadblock as it heads to Phase III

Esperion, at work on a cholesterol-lowering pill it hopes can disrupt some high-profile new injections, convinced the FDA to remove a partial clinical hold on the highest dose of its drug.

Aimmune joins the biotech IPO scrum in search of $115M

Working off of an $80 million crossover round with newly won boasting rights to the FDA's breakthrough therapy designation in hand, Brisbane, CA-based Aimmune Therapeutics is wasting no time in diving into the heated IPO waters for biotech. The biotech filed plans to raise $115 million on Nasdaq, the latest in a scrum of developers anxious to tap into the long-running boom market.