News

ArGEN-X pairs up with Leo Pharma in a $116M dermatology deal

The antibody experts at arGEN-X have teamed up with dermatology-focused biotech Leo Pharma on a treatment for inflammatory skin diseases, inking a deal worth up to $116 million.

Abivax files for IPO to finance trials of HepB vaccine, HIV antiviral

Abivax has filed the paperwork for an IPO in Paris. The listing is intended to give Abivax the cash to fund mid- to late-phase trials of its two lead candidates, a therapeutic vaccine against hepatitis B and a small-molecule inhibitor of HIV replication.

Is uniQure's gene therapy worth $1.4M?

The Federal Joint Committee is assessing uniQure's Glybera, the first-ever gene therapy approved in Europe, and now the world's most expensive drug at €1.1 million ($1.4 million). And the questions raised in Germany offer a preview of reimbursement conversations in other countries, about this and other uber-pricey gene therapies.

Lpath eyes job cuts after a crushing AMD failure

Lpath's in-development treatment for wet age-related macular degeneration flunked in Phase II, wrecking the company's value and setting a stage for a round of layoffs.

J&J picks up where Novo left off with an autoimmune licensing deal

Novo Nordisk, gradually exiting the world of autoimmune R&D, has found a home for one of its former projects, handing a development program over to Johnson & Johnson for an undisclosed sum.

Bluebird offers a promising peek at a potential cure for sickle cell

Bluebird bio, at work on a gene therapy for a rare blood disorder, unveiled some early but promising data on the one-time treatment's secondary indication of curing sickle cell disease, sending the biotech's value further skyward.

Regeneron's arthritis drug aces Phase III with the FDA in sight

Regeneron posted another round of clinical successes from its sweeping Phase III rheumatoid arthritis program, plotting to submit its Sanofi-partnered antibody for regulatory scrutiny this year.

Pfizer vet Gutiérrez-Ramos takes the reins at Synlogic

José-Carlos Gutiérrez-Ramos, long Pfizer's chief of biotherapeutic research, is heading back to the world of biotech, taking the top spot at Synlogic as the startup pursues a novel approach to drug development.

BioInvent, BiondVax pocket $9.5M each in separate stock sales

BioInvent and BiondVax Pharmaceuticals have wrapped up their respective fundraising initiatives. Sweden's BioInvent pulled in $9.5 million to fuel the advance of its oncology pipeline, while Israel's BiondVax bagged a similar amount to continue work on its universal flu vaccine.

Pluristem snags spot on EMA's nascent fast-track scheme

Pluristem Therapeutics has bagged itself a spot on the European Medicines Agency's adaptive pathways pilot project. The EMA's decision gives Pluristem a shot at slashing the time it takes to bring its PLX cell program in critical limb ischemia to market in a subpopulation.

BioNTech strikes back-to-back immuno-oncology deals with Lilly and Genmab

BioNTech has snagged a small upfront fee to enter into an immuno-oncology co-development pact with Genmab. The deal was unveiled one week after Eli Lilly invested $30 million (€27 million) in BioNTech as part of an immuno-oncology deal worth a potential $300 million per asset.

Ablynx adds Genzyme to roster of big-name collaborators

Ablynx has entered into a collaboration with Sanofi's Genzyme to investigate the use of its single-domain antibodies against a target involved with multiple sclerosis. The deal gives Genzyme the exclusive right to test the antibodies in models relevant to multiple sclerosis.

Genocea's herpes vaccine hits the mark in Phase II

Genocea Biosciences' in-development vaccine for genital herpes met its goals in a Phase II trial, sending the biotech's shares soaring.

Spurned by AstraZeneca, is Pfizer out for GlaxoSmithKline?

The latest market chatter is that Pfizer, rebuffed in its quest to acquire AstraZeneca last year, is taking a hard look at GlaxoSmithKline, and one analyst says it might be a good idea.

J&J touts a blockbuster-rich pipeline with 10 filings on the horizon

Johnson & Johnson says it's on track to submit more than 10 new drugs for FDA approval over the next four years, and the company believes each of those contenders has the potential to bring in $1 billion in peak revenue.

Sarepta surges after kicking off a rolling submission for its DMD drug

The FDA has given Sarepta Therapeutics the go-ahead to start a rolling submission for its Duchenne muscular dystrophy drug, eteplirsen. The green light comes 7 weeks after Sarepta parted company with its CEO Chris Garabedian--and his interim successor was quick to frame the regulatory breakthrough as the result of the subsequent shift in strategy.

Gene therapy pioneer ReGenX raises $70.5M to go it alone

After years of lending out its R&D platform, ReGenX Bio is turning its attention to a proprietary pipeline of gene therapies, hauling in a $70.5 million D round to get its top prospects into clinical trials.

J&J buys into Achillion's hep C pipeline for up to $1.1B

Johnson & Johnson, fighting to keep up with the blockbuster race to launch quick cures for hepatitis C, has agreed to pay as much as $1.1 billion for the rights to Achillion Pharmaceuticals' pipeline of antiviral treatments.

Moving from CV to CAR-T, Cardio3 changes its name and eyes a $115M U.S. IPO

Celyad, the former Cardio3 Biosciences, filed to make a $115 million debut on the Nasdaq, stretching its focus from heart treatments to the fast-growing field of cancer immunotherapy.

GW Pharma CEO jumps to the U.S., betting on epilepsy approval

U.K. drugmaker GW Pharmaceuticals believes its cannabis-derived epilepsy treatment is on its way to Phase III success and FDA approval, moving its CEO to the U.S. as it builds a North American presence.