News

China's Cellular Biomedicine spikes on early CAR-T data

Shanghai drug developer Cellular Biomedicine reported some positive results from a small study of its in-development cancer immunotherapy, sending its shares up more than 15% on Friday.

Chinese drugmakers snag antibody expert Ambrx in joint buyout

A group of Chinese biotech heavyweights are banding together to buy Ambrx, R&D partner to the likes of Bristol-Myers Squibb and Merck, in hopes of making the company a go-to collaborator in their native country.

Ex-Pfizer exec Gutiérrez-Ramos heads to startup Synlogic

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Eric Sagonowsky (email) or...

Novartis' duo of COPD drugs clears Phase III on the path to an FDA decision

Novartis, working to get a pair of Europe-approved COPD treatments onto the U.S. market, reported some positive Phase III data while awaiting final word from the FDA.

Amgen's PCSK9 contender lines up for first place in the blockbuster EU race

Amgen is likely to come in second in the race to launch new cholesterol treatments in the U.S., but the Big Biotech is leading the charge in Europe, securing a crucial regulatory recommendation that clears the way for approval.

Otonomy's ear disease drug slips in Phase IIb, but management keeps the faith

Otonomy's treatment for a balance-destroying ear disease missed the mark in a Phase IIb study--but it was close, and the biotech believes the drug did well enough to merit moving forward into late-stage testing.

Abivax files for IPO, Pluristem boards EMA fast-track, Ablynx inks Genzyme MS deal

In this week's EuroBiotech Report, Abivax became the latest French biotech to file for an IPO in its home country, seeking cash ahead of moving an HIV drug into two Phase IIb trials, as well as to support the clinical development of its lead candidate, a therapeutic vaccine against hepatitis B. And more.

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.