Markets & Regulations

US FDA approves first non-gene edited allogeneic CAR T-cell candidate for trials

15-Aug-2018 By Flora Southey

Unlike gene-edited CAR T-cell therapies, this approach does not cut the genome to knock out, or knock in, a gene, says Celyad.

US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

15-Aug-2018 By Maggie Lynch

Genentech’s Xolair was granted a Breakthrough Therapy Designation by the US FDA.

Regulatory eyes on Regeneron: US FDA issues CRL for Eylea

14-Aug-2018 By Flora Southey

The US Food and Drug Administration has rejected Regeneron’s eye candidate, Eylea, but the biotech says it expects a final regulatory decision within two months.

Motion to dismiss Inflectra case denied, but J&J insists ‘Pfizer’s lawsuit is without merit’

14-Aug-2018 By Flora Southey

A US district court has denied Johnson & Johnson’s motion to dismiss Pfizer’s Inflectra lawsuit, a case claiming anticompetitive practices blocked US uptake of the Remicade biosimilar.

Evolus boasts early resubmission of FDA-rejected Botox alternative

10-Aug-2018 By Flora Southey

Three months after the US FDA vetoed Evolus’ Botox alternative, the firm has announced its resubmission of DWP-450 for approval.

UPDATED

Celltrion hit with Form 483 over troublesome Incheon plant

08-Aug-2018 By Ben Hargreaves

Celltrion has told shareholders its manufacturing site received a Form 483 from the US FDA.

Grifols acquires Biotest US in $286m deal

08-Aug-2018 By Maggie Lynch

Grifols acquires the entirety of Biotest US for $286m, a deal which includes a number of plasma collection facilities and corporate offices.

Regeneron takes $100m stake in bluebird, with ‘long-view’ on drug discovery

07-Aug-2018 By Ben Hargreaves

Regeneron and bluebird bio have announced a partnership to develop six cell therapy drug candidates.

Science Exchange collaborates with AUM Biotech for time-saving R&D tech

07-Aug-2018 By Maggie Lynch

Science Exchange announces a collaboration with Philadelphia start-up, AUM Biotech, to provide users with access to R&D technologies.

Bluebird’s ‘one-time gene therapy’ receives EMA accelerated assessment

03-Aug-2018 By Ben Hargreaves

Bluebird bio’s LentiGlobin gene therapy has received an accelerated assessment from the EMA for the treatment of transfusion-dependent β-thalassemia.

Daiichi Sankyo and Glycotope reach agreement for “first-in-class” ADC

03-Aug-2018 By Maggie Lynch

Daiichi Sankyo and Glycotope have signed a licensing agreement to develop an antibody-drug conjugate that enables tumor-specific binding to TA-MUC1.

Novartis’ mAb becomes first for migraines in EU

01-Aug-2018 By Ben Hargreaves

The European Commission has given its approval for Novartis’ Aimovig, the treatment designed specifically for patients with migraines.

Pfizer: EU green light for Herceptin biosimilar, looks to US

01-Aug-2018 By Flora Southey

The European Commission has approved Pfizer’s Trazimera, a biosimilar version of Roche’s best-selling oncology monoclonal antibody, Herceptin.

Hired and retired: Gilead, Amgen, and Tenaya change execs

31-Jul-2018 By Flora Southey

Gilead Sciences CEO steps down, Amgen SVP of translational sciences steps up, and ex-bluebird bio executive joins Tenaya Therapeutics.

Fujifilm predicts Hulio to be ‘amongst first wave’ of Humira biosimilars

31-Jul-2018 By Ben Hargreaves

Fujifilm’s Humira biosimilar, Hulio, has received positive CHMP opinion to grant marketing authorisation.