Headlines

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.

LenioBio and Fraunhofer Institute to develop protein expression platform

15-Aug-2018 By Maggie Lynch

LenioBio and Fraunhofer Institute IME have entered a licensing agreement, allowing LenioBio to commercialize technology into a protein expression platform.

ABL Bio and I-Mab Biopharma ink bispecific antibody deal

14-Aug-2018 By Maggie Lynch

ABL Bio and I-Mab Biopharma have partnered to develop bispecific antibodies for immunotherapy.

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.

Amgen begins work on $200m ‘next-gen’ biomanufacturing site

10-Aug-2018 By Ben Hargreaves

Amgen has broken ground on the construction of its West Greenwich, Rhode Island-based 120,000-square-foot biomanufacturing facility.

DNA damage from CRISPR/Cas9 editing could lead to cancer, finds report

10-Aug-2018 By Maggie Lynch

Gene editing with CRISPR/Cas9 can cause genetic damage to cells leading to possible cancer risks, the study reported.

CRISPR research deal will attract new business, says Oxford Genetics

09-Aug-2018 By Flora Southey

Oxford Genetics has signed a supply and licensing agreement for CRISPR engineered mammalian cell line with an unnamed ecommerce firm.

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.

Algenuity develops green solution for pharma with algae platform

07-Aug-2018 By Ben Hargreaves

Algenuity has launched the MERIT project to develop renewable methods of producing therapeutic agents.

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.