Author Archives: Dan Stanton

GE Healthcare Spin-Off: “A Major M&A Chip Off the Tableâ€

by

GE will separate its Healthcare division over the next two to three years in efforts to reduce debt. The news may disappoint acquisition-hungry life science rivals Thermo Fisher and Danahar, say analysts. John Flannery, chairman and CEO of General Electric (GE) announced today plans to separate GE Healthcare, along with industrial services firm BHGE, in efforts to “unlock both a pure-play healthcare company and a tier-one oil and gas servicing and equipment player.†The industrial conglomerate GE has struggled over…

June 26, 2018

CAR-T Firm Autolus Raises $150m in IPO

by

Autolus Therapeutics has gone public and says it is looking to build its own T cell therapy manufacturing capabilities. Autolus launched its initial public offering (IPO) in May, and today the firm said it has raised approximately US$150 million ( €129 million) and has begun trading on the Nasdaq Global Select Market under the ticker symbol “AUTL.†The London, UK-based firm is a gene therapy developer working on personalized Chimeric Antigen Receptor (CAR) T cell therapies for cancer using its…

June 22, 2018

Pfenex: Bacterial System Overcomes Protein Challenges, Inhouse and Out

by

“The more you engineer a protein, the less natural it becomes,†says Pfenex executive Patrick Lucy. The firm is using its clinically validated microbial expression platform to overcome these challenges for both its own product pipeline and its partners. In May, Pfenex announced positive Phase III data showing its lead candidate PF708 is comparable with Eli Lilly’s osteoporosis drug Forteo (teriparatide). The candidate – classed as a biosimilar in Europe but being filed in the US as a therapeutic equivalent…

June 22, 2018

Sartorius Pumps $100m in Puerto Rico, Doubles SU Bag and Filter Capacity

by

North American demand for aseptic filters and single-use bags drove Sartorius to expand its facility in Yauco, Puerto Rico. German bioprocessing supplier Sartorius began expanding its Yauco production and distribution center in 2016 and has invested more than US$100 million (€86 million), according to spokesperson Timo Lindemann. The investment brings Sartorius an additional area covering nearly 190,000 square meters – around two million square feet – he told BioProcess Insider. “A focal area of investment will be on expanding aseptic…

June 20, 2018

Patheon On Keeping Up With Biologics Demand

by

  Patheon is doubling its biomanufacturing capacity through a $50 million investment in Missouri. We spoke with the CDMO about the continued demand for biologics services and its relationship with owner Thermo Fisher. In April, contract development and manufacturing organization (CDMO) Patheon announced plans to add 16,000 L of single-use capacity at its St Louis, Missouri facility. The US$50 million (€43 million) expansion effectively doubles the firm’s global biomanufacturing capacity. According to David Kenyon, senior director of Global Scientific and Technical…

June 19, 2018

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

by

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

June 19, 2018

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

by

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practicesâ€Â at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

June 19, 2018

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

by

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

June 15, 2018

Sanofi Inks $850m mRNA Vaccines Deal with Translate Bio

by

Sanofi Pasteur has teamed with Translate Bio to develop messenger RNA (mRNA) vaccines for up to five infectious disease pathogens. Under terms of the deal, French vaccine developer Sanofi Pasteur will make an upfront sum of US$45 million (€38 million) to Massachusetts-based firm Translate Bio but total payments could reach $850 million on the back of developmental milestones and royalties. The R&D for the undisclosed vaccine targets will be jointly conducted during an initial three-year period. mRNA vaccines work by…

June 12, 2018

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

by

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…

June 12, 2018