Therapeutic Class

Pfizer: ‘Dropped preclinical programs do not change commitment to biosimilars’

In the latest example of a Big Biopharma reducing its biosimilar presence, Pfizer has abandoned five of its preclinical programs. The decision is part of an R&D review set to cut 150 jobs in Illinois and India. In November 2018, Bioprocess Insider reported claims that Big Pharma is set to exit from the biosimilars space over the next five years. Within weeks of publishing, Boehringer Ingelheim joined the likes of Germany’s Merck KGaA and Novartis division Sandoz in abandoning elements…

Sanofi licensing deal validates Ab platform, says Biomunex

Sanofi has licensed the plug-and-play BiXAb platform to generate multi-specific antibodies. The deal validates the technology and will help fund Biomunex’s internal pipeline, says CEO Pierre-Emmanuel Gerard. Under terms of the deal, Biomunex will receive an initial upfront payment from fellow French firm Sanofi, and will be eligible to receive future milestone payments. Specific figures have not been disclosed. This is the first licensing deal for Biomunex’s BiXAb bi- and multi-specific antibody generation and optimization technology, and according to CEO…

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

The US FDA predicts it will receive more than 200 regenerative INDs per year from 2020 and will add 50 additional staff to review these products. There has been “a large upswing in the number of investigational new drug (IND) applications” for cell and gene therapies received by the US Food and Drug Administration (FDA), commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) said in a statement yesterday. The Agency has so…

Phage of consent: AmpliPhi and C3J agree to merge

AmpliPhi Biosciences will combine with C3J Therapeutics to create what it says will be a leader in targeted bacteriophage therapeutics. The combined NYSE American-listed company will boast a broad clinical-stage pipeline, including a Phase I/II-ready natural phage candidate targeting bacteremia, and a synthetic phage candidate targeting respiratory infections expected to enter Phase I later this year. In a conference call discussing the planned merger, Paul Grint, CEO of San Diego, California-based AmpliPhi Biosciences, said the joint entity will be “a…

Allogene eyes cell therapy manufacturing plant in Bay area

After raising $324 million last year, Allogene Therapeutics says it is planning to construct a cell therapy manufacturing facility near San Francisco, California. Allogene Therapeutics is focused on developing allogeneic, or off-the-shelf, T cell. In October 2018, the San Francisco-headquartered firm raised $324 million (€283 million) in an initial public offering (IPO). Since its launch, the cell therapy firm has been working with a contract manufacturing organization (CMO) but now Allogene has told BioProcess Insider that it plans to build…

Univercells to scale-up sub 30 cent polio vaccine platform

A Univercells-led consortium has received a grant extension to scale-up a manufacturing platform it claims can slash the cost of inactivated polio vaccines. In December 2016, a consortium led by Belgium biomanufacturing technology firm Univercells received a $12 million (€10.4 million) grant from the Bill & Melinda Gates Foundation to develop a low-cost vaccine manufacturing platform. The consortium also involves Batavia Biosciences which has developed the polio manufacturing process and Natrix Separations (now owned by MilliporeSigma) for the purification membrane.…

Fujifilm pumps $111m into its US biologics and stem cell network

Fujifilm Corporation will increase capacity at its North Carolina CDMO site to feed demand for mammalian and microbial manufacturing. The firm is also opening a $21m induced pluripotent stem (iPS) cell plant in Wisconsin. Fujifilm Diosynth Biotechnologies (FDB), a contract development and manufacturing organization (CDMO) division of Japan’s Fujifilm Corporation, plans to invest JPY 10 billion ($90 million) into its site in Morrisville, North Carolina. “This expansion is driven by continued demand for our manufacturing capability given that our customer’s…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

FDA paves way for insulin biosimilars, but will they be interchangeable?

Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

The US FDA has placed a partial clinical hold on MacroGenics’ CD3 bispecific candidate MGD009 following reports of hepatic adverse events. On December 6, the US Food and Drug Administration (FDA) sent Maryland-based clinical-stage biopharmaceutical company MacroGenics a letter indicating that a partial clinical hold has been placed on its Phase I monotherapy study of MGD009 and a combination study of MGD009 and MGA012 (anti-PD-1). No new patients will be enrolled in either study until the partial hold is lifted…