Joseph Keenan

1 week ago | fiercepharma.com | Joseph Keenan

New Jersey-based AACE Pharmaceuticals has been slammed in an FDA warning letter citing significant violations by its contract manufacturer Brassica Pharma, including substandard sanitary conditions and fabricated lab records. The warning letter, which was issued May 13 and posted on the regulatory agency’s website this week, comes in the wake of a January 2024 inspection of Brassica’s foreign facility used to produce ophthalmic drugs for AACE.

1 week ago | fiercepharma.com | Joseph Keenan

Bio Usawa, a private biotech company focused on boosting drug access in Africa, inked a deal with cleanroom and laboratory construction specialist Pacific Environmental Technologies to design, produce and deliver self-contained modular bio manufacturing units to Rwanda.

2 weeks ago | fiercepharma.com | Joseph Keenan

Bora Biologics, a subsidiary of Tanvex Biopharma born out of a spinoff from Bora Pharmaceuticals, is expanding CDMO operations at its San Diego facility. The new project will add 8,075 square feet of production to the site. The additions will include a pair of 2,000-liter bioreactors and design plans that will accommodate future bioreactor expansion of up to 5,000 liters, Bora Biologics said in a May 20 press release. Costs associated with the expansion weren’t disclosed.

2 weeks ago | fiercepharma.com | Joseph Keenan

Thermo Fisher Scientific, a Massachusetts-based CDMO giant, inked a collaboration deal with biotech startup Mirai Bio to develop and manufacture new gene therapies. The two aim to pair Thermo Fisher’s development know-how, manufacturing capacity and global reach with Mirai’s technology that focuses on novel nucleic acid therapeutics, according to a May 20 press release. Financial terms of the agreement weren’t disclosed.

3 weeks ago | fiercepharma.com | Joseph Keenan

Famar, a portfolio company of the private equity firm of MidEuropa, is set to acquire a sterile manufacturing facility in Homburg, Germany, from MiP Pharma as part of the Greek CDMO’s plan to expand its European operations. The deal is slated to give Famar production capabilities for "high-value dosage forms" as well as aseptic and lyophilized fill-finish capacity, MidEuropa said in a May 13 press release. Financial details of the purchase weren’t disclosed.