News

Cambridge Research Biochemicals (CRB), a supplier of peptide and antibody research reagents, has licensed new fluorescent dyes from the University of Edinburgh that enhance live-cell imaging.

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

Avista Pharma has appointed Eric Evans as CFO.

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

MilliporeSigma announced a collaboration with Angiex, a biotechnology start-up, to support the development of Angiex’s lead oncology antibody drug candidate to clinical use.

FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.

Lonza is expanding parenteral dosage development capability and capacity in its Drug Product Services (DPS) sector at the company’s Basel, Switzerland facility.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

The International Society of Automation (ISA) and Siemens entered a global partnership to increase awareness of industrial cybersecurity needs and standards.

Genentech’s Actemra (tocilizumab), a rheumatoid arthritis drug, has been approved for a new indication, treating CAR T cell-induced cytokine release syndrome (CRS), a side effect of CAR T cell therapy.

Thermo Fisher Scientific has completed the previously announced acquisition of Patheon for approximately $7.2 billion.

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

Circa Group, a biotechnology company, has announced a collaboration with formulation science consultancy iFormulate to launch Cyrene, a biosolvent.

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

MilliporeSigma, the life-science subsidiary of Merck KGaA, announced an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.