Industry News

Marchesini Group’s Extrafill, a filling and stoppering machine, contains a robotic arm gripper system designed to move like a human hand.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The report examines the increased number of companies cited by regulators for data integrity issues.

A new 3D modeling and data-extraction technique Improves X-ray crystallography analysis of proteins.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

The taskforce will work to identify opportunities to advance therapy manufacturing and the supply chain in the UK.

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

The conference discussed key industry issues including serialization, innovation, and patient-centricity.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

The US Drug Enforcement Agency (DEA) has granted permission for the import of pharmaceutical-grade cannabidiol to Catalent Pharma Solutions for a feasibility study in conjunction with Kannalife Sciences, according to a company press release.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

CPhI Russia 2016 planned for companies seeking pharma business opportunities in region.

The Eppendorf and Science Prize for Neurobiology is a research prize of $25,000, given to young scientists for their contributions in neurobiology.

Robert Califf has been confirmed by the US Senate as FDA commissioner.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.