News

The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.

Gerresheimer started producing its Gx RTF ClearJect cyclo-olefin copolymer syringes in Germany and will exhibit at CPhI WorldWide 2018.

New manufacturing and control technologies are being explored.

Advances in medicine and consumer electronics can enhance drug delivery and patient care.

The new features on the purifier deliver additional sizes and sterilization/sanitization compatibility.

The collaboration will focus on developing manufacturing solutions for biosimilars.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

The agency approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence.

FDA Commissioner Scott Gottlieb, MD, issued a statement regarding new warning letters FDA issued to Chillin Mix Kratom and Mitra Distributing, companies marketing kratom, a potential source of opioids, with unproven medical claims.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

ICS distribution center will serve manufacturers of specialty medications, biosimilars, and cell and gene therapies.

Bio-Rad introduces CHT Ceramic Hydroxyapatite XT media and Nuvia HP-Q resin resin for process protein purification.

New products were developed as next-generation process intensification technologies, MilliporeSigma reports.

Becton Dickinson’s (BD) Advanced Bioprocessing business will be integrated into Thermo Fisher's Life Sciences Solutions segment.

TruTag Technologies, a provider of product identity solutions, has added mobile-phone authentication of solid oral-dosage form tablets to its product offerings.

More than 120 healthcare organizations plan to bring competition to generic drug market.

Research from the Perelman School of Medicine at the University of Pennsylvania suggests that a universal flu vaccine that protects people against most influenza strains is one step closer to reality.

Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Lonza’s new PyroTec Pro Robotic Solution provides a fully automated workflow for endotoxin detection.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

The purchase of Novartis’ cystic fibrosis products TOBI Podhaler and TOBI solution is expected to strengthen Mylan’s global respiratory portfolio.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Skin-focused company LEO Pharma acquired Bayer’s prescription treatment portfolio.

A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.

Sharing know-how can help resolve common bio/pharma technical challenges.

Increasingly complex trial protocols have added to IMP manufacturing challenges.