News

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

FDA is examining and updating its programs for overseeing global operations and international affairs.

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.

The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).

The acquisition will expand Pfizer’s rare disease portfolio with an early pipeline candidate for treating dwarfism.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

The UK government announced during the ABPI’s recent conference that it is making improvements to the Accelerated Access Collaborative.

A UK-based company, Atelerix, has revealed that it has closed a second round of funding worth £700,000 (US$911,000).

Shakespeare Martineau, a law firm, announced that advisers from the firm have assisted Bermele with a capital-raising move worth £1 million (US $1.3 million).

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

Vibalogics has increased its single-use bioreactor and purification capacity with a new manufacturing for its specialist oncolytic virus and viral vector manufacturing services as a result of a growth in demand.

Research Point Global and WuXi Clinical Development Services have revealed that they are to combine and rebrand as a new CRO, WuXi Clinical.

EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

Catalent has revealed that it is the recipient of a silver award from the Royal Society for the Prevention of Accidents (RoSPA) in recognition of its health and safety practices.

Novartis will acquire assets associated with Takeda Pharmaceuticals’ Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

AbCellera, Niaid Vaccine Research Center, and Ichor Medical Systems have formed a partnership to develop an end-to-end platform capable of developing field-ready, nucleic acid-based countermeasures against a pandemic strain of influenza.

Ashland introduces Klucel EXF Ultra HPC, a low friability, high strength binder.

Recipharm Inhalation Solutions is an integrated service for inhalation products.

The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.

The new guidance document discusses reproductive toxicity testing and labeling recommendations.

Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.

The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.