News

The joint venture will focus on the discovery, development, and commercialization of potential new drugs for the global market as well as speed delivery of new medicines to China.

Manufacturers and trading partners struggle to meet drug tracking requirements

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

SciLog Select Go Single-Use Assemblies from Parker Hannifin uses an assortment of validated parts and assemblies to build needed devices for biopharmaceutical manufacturing.

MasterControl has added three new cloud-based analytical solutions to its MasterControl Version 11.7 software for clinical managers and regulatory/submissions professionals.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

India was ranked by international pharmaceutical companies as the third most competitive nation globally.

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.

The company has appointed Albert Bourla, PhD, as its new COO.

Company completes first successful run of what is believed to be the largest synthesis-scale done for oligonucleotide APIs.

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

Two of the medicines recommended for approval are orphan drugs.

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The company has introduced two new GMP vessel streams at its API manufacturing facility in Northumberland, UK that allows it to now offer fully integrated drug substance and drug product manufacturing.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.