News

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

The new automated service connects companies with biologics development and manufacturing services.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?

Through the agreement, Eli will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational, monoclonal antibody designed to bind interleukin-13 with high affinity.

The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.

The therapy is currently approved in the EU as a gene therapy for the treatment of patients 12 years and older with transfusion-dependent β-thalassemia.

BioMed X and Merck have extended their ongoing collaboration with the commencement of a new joint research group, bringing the total joint projects being undertaken at the BioMed X Innovation Center to six.

Generic pharmaceutical company, Hikma Pharmaceuticals, and biopharmaceutical company, Arecor, have entered into an exclusive agreement for the development and commercialization of a ready-to-use injectable medicine.

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.

The companies will kick off their partnership with CPhI North America, a conference that hosts the North American pharmaceutical supply chain.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

The new business unit, as well as a new leadership team formed by AbbVie, will be effective upon closing of the acquisition in the first quarter of 2020.

Tim Howard will assume the role of acting ISPE CEO and president after John Bournas steps down from the positions.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

The event is set to take place from Feb. 23–26, 2020 at the Bethesda North Marriott in North Bethesda, Maryland.

Phillips-Medisize has announced that it is expanding its current Global Innovation and Development (GID) site in Struer, Denmark, to include a dedicated manufacturing development and clinical build unit.

Privately owned global pharmaceutical company, Galen, has announced the completion of its acquisition of a boutique healthcare company, POA Pharma.

The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

PhoreMost, a biopharma company based in the United Kingdom, and Boehringer Ingelheim have entered into a multi-project drug discovery collaboration agreement, it was revealed.

The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo.

The companies plan to combine their preclinical candidates to develop small-molecule inhibitors against multiple drug targets.

The Ireland-based company can now offer complete elemental impurities testing services.

The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.

Molecular taggants from Applied DNA Sciences and Colorcon’s Opadry coating target counterfeit and falsified medications.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.