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.

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.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

Boehringer Ingelheim Biopharmaceuticals China is the first company to apply the adopted Marketing Authorization Holder system within the revised Chinese Drug Administration Law through its partnership with BeiGene for its monoclonal antibody, tislelizumab.

The new site can manufacture oligonucleotide APIs at large scale.

Through the acquisition, Johnson & Johnson will gain access to Taris’ lead clinical-stage product, TAR-200.

Catalent’s planning service is designed to assist in evaluating needs for launching and maintaining clinical trials.

The promise of new therapies is tempered by the need for affordability, safety, and ethics.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.