PharmTech Europe News

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.

ACG Group has announced the winners of its ‘Art in a Capsule’ competition, where entrants were challenged to create miniature works of art that could fit inside a capsule.

BioCity has invested in Maxwellia, a company based at Alderley Park in the United Kingdom that is driving industry movement towards self-care therapeutics.

BIA has signed a memorandum of understanding with AstraZeneca and the Wuxi International Life-science Innovation Campus (I-Campus) to boost access for UK SMEs in China.

EC has granted marketing authorization approval to Roche for Tecentriq (atezolizumab), in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer.

The ABPI and BMA have issued responses to the publication of a government report into the scale and distribution of prescribed medicines in England.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

The transaction is set to be completed in the fourth quarter of 2019.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

Novartis revealed results from two new clinical trials indicating that Entresto (sacubitril/valsartan) significantly improves measures of cardiac structure and function in heart failure with reduced ejection fraction.

Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.

Findings from a real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis is associated with lower rate of major bleeding compared with vitamin K antagonist, dabigatran or rivaroxaban.

Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.

AbbVie has closed the Phase III trial that was evaluating Rova-T as no survival benefit for patients receiving treatment for advanced small-cell lung cancer (SCLC) was found during the interim analysis.

PCI has divulged that it is making significant investment at its site near Dublin, Ireland to strengthen its position globally and to ensure pharmaceutical supply is uninterrupted for its customers after Brexit.

A District Court for the US District of Delaware has ruled in favor of Sanofi and Regeneron in the patent case targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).

Government statistics show that pharma can be an illustrious career for graduates, which must be taken advantage of by industry to avoid skills shortages.

As a potential ‘no-deal’ Brexit looms, pharma companies and industry bodies are preparing for the worst-case scenario but hoping that the UK won’t end up with a disorderly exit from the EU.

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

AstraZeneca has confirmed that its triple combination therapy, Breztri Aerosphere, has met its primary endpoint in a Phase III clinical trial (ETHOS).

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

The chief executive of the National Institute for Health and Care Excellence (NICE), Sir Andrew Dillon, has announced he will be stepping down from his post at the end of March 2020.

Velabs Therapeutics announced it has deepened its cooperation with Chiome Biosciences to incorporate functional antibody screening as a result of a successful feasibility study.

Oval Medical Technologies (Oval) has revealed that it is relocating to a specifically designed facility in Cambridge Research Park in the United Kingdom as a result of growth.

BioCity has revealed it will be investing in Kinomica, an early-stage precision medicine biotech company that was spun out of Barts Cancer Institute, Queen Mary University of London.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.