PharmTech Europe News

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.

Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.

Sterling Pharma Solutions has been granted a Queen’s Award for Enterprise in the field of International Trade.

Biocatalysts, a global biotechnology company, has announced it has been named as one of the winners of the Queen’s Awards for Enterprise in Innovation.

Start Codon strategic initiative has been launched, aimed at providing a life-science accelerator that offers funding and support to translate innovative research into start-up companies.

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Seqirus has taken the decision to make its cell-based flu vaccine, FLUCELVAX TETRA, using a completely cell-based production process.

EDCTP has granted EUR10 million to a collaboration of African and European antimalarial drug researchers to support late-stage clinical trials of a novel antimalarial combination.

Sandoz has signed an agreement with Shionogi for the commercialization rights of Rizmoic (naldemedine) within specific key European markets.

EC has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with advanced or non-small cell lung cancer (NSCLC).

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

Patient-centric drug development is becoming more important in the bio/pharma industry.

Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.

Legacy Pharmaceuticals has entered into a collaboration with SCHOTT to solve a technical challenge of leaching that is occurring with an antiviral drug.

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

The EU has announced that it has launched two WTO cases on unlawful import duties on ICT products and unlawful measures on pharmaceuticals, against India and Turkey, respectively.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

Sterling Pharma Solutions has acquired the US arm of complex chemistry solutions provider, CiVentiChem, which is based in Cary, North Carolina, USA.

3M Drug Delivery Systems UK organization has revealed that it is relocating its R&D team to the Charnwood Campus, which is an officially designated Life Sciences Opportunity Zone in Loughborough, United Kingdom

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.