New Drug Development & Regulatory News
Olaparib for high-risk, early-stage breast cancer is approved in Europe
The Institute of Cancer Research, London, states the news that the precision medicine olaparib has been approved in Europe for people with high-risk, early-stage breast cancer who have inherited faults in their BRCA1 or BRCA2 genes. Read more
5 Aug 2022
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Otsuka receives positive CHMP opinion for treatment of active lupus nephritis
Otsuka Pharmaceutical Europe announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion relating to the use of Lupkynis for the treatment of adult patients with active class III, IV or V lupus nephritis (LN). Read more
1 Aug 2022
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Regulatory approval gives green light for LPS trial to proceed
Poolbeg Pharma to commence its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza. Read more
22 Jul 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Actigen receives positive FDA response for rare disease treatment
Cambridge-based biotech company Actigen is a step closer to conducting clinical trials in the US for rare disease treatment, following a recent positive pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA). Read more
20 Jul 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
OBD Checkpoint inhibitor Response Test (CiRT) now available in the UK
Oxford BioDynamics Plc (OBD), has announced that its flagship Checkpoint inhibitor Response Test (CiRT) clinical blood test is now available to private physicians considering ICI therapy for their patients in the UK. Read more
18 Jul 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
Teva presents interim results from PEARL study on migraine treatment
Teva Pharmaceuticals Europe B.V. announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. Read more
12 Jul 2022
Pharma Manufacturing News + New Drug Development & Regulatory News
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Skin cancer cells harness nerve cell gene to invade new tissues
Research from the Institute of Cancer Research (ICR), London, identified melanoma skin cancer cells that harness a gene, usually used by growing nerves, to escape from their immediate area and spread through tissues. Read more
9 Aug 2022
SCHOTT establishes stand-alone company to promote business growth
SCHOTT has legally established a stand-alone company for its pharma business to advance its growth strategy. As part of the carve-out, the pharma business will now operate under the new name SCHOTT Pharma AG & Co. KGaA. Read more
8 Aug 2022
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
Asahi Kasei Bioprocess to showcase buffer management technology
Asahi Kasei Bioprocess, subsidiary of diversified Japanese technology company Asahi Kasei, will be featuring their MOTIV Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Read more
5 Aug 2022
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
UPS Healthcare to acquire Bomi Group to combine logistics services
UPS plans to acquire Bomi Group, a multinational healthcare logistics provider. The transaction will add temperature-controlled facilities in 14 countries and nearly 3,000 highly-skilled Bomi Group team members to the UPS Healthcare network. Read more
10 Aug 2022
Pharma Manufacturing News + Pharmaceutical Logistics & Distribution News
Collaboration to push therapeutic apheresis system for AKI treatment
Terumo Blood and Cell Technologies, and Eliaz Therapeutics announced an exclusive collaboration to help combat AKI and S-AKI by focusing on the selective removal of an upstream inflammatory protein called Galectin-3 (Gal-3) from blood plasma. Read more
10 Aug 2022
Accelerate Diagnostics announces CE marking of its antimicrobial kit
Accelerate Diagnostics, an in-vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis, announces CE marking of its new Accelerate Arc Module and BC kit. Read more
8 Aug 2022
Labcorp expands automated clinical trial kit production line
Labcorp, a global life sciences company, announced an expansion of its automated clinical trial kit production line in Mechelen, Belgium. Read more
8 Aug 2022
Pharma Manufacturing News + Pharma Finance and Investment News
Aptar acquires worldwide license for dry powder inhaler
Aptar Pharma, a global provider in drug delivery and active material science solutions, has acquired the worldwide rights to clinical stage drug developer Pharmaxis’ Orbital inhaler, a device designed to deliver high payload dry powder to the lungs. Read more
8 Aug 2022
Secop develops ultra-low temperature solution for vaccine transport
German-based Secop GmbH, a manufacturer of medical refrigeration compressors and a compressor supplier to the GAVI vaccination alliance, has developed a compressor for mobile refrigeration systems for temperatures ranging from -70° to -86° celcius. Read more
5 Aug 2022
Pharma Manufacturing News + Pharmaceutical Logistics & Distribution News
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1 Jun 2022
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Lonza - New Webinar: Solid Form Screening and Rapid Formulation Selection to Meet Demands of Accelerated Timelines
Compare formulation strategy advantages and disadvantages through case studies Read more
1 Jun 2022