New Drug Development & Regulatory News
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BlueRock Therapeutics announces FDA clearance
BlueRock Therapeutics has announced the clearance of its Investigational New Drug (IND) application by the FDA for OpCT-001, an induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. Read more
6 Sep 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
SeaBeLife
SeaBeLife receives Orphan Drug Designation from EMA for acute liver failure treatment
SeaBeLife, a biotechnology company developing drug candidates intended to block cellular necrosis, has announced the granting of an Orphan Drug Designation (ODD) by the EMA for its drug candidate SBL01 in the treatment of acute liver failure. Read more
4 Sep 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
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Leqembi authorised for early Alzheimer's in the UK
Eisai Co., Ltd. and Biogen Inc.announced today that the humanised amyloid-beta (Aβ) monoclonal antibody Leqembi (Lecanemab) has been granted a Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. Read more
23 Aug 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
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Everest Medicines announces Investigator-Initiated Clinical Trial for cancer vaccine programme
Everest Medicines has announced the launch of an Investigator-Initiated Clinical Trial (IIT) for a personalised mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. Read more
22 Aug 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
AMSBIO
Sensitive detection of cell culture mycoplasma infection
The MycoScope Mycoplasma PCR detection kit from AMSBIO uses polymerase chain reaction (PCR) technology to detect mycoplasma infections in less than 3 hours. Read more
21 Aug 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
BSI Group
NHS requires compliance with BSI Kitemark to promote responsible antibiotic manufacturing
Pharma companies bidding for the newly launched NHS Antimicrobial Product subscription model will be required to demonstrate the steps they are taking to promote responsible antibiotic manufacturing and minimise the risk of antimicrobial resistance. Read more
15 Aug 2024
Pharma Manufacturing News + New Drug Development & Regulatory News
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Gerresheimer presents prefillable syringe systems at CPHI Worldwide
Gerresheimer will be presenting its silicone oil-free prefillable syringe systems for ophthalmic applications at CPHI Worldwide 2024. Read more
2 Sep 2024
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Masterpress responds to sustainability trends in the packaging industry
Masterpress, a European provider of printed decorative packaging solutions, will exhibit at FACHPACK, the international European trade fair for packaging, technology and processing, between 24-26th September, in Nuremberg, Germany. Read more
30 Aug 2024
PCI Pharma Services
PCI Pharma Services’ Bedford completes ICMRA inspection
PCI Pharma Services (PCI), a global contract development and manufacturing organisation (CDMO), has completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire campus. Read more
29 Aug 2024
Pharma Manufacturing News + Pharmaceutical Manufacturing News
Biocomposites Confirms NanoBone UK Distribution
Containing the NanoBone SBX Putty and NanoBone QD solutions, NanoBone products aim to provide synthetic bone grafts for reliable, early osteogenesis and bone formation. Read more
13 Sep 2024
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
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OncoHost accepted to present poster at ESMO 2024
OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, has announced its selection to present a poster at the European Society of Medical Oncology (ESMO) Congress 2024. Read more
13 Sep 2024
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
Cellular Origins
New collaboration set to integrate cryoFIL platform with Constellation robotic system
Cellular Origins has announced a collaboration with 3P innovation to integrate 3P's cryoFIL cryovial filling platform within Cellular Origins’ robotic system, Constellation, expanding the system’s capabilities by enabling automated filling Read more
12 Sep 2024
Pharma Manufacturing News + Pharmaceutical Manufacturing News
Arrowhead Pharmaceuticals’ Plozasiran Receives Breakthrough Therapy Designation from the FDA
The treatment has the potential to reduce triglycerides and other atherogenic lipoproteins. Read more
12 Sep 2024
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
BGS US
BGS Beta-Gamma-Service announces US expansion plans
BGS Beta-Gamma-Service, a specialist for more than 40 years in the use of beta and gamma rays for radiation sterilisation for medical devices, pharmaceutical packaging, and biotechnology products, will open its first facility in the United States. Read more
12 Sep 2024
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ILC Therapeutics completes £2.5m financing round and bolsters C-suite
ILC Therapeutics, a specialist developer of hybrid interferons, a new drug class engineered for improved therapeutic profiles across multiple indications, has announced that it has successfully completed a fundraise of £2.5m. Read more
11 Sep 2024
Pharma Manufacturing News + Pharma Finance and Investment News
