New Drug Development & Regulatory News
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Infinitopes granted phase I/IIa clinical trial application approval
Infinitopes has announced that the UK Medicines and Healthcare products Regulatory Agency has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company’s ‘off-the-shelf’ cancer vaccine.
10 Apr 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
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Shilpa’s Unit-2 passes second consecutive FDA inspection
Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Administration (FDA) inspection for its Unit-2 facility in Raichur, India, with no 483 observations.
10 Apr 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
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European Commission approves expanded label for KAFTRIO
Vertex Pharmaceuticals has announced that the European Commission has granted regulatory approval for a label expansion of KAFTRIO in a combination regimen with ivacaftor for the treatment of people with cystic fibrosis.
8 Apr 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
MultiOmic Health
Companies collaborate to discover and develop renal tissue-targeting drugs
MultiOmic Health and Alloy Therapeutics have announced they have signed a Memorandum of Understanding to jointly discover and develop first-in-class renal tissue-targeting drugs.
4 Apr 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
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Johnson & Johnson announces European Commission approval
Johnson & Johnson has announced that the European Commission (EC) has approved a Marketing Authorisation for STELARA.
3 Apr 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
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Domain Therapeutics progresses drug candidate for inflammatory diseases
Domain Therapeutics has announced it has nominated and is progressing DT-9046, a candidate with "game-changing" potential in multiple inflammatory disease markets.
21 Mar 2025
Pharma Manufacturing News + New Drug Development & Regulatory News
Experience. Precision for Radiopharma Logistics - Marken
Winning the race against time with precision for critical Radiopharma shipments.
Cold Chain Technologies
Cold Chain Technologies launches universal CCT Tower elite
Cold Chain Technologies (CCT) has launched a reusable universal temperature-controlled pallet shipper – the company’s first innovation for the life sciences sector since its acquisition of reusable pallet specialist, Tower Cold Chain, in 2024.
17 Apr 2025
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
Sterling Pharma Solutions
Sterling Pharma Solutions selects Ajax Equipment agitated screw feeder
Solids handling equipment maker, Ajax Equipment, has supplied pharmaceutical developer and manufacturer, Sterling Pharma Solutions, with an ATEX-rated agitated screw feeder mounted on a mobile frame to feed an active pharmaceutical ingredient (API).
17 Apr 2025
Pharma Manufacturing News + Pharmaceutical Manufacturing News
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Meribel Pharma Solutions aims to elevate pharma services
A new, mid-size Contract Development Manufacturing Organisation (CDMO), Meribel Pharma Solutions has launched with an integrated network across Europe, led by a team of industry experts on a mission to deliver the highest quality solutions.
16 Apr 2025
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
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Concept Life Sciences gains investments to strengthen drug discovery capabilities
Concept Life Sciences has announced key strategic appointments and advancements to further strengthen its services for the global pharmaceutical and biotechnology sectors.
16 Apr 2025
Pharma Manufacturing News + Pharma Finance and Investment News
AAMI
TIR109 provides guidance on transporting sterile medical devices
Transportation of medical devices between facilities is increasingly the norm. Health care facilities often send instruments to offsite reprocessing centres miles away from the point of care.
15 Apr 2025
Pharma Manufacturing News + Pharmaceutical Logistics & Distribution News
IMA Life
Interphex NY rewards IMA Life for the fourth year in a row
Another edition of Interphex NY has ended up in a convincing demonstration of how IMA Life stays on the "crest of innovation" with its latest technology for aseptic filling, introducing a modular, fully gloveless system based on magnetic levitation.
15 Apr 2025
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
DataLase
DataLase and TamperTech partnership delivers smart tamper-evident tape
DataLase and TamperTech have joined forces to introduce an innovation in tamper-evident tape technology.
15 Apr 2025
Pharma Manufacturing News + Latest Pharmaceutical Manufacturing News
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Pharma taps LifeSphere Advanced Signals for AI-driven signal detection
ArisGlobal has announced that another pharmaceutical company has chosen LifeSphere Advanced Signals, a pharmacovigilance solution that leverages automation and AI-driven insights to streamline signal detection and management.
14 Apr 2025
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Bormioli Pharma boosts revenues and earnings
Gerresheimer recorded a jump in revenues and earnings due to the first-time consolidation of Bormioli Pharma, which was acquired in 2024.
11 Apr 2025
Pharma Manufacturing News + Pharma Finance and Investment News
Sponsored Content
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12 Mar 2025
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Experience. Precision for Radiopharma Logistics - Marken
Winning the race against time with precision for critical Radiopharma shipments.
Sponsored Content
Stevanato Group
A one-stop shop for even the most challenging Monoclonal Antibodies (mAbs)
The biologics market is expanding rapidly – with a compound annual growth rate of 15% predicted until 2027. But this new generation of drugs comes with unique challenges that require an innovative approach underpinned by extensive experience.
12 Mar 2025
08:00