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MHRA issues first UK guidance on phage therapies
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
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Antibiotics
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CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
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Preserving antibiotic efficacy with an advanced coating process to prevent Amoxicillin and Clavulanic Acid tablet degradation
IMA Pharma discusses approaches to keeping Amoxicillin and Clavulanic Acid tablets stable and effective by addressing moisture sensitivity and preventing degradation.
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Vaccines “essential” for addressing AMR, says WHO
The World Health Organization (WHO) asserts that vaccines could reduce antibiotic use as well as economic costs of antimicrobial resistance (AMR) worldwide.
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New WHO guidance to support manufacturers to reduce AMR risk
The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.
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AstraZeneca announces $1.5b ADC manufacturing facility
The new manufacturing facility for antibody drug conjugates (ADCs) will be designed to have zero carbon emissions when operational, AstraZeneca stated.
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GSK pledges £45m to support global AMR prevention
The CEO of GSK shared that the company is “proud to be a founding partner, and hope others will join us to support this urgent priority” in tackling AMR.
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Ensuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
webinar
Pharmaceutical continuous manufacturing: what’s next for industry?
13 May 2024 | By European Pharmaceutical Review, sponsored by MasterControl
During this virtual panel, industry experts will discuss adoption of continuous manufacturing in the pharmaceutical industry.
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European Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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CHMP meeting highlights: March 2024
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
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Positive CHMP recommendation for antibiotic combination
EMA has recommended granting a marketing authorisation for Emblaveo for treatment of infections caused by multidrug-resistant bacteria.
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Driving the UK’s “innovation engine” for novel AMR therapeutics
Despite the UK having “a very healthy” therapeutic pipeline, more needs to be done in the fight against antimicrobial resistance (AMR), NovaBiotics’ CEO asserts.
whitepaper
Whitepaper: Reducing gas consumption by 20% during the micronization
Discover how the coaxial jet mill transforms micronization in pharma and chemical sectors, ensuring safety, efficiency, and sustainability.
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Europe publishes first list of critical medicines
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
