Pharmaceutical environmental monitoring market to value $38.1b by 2030
European Pharmaceutical Review
by Catherine Eckford
7h ago
The global pharmaceutical and biotechnology environmental monitoring market valued $24 billion in 2023, according to a report by Verified Market Research. This figure is projected to increase to $38.1 billion by 2030. Pharmaceutical and biotechnology environmental monitoring market Influencing factors  The report also covered that due to the biotechnology industry requiring sterile conditions and products, expansion of this sector creates demand for extensive environmental monitoring. Similarly, as the industry continues to implement quality control measures to prevent product contaminat ..read more
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Quality risk management in radiopharmaceutical production
European Pharmaceutical Review
by Catherine Eckford
7h ago
A paper published in Applied Sciences has described a quality risk assessment methodology for application in sterile PET radiopharmaceutical production under Good Manufacturing Practice (GMP) regulations. According to research highlighted in the paper, applying quality standards such as GMP and ISO 9001 “guarantees the quality and safety of a radiopharmaceutical and contributes to optimising the performance and efficacy of the entire production process.” As such, the paper by Poli et al. emphasised the importance of having a risk management process for GMP production facilities. Ensuring radi ..read more
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Strong growth for Sweden’s pharmaceutical exports
European Pharmaceutical Review
by Catherine Eckford
1d ago
According to SwedenBIO, Sweden‘s life sciences industry is witnessing a continued increase in export values. Based on statistics from Statistics Sweden, at SEK 152.5 billion, exports of pharmaceuticals reached a total of 7.3 percent of Sweden’s total export value. SwedenBIO highlighted that this is an almost 10 percent increase since 2022. Value of Swedish pharmaceutical exports Swedish pharmaceuticals exports are currently “significantly larger” than exports of iron and steel. They are therefore of “growing importance to the economy”, SwedenBIO explained. With one success factor of ..read more
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First-in-class biologic approved for rare lung disease
European Pharmaceutical Review
by Catherine Eckford
1d ago
The US Food and Drug Administration (FDA) has approved WINREVAIR (sotatercept-csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1).  According to Merck (MSD outside of the US and Canada), WINREVAIR is the first activin signalling inhibitor therapy authorised for PAH. Clinical data has demonstrated that on top of background therapy, the biologic significantly improved exercise capacity compared to just background therapy. For instance, the treatment increased patient’s six-minute walk distance from ba ..read more
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Drug safety driving pyrogen testing market expansion
European Pharmaceutical Review
by Catherine Eckford
1d ago
A report by Allied Market Research has predicted that the global pyrogen testing market will value $3.3 billion by 2032. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.  Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. A higher incidence of infectious diseases is a major contributing factor for the expansion of the pyrogen testing market. This has hei ..read more
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CHMP meeting highlights: March 2024
European Pharmaceutical Review
by Catherine Eckford
2d ago
In its latest meeting, the CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec) for diabetes mellitus in adults, and Lytenava (bevacizumab) as a treatment for neovascular age-related macular degeneration. Following accelerated assessment by the EMA, its human medicines committee also adopted a positive opinion for Emblaveo (aztreonam-avibactam) as a new antibiotic against Gram-negative bacteria resistant to available antibiotics. Positive CHMP recommendation for antibiotic combination Fabhalta* (iptacopan) was given a positive opinion fro ..read more
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Next-gen Moderna COVID-19 vaccine shows promise
European Pharmaceutical Review
by Catherine Eckford
2d ago
Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax®), Moderna’s licensed vaccine for the condition. “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us con ..read more
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Astellas breaks ground on new facility
European Pharmaceutical Review
by Caroline Peachey
3d ago
Astellas Ireland, a wholly owned subsidiary of Astellas, has officially marked the start of construction of a new €330 million manufacturing facility at Kerry Technology Park in Tralee, Ireland. The ground-breaking ceremony, held on 25 March, was attended by Irish government officials as well as project partners and senior executives from Astellas. The new 17,000 square meter state-of-the-art facility will accelerate the expansion of Astellas’ in-house manufacturing capabilities, including for antibody drugs. Some 600 jobs are expected to be created during the project’s construction phase, al ..read more
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Positive CHMP recommendation for antibiotic combination
European Pharmaceutical Review
by Caroline Peachey
3d ago
The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria. “Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients very ill and at high risk of severe complications, including mortality,” said James Rusnak, Senior Vice President and Chief Development Officer, Internal Medicine ..read more
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Novo Nordisk to buy Cardior Pharmaceuticals
European Pharmaceutical Review
by Caroline Peachey
3d ago
Novo Nordisk has agreed to acquire Cardior Pharmaceuticals, a leader in the discovery and development of RNA-based therapies for heart failure for up to €1.025 billion. The agreement includes Cardior’s lead compound CDR132L, currently being investigated in a Phase II clinical trial (HF-REVERT) for the treatment of heart failure. The deal comprises an upfront payment, plus additional payments if certain development and commercial milestones are achieved. CDR132L is designed to halt and partially reverse cellular pathology by selectively blocking abnormal levels of the microRNA molecule miR-132 ..read more
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