European Pharmaceutical Review

FEBRUARY 26, 2024

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines.

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pharmaphorum

JUNE 22, 2022

The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic medicine, as well as medical supplies, antibiotics and ingredients required to manufacture treatments.

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European Pharmaceutical Review

NOVEMBER 14, 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. COVID-19 update. 5 in children five to 11 years. CHMP’s safety update.

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European Pharmaceutical Review

DECEMBER 19, 2022

A generic medicine, Diethyl fumarate Accord (dimethyl fumarate), received a positive opinion for the treatment of multiple sclerosis (MS), a chronic disease affecting the central nervous system. The committee recommended to extend the use of original Spikevax vaccine and Spikevax bivalent Original/Omicron BA.1 COVID-19 update.

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European Pharmaceutical Review

APRIL 3, 2023

It is the eighth vaccine recommended in the European Union (EU) for COVID-19. The committee adopted a positive opinion for Briumvi (ublituximab) for relapsing multiple sclerosis (MS). It relies partly on results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

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pharmaphorum

OCTOBER 17, 2022

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga ( TAK-003 ). Medicines submitted under EU-M4all are assessed by the CHMP in collaboration with the WHO and target countries.

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pharmaphorum

MAY 27, 2022

As we saw during the incredible response to the global COVID-19 pandemic, the industry demonstrated resilience and was able to rise to the challenge of an existential threat facing humanity and overcome incredible difficulties to develop and deploy lifesaving vaccines.

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pharmaphorum

MAY 26, 2022

The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus.

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European Pharmaceutical Review

FEBRUARY 3, 2025

CHMP’s positive opinions for vaccines In addition, the human medicines committee recommended the vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), as a preventative treatment for invasive disease and pneumonia caused by streptococcus pneumoniae bacteria in adults.

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European Pharmaceutical Review

FEBRUARY 20, 2025

The US imports a substantial volume of APIs and finished medicines, many of which are essential for patient care, meaning these tariffs could have far-reaching implications. 2 Introducing tariffs on pharmaceutical imports could lead to significant disruptions, particularly for generic medicines , which often rely on lower-cost API sourcing.

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