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Manufacturing and Production

International Clinical Researcher of the Year 2022

Optimization of design transfer from device development to final assembly

CPhI Discover 2021

Eli Lilly’s COVID-19 drug bebtelovimab loses FDA authorisation

The FDA have announced that Eli Lilly’s COVID-19 drug bebtelovimab is not authorised for emergency use in the US, as it is not expected to neutralise the dominant Omicron BQ.1 and BQ.1.1 subvariants.

This announcement leaves Pfizer’s Paxlovid, Merck’s Lagevrio and Gilead Sciences’ Veklury as the standard treatments for COVID-19.

Eli Lilly has halted its commercial distribution of the drug until further information is received from the FDA. The US government has also stopped the fulfillment of pending requests for the drug.

SMC accepts HRT treatment Bijuve for use across NHS Scotland

The SMC has accepted HRT treatment, Bijuve, for use across NHS Scotland. Bijuve is the first and only body-identical HRT for estrogen deficiency symptoms in post-menopausal women, which combines estradiol and progesterone in a single daily oral capsule.

Open Orphan signs £10.4 million contract with global pharma client

Open Orphan has announced that its subsidiary hVIVO has signed a £10.4 million contract with an unnamed major global pharmaceutical client, to manufacturing a new batch of H1N1 flu challenge virus, and to conduct a human challenge trial to test the client’s antiviral product.

The company said that the study would evaluate the efficacy profile of the antiviral against the specific flu subtype, generating data quickly and efficiently.

UK to offer mini dose of monkeypox jab amid low stocks

Three NHS sites will begin a pilot offering eligible patients smaller doses of monkeypox vaccine, following global shortages of the jab, according to the BBC.

Health experts say that these reduced shots have the same efficacy, and will ensure that more of the population is protected against the disease.

Over 3,000 people have been diagnosed with monkeypox in the UK since the initial outbreak in May, and most of these cases have been among gay and bisexual men. However, anybody who comes into close contact with someone with monkeypox could contract the virus.

Initiative to improve next generation cancer diagnostics

The Medical Device Innovation Consortium (MDIC) has formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project, aiming to improve the validation and regulatory review process for sequencing-based cancer diagnostics.

The initiative will seek to develop, manufacture, and validate publicly available somatic reference samples, and create public genomic datasets with the potential to be used by sponsors and regulators.

Next generation sequencing (NGS) is a parallel sequencing technology that offers extremely high throughput, scalability, and speed.

Dengue vaccine approved in Indonesia regardless of prior exposure

Takeda have announced the dengue vaccine, QDENGA®, was approved by the Indonesia National Agency for Drug and Food Control. Dengue is a mosquito-borne, viral disease that poses significant global public health threat, and is prevalent in over 125 countries.

The vaccine has been approved for the prevention of dengue disease caused by any serotype in patients aged six years to 45 years of age. QDENGA is the only dengue vaccine approved in Indonesia for use in individuals regardless of previous dengue exposure, and without the need for pre-vaccination testing.

Santen launches Ducressa for post-cataract surgery

Treatment involves a combination of levofloxacin and dexamethasone for use after cataract surgery

Santen has announced the launch of Ducressa in the UK and Ireland. The therapy is a fixed dose combination of levofloxacin and dexamethasone for use after cataract surgery.

It is part of a more convenient seven-day therapeutic strategy to optimise post-surgery care. Levofloxacin is a proven broad-spectrum antibiotic and dexamethasone is a potent anti-inflammatory agent.

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