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Keytruda scores EU approval in combination with Inlyta for first-line advanced renal cell carcinoma

The European Commission has awarded yet another authorisation in the region to MSD’s Keytruda, this time in combination with the tyrosine kinase inhibitor Inlyta (axitinib) in the first-line treatment of advanced renal cell carcinoma (RCC).

The ruling was made on the back of Phase 3 data confirming that the combination of Keytruda and Inlyta reduced the risk of death by 47% in RCC patients compared to Pfizer’s Sutent (sunitinib), while also presenting benefit in both progression-free survival and objective response rate.

FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.

The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.

HHS to fund production of MSD's Ebola vaccine V920

The US Department of Health and Human Services (HHS) has said it will fund the production of MSD’s investigational Ebola vaccine V920 in response to the ongoing Ebola outbreak in the Democratic Republic of Congo (DRC).

At least 1,900 have died from Ebola over the past year in the DRC, as the central African country experiences the second worst Ebola outbreak in history after the outbreak in West Africa in 2014-16 that killed 11,300.

Lynparza extends progression-free survival in first-line advanced ovarian cancer, with or without BRCA mutations

New Phase 3 data has emerged on AstraZeneca and MSD’s Lynparza (olaparib), showing that the PARP inhibitor achieved its primary endpoint in the first-line maintenance of advanced ovarian cancer in patients with or without BRCA mutations when added to standard-of-care bevacizumab, compared to bevacizumab alone.

The companies declared that the drug combo was found to produce a £statistically-significant and clinically-meaningful improvement in progression-free survival (PFS)”, marking the second positive set of results for Lynparza in first-line ovarian cancer.

MSD teams up with Harvard University to discover novel immune system pathways to fight cancer

A new partnership between MSD and Harvard University hopes to combine the expertise of both parties to carve a path forward in the identification of new treatment pathways to treat cancer with immune-oncology therapies.

The collaboration will run for up to four years, supplying the necessary funding for efforts to uncover novel targets within the immune system for future cancer treatments.

Keytruda/chemo combo recommended for first-line lung cancer via Cancer Drugs Fund

MSD’s Keytruda (pembrolizumab) has secured recommendation from NICE for inclusion on the Cancer Drugs Fund (CDF) in combination with chemotherapy in the first-line treatment of untreated metastatic squamous non-small cell lung cancer (NSCLC), it has emerged.

The final appraisal determination marks the first for a immunotherapy/chemotherapy combo in this indication regardless of PD-L1 expression.

MSD to bring over 400 new jobs to North Carolina with two site expansions

MSD has announced a $650 million expansion of its existing facilities in North Carolina – a move which is bring more than 400 new jobs to the US state, according to the NC Department of Commerce.

The project will include an expansion of MSD’s existing packaging operations in Wilson County, while a new production facility will be built at the company’s Maurice R Hilleman Center for Vaccine Manufacturing in Durham. The first location will see a boost of 391 jobs, while the second will see an additional 34 positions open up.

MSD's Keytruda combo hits primary endpoint at Phase 3 in triple-negative breast cancer

MSD’s blockbuster anti-PD-L1 immunotherapy Keytruda (pembrolizumab) has impressed in newly released Phase 3 data; the company announced that, when combined with chemotherapy, the drug met one of its primary endpoints in the treatment of triple-negative breast cancer (TNBC).

Findings derived from a study of 1,174 TNBC patients and analysed by the independent Data Monitoring Committee demonstrated that Keytruda generated a “statistically significant improvement” in rates of pathological complete response (pCR) compared to chemo alone, regardless of PD-L1 status, as determined by a la

Humira biosimilar from Samsung Bioepis and MSD wins marketing authorisation in the US

It’s another victory for MSD as the US drugmaker announced that its biosimilar version of AbbVie’s Humira – the world’s best-selling medicine – has received marketing authorisation from the FDA.

The approval for the drug, known as Hadlima and developed by Samsung Bioepis, covers the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, just like its reference product.

MSD trials long lasting PrEP implant for preventing HIV

MSD is trialling an implant that prevents patients from contracting HIV, The Guardian has said.

The US firm has tested a long duration pre-exposure prophylaxis (PrEP) implant in 12 healthy adults over a period of 12 weeks.

In trialling the tolerability of the drug, patients were given implants containing either 54mg or 62mg doses of the drug islatravir.

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