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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.

FDA approves MSD's combo therapy Recarbrio for urinary tract and intra-abdominal infections

MSD has announced the approval from the FDA of its combination therapy Recarbrio (imipenem, cilastatin and relebactam) in the treatment of adult patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

The therapy combines the penem antibacterial drug imipenem, the renal dehydropeptidase inhibitor cilastatin sodium, and the beta lactamase inhibitor relebactam.

US Judge blocks Trump administration law requiring pharma to include prices in TV ads

A judge has blocked the Trump administration from enacting a law that would require pharmaceutical companies to include the prices of their drugs in TV ads.

On 8 July 2019, District Judge Amit Mehta in Washington, DC ruled in favour of pharma giants Amgen, Eli Lilly and MSD in preventing the Department of Health and Human Services (HHS) new law from taking effect.

Top Ten most popular articles on Pharmafile.com this week

It's Friday, and time for another run-down of the week's most popular articles.

MSD's Keytruda snatches up first approval in small cell lung cancer

MSD has revealed that its anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been awarded marketing authorisation from the FDA as a monotherapy in the treatment of metastatic small cell lung cancer (SCLC) in adults whose disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The approval was given under the FDA’s accelerated review pathway, and was based on data from 83 participants across two trials, 64% had received two prior lines of therapy and 36% had received three or more; 60% had received prior thoracic radiation therapy

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