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MSD

Lynparza tablets approved for NHS use in platinum-sensitive, BRCA-mutated ovarian, fallopian tube or peritoneal cancer

It has been announced that tablet form of Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has secured recommendation from NICE  for the treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in adult patients with a BRCA1 or BRCA2 mutation.

Data supplied in support of the case for the drug’s recommendation demonstrated that Lynparza presented a progression-free survival benefit of 19.1 months, compared to 5.5 months for placebo.

MSD's Keytruda chalks up bladder cancer approval in the US

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

Bittersweet Phase 3 Keytruda data hits one of two goals in extensive stage small cell lung cancer

MSD has lifted the curtain on new Phase 3 data on the efficacy of its blockbuster immunotherapy Keytruda, in combination with etoposide plus cisplatin or carboplatin chemotherapy, in the treatment of extensive stage small cell lung cancer (ES-SCLC) in the first-line setting, showing that the combo met one of its primary endpoints, but not both.

MSD set to acquire ArQule in deal worth up to $2.7 billion

MSD has revealed its intention to acquire biopharma firm ArQule in a deal worth a potential total of $2.7 billion, valued at $20 per share in cash.

ArQule is a company leveraging kinase inhibitor discovery in the pursuit of new treatments for cancer, among other conditions. The deal means that MSD scoops up the firm’s lead candidate ARQ 531, a Bruton’s tyrosine kinase (BTK) inhibitor currently in development at Phase 2 for the treatment of B-cell malignancies.

Keytruda overtakes Opdivo to lead sales in global immune checkpoint inhibitor market, report reveals

MSD’s Keytruda (pembrolizumab) overtook Bristol-Myers Squibb’s (BMS) blockbuster drug Opdivo (nivolumab) in total sales in the third quarter of 2019 to emerge as leader in the global immune checkpoint inhibitor market, according to a new report from GlobalData.

According to the findings, MSD’s drug saw a 62% growth in revenue compared to Q3 2018 to reach $3.1 million. Over the same period, Opdivo experienced sales growth of just 1%, generating $1.8 million

Bayer and MSD's chronic heart failure drug meets main goal at Phase 3

MSD and Bayer have made it known that their jointly-developed soluble guanylate cyclase (sGC) stimulator vericiguat met its primary endpoint as a therapy to treat patients experiencing worsening chronic heart failure.

Phase 3 data from the VICTORIA study revealed that the pair’s therapy, when combined with available heart failure therapies, successfully reduced the risk of hospitalisation or cardiovascular death as a result of chronic heart failure compared to placebo in patients with reduced ejection fraction (HFrEF).

MSD's proposed sale of French manufacturing plant puts over 200 jobs in jeopardy

MSD has announced its plans to put its Centre de Mirabel production facility in Riom, France up for sale – a move that will see the company axe more than 200 staff as part of its $1.2 billion reorganisation of its manufacturing operations to “further optimise the company’s manufacturing and supply network, as well as reduce its global real estate footprint”.

The sale will terminate 101 positions in production and 106 in R&D, a considerable portion of the 584 total active roles at the facility, which predominantly deals with the production and packaging of sterile antibiotic inj

MSD secures EU approval for its Zaire Ebola vaccine Ervebo

MSD has scored approval from the European Commission for Ervebo, the company’s Zaire Ebola vaccine, for the prevention of Ebola virus disease (EVD) in patients at least 18 years old, it has emerged.              

The decision follows a positive recommendation from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in October. The vaccine is currently under review in the US under the FDA’s priority review pathway, with a final decision due by 14 March 2020.

MSD's Keytruda approved for first-line lung cancer use on NHS Scotland

MSD and lung cancer patients will be celebrating the news that the pharma giant’s immunotherapy Keytruda (pembrolizumab) has been accepted by the Scottish Medicines Consortium (SMC), in combination with carboplatin and paclitaxel chemotherapy, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

The decision means that Keytruda becomes the first drug approved in Scotland in the first-line treatment of this indication; patients will be able to access the drug on the NHS, but only those whose tumours express programmed death ligand 1 (PD-L1) with a

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.

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