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MSD faces delay in C. diff drug approval as FDA requests more data

MSD, known as Merck in the US and Canada, has received a setback in its bid to get new C. diff infection treatment, bezlotoxumab, after the US Food and Drug Administration (FDA) requested more data from previously submitted clinical trials.

The additional data and analyses required will not set back the data for final date for approval by three months. The new prescription drug user fee act goal date has been set for October 23rd.

UK medical charity sells part of interest in MSD’s Keytruda for $150 million

UK medical research charity MRC Technology sold part of its royalty interest in US pharma major MSD’s (NYSE: MRK) immunotherapy Keytruda (pembrolizumab) for $150 million to raise funds for new research.

The charity sold part of the interest in a leading cancer drug to private equity fund managed by DRI Capital.

MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer

MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive opinion for a recommendation from of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Merck & Co says Keytruda shows better results than chemotherapy in Phase III trials for lung cancer

US drug major Merck & Co (NYSE: MRK) said late-stage trials for its immunotherapy Keytruda (pembrolizumab) to treat advanced non-small-cell lung cancer showed superiority to standard chemotherapy.  

Based on the results, an independent data monitoring committee recommended that the trial be stopped and that patients in the chemotherapy arm of the study have the opportunity to receive Keytruda.

MSD insulin glargine biosimilar meets primary endpoint in late-stage trials

MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating its insulin glargine biosimilar candidate, MK-1293.

FDA committee recommends MSD’s c. diff prevention drug

The US Food and Drug Administration’s (FDA) antimicrobial drugs advisory committee has voted by 10 to 5, with one abstention, to recommend Zinplava (bezlotoxumab), an investigational biologic for the prevention of Clostrodium difficile (c.difficile).

Bezoltoxumab is a fully monoclonal Ig61/kappa antibody, developed by MSD, that binds to and neutralises C difficile toxin B, likely by preventing it from binding to colonic cells and causing their inflammation.

MSD says Phase III trials for Keytruda to treat advanced melanoma shows better survival

Merck & Co (NYSE: MRK) said late-stage trials for its immunotherapy Keytruda (pembrolizumab) to treat advanced melanoma showed over half of the patients were alive two years after starting treatment. 

The data was part of multiple study results for its immunotherapy Keytruda in several cancer indications. 

The drugmaker said the trial drug showed better results compared with a 43% survival rate for patients receiving ipilimumab. 

MSD to collaborate with Fujifilm Diosynth on new microbial biologics facility

MSD, known as Merck in the US and Canada, has entered into a collaboration with Fujifilm Diosynth Biotechnologies to invest in and operate a large-scale microbial-biologics facility for supply of active pharmaceutical ingredients to its customers.

The collaboration will involve a $60 million investment by MSD at its Brinny manufacturing plant in Innishannon, in County Cork, Ireland. The site at Brinny has been in operation for more than 30 years and is an integrated site for development, testing and manufacturing of biologics.

Judge reverses verdict in MSD/Gilead hepatitis C dispute

A US district judge has reversed a previous court decision which favoured MSD, called Merck in the US, over Gilead in a dispute related to patents on blockbuster hepatitis C drugs.

Trial data shows promise for Lilly/MSD combo regimen in lung cancer

Eli Lilly (NYSE: LLY) has presented data at the American Society of Clinical Oncology (ASCO) annual congress showcasing its collaborations with MSD (NYSE: MRK) in patients with non-small cell lung cancer.

The pair’s immune-oncology partnership has seen a combination of Lilly’s Alimta (permetrexed), plus carboplatin, with MSD’s Keytruda (pembrolizumab). Keytruda has also been trialled in combination with Lilly’s Cyramza (ramucirumab).

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