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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

EU approval for MSD and AZ's Lynparza in first-line BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD’s jointly-developed therapy Lynparza (olaparib) has scored its third EU approval, the pair announced, with authorisation for the first-line treatment of female patients with BRCA-mutated advanced ovarian cancer.

Specifically, the authorisation covers the maintenance of FIGO Stages III and IV BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in those who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.

Drugmakers sue Trump over prices in TV ads

Amgen, Eli Lilly and MSD have sued the Trump administration to try and block measures to force pharma companies to include prices in TV ads.

Three of America’s biggest drugmakers filed a lawsuit against the Trump administration over the Department of Health and Human Services (HHS) ruling to force pharmaceutical companies to list the prices of their drugs in adverts on TV.

FDA ask MSD to join blockchain supply chain network

The FDA has asked MSD to join a shared permission blockchain network to help track and trace prescription medicines and vaccines distribution in the United States.

Alongside IBM and Walmart, US firm Merck will join the blockchain network to allow for real time monitoring of medical products.  

MSD scoops up biopharma firm Tilos for $773 million

US-based firm MSD has announced it intends to acquire biopharma firm Tilos Therapeutics, and has signed a deal with the company to this effect, valued to a total of $773 million.

This new deal means that MSD will acquire all outstanding shares of Tilos through a subsidiary, which altogether come to a potential consideration of $773 million, which includes both an upfront payment as well as milestone payments dependent on the achievement of certain developmental and commercial goals.

Longest follow up trial of Merck's Keytruda sets new standard for five year survival in lung cancer

Nearly a quarter of previously untreated lung cancer patients who took Keytruda (Pembrolizumab) were alive after five years, according to the results of the longest follow-up trial for Merck’s cancer immunotherapy.

In total, 23.2% of treatment naïve patients with advanced non-small cell lung cancer (NSCLC) were alive after five years.

The data from the phase 3 KEYNOTE trial of 616 patients showed that 23.2% of previously untreated and 15.5% of previously treated patients lived for more than five years after receiving MSD’s immunotherapy.

NICE recommends MSD's Prevymis for CMV prevention following allogeneic haematopoietic stem cell transplant

MSD has revealed that its non-nucleoside CMV inhibitor Prevymis (letermovir) has secured recommendation from NICE, meaning it will now be made available on the NHS to patients in England and Wales for the prevention of cytomegalovirus (CMV) reactivation and disease following an allogeneic haematopoietic stem cell transplant (HSCT) in adult patients seropositive for CMV.

It is estimated that between 50% and 80% of UK adults are infected with CMV, which exists in the body in an inactive state.

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