Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback as the FDA turned down the pharma giant’s application and asked for additional efficacy data. No safety issues were raised, according to Merck.
Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron Pharma as fitting the bill. The pharma giant is paying $11.5 billion to acquire the biotech, and executives say they’re still on the hunt for more deals.
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FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.
Vaxneuvance, a Merck pneumococcal vaccine, is now approved by the FDA. The intramuscular shot protects against 15 pneumococcal strains—five fewer than the 20 covered by a Pfizer pneumococcal vaccine that the FDA approved in June.
Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those in the hospital.
Merck agreed to pay $215 million up front to acquire Alydia Health, a startup that has commercialized a medical device that controls bleeding during childbirth. That product will join the portfolio of Merck spinout company Organon.
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Merck's top immunology drugs face biosimilar competition. The $1.85 billion acquisition of Pandion Therapeutics gives the pharma giant an opportunity to build up its immunology pipeline with a new approach to treating autoimmune disorders.
One deal is a $4.2 billion development and commercialization partnership focused on ladiratuzumab vedotin, while the other would expand the reach of the breast cancer drug Tukysa.
The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
In three announcements, the drugmaker said it would acquire an Austrian vaccine developer and partner with a private biotech company and nonprofit organization on an antiviral drug and a vaccine.
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The company, currently labeled only "NewCo," will focus on Merck's women's health, legacy products and biosimilars, while Merck itself focuses on oncology, vaccines, hospital drugs and animal health. The drugmaker's shares fell more than 4% when markets opened Wednesday.
The FDA approved Lynparza for patients with pancreatic cancer after chemotherapy whose tumors harbor a certain genetic mutation.
The agency was expected to rule on whether or not to approve the vaccine, Ervebo, by March 2020. The vaccine protects against Zaire ebolavirus, but not other strains of the virus or the related Marburg virus.
The agency is expected to rule on the vaccine by March 14 of next year. The company has shipped nearly a quarter of 1 million doses of the vaccine to the WHO for countries facing outbreaks like the Democratic Republic of the Congo.
Recarbrio was approved for treating complex urinary tract and intra-abdominal infections among adult patients who have limited or no therapy options.