In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake…

At its annual re:Invent event, Amazon Web Services (AWS) announced expanded alliances with two leading drug developers, Amgen and Merck, to create generative artificial intelligence (AI) technologies aimed at accelerating drug discovery and increasing efficiencies in manufacturing processes. Merck has been working with AWS and Accenture for several years whereas Amgen and AWS have collaborated…

The biopharma industry is pushing back against increased scrutiny of mergers and acquisitions from the Federal Trade Commission (FTC). More than 30 biopharma companies and industry associations announced the formation of the Partnership for the U.S. Life Science Ecosystem (PULSE) to advocate for the role of M&A activity in the biopharma sector. A M&A landscape…

Marking the first legal challenge of its kind, pharma giant Merck & Co. took to the courts on Tuesday, directly contesting the U.S. government over the Medicare drug price negotiation program. The Big Pharma company’s lawsuit, filed in the U.S. District Court for the District of Columbia, contends the program’s basis — the Inflation Reduction…

The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…

Endometrial cancer, a common gynecological malignancy, leaves considerable unmet needs for patients with advanced or recurrent disease. GSK‘s (NYSE:GSK) Jemperli (dostarlimab), a PD-1 receptor antagonist, brings hope to the numerous women diagnosed with this cancer each year. As the first immunotherapy approved for patients with deficient mismatch repair (dMMR) endometrial cancer, dostarlimab has the potential…

FDA has informed Merck (NYSE:MRK) that its investigational anticoagulant therapy MK-2060 has received Fast Track designation. The program accelerates the review of new drugs to treat serious conditions or unmet medical need. The Fast Track designation covers the risk reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). “We are encouraged…

New York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis.  The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology to interrogate the hormonal and neural signaling pathways that comprise the gut-brain axis.  The…

Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer. Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended. The primary endpoint…

Merck & Co. (NYSE: MRK) has announced that the Vaxneuvance pneumococcal 15-valent conjugate vaccine has won approval for children 6 weeks through 17 years of age. The vaccine is indicated to protect against infection from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. The…

If 2020 underscored the importance of the pharma industry’s social importance, 2021 demonstrated the ability of R&D spenders to yield profitable commercialized products.  But while strong demand for COVID-19 therapies in 2021 provided unprecedented revenue levels for a handful of Big Pharma companies, it didn’t result in substantial changes in R&D spending. (Look out for more insights…

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. This roundup of best-selling pharmaceuticals in 2021 highlighted a banner year for the industry. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the…

Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN). Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer. The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival…

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro. The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the…

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801).  In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir.  FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir).  FDA’s authorization of…

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid. CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease. CHMP also stressed the…

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek. The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall…

FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks. A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions. FDA generally follows the advice of its advisory committees. “This was clearly…

An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir. One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion. The U.S. has committed to buy approximately 3.1…

The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the drug in Great Britain. Furthermore, it has allowed emergency use authorization of the drug for Northern Ireland. MHRA recommends that…

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected. Sales of the drug could be higher, assuming it finds widespread use in wealthy countries. Merck expects sales between $500 million and $1 billion…

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market. Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA. The…