Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics

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 of de-identified patient records spanning over 40 years.

Dr. Lincoln Nadauld, CEO of the startup, notes that the funding is evidence that the data it has collected can address pharma’s longstanding quest to boost the efficiency of drug discovery and development. Frequently, pharma companies have “access to vast datasets, but those datasets are often not the right kind of data,” Nadauld said. “It’s fragmented, or it’s unstructured, or it’s deficient in some fashion.”

Culmination Bio readies data lake based on four decades of patient health records

Consequently, Culmination Bio is confident that t…

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AWS expands collaborations with Amgen and Merck to advance AI in drug discovery and manufacturing

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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 for more than a decade.

Reflecting on AWS’s presence in the life sciences, Dan Sheeran, general manager of healthcare and life sciences at AWS, noted the company works with thousands of global healthcare and life sciences customers, including nine of the top 10 pharma companies.

“Healthcare and life sciences organizations are increasingly turning to AWS and technology as a business differentiator—especially with the explosion of generative AI,” Sheeran said. “Our pharma c…

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A timeline of Merck’s legal battle over Medicare negotiation

[Photocreo Bednarek/Adobe Stock]

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 Act (IRA) — infringes upon the Fifth and First Amendments of the U.S. Constitution.

The legislation has put pricing pressure on the industry and contributed to a wave of recent M&A deals.

Merck, and the wider pharmaceutical industry, are raising the alarm. They claim the law, in effect, coerces drugmakers into accepting below-market rates. The lobbying group PhRMA (Merck is a member) released a statement in April 2023 arguing that the Inflation Reduction Act threatens patient access and complicates R&D efforts.…

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The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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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 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and  other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

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Merck wins Fast Track designation from FDA for experimental anticoagulant therapy

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 by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a news release. “Today, there is no anticoagulation standard of care for such patients.”

A Phase 2 Study of MK-2060 is now underway in people with end-stage renal disease who are undergoing hemodialysis.

The FXI…

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Kallyope’s focus on the gut-brain axis yields a diverse portfolio

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. 

The company has raised $479 million to date, including a $236 million Series D financing in February.

Jay Galeota

The president and CEO of the company is Jay Galeota, who worked at Merck & Co. (NYSE:MRK) for almost three decades.  

“I was fortunate enough to lead the team that brought Merck into diabetes with Januvia (sitagliptin) and Janumet (sitagliptin/metformin),” Galeota said. Last year, the drugs generated $5.3 billion in revenue.

The discoverers of sitagliptin, Nancy Thornberry and Ann Weber, are both Merck alumni who are now senior executives at Kallyope. Thornb…

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Senate Finance Committee chair says Abbott, Merck aren’t complying

Ron Wyden [Image from U.S. Senate Finance Committee]

Senate Finance Committee Chair Ron Wyden (D-Oregon) wrote a letter demanding compliance from Merck and Abbott.

The letter demands that Merck and Abbott complay with the Senate Finance Committee’s investigation into the tax practices of Big Pharma.

According to a news release from the Senate Finance Committee, the two companies have, to this point, “stonewalled” the committee, refusing to provide specific information related to where they book profits from U.S. drug sales. That includes the refusal to provide specific data on how much taxable income is reported by offshore subsidiaries — known as controlled foreign corporations — for tax purposes, the committee said.

The data would allow the committee to better understand the discrepancy between U.S. sales and where income is booked, the Senate Finance Committee noted, adding …

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Merck halts Phase 3 Lynparza for futility

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 of the trial was progression-free survival.

The study focused on patients without progression after first-line therapy.

Merck made the decision after receiving feedback from an independent Data Monitoring Committee (DMC) following review from an interim analysis.

The PARP inhibitor Lynparza was first developed by KuDOS Pharmaceuticals and the University of Pennsylvania.

AstraZeneca acquired KuDOS Pharmaceuticals in 2005.

In 2021, the drug jointly earned AstraZeneca and Merck $3.7 billion.

The two companies continue to develop Lynparza for a variety of on…

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Merck moves forward with Seagen acquisition plans 

Executives from Merck & Co. (NYSE:MRK) and Seagen (Nasdaq:SGEN) are reportedly considering a $40 billion acquisition deal.

Readington, New Jersey–based Merck has offered to spend about $200 per share for Seagen, according to The Wall Street Journal.

Executives from the company aim to finalize the deal before Merck announces its Q2 earnings on July 28, according to WSJ.

Seagen shares were up about 2%, trading at $178.56 in afternoon trading.

Merck shares held steady, hovering around $92.90.

In a Q1 earnings call, Merck CEO Robert M. Davis said the company is working to diversify its business as it plans to lose exclusivity for its megablockbuster immunotherapy drug Keytruda. “In oncology, we remain committed to building on the foundational position that we have achieved with Keytruda, and we aim to expand our presence in this key therapeutic area and to establish an enduring leadership position,” Davis said.

The patent protections…

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Illumina, Merck launch test for cancer development, progression insights

[Image from Illumina/Merck]Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK).

The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD). HRD, a genomic signature, describes when cells are unable to effectively repair double-stranded DNA breaks, an occurrence that can lead to genomic instability and eventually tumor formation.

According to a news release, the new test will be made available globally, excluding the U.S. and Japan. The two companies originally announced that they partnered in September 2021 to develop and commercialize tests that identify genetic mutations used in the assessment of HRD.

“HRD status has emerged as an important biomarker …

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Merck reportedly mulling Seagen acquisition

Approximately one month after Seagen (Nasdaq:SGEN) CEO Clay Siegall resigned following a domestic abuse arrest, Merck & Co. (NYSE:MRK) is considering purchasing the company, according to WSJ.

One potential hurdle is the possibility of increased antitrust enforcement from the DOJ and FTC focused on the pharmaceutical sector.

To sidestep such risks, the two companies could enter a joint marketing arrangement instead, according to the WSJ article, which cited anonymous sources. The two companies have already had strategic collaborations in oncology.

Investors reacted to the news by sending SGEN shares up almost 13% to $165.45.

Merck shares were mostly flat, closing at $84.62.

Last year, Merck generated $48.7 billion in revenue. More than one-third of it, however, came from the immunotherapy drug Keytruda (pembrolizumab). Keytruda patent protections are set to expire in 2028.

Seagen had $1.6 billion in revenue in 2021.

In Apri…

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Propecia label gets new warning related to possible suicidal risk 

A number of patient advocates, including the Post-Finasteride Syndrome Foundation (PFSF), had petitioned the FDA to remove the anti-baldness drug Propecia (finasteride) from the market. 

The FDA recently announced that the drug would remain on the market but agreed to revise the label for finasteride to include a notice about reports of suicidal behavior. 

Merck & Co.’s Organon division is the manufacturer of Propecia, which 

The agency had earlier agreed to add a warning to the label about the risk of persistent sexual depression and depression. 

In September, the nonprofit watchdog group Public Citizen filed a lawsuit on behalf of PFSF, asking FDA to either halt sales of the drug or add new warnings to its label.    

Merck won approval to market finasteride (1 mg) to treat male pattern hair loss. A 50-mg dose of the drug initially won FDA approval in 1992 to treat benign prostatic hyperplasia.  

In 2001, FDA decided not to incl…

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