Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy 

The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%.

One potential hurdle for the drug is whether unvaccinated individuals will accept the treatment, given their higher likelihood of contracting severe COVID-19. According to McKinsey, unvaccinated individuals tend to be most concerned about the potential of COVID-19 vaccines to cause long-term side effects.

The lack of long-term safety data concerning molnupiravir could be an obstacle for skeptical patients. That’s especially the case given early conclusions that there are “persistent side-effect concerns with mutagenic molnupiravir,” as a Clinical Trials Arena article observed. That article goes on to cite Ron Swanstrom, a professor at the University of North Carolina, Chap…

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Lilly wins Erbitux label expansion for colorectal cancer indication

FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test.

The indication covers previously-treated patients.

Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor (EGFR). Merck (NYSE:MRK) was also involved in developing the drug.

The recent label expansion is based on data from Pfizer’s Phase 3 BEACON CRC study, which focused on patients with metastatic colorectal cancer with a BRAF V600E mutation.

The latest approval gives Erbitux a total of seven indications covering various colorectal and head-and-neck cancers.

“The BEACON study showed that the combination of ERBITUX and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mu…

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Merck and Vesselon preclinical study reports dramatic tumor pharmacokinetics findings

Merck & Co. (NSDQ:MRNA) scientists have explored fighting cancer by way of the STING (stimulator of interferon genes)-controlled innate immune pathway.

Now, the company has published research in Advanced Therapeutics detailing a preclinical study with its partner Vesselon Inc. that reported impressive pharmacokinetics results related to MSA-1, a STING agonist.

The researchers found that low intravenous doses of MSA-1 alone did not have anti-tumor properties. But pairing MSA-1 with Vesselon’s FDA-approved acoustically-active drug Imagent led to complete tumor regressions. Vesselon makes use of a phenomenon known as sonoporation, which involves a temporary opening of cell membranes as a result of ultrasound exposure.

Imagent is FDA approved as a contrast agent for diagnostic ultrasound.

Specifically, Merck scientists reported that sonoporation dramatically improved the pharmacokinetics of MSA-1, boosting tumor uptake 658% 15 minutes after …

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Hookipa Pharma announces oncology partnership with Merck

Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC).

Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.

“There remains considerable unmet treatment need for people with metastatic head and neck cancers, and we believe the combination of HB-200 and Keytruda may offer hope,” said Joern Aldag, Hookipa CEO, in a statement.

Hookipa reports that the company has seen early success with combining Keytruda and HB-200 in heavily pre-treated patients.

The company plans on launching a Phase 2 trialing the combination of HB-200 with Keytruda in 2022.

The company is developing a range of novel arenaviral immunotherapies for onc…

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Illumina, Merck partner on diagnostics for identifying specific cancer mutations

Illumina (NSDQ:ILMN) and Merck today announced a partnership to develop diagnostics for identifying certain genetic mutations.

The partnership aims to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD), leveraging Illumina’s TruSight Oncology 500 (TSO 500) content, enabling what the companies tout as the most comprehensive genomic profiling assays in a single worfklow.

San Diego-based Illumina said in a news release that the partnership builds upon an initial study conducted between the two companies and uses Illumina’s relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad’s FDA-approved myChoice CDx companion diagnostic test.

Under the partnership, Illumina will develop a new HRD CDx test for the European Union and the UK to aid in the identification of ovarian cancer patients with positive HRD status who …

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Kaiser files lawsuit against Merck over cholesterol drugs

The managed care consortium Kaiser Permanente is suing Merck (NYSE: MRK) over alleged pay-to-delay agreements to withhold the production of generic drugs for Zetia and Vytorin.

Zetia (ezetimibe) is a cholesterol absorption inhibitor while Vytorin combines ezetimibe with simvastatin, an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. FDA drugs treat high cholesterol levels.

The lawsuit also names Glenmark, a manufacturer of generics of Zetia and Vytorin. It alleges that Merck’s plan to delay the introduction of generics for those drugs had cost Kaiser hundreds of millions of dollars, according to a report from the San Francisco Business Times.

The Oakland, Calif.–headquartered Kaiser Foundation Health Plan first filed the suit in San Francisco Superior Court. That court, however, transferred the case to the U.S. District Court in San Francisco.

FDA first approved Zetia in October 2002.

FDA approved Vytorin in July 20…

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Merck results miss in Q2

Merck (NYSE: MRK) posted second-quarter results today that missed the consensus forecast on Wall Street, though the company expects up to 14% sales growth this year.

The Kenilworth, N.J.–based pharmaceutical giant reported profits of $1.213 billion, or 48¢, off $11.402 billion in sales, nearly halving its bottom line while boosting sales 19% from Q2 2020. Merck adjusted earnings and revenue to take into account its June 2021 spinoff of Organon, which brought Merck a $9 billion windfall.

Adjusted to exclude one-time items, earnings per share were $1.31, 13¢ behind The Street, where analysts looked for EPS of $1.44 on sales of $11.54 billion.

Related: FDA approves Merck’s Keytruda to treat certain types of breast cancer

“We are encouraged by the strong momentum of our underlying business led by our key growth drivers as the impact of the pandemic on our performance lessens,” said Merck CEO Rob Davis said in a news release. “We are confident that we …

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FDA approves Merck’s Keytruda to treat certain types of breast cancer

Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC).

Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based on the Phase 3 Keynote-522 trial.

Keynote-522 demonstrated that Keytruda, in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival when compared against the same neoadjuvant chemotherapy regimens alone.

The FDA also converted the accelerated approval of Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic TNBC whose t…

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34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021. 

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma 

Adhansia XR (methylp…

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Could the controversial drug ivermectin save lives?

[Photo by Fusion Medical Animation on Unsplash]

The antiparasitic drug ivermectin holds promise as a COVID-19 treatment, according to a new study published in the American Journal of Therapeutics. The study authors conclude that ivermectin could reduce the risk of COVID-19-related death with moderate-certainty evidence. “Using ivermectin early in the clinical course may reduce numbers progressing to severe disease,” they conclude, adding that the drug is “likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

The meta-analysis analyzed databases up to April 2021, drawing from 24 randomized controlled trials with 3,406 patients. 

Another study published in Lancet found a concentration-dependent antiviral activity of oral high-dose ivermectin in a trial involving 45 patients.  

Many experts, however, have voiced skepticism regarding the use of ivermectin as a COVID-19 treatment.…

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MedTech 100 roundup: Industry climbs again

The medtech industry built off a strong performance two weeks ago with another uptick in the midst of an up-and-down year.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 18) at 110.64 points, producing a 0.9% rise from the 109.63-point mark set one week prior (June 11). In all, the industry has risen 3.4% over the past two weeks.

The recent upswing provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks poised to pick up again as it nears the high points registered when April brought the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered an 19.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 78.1% increase from the …

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Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the  Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …

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