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50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer

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 benefit in early breast cancer, according to AstraZeneca.

AstraZeneca developed the drug with Merck & Co. (NYSE:MRK), a company known as MSD outside of the U.S.

The OlympiA study showed that olaparib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Patients in the study had received earlier local treatment and standard neoadjuvan…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

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 in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

Molnupiravir holds up to omicron in lab studies

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 UK, Taiwan, Japan, India and Australia.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” said Wendy Holman, Ridgeback Biotherapeutics CEO, in a statement. “We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic.”

The recent lab studies were conducted by independent researchers using cell…

Merck senior exec Frank Clyburn to depart

Merck & Co. (NYSE:MRK) has revealed that Frank Clyburn, executive vice president and president, Human Health, will depart the company on Feb. 1, 2022.

At Merck, Clyburn had P&L responsibility for almost 90% of Merck’s business. Clyburn will assume the CEO role at International Flavors & Fragrances (IFF/NYSE:IFF) on Feb. 14.

“I’m excited to join IFF, an industry leader with a bright future, and to lead IFF to continue to deliver outstanding customer experience and sustained long-term growth,” Clyburn wrote on LinkedIn.

At IFF, he will receive a base salary of $1.3 million.

Frank Clyburn

Clyburn joined Merck in 2008.

Clyburn was involved in launching Merck’s blockbuster drug Keytruda. In 2020, Keytruda racked up $14.4 billion in global sales, making it the second-best-selling drug of that year.

“Frank’s strategic and operational excellence helped establish Merck a…

Generic manufacturers to make cheaper version of Merck’s COVID-19 pill for developing countries

Image courtesy of Merck & Co.

The Medicines Patent Pool (MPP) announced today that it signed agreements with 27 manufacturers to produce Merck’s COVID-19 pill.

MPP’s agreements with the generic manufacturing companies cover the manufacturing of the oral COVID-19 antiviral medication molnupiravir, with supply set for 105 low- and middle-income countries (LMICs). The agreements come as a result of the voluntary licensing agreement signed by MPP and MSD, a trade name of Merck, to facilitate the affordable global access of the antiviral drug that MSD is developing in partnership with Ridgeback Biotherapeutics.

Companies offered the sublicenses — which allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself — successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance and t…

COVID-19 oral antiviral molnupiravir wins FDA nod

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 molnupiravir covers its use to treat mild-to-moderate COVID-19 in individuals at least 18 “who are at high-risk for progression to severe COVID-19.” The authorization constrains the use of the drug to individuals who cannot feasibly use other authorized COVID-19 treatments. FDA does not recommend the medication for patients who are hospitalized with COVID-19.

The authorization does not support the use of molnupiravir as pre-exposure or post-exposure prophylaxis for COVID-19.

Pfizer’s COVID-19 antiviral pill could be poised for European regulatory authorization

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 importance of administering Paxlovid as soon as possible after a COVID-19 diagnosis to boost efficacy.

The guidance, which proceeds marketing authorization, could inform health officials’ planning efforts for Paxlovid.

“The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with COVID-19,” said Albert Bourla, Pfizer CEO, in a press release. “If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring th…

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

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 score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

Baxter, 3M, Abbott near the top of Newsweeks’ most reponsible companies list

Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), 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 score out of 100 that combined environmental, social and corporate governance performance assessments.

Baxter, 3M, Abbott and BD (NYSE:BDX) were among the highest-ranking big-name medical device makers. Cancer diagnostic company Illumina was the highest-ranking company under the healthcare and life sciences umbrella, sitting in second behind HP.

In sixth sat Baxter, registering an overall score of 89.5 points, with its highest performance coming in environmental i…

FDA advisory committee votes in favor of COVID-19 pill molnupiravir

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 a very difficult decision,” said Dr. Michael D. Green, a member of the advisory committee and professor at the University of Pittsburgh School of Medicine. “I would use it in high-risk non-vaccinated individuals,” Green said, adding he would consider the drug for people with obesity and multiple other risk factors. “For pregnancy, I would only use it if there’s no alternative therapy available, and I don’t think I would use it in the first trimester.”

Committee members who voted ‘no’ voiced several concerns.

Dr. Timothy Burgess of the Uniformed Services University cited the unconvincing cli…

Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir

Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir.

If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.

First, Carome argued that the drug appeared to have modest efficacy, offering a relative risk reduction against hospitalization or death of 30% through day 29 of the MK-4482-002 Phase 2/3 study.

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