Bristol Myers Squibb plans $400M expansion in Ireland

A rendering of the new Cruiserath campus in Dublin, Ireland. [Image courtesy of Bristol Myers Squibb]

Bristol Myers Squibb announced that it invested $400 million to build a sterile drug product (SDP) facility in Dublin, Ireland.

This Cruiserath facility will support the manufacturing and supply of existing medicines and serve as a launch excellence facility for pipeline assets. It marks the first European SDP facility for biologics manufacturing at Bristol Myers Squibb. It remains in the design phase, according to a news release.

Bristol Myers Squibb plans to begin construction in March 2024. With planning approval granted, it expects to complete construction in 2026.

The company anticipates a further 350 positions created in Ireland as a result of the investment. That brings the total for the company in Ireland to 1,000 at that campus. The new investment and the roles it creates significantly exp…

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Pharma M&A activity primed for another high-flying year in 2024

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Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While the pandemic boosted research into areas such as mRNA, it had something of a chilling effect on M&A. As pharma companies begin to put the pandemic in the rearview mirror, M&A activity has gained momentum. 

Analysts upbeat on biopharma M&A activity in 2024

According to PwC, the M&A activity in the pharmaceutical and life sciences sector could continue humming in 2024. Despite a challenging interest rate environment, PwC projects the sector to see deal values ranging from $225 billion to $275 billion. Deal volume in 2023 was in line with pre-pandemic levels. …

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BMS sees new drug sales surge as Revlimid dips in Q3

Bristol-Myers Squibb (BMS) reported a mixed bag of results for the third quarter, with new drug sales up even as its popular blood cancer drug Revlimid fell 41% to $1.43 billion owing to generic competition. The anticoagulant Eliquis is in a similar position, but was also selected to be one of the first 10 drugs eligible for the new Medicare negotiations under the Inflation Reduction Act.

In the third quarter, BMS’s new product portfolio raked in $928 million in the quarter — up 68% year-over-year. “Based on the performance year to date, we now expect the new product portfolio to deliver roughly $3.5 billion for the full year 2023,” said CFO David Elkins in an earnings call. The company expects its new drug portfolio to reach $10 billion in sales by 2026.

Still, the company delayed its projections that its new drugs would hit at least $10 billion to 2026 from its earlier projection of 2025. The de­lay comes as departing CEO Gio­van­ni Caforio …

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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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100 top cell and gene therapy companies to watch in 2023

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The cell and gene therapy sector is poised to deliver a wave of new therapies that could potentially cure rare and common diseases. As many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023.

While manufacturing and regulatory challenges remain, the cell and gene therapy industry continues to offer significant therapeutic potential and commercial opportunities.

This year, we have beefed up our list of leading cell and gene therapy companies, doubling the number of organizations from 50 to 100.

In selecting the companies for this list, we weighed public companies’ degree of involvement in cell and gene therapy, including drug developers, equipment vendors and CDMOs specializing in the area. For private companies, we factored in their funding levels, pipeline and degree of history for the list.


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Evotec enters drug discovery alliance with Janssen

Evotec SE (Nasdaq:EVO) announced that it will work with Janssen Pharmaceutica NV, a subsidiary of the Janssen Pharmaceutical Companies (NYSE:JNJ), to identify drug targets and to partner on hit identification and lead optimization of chemical assets.

The partnership will center around Evotec’s end-to-end drug discovery and development platform.

“We are very proud to enter into this collaboration to explore unique approaches to high potential cell surface drug targets with novel therapeutic modalities and to deliver and make innovative therapeutic options available to patients,” said Dr. Cord Dohrmann, chief scientific officer of Evotec, in a press release.

Evotec could receive up to €210 million per project plus tiered royalties related to products ensuing from the partnership.

Earlier this year, Evotec announced a similar collaboration with Bristol Myers Squibb focused on protein degradation.

The company also announced a pact with the biop…

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FDA approves new Opdivo indications for upper gastroesophageal cancers

Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC.

Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.

First FDA approved in 2014 for advanced melanoma, Opdivo has won a score of oncology indications over the years.

The drug now has five indications covering upper gastroesophageal cancers.

The two recent approvals are based on data from the Phase 3 CheckMate -648 trial, which Bristol Myers Squibb notes is the largest Phase 3 trial of an immunotherapy in first-line ESCC. In that study, Opdivo with chemotherapy offered a superior overall survival rate than chemotherapy alone.

Opdivo with Yervoy also led to improved survivability…

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

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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…

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FDA approves Bristol Myers Squibb drug to prevent graft versus host disease

The FDA today approved Bristol Myers Squibb’s Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD).

According to an FDA release, this is the first FDA drug approval for aGVHD prevention, incorporating real-world evidence as a component of the determination of clinical effectiveness.

Orencia — originally approved by the FDA in 2005 for treating adult rheumatoid arthritis and also approved for treating polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis — may now be used in adults and pediatric patients two years of age or older undergoing hematopoietic stem cell transplantation (commonly known as bone marrow transplantation or stem cell transplantation) from an unrelated donor.

Bristol Myers Squibb had previously received breakthrough, orphan drug and priority review designations with the development of the product partially supported by the FDA’s Orphan Products Grants Program.<…

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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.…

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FDA postpones decision on Bristol Myers Squibb’s mavacamten

FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin.

Bristol Myers Squibb is aiming to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening.

Mavacamten addresses the molecular defect involved in oHCM.

FDA now expects to decide on whether to approve the drug for oHCM by April 28, 2022.

The agency requested extra time to review Bristol Myers Squibb’s proposed risk evaluation mitigation strategy.

“We are confident in the profile of mavacamten. This first-in-class cardiac myosin inhibitor demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in the pivotal EXPLORER-HCM trial,” said Dr. Samit Hirawat, executive vice president, chief medical officer, global drug development at Bristol …

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FDA accepts priority review for BMS’s relatlimab and nivolumab in melanoma

Bristol Myers Squibb (NYSE: BMY) has won priority review for its Biologics License Application for the fixed-dose combination of the checkpoint inhibitors relatlimab and nivolumab to treat patients 12 and older who weigh at least 40 kg (88 pounds) with unresectable or metastatic melanoma.

Relatlimab would be a novel lymphocyte-activation gene 3 (LAG-3) blocking antibody. The drug would be the third distinct checkpoint inhibitor from Princeton, New Jersey–based Bristol Myers Squibb to help appropriate patients. 

Nivolumab, whose brand name is Opdivo, generated $6.9 billion in sales last year. The drug came in at slot 10 in our list of best-selling pharmaceuticals in 2020. Nivolumab targets programmed cell death protein 1 (PD-1).   

“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there remain patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Che…

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