Pharmaceutical Processing World Archives - Page 5 of 64

No room for error: How a holistic quality management strategy can help pharma firms adhere to strict quality standards

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Ever heard the phrase “one bad apple spoils the barrel”? The proverb rings especially true in pharmaceutical manufacturing, where even trace amounts of contaminants can have grave consequences for patient safety. “In the case of pharma, the stakes are so high that even the tiniest contaminants can endanger patients and result in wasted therapeutics, amounting to millions of dollars,” says Dan UpDyke, life sciences strategic marketing manager at Rockwell Automation.

In the following interview, UpDyke explains how a holistic quality management strategy in pharma can help manufacturers adhere to the industry’s strict regulatory standards. Such an approach can help pharma companies avoid problems related to sub-standard ingredients, possible contamination, or a temperature excursion during delivery, all of which can jeopardize the integrity of the entire product.

In the following interview, UpD…

FDA resolves drug shortage for Novartis’ prostate cancer drug Pluvicto

Novartis has announced that the FDA has resolved the drug shortage status for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The development comes after Novartis significantly scaled up production, more than doubling its weekly production capacity since May.

The company initially halted production of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) along with Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada in mid-2022 over possible quality concerns. The company restarted production soon thereafter.

Pluvicto is a radiopharmaceutical medication for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. Lutathera is indicated for gastroenteropancreatic neuroendocrine tumors.

Burgeoning demand for Pluvicto

Pluvicto is approved in the U.S., the European Union, and other countries to treat adults with advanced PSMA-positive metastatic castration-resistant prostate…

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 …

Merck’s Q3 2023 revenue guidance put it in line with Pfizer’s

Merck & Co. has announced its third quarter results, projectings its full-year 2023 revenue to be in the range of $59.7 billion to $60.2 billion. That’s roughly in line with the guidance from Pfizer, which recently adjusted its revenue forecast from $58 billion to $61 billion.

As Pfizer deals with reduced demand for COVID-19 products, which helped catapult its overall revenue beyond $100 billion in 2022, Merck saw a surprise Q3 lift from Lagevrio (molnupiravir), whose sales were up 47% to $640 million.

Other top sales drivers include the oncology stalwart Keytruda, which generated $6.3 billion in sales, marking a 17% year-over-year increase. Sales for the HPV vaccine Gardasil/Gardasil 9 amounted to $2.6 billion, reflecting a 13% growth.

Merck Q3 2023 revenue remains robust

The figures keep Merck in the upper echelon of Big Pharmas. In 2022, the company was the second largest with $59.3 billion in overall revenue compared to Pfizer’s $100.3 billion…

Embracing change management in pharmaceutical sales: Ensuring smooth transitions amidst industry evolution

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Embracing change management in pharmaceutical sales has become an essential competency for sales leaders. As a sales performance consultant who has worked with pharmaceutical and life sciences companies for over two decades, I’ve seen firsthand how the pace and frequency of change within pharma organizations has rapidly accelerated, making adaptation a constant requirement. Pharmaceutical sales reps now operate in an environment of perpetual fluctuation, with frequent concurrent changes across products, regulations, technologies, processes, and competition. They’re looking to their sales leaders to help them through the confusion and complexity so they can perform at the levels they are being held accountable for.

Change management: An essential competency for sales leaders

The ongoing reality of constant change within the pharma industry means sales leaders can no longer view change man…

Lilly reshuffles leadership deck

Lilly has announced that Mike Mason, executive vice president and president of Lilly Diabetes and Obesity, will retire at the end of the year after 34 years with the company. The segment has been a key growth driver for the company and Lilly’s tirzepatide in particular has significant revenue growth potential.

Lilly’s foray into the weight loss market, alongside advances in Alzheimer’s and obesity treatments, has launched its stock to new heights. Analysts forecast a revenue increase of $900 million for 2023. The diabetes/obesity drug Mounjaro, which raked in $1 billion in sales in Q2 2023 alone, was a factor in the jump. Investors are also optimistic about Lilly’s Alzheimer’s treatment donanemab, which could win FDA approval by the year’s end. To date in 2023, the company’s stock is up close to 53%, trading most recently around $558 per share.

The company has tapped Patrik Jonsson to assume leadership of Lilly Diabetes and O…

Lilly acquires Point Biopharma amid third FDA rejection in 2023

Eli Lilly and Company has recently received its third FDA rejection for the year 2023. The most recent came for lebrikizumab, the company’s investigational treatment for atopic dermatitis. FDA made the decision following an inspection of a third-party contract manufacturing organization. The agency had no complaints concerning the clinical data, safety, or labeling of lebrikizumab, but instead focused on quality control deficits.

Setbacks earlier in the year

Before the lebrikizumab setback, Lilly faced rejections for another antibody, mirikizumab, intended for ulcerative colitis. Donanemab, its Alzheimer’s disease was also affected. The former’s rejection also stemmed from manufacturing-related issues, while the latter faced concerns regarding the limited patient exposure during clinical trials.

Despite the hurdles, Lilly has fared extremely well on the stock market in 2023. Its share price is up more than 40% so far in 2023, trading most recently at $517…

Two continents, two milestones: Schott Pharma’s American commitment and European stock market debut

Drug containment company Schott Pharma recently celebrated major milestones related to its longstanding U.S. presence and high-profile stock market debut in Germany. The company, a division of specialty glass manufacturer Schott AG based in Mainz, Germany, commemorated 60 years of operations in the U.S. in August. Its primary American facility located in Lebanon County, Pennsylvania has played a role in providing drug containment for the U.S. pharmaceutical market. The company also offers drug delivery products.

Schott Pharma goes public

In parallel, Schott Pharma successfully launched its initial public offering on the Frankfurt Stock Exchange in late September, debuting at €30 per share and valuing the company at up to €4.1 billion. The offering was a strategic move to access capital markets and match competitors’ capabilities. Schott Pharma reported sales growth of 8.4% year-over-year for the first nine months of 2023, reaching €670 million.

With a portfolio…

Pharma giants in 2023: Breaking down revenue streams by leading product categories

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The pharma sector saw robust revenues across several key therapeutic areas in the second quarter of 2023, with oncology, immunology, and infectious diseases leading the pack. Merck’s blockbuster cancer drug Keytruda maintained its oncology dominance with sales topping $6 billion, while AbbVie’s Humira regained its crown as the world’s best-selling drug despite new competition. Gilead’s HIV regimen Biktarvy and Merck’s human papillomavirus vaccine Gardasil also posted strong growth. Additionally, neurology emerged as an area of expansion for companies like Roche, AbbVie and Biogen.

Our breakdown of 2023 pharma revenue by product categories, based on an analysis of Q2 data from 15 Big Pharma companies, reveals that oncology led the way with revenues surpassing $52 billion. Following closely was immunology with over $23 bil…

Major pharma players ST Pharm, Astellas and Celltrion unveil ambitious expansion blueprints

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A handful of pharma companies, including ST Pharm, Astellas Pharma, Avalon Pharma, and Celltrion have recently announced expansion projects.

Major pharma expansion efforts underway in South Korea

South Korean CDMO firm ST Pharm announced a second manufacturing facility in its home country — in Ansan, Gyeonggi Province. The plant is geared toward supporting burgeoning demand for oligonucleotide active pharmaceutical ingredients (APIs). The 1.1 trillion won investment speaks to the company’s dedication to advancing the oligonucleotide API sector. The company has supplied nucleoside-API’s for global pharma customers since the 1980s.

Also in South Korea, Celltrion is setting aside 126 million South Korean won for a new manufacturing plant at its Songdo campus near Seoul. Expected to be operational by 2027, this facility will have an annual production capacity of 8 million vials…

Compass Pathways names board member at pivotal moment for psychedelic industry

Compass Pathways has named biotech exec Daphne Karydas to its board. Karydas is the president and chief financial officer of Flare Therapeutics Inc., which is developing drug discovery programs targeting transcription factors for cancer and other diseases. Signs point to a potential FDA approval of psilocybin and MDMA under strict controls in the coming years, but the psychedelic therapy market has seen significant volatility in recent years. Since the company went public in September 2020, Compass has seen its valuation drop by more than two-thirds. Its stock, however, has shown some recent resilience rebounding by 17.49% year-to-date.

The volatility isn’t unique to Compass. Fellow psychedelic stock company ATAI Life Sciences NV (NASDAQ:ATAI) has seen its valuation plummet by 93% since its debut in mid-2021. The market fluctuations mirror the challenges of navigating the psychedelic therapy space, increasing the need for seasoned leadership.

In addi…

Pfizer beefs up while J&J slims to focus on oncology

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Both Johnson & Johnson and Pfizer are gearing up to release third-quarter results. While J&J continues to display resilience with its diverse portfolio, Pfizer continues to face challenges with waning demand for its COVID-19 therapies.

To date, Pfizer’s stock is down by roughly a third so far this year, reflecting concerns over its ability to maintain the sky-high revenue levels driven by its COVID-19 portfolio. Also reflecting this trend is moderate volatility in its stock price

J&J, on the other hand, has seen a more modest dip in its stock price so far in 2023 — 8.82% to $162.47. Unlike Pfizer, J&J’s diverse portfolio, spanning consumer health, pharmaceuticals, and medical devices, provides it with a more balanced revenue stream. The company has also been active in addressing challenges, from legal issues to the loss of exclusivity for key drugs li…