Pharmaceutical Processing World Archives - Page 5 of 64

Commitment to operational efficiency and partnerships yield dividends for Teva

Teva’s strategy to boost its operational efficiency and tap strategic partnerships seems to be paying off. In its Q3 earnings report, Teva announced that global revenues were up to $3.9 billion, marking a 7% rise from the previous year’s third quarter. Factors fueling the growth include the robust performance of their specialty medications, Austedo and Ajovy, as well as a strong showing from their generics portfolio. However, despite these promising stats, investors appear to be cautious. Teva’s stock is down almost 8% so far this year, currently trading at $8.77.

For Austedo, Sven Dethlefs, the company’s head of North America commercial, noted that the company has seen growth for the extended-release version of the drug. In an earnings call, Dethlefs said the company has seen “a significant number of new prescribers that have never prescribed Austedo before that now start prescribing Austedo XR.” He added that the demand for the …

Transparency-Rx promises reform in the PBM landscape

Image from https://torange.biz/medications-big-money-19928

Pharmacy benefit managers (PBMs) have recently emerged as a punching bag with the pharma trade group PhRMA accusing such orgs of driving up drug prices. Now, an alliance of PBMs known as Transparency-Rx has emerged, promising a reform initiative in a digital campaign attempting to put pressure on rival PBMs. This coalition’s efforts could reshape drug pricing dynamics, with potentially significant consequences for pharma companies, which may potentially need to adapt to a market with more straightforward and possibly more stringent pricing structures.

Transparency-Rx pushes for PBM reform

Transparency-Rx, comprising PBMs such as AffirmedRx, Liviniti and SmithRx, claim they can generate major per-prescription savings. In doing so, they aim to differentiate themselves from the “big three” PBMs, which include CVS Caremark, Express Scr…

Pfizer’s $3.5B cost-cutting strategy hits Peapack site in New Jersey

After news emerged regarding Pfizer’s plans to close sites in North Carolina, the company is adding New Jersey to the list. The company expects its Peapack facility to cease operations in early 2024.

A Worker Adjustment and Retraining Notification(WARN) Notice notes that 791 workers could potentially be cut from its Somerset County corporate office. The company hasn’t released an official tally, and notes that the “vast majority” of workers at the New Jersey site to be re-assigned to the company’s New York headquarters with another portion transitioning to the company’s site in Parsippany.

Peapack closure part of Pfizer’s $3.5 billion cost-savings plan

To respond to weak demand for its COVID-19 therapies, Pfizer has announced a $3.5 billion cost-cutting drive, aiming to save at least that figure by the end of 2024. It will incur a one-time cost of $3 billion in the process.

The 595,000 Peapack site is situated on 130-acres in the Borough o…

FDA warns against compounded oral ketamine for psychiatric disorders

[3D model of Ketamine from Wikimedia Commons]

In recent years, interest in the use of oral ketamine has surged for mood disorders, thanks to the marketing efforts of companies like Mindbloom, Better U, Nue Life and Joyous. FDA released a statement describing the risks involved in taking compounded oral ketamine, noting that the dissociative anesthetic is not FDA approved for any psychiatric disorder.

Compounded oral ketamine risks

The agency specifically warned against the use of compounded ketamine without proper medical oversight, warning that sedation, dissociation, and vital sign changes “may put patients at risk for serious adverse events.”

The FDA’s warning included several considerations related to the use of compounded ketamine for psychiatric disorders, including its potential for abuse and misuse. The agency also noted that ketamine use could lead to psychiatric events, given its associa…

Pfizer to close Durham and Morrisville, North Carolina facilities amid major restructuring effort

In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs.

The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina.

The closures will not affect Pfizer’s two largest facilities in North Carolina — Sanford and Rocky Mount. The Rocky Mount facility, which specializes in producing injectable medicines for hospitals, employs approximately 3,200 people and has recently resumed operations after a tornado damaged it in July. The Durham Clinical Manufacturing Facility, on the other hand, opened in December 2021. The company initially planned for the facility to create 50 jobs and relocate 40 employees from Chapel Hill. The exact number of people employed at the facility at the time of the announcement remains unclear.

The company has lowered its full-year revenue guidance to $58.0 to $61.…

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

[Adobe Stock]

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

[Mark/Adobe Stock]

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…