Pharmaceutical Processing World Archives - Page 8 of 64

Difficult transmembrane protein targets for therapeutic antibodies

What is the current landscape of antibodies targeting membrane proteins?

As of June 2022, 162 antibodies had been approved for a wide array of diseases in the world, including cancers, immune-related diseases, infectious diseases, and hematological diseases1. Over half target membrane proteins, primarily proteins with large extracellular domains and simple transmembrane domains such as tyrosine kinase receptor proteins. Only two target complex transmembrane proteins like G-protein-coupled receptors (GPCRs)2.

What are the established and emerging membrane protein targets for antibody therapies?

Established antibody targets include transmembrane proteins EGFR, VEGFR2, FGFR2, HER2, and complex membrane proteins CCR4 and CGRPR. Monoclonal and bispecific antibodies targeting complex membrane proteins such as GPRC5D, Claudins (Claudin 6 and Claudin 18), SSTR2, and CXCR4 have shown successful results in CAR-T cell therapy at the preclinical and clinical…

Astellas latest to wage war against the Inflation Reduction Act

In a recent move, Astellas Pharma challenges IRA, a step that sees them join other pharmaceutical heavyweights in a lawsuit against the federal government. The bone of contention is the Inflation Reduction Act (IRA), a law primarily designed to drive down prescription drug prices, a proposition that no Republican supported.

Astellas, along with the other pharma companies, takes issue with the IRA’s plan to let Medicare negotiate prices on their top-selling drugs. They argue this will not only be financially burdensome but also stifle new drug development and breach their constitutional rights.

Constitutional violations: Astellas Pharma challenges IRA

Astellas Pharma, in its public statement last week, outlined three ways in which it believes the new Medicare Drug Price Negotiation Program is in violation of the Constitution. The key concern is that it’s essentially theft or a “taking of property” by forcing companies to offer lower price…

The recent FDA thumbs-up for Beyfortus could kickstart a new chapter in RSV prevention

Respiratory syncytial virus (RSV) is a common cause of severe lower respiratory tract infections like pneumonia and bronchiolitis in infants and young children. Traditionally there have been no approved treatments for RSV infections, with care being largely supportive. But the landscape is quickly changing.

The FDA recently approved Beyfortus (nirsevimab), the first immunoprophylactic to prevent RSV disease in newborns, infants and toddlers. On the RSV vaccine front, FDA also approved GSK‘s (NYSE:GSK) Arexvy. Other RSV vaccine candidates are waiting in the wings.

A shift in the RSV treatment landscape

Beyfortus is a monoclonal antibody developed by AstraZeneca and Sanofi that provides protection against RSV with a single intramuscular injection. It is the first innovation in RSV prevention in over two decades. Until recently, the only preventive therapy on the market was Synagis, a monoclonal antibody used to help prevent serious lung disease from RSV in …

Sanofi, Merck and Novartis top pharma M&A in recent years

Despite a temporary slowdown during the early days of the pandemic, the pharma sector has witnessed a steady rise in M&A activity over the years. The number of deals climbed from 23 in 2018 to 43 in 2022. Major players driving this trend include Sanofi, Merck & Co. and Novartis. Those three players have made significant acquisitions to bolster core assets and capabilities in specialized areas such as immunology, oncology and gene therapy.

For instance, in 2022, Merck acquired Prometheus Biosciences for $11 billion to strengthen its presence in immunology, while Sanofi purchased Provention Bio for roughly $2.9 billion to add a first-in-class therapy for type 1 diabetes. Novartis has also been on the hunt, with approximately $31 billion in deals since 2018 that have strengthened its Innovative Medicines portfolio.

Bar chart showing the top 10 most active pharmaceutical companies in M&A activity fr…

Solenis-Diversey deal highlights trend for strategic, sustainability-focused acquisitions

Solenis, a specialty chemicals company serving water-intensive industries, wrapped up its $4.6 billion acquisition of Diversey Holdings, Ltd., a supplier of hygiene, infection prevention, and cleaning products to global pharmaceutical companies.

This acquisition comes amid a trend of smaller, more strategic M&A activity in the pharma sector during the second quarter of 2023. While the Solenis-Diversey deal bucks this trend in terms of deal size, it aligns with the strategic nature of recent acquisitions in the industry.

The merger creates a global firm specializing in integrated water and hygiene that operates in more than 130 countries with 71 sites and 15,000 employees.

Before the acquisition, Solenis already served a diverse number of industrial sectors, including pulp, paper, oil and gas, chemical processing, mining, biorefining, power and municipal markets.

Solenis-Diversey deal could be harbinger of more chemicals sector M&A deals

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Novartis aims to offload eye care unit to Bausch + Lomb for $2.5 billion

Novartis has agreed to sell ophthalmology assets to Bausch + Lomb for an upfront payment of $1.75 billion, with potential milestone payments of up to $750 million. The total value of the deal could reach $2.5 billion. Novartis expects the deal to improve their focus more on higher-margin drugs.

Under the terms of the deal, Bausch + Lomb will get Novartis’ Xiidra, a treatment for dry eye disease, as well as two experimental products: libvatrep (formerly SAF312), an experimental treatment for chronic ocular surface pain with Phase 2b test results expected later this year. It will also receive AcuStream, a medical device being for delivery of topical eye medications.

Xiidra generated more than $400 million in 2022 revenue.

In addition to Xiidra, Bausch + Lomb already has a presence in the dry eye disease market, bagging FDA-approval for a drug called Meibo in May. The two drugs are expected to complement each other, targeting different aspects of the …

Discover new levels of efficiency in pharma manufacturing with advanced analytics

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Digitalization empowers pharmaceutical companies to bring therapies to patients faster by using advanced analytics strategies to profitably optimize manufacturing operations.

In the pharmaceutical industry, operational issues from efficiency losses to failed batches can delay delivery of potentially lifesaving therapies to patients. For this and other reasons, pharmaceutical organizations require resources dedicated to batch prediction, planning and rapid issue resolution throughout the entirety of a drug’s lifecycle. Because the field is both highly regulated and consequential, decisions must be data-based to ensure compliance and product integrity.

Adding to the challenge, patient populations are ever-evolving and conditions in the supply chain are variable. At the same time, there is growing pressure to lower the cost of bringing drugs to market, without compromising safety and…

Life sciences single-use instrumentation trends

Figure 1: For better flexibility to produce a wider variety of targeted drugs, especially biologics, life sciences manufacturers are moving toward single-use options for operating both batch and continuous processing equipment.

Single-use instrumentation, especially new pH sensors designed for upstream and downstream applications, are helping manufacturers develop production suites for creating a greater variety of small-run yet highly targeted drugs.

Life sciences manufacturers already incorporate leading measurement and automation technologies to ensure the quality of the drugs and medicines they bring to market. Yet because the life sciences industry and associated products are evolving in many ways, it remains important for both manufacturers and OEMs to evaluate updated measurement and automation technologies to meet new needs.

In most industries, scaling up is the path forward to gain production efficiencies, with large batc…

Pfizer drops one weight loss drug, bets on another

Pfizer has made a strategic decision in the battle against obesity and diabetes. The pharmaceutical giant has chosen to discontinue its GLP-1 RA candidate, lotiglipron, to focus resources on the development of another – danuglipron. This Pfizer weight loss drug is now the lead candidate in late-stage trials for the treatment of obesity and diabetes. The decision comes after the discovery of elevated liver enzyme levels in some early trial patients for lotiglipron. However, similar concerns have not arisen with danuglipron.

The shift comes as the company aims to tap full receptor agonism for potential robust efficacy, capitalizing on its small molecule design expertise. With more than 1,400 patients already enrolled, the clinical trial results could potentially expand the treatment options for adults with obesity and Type 2 diabetes.

Already, GLP drugs semaglutide and tirzapatide are beginning to reshape the way we treat obesity.

Novo Nordisk’s sema…

The economic impact of pharma giants’ fight with the U.S. government over drug pricing reform

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Big Pharma firms Merck and Bristol Myers Squibb are challenging President Biden’s Inflation Reduction Act, alleging the law’s plan to lower drug prices infringes on their rights. The U.S. Chamber of Commerce — whose members include drugmakers AbbVie and Eli Lilly — is also aiming to block Medicare from rolling out the program.

In 2022, President Biden signed the Inflation Reduction Act (IRA) into law to fund major healthcare and climate change initiatives. No Republican supported the bill. The IRA allows Medicare to negotiate the prices of certain high-cost drugs. The program would first focus on 10 drugs in 2026. From there, it is slated to expand to 15 drugs in 2027 and 2028, and 20 drugs per year from 2029 on. Only medications on the market for years without competition are eligible.

Assessing the impact of the Inflation Reduction Act on drug …

McKinsey has a digital prescription for pharma processing

Digital plant maturity model. Image courtesy of Emerson.

Given the recent surge in interest in generative AI, it’s no wonder that consultancies like McKinsey are making hay of the situation. The consultancy recently argued that “Rewired pharma companies will win in the digital age.” In a separate feature, it noted that generative AI could boost biopharma R&D productivity by billions, as we reported on Drug Discovery & Development.

It is true that the pharma sector faces significant headwinds as digital and analytical capabilities reshape healthcare. To keep up with this rapid pace of change, McKinsey argues that pharma companies must tap digital technologies to improve patient outcomes, increase efficiency and drive growth. Many firms are hiring chief digital and technology officers, it noted, but digital adoption in pharma generally remains at an early phase.

Building a solid d…

How 11 Big Pharma companies are using AI

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Pharma companies are ramping up their reliance on AI in drug discovery, clinical trials and manufacturing. Bloomberg recently frame the technology as providing a $50 billion opportunity to the sector. GlobalData noted that the pandemic played a role in stoking interest in AI. But given the hype often surrounding the technology, it can be difficult to gauge actual impacts and outcomes of such initiatives, which largely remain undisclosed.

The pharma industry faces mounting pressures to discover and develop new drugs faster and at lower costs. AI has emerged as a promising tool to help overcome long-standing challenges like high failure rates, lengthy development timelines, and resource inefficiency.

While pharma companies are making big bets on AI, the actual impacts and outcomes of many initiatives remain largely behind the scenes. Still, there are some examples that provide…