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On June 20, 2024, FDA announced that it had expanded its approval of delandistrogene moxeparvovec-rokl (Elevidys), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD), to cover both [...]

Despite the bio/pharma industry's stringent regulations and general tendency to adopt newer technologies more slowly than other industries, automated processes and robotics are increasingly commonplace in manufacturing facilities. Although initially [...]

Research efforts are continuing to expand in the area of biological therapies. These large-molecule drugs are proving to be significant revenue drivers for bio/pharma companies and are providing therapeutic options [...]

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body's cancer-immune cycle. When the system [...]

Novo Holdings' acquisition of Catalent, in retrospect, was entirely logical (1). We are tempted to see echoes of Thermo Fisher's buyout of Patheon, or Lonza's swallowing of capsule maker Capsugel. [...]

Given its positioning at each new year's commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed. It is rare for major new [...]

In June 2023, FDA Commissioner Robert Califf ascribed most drug shortages to 'generic-drug companies going out of business, either because they fail to invest in quality operations or because they [...]

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation. It will not be an easy process. It's an evolution long in the [...]

As of mid-October 2023, there were 9342 clinical trial studies targeting COVID-19 (1). This is alongside 12,086 patents that relate to COVID-19 (2). Messenger RNA (mRNA) clinical trials, however, stand [...]

A July 2022 Pharmaceutical Technology[R] article (1) outlined that new therapeutics and breakthroughs in neurosciences have lagged far behind oncology or infectious diseases. In Alzheimer's disease, despite knowing for decades [...]

From a pure business perspective, while equal in many respects to computer chip manufacturing, the pharmaceutical industry pulls ahead because it does not experience the same high amplitude boom and [...]

At the G7 Summit held from May 19-21, 2023 in Hiroshima, Japan, President Biden announced a $250 million contribution, subject to Congressional notification, to the World Bank's Pandemic Fund 'to [...]

The ink is still drying on commencement speeches with graduates soon to be alternately encouraged and exhorted. Encouraged to be open to their new possibilities and adventures. Exhorted to be [...]

In pharmaceuticals, the patients' rights movement in the 1970s blended (as an unintended consequence) with the consumers' rights movement in the 1990s (which required health insurance companies to provide information [...]

From a drug price policy perspective, we might well describe the COVID-19 pandemic as an extended period of slack water, a prolonged moment unstressed in the tidal stream of price, [...]

FDA approved 37 drugs in 2022, within the normal range for the past decade or so. This is quite impressive for the industry given continuing headwinds thrown off by COVID-19 [...]

In Pharmaceutical Technology's annual employment survey, respondents have been asked a consistent set of questions year to year to build some inherent statistical confidence in the replies. In this year's [...]

No matter how busy or complicated life becomes, science news can occasionally stop us in our tracks. Science news can be just so weird, or weirdly useful, that everything else [...]

As a CEO in a well-regulated industry, it is a straightforward path to respect the utility of authority guidance, standards, laws, and penalties. Complex systems function more crisply when rules [...]

Post-approval changes (PACs) are inextricable sequelae of living in the real world. 'They are inevitable and necessary throughout the life of a drug product--to implement new knowledge, maintain a state [...]

The recent passing of the Inflation Reduction Act expands the Affordable Care Act and allows Medicare to negotiate for the price of prescription drugs, in a limited and phased introduction. [...]

In the pharmaceutical industry, the Venn diagram intersection between shortages and quality manufacturing issues occupies more space than anyone wants. There has long been discussion about the best way to [...]

As we reach the midpoint of the year, it's appropriate to reexamine the topics we're addressing. I'd like to point to a special podcast Pharmaceutical Technology conducted where Editorial Director [...]

Spring is a time for renewal of energies, setting fresh goals and making new friends. As we have done for many years, Pharmaceutical Technology is proud to organize the keynote [...]

If a major league team was guaranteed to lose half of its best players (by far) over the next few seasons, the outlook would be gloomy. Our industry will lose [...]

In April 2020, a clarion call by Outsourced Pharma set a major goal in 'A Declaration of Drug Independence.' This call sought to '... dedicate ourselves to the goal of [...]

The JP Morgan Healthcare conference in San Francisco is the pharmaceutical world's equivalent of the world economic development forum in Davos--an event CEOs and innovators schedule the rest of the [...]

Like oncoming hurricanes, we respond with trepidation to Greek letters for emerging COVID-19 variants. Apart from fraternities, or perhaps high-tech product names, we mostly ignore the ancient Greek alphabet. But [...]

Following a somewhat static decade, FDA has shaken up one half of the drug world by introducing the Novel Excipient Review Pilot Program. Proposals are accepted through Dec. 7, 2021. [...]

While innovation and invention can sometimes be daunting, the willingness and capacity to harness automation and artificial intelligence to improve drug manufacturing is becoming a differentiator in the industry. Those [...]

To produce more effective, patient-friendly medicines, drug formulators continue to search for optimal formulations. If a patient can take one versus multiple pills per day or go to a medical [...]

In research laboratories around the world, thousands of compounds are being studied as potential drugs to treat cancers, infectious and chronic diseases, and other conditions. The route of delivery for [...]

Was it natural zoonotic spillover that catapulted SARS-CoV-2 from an emerging virus into a pandemic pathogen or was it something much more sinister? Is it at all possible that a [...]

In the past 16 months, the public gained some insight into the complexities of drug development. The rapid development and emergency approval of the Pfizer/BioNTech and Moderna COVID-19 messenger RNA [...]

Nine months. In March 2020, the United States was in the early stages of the COVID-19 pandemic. We shut the entire country down and ground the economy to a halt [...]