pharmaceutical industry Archives - Page 2 of 3

Decade-plus review of drug recall trends from 2011 to 2023

Earlier this year, we took a look at the most common causes of drug-related recalls in 2022 and the first quarter of 2023. Now, we are expanding our lens to examine drug-related FDA recalls from 2011 to 2023.

Understanding the recall landscape

In recent decades, prominent incidents like the Tylenol poisonings in 1982 have underscored the need for attentive tracking, swift reaction and careful mitigation measures when facing possible hazards to health. To get a sense of the current landscape of pharmaceutical recalls, we analyzed an FDA dataset spanning from 2011 to 2023. The data, which includes an array of drugs and recall reasons, found that lack of assurance of sterility continues to be far and away the most common reason for pharmaceutical recalls.

Sterility issues continue to clearly be the most common reason for FDA drug recalls. Data source: FDA

While FDA recalls of drugs have fluctuated widely…

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…

Working backwards: AWS’s strategy for pharma’s cloud-enabled transformation

[Bo Dean/Adobe Stock]

The meteoric rise of the AI sector is hard to fathom. Projections from Precedence Research suggest that the global AI market could balloon by 2600% from 2022 to 2032, hitting $1.87 trillion — an annual growth rate of 39%.

In pharma, AI and data science demand is surging though overall growth is sluggish. Despite advances such as the rapid development of COVID-19 vaccines, the broader sector has struggled to keep up with the overall stock market. But the future could tell a different story. McKinsey projects that the pharma and medical products sector could gain 9% in EBITDA from cloud computing.

To tap this potential, cloud vendors are allying with pharma companies. “Nine of the top 10 pharma companies in the world have a large majority of the workloads running on AWS,” noted Tehsin Syed, general manager of AWS Health. These workloads encompass diverse areas including IT infras…

CGT demands vision, partnership and patient-centricity to transform healthcare

[catalin/Adobe Stock]

As personalized medicine continues to progress, cell and gene therapy (CGT) development is poised to enable tremendous medical breakthroughs. Unlike traditional treatments which merely manage symptoms, CGT could treat the root biological cause of many diseases: the faulty genes.

“The cell and gene therapy space is truly exciting. What this ultimately means for patients and caregivers, and our ability to play an important part within this paradigm, is exhilarating,” said Dr. Panteli Theocharous, the global vice president and cell and gene therapy strategy lead at PPD.

With more than 20 years of experience in the pharma and biotech industries, Theocharous provides guidance on developing CGTs. He accentuates the importance of partnerships, data-driven approaches and patient-centricity in overcoming challenges.

Yet the path forward is filled with obstacles. In 2021, cell and gene …

Amgen v. Sanofi: A Supreme Court decision steers drug developers into uncharted waters

[Image courtesy of Philip/Adobe Stock]

The Supreme Court’s recent decision in the case of Amgen v. Sanofi (No. 21-757) could chart a new course for both the pharmaceutical industry and patent law. In its decision, the Supreme Court clarified the enablement requirement in the Patent Act, raising the bar for the level of detail needed in patents. In particular, the Court emphasized the need for ‘genus’ type patents, which encompass an entire class of substances or processes, to provide adequate detail to reproduce and use the entire class of items covered.

At the heart of the case were Amgen’s patents covering their pioneering monoclonal antibody Repatha (evolocumab), an LDL cholesterol-lowering agent, and two related patents. Amgen’s patents detailed 26 specific antibodies alongside a broader genus patent covering a potential universe of antibodies. Despite an extensive 400-page docu…

CRB installs new senior director of sustainability

The life sciences and food and beverage consulting firm CRB has named Mike Dieterich as its senior director of sustainability. Dieterich has more than 17 years of experience working in energy and sustainability. He’s led sustainability initiatives at companies such as AstraZeneca where he served as director, U.S. sustainability from January 2018 to April 2023.

With his appointment as the sustainability lead at CRB, Dieterich’s primary responsibility is to build the company’s energy and sustainability consulting services group, focusing on front-end energy and sustainability needs for biopharma and food and beverage manufacturing clients.

Pharma getting serious about sustainability

Pharma’s environmental impact is under the microscope, and companies ranging from AbbVie to Amgen have set ambitious goals to slash carbon emissions, waste and water consumption in the coming years.

A recent Cornell University study suggests the industry…

Navigating generative AI in drug discovery and data analysis: Seizing the opportunity and avoiding pitfalls

[Made/Adobe Stock]

Along with predictive AI, generative AI is emerging as a promising tool in drug discovery. Thanks in part to the rise of ChatGPT, interest in the technology in drug discovery is on the upswing. In March, a preprint appeared examining the potential to use generative AI to enable de novo antibody design. Also this year, the Japanese conglomerate Mitsui & Co. began working with NVIDIA to launch Tokyo-1, a project aimed at boosting Japan’s pharma industry with generative AI models. The initiative will give Japanese pharma companies and startups access to an NVIDIA DGX AI supercomputer, providing a shot in the arm to the country’s $100 billion pharma sector, which is the third largest globally.

As generative AI gains ground in pharma, businesses considering using the technology to speed up drug discovery should also take its potential drawbacks into considering. To that end, Ali Arsanjan…

Discover the 25 top pharma employers of 2023

[tilialucida/Adobe Stock]

The pharma and biotech sectors continue to face rapid change. On one hand, top pharma employers have continued to face talent shortages as demand increases for experienced workers. But on the other, the pharma sector has not been immune to layoffs. One factor driving the trend is the increased clip of mergers and acquisitions (M&A) activity, which can result in restructuring but also new job opportunities as companies sharpen their focus on pipeline gaps and developing novel therapeutics. The pharma industry is in the process of reassessing long-term strategies in domains such as sourcing, manufacturing and supply chain management, according to McKinsey. These trends have gained steam in recent years as a result of factors such as inflation, the ongoing pandemic, the shifting geopolitical climate and the development of novel therapeutic methods and new ways of working. The rapid evolution …

Science 37, Crinetics and Gritstone Bio announce inducement grants to boost talent acquisition

[ipopba/Adobe Stock]

Science 37 Holdings (Nasdaq:SNCE), Crinetics Pharmaceuticals (Nasdaq: CRNX) and Gritstone Bio (Nasdaq:GRTS) have announced recent inducement grants to attract new non-executive employees under Nasdaq Listing Rule 5635(c)(4). This move showcases the companies’ focus on talent acquisition and retention in the competitive pharmaceutical and biotechnology markets.

A clinical trial research organization based in Durham, North Carolina, Science 37 announced today that its compensation committee signed off on inducement equity awards. In all, the company granted options to purchase an aggregate of 110,800 shares of its common stock at an exercise price of $0.29 per share to three new employees. The options have a 10-year term and a four-year vesting schedule.

Grants for Critics and Gritstone

The clinical-stage pharma firm Crinetics Pharmaceuticals specializing in rare endocrine disease…

The new National Cancer Plan launches with goal of cutting cancer death rate by half in 25 years

[Image courtesy of National Institutes of Health]

Today, the U.S. Department of Health and Human Services (HHS) debuted the National Cancer Plan with an ambitious albeit vague quest to “end cancer as we know it.”

Specifically, the initiative will serves as a guideline to support President Biden’s Cancer Moonshot objectives, which aims to reduce the cancer mortality rate by 50% over a 25-year period.

NCI will lead the National Cancer Plan and Cancer Moonshot program

HHS will put the National Institutes of Health’s (NIH) National Cancer Institute (NCI) in charge of the program, which supports the Cancer Moonshot initiative from President and First Lady Biden.

The President’s Cancer Moonshot has galvanized the goal of advancing the fight against cancer,” said Dr. Monica M. Bertagnolli, National Cancer Institute director, in a press release.

Despite Biden’s focus on ramping up oncology res…

FDA releases guidance on pharmaceutical supply chain security

[Corona Borealis/Adobe Stock]

The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S.

So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.

Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). Read more

Pharmaceutical industry trends: 2023 outlook

[Gene editing image courtesy: Illustration by Jill George using images from the National Human Genome Research Institute & the National Institute of Allergy and Infectious Diseases]

If your only tool is a hammer, everything looks like a nail. Such was the state of the pharmaceutical industry a decade ago. Gone are the days of pharmaceutical companies predominantly specializing in single modalities such as traditional vaccines, monoclonal antibodies, plasma-derived therapies or small molecules. Today’s Big Pharma, fueled by the acquisition of countless startup companies, are ensuring their toolboxes are flush with the trusty tools of the past decades. In addition, Big Pharma companies are leveraging the power of new tools in the form of advanced therapeutic modalities. Consequently, the pipelines of leading companies in the pharmaceutical industry are increasingly comprised of complex new modalities such as cell the…