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Biogen and Eisai’s drug, Aduhelm (aducanumab) has become the first new treatment to gain US Food and Drug Administration approval for Alzheimer’s since 2003 and the first therapy that targets the fundamental pathophysiology of the disease.
The drug was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Read more.
Entegris will expand its manufacturing facilities located in Billerica, MA, Bloomington, MN, and Logan, UT as part of an approximately $30 million plan to invest in life sciences capacity and capabilities this year.
The facilities will develop and manufacture bioprocessing assemblies, such as the company's Aramus critical fluid handling product line currently used to produce and deliver vaccines worldwide. Read more.
EmpowerPharm has become the first company to receive approval from the Canadian health authority to manufacture cannabidiol (CBD) products to prescription drug standards. Read more.
The COVID-19 pandemic slowed pharma M&A activity in 2020, but only temporarily with deals since June of that year suggesting drug firms are still hungry for the right takeovers.
At first glance, it would be fair to assume the pandemic had a huge impact on drug industry acquisitions in 2020. Read more.
MedPharm has announced it is expanding its CDMO services in topical and transdermal delivery by opening a new location in Raleigh-Durham, North Carolina.
The new facility, located within a few miles of the CDMO's current Center of Excellence, will support process development and clinical and small-scale commercial manufacturing for semi-solid and liquid pharmaceutical products. Read more.
As of August 2019, the FDA reported that only 28% of the manufacturing facilities making active pharmaceutical ingredients (APIs) for the US market were actually based in the US, and just 2% were located in Canada. The remaining 70% were abroad, with 18% in India and 13% in China. Read more.
After consulting with pharma industry stakeholders, we’ve seen a strong consensus that in-person interactions are very much needed for business to be done.
CPhI North America 2021 will be a hybrid event, featuring a 3 week high-level content program as well as smart networking and business matchmaking (July 26 - August 6). The event culminates with an in-person event in Philadelphia hosting the full supply chain for drug manufacturing and development, and we will do this in the most safe and secure manner (August 10-12).
Is the pharma industry making the most of AI’s potential when it comes to accelerating and enhancing pharmaceutical drug development? The utilisation of artificial intelligence (AI) by the pharmaceutical industry is gathering pace rapidly. The technology has evolved beyond simple neural networks and machine learning towards a deep learning approach geared at producing insights which should in theory enable better business decision making.
FDA approval of GW Pharmaceuticals’ Epidiolex® is widely considered to be a landmark in cannabinoid-derived drug development. Not only is Epidiolex® the first FDA-approved drug that contains a purified drug substance (cannabidiol) derived from the Cannabis sativa plant (marijuana), but it is also the first FDA approved drug for the treatment of patients with a rare and severe form of childhood epilepsy, Dravet syndrome.
Pipeline diversification, emerging therapies and shifting customer demands are the real dynamics reshaping the contract manufacturing market, according to experts. Almost every article written about contracting reports that demand for outsourced manufacturing services is growing and states that the CDMO sector is consolidating.
Empathy is the ability to understand another person’s feelings and perspectives. By taking the time to relate to others, you build trust,
encourage honesty and open up communication lines. Not only does this create an environment where everyone can fulfil their potential, it also provides far greater scope for innovation.
The biopharma market has enjoyed near exponential growth over the last few decades, which has boosted total revenues by over 6,000% from USD 4 billion since the 1990s to $275 billion today. With biopharmaceuticals now comprising 25% of the total pharma market, the pressure is on to maintain this growth and innovation.
As the pharmaceutical industry tirelessly seeks to accelerate its medicines to market, drug manufacturing remains a key opportunity area for it to reduce costs and improve quality. The technology advances promised from Pharma 4.0 -- such as big data, interconnectivity, robotics and artificial intelligence -- and smart manufacturing techniques have given business leaders greater visibility into their pipelines and processes.
The biopharmaceutical industry is at a crossroads when it comes to drug development. On the one hand, this time-intensive process of navigating a molecule successfully through the preclinical and clinical stages all the way to market has been saddled with high capital costs and stringent regulation; two factors that justify both a risk-averse approach and an urge to rein in R&D expenses.
With CPhI North America fast approaching, we asked several industry experts what they see as the main trends emerging across the US pharma supply chain this year.
Players in the pharmaceutical value chain will need to fully harness cutting-edge digital technologies such as artificial intelligence (AI) and cyber-security solutions to make greater efficiency...
We sat down with the former senator shortly before his address to discuss the trajectory of another potent topic: immigration reform. Despite their indispensable role in the pharma supply chain, the ability of U.S. companies to hire the best talent from around the world has recently been thrown into doubt.
The biomanufacturing industry is in the midst of a serious shortage of skilled bioprocess engineers, limiting productivity and the field’s ability to innovate and expand. For the industry to grow and accommodate revolutionary new drug modalities, like CAR-T therapies, far greater emphasis needs to be placed on training and retaining skilled workers.
Alise Cortez, Ph.D., is an Engagement and Purpose Catalyst based in Dallas. She designs and delivers professional development, leadership, and engagement workshops. She is a speaker, consultant, author, industry thought-leader, and host of VoiceAmerica’s “Working on Purpose” radio show.