The big pharma company GlaxoSmithKline will inject up to $800 million into its manufacturing site in Marietta, Pennsylvania, to double its size and capacity.
The expansion will involve the construction of a new buffer media facility and represents the largest investment from Rentschler at its Germany headquarters.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna (ataluren), PTC Therapeutics’ treatment for the genetic disease Duchenne muscular dystrophy (DMD).
The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.
Artificial intelligence (AI) is now infiltrating core industries and according to Forbes, the market is expected to reach a value of $22.6 billion dollars by next year (2025).
One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.
uMotif, a fast-growing company in the clinical research technology sector, has taken a significant step in expanding its platform with the acquisition of ClinOne, a provider of site platform solutions.
CluePoints, the leading provider of risk-based quality management (RBQM) and data quality oversight software, has announced the full agenda and speaker line-up for the highly anticipated RBQMLive 2024.
Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.
Dalgety, one of the UK's leading medical cannabis cultivators, has achieved a significant milestone by securing a Home Office licence to supply medical cannabis within the UK.
UCB, a global biopharmaceutical leader, has taken a significant step in refining its strategic focus by divesting its mature neurology and allergy portfolio in China.
The Danish company Bavarian Nordic plans to supply up to 2 million vaccine doses this year in response to the World Health Organization’s declaration of mpox as a Public Health Emergency of International Concern (PHEIC) earlier this month.
Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).
Intelliguard, a leader in medication management and data-intelligence solutions, has announced a partnership with Cencora, a global pharmaceutical solutions provider.
In the ever-evolving world of pharmaceutical logistics, nuVizz has emerged as a key player, delivering innovative solutions that streamline the delivery management process.
In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.
In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine...
Red Queen Therapeutics, a new clinical-stage biotechnology company, has launched with a mission to develop antiviral treatments for serious viral diseases, including coronaviruses, influenza, and respiratory syncytial virus (RSV).
As the BioSecure Act approaches its 2032 implementation, Contract Development and Manufacturing Organizations (CDMOs) must prepare for significant industry shifts.
The recent draft guidance released by the US Food and Drug Administration (FDA) in collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) marks a significant update in Good Clinical...
On Friday (July 26), the European Union’s drugs regulator, the Committee for Medicinal Products for Human Use (CHMP), advised that the drug lecanemab, a treatment for Alzheimer’s disease, should not be approved for use in the EU.
In a candid interview at the DIA conference, James, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.
Philips has just published its latest Future Health Index, the ninth edition of the largest global survey of its kind, read on to find out which key areas are impacting the future of healthcare.
Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.
Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10mg tablets for the relief of heartburn...
Avista, a New York-based private equity firm focused on healthcare, and Hamilton Lane, a global private markets investment management firm, have announced that funds managed by Hamilton Lane have acquired a significant equity interest in Cosette Pharmaceuticals...
Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry – a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward...
Japanese medical devices company, Nipro Medical Corporation, a giant in the healthcare and medical device industry, has announced a major investment of $397.8 million to establish its first North American manufacturing center of excellence in Greenville,...
At the DIA 60th annual conference in San Diego, senior editor Liza Laws from Outsourcing Pharma had the opportunity to sit down with Marwan Fathallah, President and CEO of DIA.
Dr. Catherine Duggan, chief executive officer of the International Pharmaceutical Federation (FIP), has been at the helm since June 2018, based in The Hague.
Blow-fill-seal (BFS) technology has long been a cornerstone of pharmaceutical manufacturing, relied on for packaging sterile liquid medications, including but not limited to ophthalmic and respiratory drug products.
Cellibre, a leader in sustainable biochemical manufacturing, has secured a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Ketaki Patwardhan, a global technical developer at Roquette, has built a remarkable career in the pharmaceutical industry by leveraging her curiosity and passion for science.
In an exclusive interview, Akash Bakshi, CEO of YourChoice Therapeutics, delves into the inspiration and journey behind developing a hormone-free birth control pill for men.
The growing opioid crisis in the US has been exacerbated by various systems and biases, preventing individuals from accessing critical treatments like methadone and buprenorphine.
dsm-firmenich has announced the launch of CBtru – an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).
Yesterday (June 24) Novo Nordisk unveiled plans to invest $4.1 billion (approximately €3.8 billion) in a new manufacturing facility in Clayton, North Carolina.
During a panel discussion held at DIA Global in San Diego this week, which was moderated by Peter Wahl, vice president and global head of scientific affairs at CorEvitas, industry experts delved into the integration of real-world data (RWD) and advanced...
CluePoints, a leading provider of AI-driven software solutions for Clinical Data Review, has secured significant investment from EQT for its continued growth.
