Featured Stories
Celltrion Ventures into CDMO Market and Eyes Expansion
Celltrion Inc., a South Korean biosimilar manufacturer, has announced its entry into the CDMO market. Founder and Chairman Seo Jung-jin shared the update during the Morgan Stanley Global Healthcare Conference, announcing the company’s plans to establish a wholly owned subsidiary focused on the CDMO market, adding that the company would explore options for new plant construction, either domestically or internationally.
BioCentriq Appoint New CEO
Specialist CDMO BioCentriq has appointed Syed T. Husain as its new CEO. Husain will guide the company through its next growth phase as it focuses on advancing cell and gene therapy manufacturing from clinical to commercial stages. Husain’s previous expertise as Chief Commercial Officer at Resilience saw him lead commercial strategies across biologics and emerging therapies and will be crucial for BioCentriq’s expansion and support of innovative therapies.
Phillips Medisize to Acquire Vectura, Expanding Inhalation Drug Delivery Capabilities
Global electronics company Molex, through its subsidiary Phillips Medisize, has entered into an agreement to acquire Vectura Group Limited from Philip Morris International. Vectura, based in the UK, specializes in inhalation drug delivery, including device and formulation development for dry powder inhalers, metered dose inhalers, and nebulizer products.
Agilent Completes Acquisition of BIOVECTRA to Expand CDMO Capabilities
Agilent Technologies has completed its acquisition of BIOVECTRA, a Canadian CDMO specializing in biologics, highly potent pharmaceuticals, and targeted therapeutics. Now part of Agilent's Diagnostics and Genomics Group, the acquisition will enhance Agilent's portfolio with advanced manufacturing capabilities for gene editing and biologics production.
FDA Inspection Backlog Delays Overseas Drug Approvals
A significant FDA inspection backlog is delaying new drug approvals, particularly for drugs manufactured overseas. Exacerbated by the pandemic, the delay in regulatory approval impacts the availability of new treatments in the U.S. and could hinder the introduction of innovative therapies. Although the FDA is working on reducing the backlog, the delays are causing concerns across the pharmaceutical industry.
GLP-1 Discovery Award Recognition
The 2024 Lasker Award, given to the living person or persons considered to have made the greatest contribution to medical science, has been awarded to scientists Joel Habener, Jens Juul Holst, and Dr. Gojko Mojsov for their discovery of GLP-1 (glucagon-like peptide-1). Their groundbreaking work has paved the way for life-changing treatments for diabetes and obesity, revolutionizing the management of these conditions through drugs like Ozempic and Wegovy, resulting in a wave of new medications entering the market.
Novo's Monlunabant Shows Side Effects in Phase 2 Trial
The Danish pharma giant’s latest obesity product, a cannabinoid CB1 receptor blocker, was linked to mild to moderate neuropsychiatric side effects in a Phase 2 clinical trial. While its prospect showed promise in addressing obesity, some trial participants experienced unwanted side-effects such as mood swings and mild cognitive changes. The company is closely monitoring these symptoms as it prepares for further trials. Despite these concerns, the company says its CB1 receptor blocker continues to offer hope for patients struggling with obesity.
Gelita to Showcase New Softgel and Collagen Solutions
Gelita, the German headquartered supplier of peptides and gelatin solutions for the nutritional sector, will introduce its latest innovations, including its softgel controlled release portfolio featuring DELASOL for enteric softgels, RAPISOL for rapid release, and RXL Ultra to combat crosslinking, which can cause softgels to harden and affect gastrointestinal dissolution and release rates. At a presentation during the event, experts from Gelita will discuss overcoming crosslinking using plant-based ingredients. The company will also present EASYSEAL, a solution to reduce leaks in softgel production.
Steriline to Showcase Advanced Robotic Vial Filling and Capping Machine
As demand for sterile injectable fill/finish services continues to grow, Steriline will present its latest robotic vial filling and capping machine. By using robotics to handle high-quality vial filling and capping operations, the automated system promises precision, reducing contamination risks, and increasing production efficiency.
M&M to Address Packaging Trends and Solutions
M&M Packaging will discuss key market trends, challenges, and solutions in pharmaceutical packaging at CPHI Milan 2024. With growing demands for sustainable materials, compliance with global regulations, and innovative designs for drug delivery, M&M aims to present the latest advances that meet industry needs. Their focus will be on improving safety, usability, and sustainability in packaging to keep pace with the evolving pharmaceutical landscape.
Sanner Acquires Gilero to Expand Medical Device Offering
Sanner Group, the healthcare packaging and medical device CDMO, has announced it has acquired Gilero, a medical device designer, developer, and contract manufacturer headquartered in Durham, North Carolina. The acquisition helps position Sanner as a leading provider of end-to-end services across drug delivery, diagnostics, and MedTech device sectors. Gilero brings with it 130 engineers based across facilities in the U.S., Mexico, and Ireland.
Berry to Showcase Innovative Drug Delivery Solutions
Plastic packaging manufacturer Berry Global will unveil its latest patient-centric drug delivery systems in Milan, focusing on enhancing ease of use and safety for patients. Key innovations from the company include cutting-edge inhalers, injectors, and other sustainable packaging solutions tailored to pharmaceutical needs. The company will offer attendees the opportunity to explore its expertise in creating customizable solutions that improve patient outcomes and reduce environmental impact.
Serán More Than Doubles US Clinical Manufacturing Capacity
Serán BioScience announced that it had completed an expansion to add eight state-of-the art process manufacturing suites at its facility in Bend, Oregon, adding around 130% more CGMP clinical manufacturing capacity. The suites will provide increased flexible capacity for late-stage clinical trial supply for small-molecule drugs.
eGenesis Secures $191 Million for Pig Kidney Transplants
Biotech firm eGenesis has raised $191 mn to advance its genetically modified pig kidney transplant program, utilizing its gene-editing technology that makes pig organs more compatible with human immune systems. The raised funds will be used to support clinical trials for the company's lead candidate - EGEN-2784 - a pig kidney engineered to be human-compatible after successful, though short-lived, human transplant earlier in 2024.
Lilly and Haya Join Forces for Breakthrough Metabolic Treatments
Eli Lilly has entered a major collaboration with Swiss biotech Haya Therapeutics to develop innovative drugs targeting metabolic conditions like obesity. The partnership, which could be as valuable as $1 bn, focuses on exploring the "dark genome" — the 98% of human DNA that does not code for proteins but plays critical regulatory roles.
Bayer Launches Healthy Aging Ecosystem for Consumers
Bayer has unveiled a new ecosystem aimed at supporting healthy aging, responding to growing consumer interest in wellness and longevity, by offering a range of products and services designed to promote better health outcomes as people age.
Amgen's MariTide to Face Phase 3 Trials in Targeting Liver and Kidney Diseases
Amgen is advancing its next-generation obesity drug, MariTide, into a Phase 3 clinical program aimed at addressing obesity in conjunction with other weight-related conditions such as heart, liver, and kidney diseases. The injectable therapy, which activates the GLP-1 receptor while blocking the GIP receptor, demonstrated a 14.5% reduction in body weight during Phase 1 trials.
Key Insights from CDMO Trends in Oral Solid Dosage
The first pills date back to roughly 1,500 BC, and whilst the pharmaceutical landscape continues to evolve, drug delivery via oral solid dosage (OSD) remains a dominant form due to the ease with which tablets are administered, patients’ familiarity with the dose form, and efficient manufacturing techniques.
Lonza Expands Microbial Manufacturing to Meet Biotech Demand
Lonza has completed an expansion of its microbial manufacturing facility at Visp, Switzerland, to address the growing demand for microbial manufacturing - driven by the rise of smaller, more complex molecules in the biotech pipeline - and boost its capacity to meet the increasing demand for microbial-based biologics.
UK to Ban More Dangerous Drugs
The UK government has introduced legislation to ban xylazine and 21 other dangerous substances, including six highly potent synthetic opioids. Xylazine, a veterinary sedative also known as "tranq," is used illicitly to extend opioid doses and has caused severe health issues and overdose deaths. The new law categorizes xylazine as a Class C drug and other potent opioids as Class A, imposing strict penalties for production and distribution.