Featured Stories
CPHI Americas 2025: Meeting Biomanufacturing Demand
As demand for biologic drug substance manufacturing rises, The Pharma Navigator, chats with Carrie Bracco from Novartis Contract Manufacturing about how this trend is impacting service providers, the challenges facing CDMOs in the space, and the benefits of strategic partnerships.
CPHI Americas 2025: A Growing Service Offering
In this interview with The Pharma Navigator, Dan Dobry from Bend Bioscience chats about the value of comprehensive end-to-end services, challenges and future trends for OSD CDMOs, and the company’s focus for this year’s CPHI Americas event.
CPHI Americas 2025: Navigating Complexities with Strategic Partnerships
The Pharma Navigator discusses the increasingly complex therapeutic landscape and how strategic partnerships can be beneficial with Dr. Srinivasan Shanmugam from Adare, and finds out more about the company’s plans for CPHI Americas with Steven Facer, Senior Vice President, Global Sales and Marketing.
Reflecting a Broader Audience: CPHI Americas Event Preview
As the month of May marches on, the city of Philadelphia prepares itself to once again play host to CPHI — this year under its new guise of CPHI Americas. For 2025, the event organizers have updated the name of the show to reflect the broader audience, which incorporates Latin America and Canada in addition to North America.
Verastem Gets Nod from FDA for Rare Ovarian Cancer Combo Therapy
The oral combination therapy has been shown to provide a significant overall response rate in LGSOC patients with disease progression despite prior systemic treatment.
Chikungunya Vaccine Under Safety Review by EMA
The European regulatory body’s safety committee has started its review of the vaccine after receiving reports of serious adverse events in elderly patients.
FDA Starts Implementing AI Rollout Across All Centers
After a successful AI-assisted scientific pilot review, the agency has decided to implement the use of AI across all centers in an accelerated timescale.
Sanner Launches Enhanced Packaging for Tablets and Capsules
The company’s redesigned oral solid dose packaging has been optimized to meet the rising demand for safer, more user-friendly pharmaceutical packaging.
Regeneron's Multiple Myeloma Therapy Receives E.U. Approval
The bispecific monoclonal antibody has demonstrated robust and durable responses in patients with relapse/refractory multiple myeloma.
3P Innovation Launches Generic Next-Gen DPI Filling Technology
The new DPI filling technology is an enhanced equivalent to the original filling system for the GSK Diskus DPI and will be available to manufacturers looking to produce generic products from the original Diskus and Ellipta products.
Merck Enters Definitive Agreement to Acquire SpringWorks Therapeutics
Through this sizable acquisition, Merck will accelerate its growth in the rare tumor segment and boost its U.S. oncology presence.
FDA Approves AbbVie’s JAK Inhibitor Therapy to Treat GCA
Supported by clinical trial data, this new indication for upadacitinib provides GCA sufferers with an alternative treatment option that can achieve sustained remission.
Riding the Oral GLP-1 Wave
As more innovators look to develop orally administered GLP-1s further demand will be placed onto CDMOs to provide the expertise and capabilities needed to support the next generation of these drugs.
Amgen Further Commits to U.S. Manufacturing with Ohio Investment
This latest investment into expanding its manufacturing capabilities reinforces the company’s commitment to the U.S. and enhances its global biomanufacturing network.
PCI Expands U.S. Fill/Finish Capabilities with Althea Acquisition
The acquisition will provide PCI with a large-scale manufacturing hub on the West Coast of the U.S., complementing its existing global facilities.
Granite Bio Emerges from Stealth to Advance Immunology Pipeline
Significant funds, in series A & B funding rounds, have been raised from leading investors to advance the company’s two first-in-class monoclonal antibodies targeting inflammation, autoimmunity, and fibrosis.
Roche Commits Billions to Strengthening U.S. Presence
Over the next five years, Roche will invest USD 50 billion to expand and upgrade existing facilities and build new facilities across its Pharmaceutical and Diagnostics Division in the U.S.
GemPharmatech Advances Expansion Strategy with New Facility in San Diego
The CRO is expanding its headquarters to include a comprehensive laboratory and rodent vivarium, which enhances its preclinical research infrastructure in the U.S.
Syntegon Launches New Filling Machine for RTU Syringes
The company’s MLD Advanced uses a combination of proven technologies to enable manufacturers to quickly and efficiently meet the requirements of high outputs.
Navigating the Hot Topics for Bio/pharma
As the bio/pharma industry faces the looming threat of tariffs, it is clearer than ever that reporting on the key issues and trends set to shape industry is imperative to help stakeholders stay informed.