Formulation Development
Evonik Launches EUDRACAP Colon Functional Capsules in GMP Quality at CPHI Frankfurt
Evonik’s EUDRACAP colon functional capsules are now available produced under good manufacturing practice (GMP). Launched last year, EUDRACAP colon is the first functional, ready-to-fill capsule…
Roquette Returns to SupplySide Global With New, Unified Vision for Health & Nutrition
Roquette, a global leader in plant-based ingredients, will debut its newly expanded portfolio at SupplySide Global 2025. The event marks the company’s first presentation combining…
Hovione Completes Initial $100M Investment Cycle to Expand US Operations at New Jersey Manufacturing Campus
Hovione, a fully-integrated global CDMO, today announced the completion of an initial multi-million-dollar investment cycle to expand its manufacturing campus in East Windsor, New Jersey.…
XOMA Royalty & LAVA Therapeutics Announce Amendment to Purchase Agreement
XOMA Royalty Corporation and LAVA Therapeutics N.V. recently announced that they have reached an agreement to amend their previously announced definitive share purchase agreement .…
New Roquette Pharmaceutical Innovation Center to Strengthen Latin America as Collaborative Hub
New Roquette Pharmaceutical Innovation Center to Strengthen Latin America as Collaborative Hub The Health & Pharma Solutions facility offers state-of-the-art laboratory and training rooms for…
Enterome Receives FDA Fast Track Designation in Follicular Lymphoma for Lead OncoMimics Immunotherapy
Enterome recently announced the US FDA has granted Fast Track designation for follicular lymphoma in the low tumor burden “watch-and-wait” setting for its lead OncoMimics…
Entera Bio to Present New Clinical Data From Phase 2 Trial of EB613 at the 2025 North American Menopause Society (NAMS) Annual Meeting
Entera Bio Ltd. recently announced it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society…
Gyre Therapeutics Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Pirfenidone Capsules for the Treatment of Pneumoconiosis
Gyre Therapeutics recently announced its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial…
Amphista Therapeutics Nominates Orally Available Targeted Glue Degrader as its First Clinical Development Candidate
Amphista Therapeutics recently announced the nomination of AMX-883; a potent, selective and orally bioavailable degrader of BRD9, as its first clinical development candidate. Amphista is…
Owen Mumford Launches EcoSafe Safety Syringe Platform - Smarter for Budgets & Kinder to the Planet
The EcoSafe 1ml safety syringe (previously branded UniSafe) is compatible with the new reusable EcoSafe autoinjector – creating the first and only fully integrated safety…
Tagworks Pharmaceuticals Announces CTA Authorization & Initiation of Phase 0/1 Clinical Trial for TGW211, a Radiopharmaceutical for the Treatment of HER2+ Tumors
Tagworks Pharmaceuticals BV recently announced the Dutch regulatory authorities approved the Clinical Trial Application (CTA) for the CleavHER Phase 0/1 clinical trial, sponsored by the…
Quotient Sciences & Biorasi Partner to Accelerate Early Phase Clinical Trials to Patient Proof-of-Concept
Quotient Sciences recently announced a strategic partnership to deliver fully integrated early phase clinical trial solutions. The partnership will combine Quotient Sciences’ expertise in early clinical…
Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced the US FDA has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa…
Roquette Debuts its Next Chapter at CPHI 2025 Following Qualicaps & IFF Pharma Solutions Acquisitions
At this year’s CPHI Frankfurt (booth 8.0P24, hall 8), Roquette will share its unified portfolio and strategic vision for the first time after having completed…
Traws Pharma Doses First Patient With Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025
Traws Pharma, Inc. recently announced the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed…
Ensera Launches as New Brand Identity for SteriPack
SteriPack, a global contract design and manufacturing organization (CDMO) for the pharmaceutical and medical device industries, has announced its trading name change to Ensera, signaling…
Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation
Bicara Therapeutics Inc. recently announced the US FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line…
MannKind Announces FDA Accepts for Review its sBLA for Inhaled Insulin in Children & Adolescents
MannKind Corporation recently announced the US FDA has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children…
Shape Therapeutics Shares Breakthrough Preclinical Data for Non-Invasive Treatment of Parkinson’s Disease Using a Brain Targeted AAV Gene Therapy
Shape Therapeutics recently announced it presented new preclinical data highlighting the therapeutic potential of its lead product (SHP-201), a disease-modifying gene therapy for the treatment…
AviadoBio & UgeneX Therapeutics Announce Exclusive Option-License Agreement to Develop Next Generation Optogenetics Gene Therapy to Restore Vision in Patients With Retinal Disease
AviadoBio Ltd. and UgeneX Therapeutics, today announced an exclusive option and license agreement for the development and commercialization of UGX-202, an investigational, AAV-based gene therapy…
