Formulation Development
Oncorus to Build GMP Viral Immunotherapy Clinical Manufacturing Facility
Oncorus, Inc. recently announced it has signed a 15-year lease to build a state-of-the-art, 88,000-square-foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility in…
Inozyme Pharma Announces Authorization to Proceed in US & UK With Phase 1/2 Clinical Trial
Inozyme Pharma, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application and that the United Kingdom Medicines and Healthcare…
EyePoint Pharmaceuticals Announces $15.7-Million Equity Investment
EyePoint Pharmaceuticals, Inc. recently announced Ocumension Therapeutics has made a $15.7-million equity investment in EyePoint. Under the terms of the agreement, Ocumension has purchased approximately…
Ajinomoto Bio-Pharma Services & Revance Therapeutics Announce Manufacturing Agreement
Ajinomoto Bio-Pharma Services and Revance Therapeutics, Inc. recently announced a strategic commercial manufacturing agreement for the supply of DaxibotulinumtoxinA for….
Vectura Earns $11-Million Milestone as Hikma Receives US FDA Approval for Generic Advair DiskusR
Vectura Group plc recently announced its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder)….
Aurinia & Lonza Announce Exclusive Agreement for Dedicated Voclosporin Manufacturing Capacity
Aurinia Pharmaceuticals Inc. and Lonza recently announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build….
Gattefossé Continues International Development & Builds Production Site in Texas
Gattefossé is investing 30 million euros in its industrial operations and announced the construction of a brand new manufacturing plant in Lufkin, TX. This asset will produce lipid-based….
Passage Bio Teams With Catalent to Start cGMP Manufacturing for Lead Gene Therapy Products
Passage Bio, Inc. and Catalent recently announced that manufacturing operations have commenced to support adeno-associated virus (AAV) production for Passage Bio’s lead….
Syneos Health & ConcertAI Announce Strategic Collaboration to Accelerate the Use of Real World Evidence & AI to Advance Oncology Research
Syneos Health and ConcertAI recently announced a strategic collaboration to accelerate and streamline the implementation of novel oncology clinical trial research and study designs…..
Theratechnologies Announces New Findings for its Lead Investigational Compound for the Treatment of Several Additional Cancers
Theratechnologies Inc. recently announced new preclinical in vivo findings regarding the efficacy and tolerability of its novel investigational proprietary peptide-drug conjugate (PDC), TH1902, for the….
Daré Bioscience Announces Positive Topline Results From Phase 3 Trial
Daré Bioscience, Inc. recently announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with…
Kronos Bio Announces FDA Clearance of IND for Oral CDK9 Inhibitor
Kronos Bio, Inc. recently announced US FDA clearance of the company’s Investigational New Drug (IND) application for KB-0742, a highly selective, orally bioavailable inhibitor of…
Ionis Announces Initiation of the Global Phase 3 BALANCE Study
Ionis Pharmaceuticals, Inc. recently announced the initiation of the Phase 3 BALANCE study for AKCEA-APOCIII-LRx in adult patients with familial chylomicronemia syndrome (FCS). FCS is…
Catalent to Invest $10 Million to Expand High Potency Containment Capabilities for Micronization
Catalent recently announced it is investing $10 million in isolator capabilities at its sites in Malvern, PA, and Dartford, UK, to expand its micronization capabilities…
BioAge Raises $90 Million to Treat Aging & Age-Related Diseases
BioAge Labs, Inc. recently announced it has raised $90 million in an oversubscribed Series C financing. The raise was co-led by Andreessen Horowitz and serial…
Excellence in Production: A Critical Contribution to the Pharmaceutical Industry
When it comes to the production of high-quality pharmaceuticals, excellence is the name of the game – in all production areas. It is the overarching goal of a well-defined course of action for….
WEBINAR ALERT! - Beyond Elemental Impurities: New Applications of ICP-MS
During this educational event, scientific experts will discuss several newer applications of ICP-MS in the pharmaceutical industry that capitalize on the technique’s versatility beyond the scope of elemental impurities.
Vectura Signs Development Agreement With Kinaset Therapeutics
Vectura Group plc recently announced it has signed a global outlicense and development agreement with Kinaset Therapeutics Inc. for the development and commercialization of….
Lonza Expands Development & Manufacturing Capabilities
Lonza recently announced a significant investment to expand its particle engineering and drug product capabilities to meet increased market demand at its Bend, OR, site…..
Kindeva & BOL Pharma Sign Agreement for Development of Inhaled Cannabinoid Products
Kindeva Drug Delivery and Breath of Life International recently signed an agreement to study the feasibility of multiple inhaled cannabinoid products…..