Market News & Trends
Symbiomix Submits New Drug Application to US FDA
Symbiomix recently announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the US…
Tetraphase Pharmaceuticals Doses First Patient in Phase III Trial
Tetraphase Pharmaceuticals, Inc. recently announced dosing of the first patient in IGNITE3, the company’s Phase III clinical trial evaluating the efficacy and safety of once-daily…
Cycle Pharmaceuticals to Develop New Vascular Disease Treatment
Cambridge Enterprise has exclusively licensed intellectual property relating to the use of PARP inhibitor drugs for treating vascular disease to Cycle Pharmaceuticals. The University of…
Horizon Broadens Industry-Leading Gene Editing Capabilities
Horizon Discovery Group plc recently announced it has broadened its gene editing capabilities through the amendment of a pre-existing license with ERS Genomics to include…
Dalton Pharma Services Announces Development & Manufacturing Agreement
Dalton Pharma Services recently announced the signing of a drug development and manufacturing services agreement with Cerium Pharmaceuticals, Inc., an emerging biopharmaceutical company based in…
Egalet Receives FDA Approval for Extended-Release Product Formulated With Abuse-Deterrent Properties
Egalet Corporation recently announced the US FDA has approved ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to…
University of Pittsburgh & Bayer Form Alliance to Advance Research for New Therapies
The University of Pittsburgh and Bayer have established a master collaboration agreement to advance research for heart, lung, and blood disease indications. This broad collaboration…
Pluristem’s Phase III Study Cleared by FDA
Pluristem Therapeutics Inc. recently announced that the company’s Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared…
MilliporeSigma Expands End-to-End Biodevelopment Centers
MilliporeSigma, a leading science and technology company, recently announced the expansion of its end-to-end biodevelopment centers to meet increasing customer demand for its turnkey portfolio…
G1 Therapeutics Initiates Three Drug Development Programs
G1 Therapeutics, Inc., a clinical-stage oncology company, recently announced the expansion of its pipeline of novel cancer therapies with the initiation of three development programs…
CytoDyn Files for Breakthrough Therapy Designation With the FDA
CytoDyn Inc. recently announced the company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection…
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients
By: Ulrich Reichert, PhD, Head of Pharma & Food Materials, Regulatory Management, Merck KGaA, Darmstadt, Germany Introduction The International Conference on Harmonization (ICH) finalized the…
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients
By: Ulrich Reichert, PhD, Head of Pharma & Food Materials, Regulatory Management, Merck KGaA, Darmstadt, Germany Introduction The International Conference on Harmonization (ICH) finalized the…
Gerresheimer Introduces Metal-Free Syringe
Biopharmaceuticals demonstrate a series of special features. They are often highly viscous and in individual cases tend to interact with silicone oil or, for example,…
PCI Clinical Services & Suvoda Announce Strategic Partnership
Leading clinical outsourcing services provider, PCI Clinical Services (PCI), recently announced a partnership with Suvoda LLC. The agreement will benefit clinical trials, delivering Suvoda’s cutting-edge…
Nemus Bioscience Announces Licensing Agreement for a Cannabinoid-Based Anti-Infective Platform Directed Against Drug-Resistant Organisms
NEMUS Bioscience, Inc. (NMUS) announced that the company had signed a licensing agreement with the University of Mississippi (UM) for a platform of cannabinoid-based molecules…
Catalent to Develop Softgel Capsules for JOT's Leading Orphan Disease Candidates
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced that it is…
Spark Therapeutics Announces $15-Million Milestone Payment
Spark Therapeutics recently announced it has earned a $15-million payment from Pfizer Inc. for achieving a pre-specified safety and efficacy profile development milestone in the…
RedHill Biopharma Announces Exclusive US Co-Promotion Agreement With Concordia
RedHill Biopharma Ltd. recently announced the signing of an exclusive co-promotion agreement with a subsidiary of Concordia International Corp., an international specialty pharmaceutical company focused…
Protalix BioTherapeutics Announces Positive Interim Results
Protalix BioTherapeutics, Inc. recently announced positive interim results from the company’s Phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF)…
