Market News & Trends
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…
Flamel Technologies Completes Cross-Border Merger & Becomes Avadel Pharmaceuticals
Flamel Technologies SA, completed its previously announced cross-border merger with and into its wholly owned Irish subsidiary, Avadel Pharmaceuticals plc, effective January 1, 2017, with…
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)…
M Pharmaceutical Enters Into Exclusive Negotiations to Acquire 40J’s
M Pharmaceutical Inc. recently announced it has executed on a Letter of Intent to acquire the assets of Cincinnati-based private research and development partnership 40J’s…
MyoKardia Announces Advancement to Next Phase of Global Collaboration With Sanofi
MyoKardia, Inc. recently announced that Sanofi has notified the company it has elected to continue the global cardiomyopathy research collaboration formed in August 2014. The…
Dalton Enters Into Agreement With USAMMDA in Support of US Army’s Drug Development Program
Dalton Pharma Services, a privately owned pharmaceutical services provider, recently announced that it has entered into a contract service agreement with the United States Army…
UroGen Pharma Announces FDA Acceptance of Investigational New Drug Application
UroGen Pharma Ltd. recently announced the acceptance of its Investigational New Drug (IND) application by the US FDA for MitoGel for the treatment of low-grade…
H&T Presspart & Cohero Health Launch First Market-Ready, Fully Connected MDI
H&T Presspart and Cohero Health have recently launched the first market-ready, intuitive, fully embedded and connected metered dose inhaler (eMDI) aimed at improving adherence and…
