Market News & Trends
Pfenex Receives US FDA Approval for PF708 to Treat Osteoporosis
Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…
Increased Security for Connected Medical Devices to Drive Cybersecurity Market to $143 Billion
The Food and Drug Administration (FDA) recently released a safety communication regarding a set of 11 cybersecurity vulnerabilities, referred to as the URGENT/11, which could…
Sienna Biopharmaceuticals Files 510(k) Submission With FDA
Sienna Biopharmaceuticals, Inc. recently announced the company has filed a Premarket Notification 510(k) submission to the US FDA for SNA-001, a topical pre-treatment to standard…
Stevanato Group Signs License Exclusive Agreement With Haselmeier
Stevanato Group, an Italy-based producer of glass primary packaging and global leader in providing integrated capabilities and solutions for combination products, and Haselmeier, a Switzerland…
MilliporeSigma Becomes the First to Use Acoustic Technology for Cell Therapy Manufacturing
MilliporeSigma recently announced it has acquired FloDesign Sonics, of Wilbraham, MA, developer of a unique acoustic cell processing platform for the industrialization of cell and…
Akcea & Pfizer Announce $250-Million Licensing Agreement for Investigative Therapy
Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Pfizer Inc. recently announced the companies have entered into a worldwide exclusive licensing agreement…
Bormioli Pharma Completes Acquisition of Remy & Geiser
Bormioli Pharma S.p.A. recently announced the successful completion of its acquisition of Remy & Geiser GmbH (R&G), a German company active in the business of…
Streamlining Drug Development Processes Through the Accenture INTIENT Clinical Platform
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….
Gerresheimer Opens US Glass Innovation & Technology Center
Gerresheimer is driving innovation in pharmaceutical glass, primary packaging glass products, technologies, and digitized processes. In the future, highly qualified engineers at the recently opened Gx Glass Innovation and Technology Center will develop….
Cue Biopharma Doses First Patient in Clinical Trial
Cue Biopharma, Inc. recently announced it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of….
VivaLNK Delivers Continuomics Using Wearable Medical Sensors
VivaLNK, a leading provider of connected healthcare solutions, is improving clinical trials with continuomics by using wearable medical sensors for….
Cabaletta Bio Receives IND Clearance From FDA to Initiate First Clinical Trial
Cabaletta Bio, Inc. recently announced it has received clearance of its IND application from the US FDA to initiate a first-in-human clinical trial of…..
Thermo Fisher Scientific Expands API Manufacturing Capabilities
Thermo Fisher Scientific recently announced the expansion of its API manufacturing capabilities following the completion of its previously announced acquisition of an active pharmaceutical ingredient…
Ocugen & CanSinoBIO Enter Strategic Co-Development & Manufacturing Partnership
Ocugen, Inc. has recently entered into a strategic partnership with CanSino Biologics on Ocugen’s gene therapy pipeline product candidates for inherited retinal diseases, which are…
Novel Silica Delivery System Enters Final Preclinical Development Stage
N4 Pharma Plc recently announced results from the company’s latest research study into its novel silica nanoparticle for cancer treatments and vaccines, Nuvec. The work,…
TrakCel Announces Strategic Partnership With WuXi AppTec Advanced Therapies
TrakCel and WuXi AppTec Advanced Therapies recently announced a collaborative agreement designed to accelerate the seamless delivery of advanced therapy treatments to bring an end-to-end…
AGTC & Otonomy Announce Strategic Collaboration to Develop & Commercialize Gene Therapy
Applied Genetic Technologies Corporation and Otonomy, Inc. recently announced they have entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to…
North America Leads in Number of Strategic Pharma Partnerships
From 2014 to the first half (H1) of 2019, there were more than 1,300 separate strategic partnerships and 1,000 licensing agreements made in the global…
Entera Bio Reports Positive Results from a Phase 2 PK/PD Study of Oral PTH
Entera Bio Ltd. recently announced the presentation of positive results from its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its…
Dance Biopharm Presents Phase 2 Clinical Data Highlighting Rapid Effects of Inhaled Human Insulin
Dance Biopharm Holdings, Inc., recently presented data from its Phase 2 clinical study of Dance 501, a novel gentle mist formulation of human insulin administered with its….
