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GLOBAL FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.

-10 Notable Drug Delivery & Formulation Approvals of 2015
-10 Notable Drug Delivery & Formulation-Related Transactions of 2015
-10 Notable Drug-Device Approvals of 2015
-10 Notable Fixed-Dose Combination Drug Approvals of 2015
-Drug Delivery


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The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past year. We thought it would be intriguing to hear what some of your colleagues said surprised them most.
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
Roelof Rongen, MBA, MS, indicates drugs for serious fungal and microbial infections currently require IV administration at doses associated with significant toxicity. Orally administered, encochleated formulations of a broad-spectrum of fungicidal and anti-microbial medications may provide delivery of anti-infective drugs at therapeutic levels while minimizing drug-associated side effects.
Jeffrey Bacha, Chairman & CEO of DelMar Pharmaceuticals, discusses his company’s unique approach to developing VAL-083, the challenges in working within cancer indications associated with low survival, and the importance of strategic collaborations with universities and organizations to further develop its technology.
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.
Joseph S. Dillon, PhD, MBA, and Lainie Mulvanny discuss the transformation of CNTs into a unique composition of matter, marking a complete departure from the dirty, tangled micron bundles of CNTs that frustrated medical researchers for years.
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
Ronald Aung-Din, MD, reports topical CBD is beneficial in treating symptoms of a number of neuropathic and psychiatric conditions. Individual clinical response varied depending on condition treated and on severity and longevity of symptoms, and overall, topical CBD therapy was well tolerated.
Tom Johnson says on the surface, rights management protection may look like another expense and another system to maintain, and while that may be true, it is a critical security component that delivers rapid and significant return on investment.
Ian Fotheringham, PhD, and Mathew Upton, PhD, report that Infections caused by antibiotic resistant bacteria are an ever-increasing threat to public health, creating an urgent, growing demand for the identification and development of new therapies.
Exclusive Online Content
AMRI Licenses CRISPR-Cas9 Gene Editing Technology AMRI Licenses CRISPR-Cas9 Gene Editing Technology
AMRI recently announced that it entered into a non-exclusive commercial license agreement with the Broad Institute of MIT and Harvard for the use of CRISPR-Cas9 gene editing technology and has completed several projects for its customers. The company will continue to use the technology to enhance its drug discovery service offerings and internal research and development. Financial terms were not disclosed.

Cell Medica & University College London Collaborate to Develop Modified T Cell Receptor Products for the Treatment of Cancer Cell Medica & University College London Collaborate to Develop Modified T Cell Receptor Products for the Treatment of Cancer
Cell Medica announces new research collaboration with UCL (University College London), which will see the company utilize UCL’s novel T cell receptor (TCR) technology to generate leading-edge modified TCR products for the treatment of cancer.

ACG ACPL Becomes the First Empty Hard Capsule Manufacturer in Asia to Receive EXCiPACT™ CertificationACG ACPL Becomes the First Empty Hard Capsule Manufacturer in Asia to Receive EXCiPACT™ Certification
ACG Worldwide is pleased to announce that ACG Associated Capsules Pvt. Ltd. (ACG ACPL) has received EXCiPACT™ certification for its plant at Dahanu - Maharashtra, India. ACG ACPL is the first empty hard capsule manufacturing company in Asia to receive EXCiPACT™ certification.

Cystic Fibrosis Therapies Will Push Vertex Ahead of GSK in $46.6-Billion Respiratory MarketCystic Fibrosis Therapies Will Push Vertex Ahead of GSK in $46.6-Billion Respiratory Market
The market size for respiratory therapeutics, covering asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and cystic fibrosis, is expected to rise considerably from $28.1 billion in 2015 to $46.6 billion by 2022, at a compound annual growth rate (CAGR) of 7.5%, according to business intelligence provider GBI Research.

Novel Lipid-Altering Therapies Will Steer ACS Market Beyond $12 Billion Novel Lipid-Altering Therapies Will Steer ACS Market Beyond $12 Billion
The launch of several new lipid-targeting therapies that offer clinical effectiveness for statin-intolerant patients and patients who require additional lowering of low-density lipoprotein C (LDL-C) in combination to statin therapy, will drive the ACS market, according to research and consulting firm GlobalData.

Top Three Therapy Areas Account for 68% of Overall Pharmaceutical Industry Pipeline Top Three Therapy Areas Account for 68% of Overall Pharmaceutical Industry Pipeline
The top three therapy areas – namely oncology, infectious diseases, and central nervous system (CNS) disorders – accounted for a combined 68% of the overall pharmaceutical industry pipeline as of Q1 2016, according to business intelligence provider GBI Research.

Mayne Pharma Receives FDA Approval; Acquires Portfolio From Teva & AllerganMayne Pharma Receives FDA Approval; Acquires Portfolio From Teva & Allergan
Mayne Pharma Inc. has received approval from the US FDA to market dofetilide capsules, a generic alternative to Tikosyn, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.......

MilliporeSigma Expands Excipients Portfolio, Adding Polymers for Sustained Release InjectablesMilliporeSigma Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables
MilliporeSigma has entered into an agreement with PCAS S.A. (Longjumeau, France) to expand MilliporeSigma's excipients portfolio. Under the agreement, MilliporeSigma will be the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers.

West’s SmartDose(®) Drug Delivery Technology Platform Selected by Amgen for Pushtronex™ SystemWest’s SmartDose(®) Drug Delivery Technology Platform Selected by Amgen for Pushtronex™ System
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, recently announced that the U.S. Food and Drug Administration (FDA) has approved the first combination product that incorporates its SmartDose® technology for use in the United States.

Catalent to Commercially Supply Palatin Technologies’ New Bremelanotide FSD Product in Pen InjectorsCatalent to Commercially Supply Palatin Technologies’ New Bremelanotide FSD Product in Pen Injectors
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has reached a commercial supply agreement with Palatin Technologies, Inc., to support the global commercial product launch of Palatin’s bremelanotide pen injector product, which is used to treat female sexual dysfunction (FSD).
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