Featured Articles From The Current Issue
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
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).

Major Players in Type 2 Diabetes Shifting Focus to Pricing to Maintain Market ShareMajor Players in Type 2 Diabetes Shifting Focus to Pricing to Maintain Market Share
The highly mature type 2 diabetes (T2D) market, which is forecast to be valued at $58.7 billion by 2025, will see pharmaceutical companies prioritizing competitive pricing in order to offset the impact of patent expiries ahead of improving existing products, says research and consulting firm GlobalData.

Co-Processed Excipients Benefit Market, Offer OpportunityCo-Processed Excipients Benefit Market, Offer Opportunity
The excipients market is pharmaceutical manufacturing dependent, and the demand for excipients is constantly changing according to the production needs of manufacturers’ business strategies, marketing environments, and consumer demand.

Hearty CAGRs for Global Cardiac Biomarker MarketHearty CAGRs for Global Cardiac Biomarker Market
The global cardiac biomarker market should see excellent growth rates among major regions due to the growing prevalence and incidence rates of cardiac diseases. BCC Research reveals in its new report that the Asia-Pacific (APAC) region, in particular, should see a substantial growth rate percentage well into the teens.

Pharmaceutical Industry Licensing Deals Soared to Record $46.2 Billion in 2015Pharmaceutical Industry Licensing Deals Soared to Record $46.2 Billion in 2015
Licensing deal values in the pharmaceutical industry rose by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi, which struck three licensing deals that totaled nearly $9 billion, according to research and consulting firm GlobalData.

Q&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug CandidatesQ&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug Candidates
At Metrics Contract Services, Dr. Michael DeHart manages all aspects of personnel and operations relating to formulating and manufacturing a client’s pharmaceutical materials for Phase I, II and III clinical trials. In this article, Dr. DeHart discusses how scientific advances are addressing challenges posed by the poor solubility or stability of drug candidates.

Pharmaceutical Companies Increasingly Looking to Innovate High-Risk, First-In-Class Products Pharmaceutical Companies Increasingly Looking to Innovate High-Risk, First-In-Class Products
With the cost of bringing a single novel drug to market estimated to be $2.6 billion in 2015, pharmaceutical companies are increasingly looking towards developing first-in-class treatments to maximize revenue and stay ahead of competition, according to business intelligence provider GBI Research.
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AAPS National Biotechnology Conference
May 16-18
Boston, MA

Cleaning Validation Summit
May 23-24, 2016
Racquet Club of Philadelphia, PA

BIO 2016
June 6-9
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PharmaPack
June 14-15
New York, NY

Controlled Release Society Meeting
July 17-20
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Process Validation Summit
June 27-28, 2016
Racquet Club of Philadelphia, PA

Transdermal Drug Delivery Systems
September 12-13, 2016
Racquet Club of Philadelphia, PA

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October 4-6
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PDA – Universe of Pre-filled Syringes & Injection Devices
October 17-18
Huntington Beach, CA

Pharma Ed's Extractables and Leachables Forum
October 24-25, 2016
Racquet Club of Philadelphia

AAPS Annual Meeting
November 13-17
Denver, CO

 



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