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January 02, 2018

Today's Rundown

Featured Story

After disappointing 2016, new drug approvals roared back to life in 2017

After a slow 2016, with only 22 new molecular entities, new drug approvals picked back up. Here are the ones that made the grade.

Top Stories

New Year biotech IPO hopefuls gun for $369M

Four biotechs spanning a diverse set of therapy targets are seeking out nearly $400 million in a series of IPOs announced just before the New Year.

Kindler’s Centrexion raises $67M to fund phase 3 pain trial

Centrexion Therapeutics has raised $67 million. The Jeffrey Kindler-helmed biotech will use the cash to move nonopioid pain drug CNTX-4975 into a phase 3 trial in patients with knee osteoarthritis in the coming months.

Israel’s Protalix claims early success with oral anti-TNF candidate

An oral alternative to injectable anti-TNF drugs—a mainstay of inflammatory disease therapy for decades—has shown encouraging activity in a phase 2 trial.

Using an old Merck drug, Menlo hopes to scratch an itch with $98M IPO

Six months after getting off a $50 million series C, late-stage California dermatology biotech Menlo Therapeutics is looking to take advantage of the strong IPO window with a $98 million offering.

Last-ditch efforts fail to stop medical device tax

A tax on medical device sales has come into force after a last-ditch effort to extend the suspension fell short. The failure to stop the progress of the tax means manufacturers will have to report sales to the Internal Revenue Service and pay 2.3% on revenues generated by products covered by the levy.

Could a three-part diabetes drug ease memory loss in Alzheimer’s?

The Alzheimer’s field is littered with drug-development failures, but that isn’t deterring a group of British scientists from looking for hope in an unlikely source: diabetes treatments. The team, from Lancaster University, is reporting that an experimental three-part drug originally developed for use in Type 2 diabetes seems to reverse memory loss in mice.

Mallinckrodt inks $1.2B Sucampo buy, ending rough 2017 on a high note

Mallinckrodt, which has landed in hot water multiple times this year, is diversifying beyond its controversial lead seller.

Enrollment Showcase

Online Graduate Programs Designed for Your Career

Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.

Resources

[Whitepaper] Choosing the Right Solution: Improving the Site Feasibility Process

Selecting the right sites to conduct your clinical trials will determine the success or failure of meeting your enrollment goals.

[Whitepaper] How biopharma companies are bolstering R&D pipelines through deal-making

Sourcing research externally seems to be the preferred path for biopharma companies to strengthen their R&D pipeline.

[Whitepaper] 5 Steps to Managing Quality Globally

Read this guide if you’re a global life sciences company - conducting clinical trials across several countries, or manufacturing and distributing products in multiple regions - to learn five steps to align and improve quality oversight, as well as avoid common mistakes in harmonization initiatives.

[Whitepaper] Growing Regulatory’s Strategic Value: The Value of a Holistic RIM Capability

Read Deloitte Consulting's whitepaper on the value of a holistic RIM capability, covering the potential cost savings and revenue gains from doing RIM right.

[Whitepaper] How Do Sponsors Ensure Quality in Global Clinical Trials?

Global clinical trials are the trend and gaining in popularity, but running a global trial is not a straightforward process. This white paper explores some of the challenges associated with global clinical trials and considerations for ensuring that the collected data comply with the trial's overall objectives.

[Whitepaper] DSM Looks to Challenge Traditional Stent Graft Materials with its Dyneema Purity® Membrane Edit

Discover DSM's Dyneema Purity® membrane, an effective and efficient material to construct stent grafts used in minimally invasive surgeries to treat both cardiovascular and peripheral arterial diseases.

[Webinar] Validating a 7 Day Membrane Filtration Sterility Test using Celsis®

Join us as we discuss how Charles River Celsis® helped Labor L+S AG validate a 7-day membrane filtration sterility test using existing protocols.

[Infographic] Evolution of Flexible Commercial Biologics Manufacturing

Learn how Catalent Biologics is paving the way for flexible biologics development and manufacturing through advanced technologies and fully integrated multi-product facility.

[eBook] Developing Site-specifically Modified ADCs: Using a Chemoenzymatic Approach

Download the eBook to get articles from various Elsevier journals highlighting developments in ADC technology.

[Article] Optimizing titer and use of a specific enzyme for generating a fully processed antibody

Learn how cell development and process scale-up can be optimized for antibodies requiring additional processing.

[Webinar] Within-Subject Clinical Trials: Intro to New Methods & Stat. Models

In this webinar, we will introduce the rapidly-evolving within-subject clinical trial (WSCT) methods for early phase evidence generation that require fewer people, less time, and usually less funding than traditional early phase methods.

Events

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