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July 26, 2019___

Today's Rundown

Featured Story

J&J's multiple sclerosis prospect beats Sanofi drug in phase 3

A phase 3 trial of Johnson & Johnson’s multiple sclerosis prospect ponesimod has met its primary endpoint. The readout sets J&J up to file for approval this year, boosting its prospects of getting a return on its $30 billion takeover of Actelion.

Top Stories

Editas, Allergan kick off long-awaited in vivo CRISPR trial

Though Editas and Allergan are not the first companies to test a CRISPR-based medicine in humans—that distinction goes to CRISPR Therapeutics and Vertex—their treatment is the first that edits DNA within the body.

FDA delays AdComm for Nektar's pain drug a month ahead of decision deadline

Two months after Nektar Therapeutics handed off its lead pain drug to a new subsidiary, the FDA is postponing an advisory panel meeting for that drug, a mu-opioid agonist designed to relieve pain without triggering euphoria.

NeuroBo backs onto Nasdaq via merger with Gemphire

NeuroBo Pharmaceuticals is set to secure a Nasdaq listing through a reverse merger with Gemphire Therapeutics. The move comes as NeuroBo plans to start a phase 3 trial of nerve growth factor therapy NB-01 in patients with diabetic neuropathic pain.

Italian pharma Zambon takes in Breath Therapeutics through €500M deal

The Italian drugmaker Zambon has bought up Breath Therapeutics, developer of a custom inhaled drug delivery platform, in a deal worth up to €500 million, or about $558.7 million U.S.

EuroBiotech Report—GSK R&D update, Medicxi's €400M fund and Intec fails phase 3

In this week's EuroBiotech Report, GSK provides a pipeline update, Medicxi raises a €400 million fund and Intec flunks a phase 3 test.

FiercePharmaAsia—Samsung's Humira biosim; Celltrion's China JV; GenScript's new facility

Samsung Bioepis won an FDA nod for a Humira biosimilar to be sold by Merck & Co. in the U.S. Celltrion formed a JV to develop three biosimilars for China. GenScript opened a plant as it works on a commercial facility for gene and cell therapy.

Chutes & Ladders—Vertex CMO Kewalramani steps into pharma's exclusive female CEO club

Vertex taps CMO Kewalramani as newest CEO; Verb Surgical brings SurgiQuest founder Azarbarzin on board; Disarm names Enzyvant head Shih to leadership role.

Resources

[Whitepaper] The Truth about Physician Referrals and Clinical Trials

The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process.

[eBook] Small molecules 2.0: the bigger picture

The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry.

[Paid Marketplace] Faster Research. Smarter Bibliographies.

Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery.

[Video] Almac Launches Almac Adapt™ - a New Patient-Centric Supply Solution

Innovative Just in Time Manufacturing solution enables sponsors full late stage customisation of clinical trial materials

[Video] PwC Webcast: Goodbye cost shifting, hello employer activism

How are employer activism strategies beginning to replace the cost-sharing of the past, and improve the health of the workforce?

[Whitepaper] Transforming the future of medical shipments

The combination of SAVSU technology with United Airlines’ global network has made it easier than ever to bring cell and gene therapies to destinations beyond major markets.

[Whitepaper] IoT Technologies & Informatics Integration in Pharmaceuticals

Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies.

[Whitepaper] Managing Demand Uncertainty in Biologics Production

When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. Learn more here.

[Report] NEW Report on 2019 e-Prescribing Regulations and Potential Impact

Patient demand for more information on their care is driving new e-prescribing regulations, and technology is evolving to help providers meet them. This report provides an overview of key areas where such regulation has emerged, and what it could mean for providers and healthcare IT companies.

[Whitepaper] Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Anticipate challenges in formulation early.

[Whitepaper] Managing Comorbidities in Type 2 Diabetes – Real World Evidence for Change

Patients living with diabetes deserve better – Real-World Evidence for effecting/realizing change in the management of type 2 diabetes and cardiovascular/renal comorbidities.

[Case Study] Clinical Supply Management

Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study.

[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

Download the eBook to explore a proactive approach for clinical supply management.

Events