EuroBiotech Report: EMA disruption, Bristol-Myers, Erytech pulls filing, Stallergenes-Stanford and Grünenthal

europeGOOD
GlaxoSmithKline, Bristol-Myers Squibb and Erytech were in the news this week.

Welcome to the latest edition of our weekly EuroBiotech Report. GlaxoSmithKline CEO Andrew Witty discussed biopharma industry unease with the United Kingdom’s slow move toward the European Union exit door this week. Witty is particularly concerned about the “tremendous disruption” Brexit could cause at Europe’s regulator. Bristol-Myers Squibb struck a deal with Enterome to add microbiome know-how to its immuno-oncology operation. Erytech withdrew a marketing application after the regulator demanded more data. Stallergenes Greer teamed with Stanford University to look for biomarkers of peanut oral immunotherapy efficacy. Grünenthal bought Thar Pharmaceuticals for its Phase III-ready complex regional pain syndrome candidate. And more. Nick Taylor

1. Witty warns of ‘tremendous disruption’ if EMA exits London

GlaxoSmithKline CEO Andrew Witty has said moving the European Medicines Agency (EMA) from London will cause “tremendous disruption.” Witty is worried moving EMA and its 900 staff members from London to another European city post-Brexit will cause upheaval that affects the smooth running of the regulatory machinery.

2. Bristol-Myers, Enterome pen microbiome I/O research pact

Bristol-Myers Squibb has teamed with Enterome to discover microbiome-derived biomarkers, drug targets and bioactive molecules relevant to its immuno-oncology operation. The alliance positions Bristol-Myers to try to harness the potentially modulating effect of the gut microbiome on cancer immunotherapies.

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

3. Erytech pulls ALL filing after CHMP demands more data

Erytech has withdrawn an application for approval of its tumor starvation drug in Europe after the regulator demanded more data. Generating the data and preparing a fresh submission in acute lymphoblastic leukemia will take until the middle of next year, a delay that prompted investors to drive down Erytech’s stock price by more than 20%.

4. Stallergenes, Stanford pen allergy immunotherapy pact

Stallergenes Greer and Stanford University have teamed up to look for biomarkers of peanut oral immunotherapy efficacy. The transatlantic biopharma is working with a research center bankrolled by Napster founder Sean Parker to figure out which patients are likely to respond to oral immunotherapies against peanut allergies.

5. Grünenthal buys Thar to expand late-phase pain pipeline

Grünenthal has bought Thar Pharmaceuticals to add another complex regional pain syndrome (CRPS) candidate to its late-phase pipeline. The takeover means Grünenthal now owns two of the leading pipeline prospects in CRPS, a recently minted orphan disease for which no drugs are approved in the U.S. or Europe.

And more articles of note>>

Suggested Articles

NASH leaders weigh in on the need for a drug for the disease and the challenges in getting it to patients.

The $210 million fund began life by leading a $17 million series A round in Quellis Biosciences.

The nine-story building will house Amgen’s Bay Area employees when it opens early in 2022.