Protocols

Roche touts CHMP nod for Hemlibra; Alder raises $200M for migraine drug launch

Roche’s $RHHBY Hemlibra has just scored a positive opinion from CHMP, as it continues to tout the hemophilia drug as a potential blockbuster. The committee, whose recommendations are usually adopted by the European Commission, gave a thumbs up for Hemlibra’s prophylaxis of bleeding episodes in hemophilia A patients with factor VIII inhibitors of all age groups. The expected approval puts additional pressure on Shire, which bet big to establish itself in the hemophilia arena.

→ Migraine drugmaker Alder BioPharmaceuticals $ALDR is offering $200 million in convertible senior notes to fund development and commercialization of its lead drug eptinezumab. Formerly known as ALD403, eptinezumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that plays a key role in migraine progression. The drug is in several Phase III studies, but faces fierce competition. With new cash from this offering, Alder plans to pay for activities leading up to FDA approval along with commercial launch. The senior notes, due 2025, are offered along with a 30-day option to buy up an additional $30 million to cover over-allotments. Alder’s stock price is down over 7% on the news as of mid-morning Monday.

Covance CEO John Ratliff has been elected 2018 chairman of the Association of Clinical Research Organizations. Cynthia Verst, president, clinical operations at IQVIA, was voted in as vice chairman of the group, which lobbies regulators and lawmakers on CROs’ behalf.


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RAPS Convergence 2018

Head of DMPK, Director
Magenta Therapeutics Cambridge, MA
Research Scientist - Disease Biology & Cellular Pharmacology
Recursion Pharmaceuticals Salt Lake City
Sr/Medical Director, Medical Affairs
A Rare Disease Biotech New Brunswick, NJ
VP, Pharmacovigilance
Aeglea BioTherapeutics Austin, TX
Process Scientist/Lead
Tmunity Therapeutics Philadelphia, PA

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