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J.P. Morgan Notebook Day 4: CRISPR's Not Worried; Theratechnologies' HIV Niche; And Is Moderna's IPO Coming Soon?

 
• By Mandy Jackson, Jessica Merrill, and Emily Hayes

Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference: Alder's Options for CGRP drug; CRISPR's not worried about Cas9 controversy; Theratechnologies seeks more HIV niche products; Moderna is shaping up to have a big 2018; TG Therapeutics and Immunomedics milestones ahead.

San Francisco Street view

Alder BioPharmaceuticals Inc. was talking to potential partners at J.P. Morgan for its calcitonin gene-related peptide (CGRP) drug eptinezumab, which has shown promising efficacy in Phase III clinical trials. The company released positive Phase III data on the migraine treatment during the conference, which ran Jan. 8-11 in San Francisco, showing 15% of patients treated with the drug experienced a 100% response for three months following a single intravenous infusion; 61% achieved a 50% reduction in migraine days or greater from baseline.

The company is still awaiting some additional data readouts from the four studies that make up the clinical program for...

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Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

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Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 
• By Neena Brizmohun

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.