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Latest From Boehringer Ingelheim GmbH
PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.
Viking Plans To Go Directly To Phase III With Obesity Drug
In its Q2 earnings call, the biotech expressed optimism about developing VK2735 as a monthly injection, with an oral version moving into Phase II. An EOP2 meeting for its MASH drug is expected in Q4.
Slimmer, Faster: Roche Aims To Speed Its Obesity Pill To Market
Roche is taking a more hard-nosed approach to portfolio prioritization, and said in its Q2 call that it believes it can move faster with a more slimmed down R&D pipeline.
Pfizer’s Hemophilia A Gene Therapy Superior To Prophylaxis In Phase III
The company’s giroctocogene fitelparvovec, partnered with Sangamo, could compete with BioMarin’s hemophilia A gene therapy Roctavian, but longer-term data may be needed.
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- Abexxa Biologics Inc
- AMAL Therapeutics SA
- ICD Therapeutics
- NBE Therapeutics AG
- SSP Co., Ltd.
- Vira Therapeutics GmbH (Vira T)
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