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Boehringer Ingelheim GmbH

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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.

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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.

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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.

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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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Company Information

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  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Abexxa Biologics Inc
    • AMAL Therapeutics SA
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    • SSP Co., Ltd.
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