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Latest From AbbVie Inc.
Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA
Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.
Finance Watch: Adlai Nortye Raises $97.5m In IPO, Brings US Total To 18
Public Company Edition: Cancer-focused Adlai Nortye launched a concurrent initial public offering and private placement, while four other drug developers announced or completed SPAC mergers. Also, Sobi grossed $540m in a rights issue and Immunovant followed early data with a $450m FOPO.
Amicus Piggybacks Off Galafold Commercial Infrastructure For Pombiliti + Opfolda Launch
The company anticipates potential sales in excess of $1bn for the late-onset Pompe disease drug by the end of the decade.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.
Company Information
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- Pharmaceuticals
- Other Names / Subsidiaries
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- Luminera
- Mavupharma
- Pharmacyclics, Inc.
- Stemcentrx, Inc.
- Syndesi Therapeutics SA
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