BioCentury | Feb 18, 2020
Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat...
BC Extra | Dec 21, 2019
Company News

Management Tracks: Ionis promotes co-founder to CSO; Syros adds Celgene vet Alles to board; plus Encoded, Cygnal, Harvard Medical School, Immunitas and more

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said co-founder C. Frank Bennett will become CSO, with Eric Swayze succeeding him as SVP of research. Bennett will remain the antisense oligonucleotide company’s franchise leader for neurology drug discovery. Swayze...
BC Extra | Dec 19, 2019
Company News

PharmaMar deal adds late-stage asset to Jazz’s growing cancer pipeline

Jazz’s deal to gain exclusive, U.S. rights to PharmaMar’s Zepsyre marks the company’s third cancer partnership of the year, adding a late-stage asset in small cell lung cancer as it continues to expand its pipeline...
BC Extra | Dec 12, 2019
Clinical News

PureTech’s Akili reports positive data for depression video game

In a busy week for PureTech affiliates, Akili reported data for its video game-based digital therapeutic to help treat cognitive impairments associated with depression. PureTech Health plc (LSE:PRTC) founded Akili Interactive Labs Inc., which raised...
BC Extra | Dec 4, 2019
Clinical News

Axsome plans Phase III trial for narcolepsy therapy following positive Phase II data

Axsome is readying for a Phase III trial next year of narcolepsy therapy AXS-12 after the candidate met the primary endpoint of a Phase II trial, sending the company's stock up $5.99 (15%) to $45.61...
BC Extra | Nov 16, 2019
Company News

Novartis gains CHMP support in MS, Cushing syndrome

Included November roundup of EMA’s CHMP were a positive opinion for Mayzent siponimod, which Novartis hopes will become the treatment of choice for active secondary progressive multiple sclerosis. CHMP backed an MAA for Mayzent to...
BC Extra | Nov 7, 2019
Financial News

Nov. 6 Financial Quick Takes: NEA backs Shape's series A; plus Royalty-Eisai-Epizyme, Sinomed, Genecast and Cadence

Shape raises $35.5M A round  RNA editing company Shape Therapeutics Inc. raised $35.5 million in a series A round led by New Enterprise Associates, with participation from CureDuchenne Ventures. The company uses guide RNAs to...
BC Extra | Oct 8, 2019
Company News

Management tracks: BioMarin's first chief scientific strategy officer; plus Ascletis, Grail, Aerie and more

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) promoted Lon Cardon to the newly created role of chief scientific strategy officer from CSO. Prior to BioMarin, Cardon was SVP of alternative discovery and development and head of target sciences...
BC Extra | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
BC Extra | Aug 12, 2019
Company News

Aug. 12 Company Quick Takes: Jazz buying Cavion; plus Boehringer, AC Immune, Oncologie

Jazz gains essential tremor asset via Cavion takeout   Jazz Pharmaceuticals plc (NASDAQ:JAZZ) acquired Cavion Inc. for $52.5 million up front and up to $260 million in clinical, regulatory and sales milestones in a deal...
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1 - 10 of 493
BioCentury | Feb 18, 2020
Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat...
BC Extra | Dec 21, 2019
Company News

Management Tracks: Ionis promotes co-founder to CSO; Syros adds Celgene vet Alles to board; plus Encoded, Cygnal, Harvard Medical School, Immunitas and more

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said co-founder C. Frank Bennett will become CSO, with Eric Swayze succeeding him as SVP of research. Bennett will remain the antisense oligonucleotide company’s franchise leader for neurology drug discovery. Swayze...
BC Extra | Dec 19, 2019
Company News

PharmaMar deal adds late-stage asset to Jazz’s growing cancer pipeline

Jazz’s deal to gain exclusive, U.S. rights to PharmaMar’s Zepsyre marks the company’s third cancer partnership of the year, adding a late-stage asset in small cell lung cancer as it continues to expand its pipeline...
BC Extra | Dec 12, 2019
Clinical News

PureTech’s Akili reports positive data for depression video game

In a busy week for PureTech affiliates, Akili reported data for its video game-based digital therapeutic to help treat cognitive impairments associated with depression. PureTech Health plc (LSE:PRTC) founded Akili Interactive Labs Inc., which raised...
BC Extra | Dec 4, 2019
Clinical News

Axsome plans Phase III trial for narcolepsy therapy following positive Phase II data

Axsome is readying for a Phase III trial next year of narcolepsy therapy AXS-12 after the candidate met the primary endpoint of a Phase II trial, sending the company's stock up $5.99 (15%) to $45.61...
BC Extra | Nov 16, 2019
Company News

Novartis gains CHMP support in MS, Cushing syndrome

Included November roundup of EMA’s CHMP were a positive opinion for Mayzent siponimod, which Novartis hopes will become the treatment of choice for active secondary progressive multiple sclerosis. CHMP backed an MAA for Mayzent to...
BC Extra | Nov 7, 2019
Financial News

Nov. 6 Financial Quick Takes: NEA backs Shape's series A; plus Royalty-Eisai-Epizyme, Sinomed, Genecast and Cadence

Shape raises $35.5M A round  RNA editing company Shape Therapeutics Inc. raised $35.5 million in a series A round led by New Enterprise Associates, with participation from CureDuchenne Ventures. The company uses guide RNAs to...
BC Extra | Oct 8, 2019
Company News

Management tracks: BioMarin's first chief scientific strategy officer; plus Ascletis, Grail, Aerie and more

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) promoted Lon Cardon to the newly created role of chief scientific strategy officer from CSO. Prior to BioMarin, Cardon was SVP of alternative discovery and development and head of target sciences...
BC Extra | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
BC Extra | Aug 12, 2019
Company News

Aug. 12 Company Quick Takes: Jazz buying Cavion; plus Boehringer, AC Immune, Oncologie

Jazz gains essential tremor asset via Cavion takeout   Jazz Pharmaceuticals plc (NASDAQ:JAZZ) acquired Cavion Inc. for $52.5 million up front and up to $260 million in clinical, regulatory and sales milestones in a deal...
Items per page:
1 - 10 of 493