BioCentury | Feb 7, 2020
Product Development

Roche, PTC provide first look at pivotal SMA data in adults

Roche and PTC reported the first pivotal data for a spinal muscular atrophy therapy in adults with established disease on Thursday when they unveiled the detailed data supporting their bid for risdiplam to treat SMA...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BC Extra | Jan 25, 2020
Politics & Policy

Court ruling favors EMA’s transparency policy

The Court of Justice of the European Union has ruled in favor of EMA in response to an appeal by PTC and Merck & Co.’s animal health unit, which were challenging the legality of agency...
BC Extra | Jan 23, 2020
Clinical News

Risdiplam hits again in FIREFISH, setting up oral option for SMA patients

As risdiplam inches closer to the market in spinal muscular atrophy, the oral candidate notched another win, hitting the primary endpoint in the Phase II/III FIREFISH study and setting up a new alternative for SMA...
BC Extra | Nov 26, 2019
Company News

Priority Review roundup: Roche-PTC, Intercept, Zogenix

FDA granted Priority Review to a trio of compounds Monday, accepting NDAs from partners Roche and PTC, as well as Intercept and Zogenix to treat neurological and hepatic diseases. Risdiplam from Roche (SIX:ROG; OTCQX:RHHBY) and...
BC Extra | Nov 12, 2019
Clinical News

Roche oral therapy hits endpoint in older SMA patients, offering advantages over Zolgensma, Spinraza

After reporting positive data earlier this year in infants with spinal muscular atrophy, Roche’s risdiplam has now met the primary endpoint in a separate pivotal trial in older patients, paving the way for the therapy...
BC Extra | Oct 19, 2019
Company News

CHMP backs Merck’s Ebola vaccine, a first

EMA’s CHMP issued its first positive opinion for an Ebola vaccine and backed AbbVie’s rheumatoid arthritis treatment. The agency recommended approving Ervebo (rVSV-ZEBOV) from Merck & Co. Inc. (NYSE:MRK), to prevent infection by the Ebola...
BC Extra | Oct 4, 2019
Politics & Policy

EMA looks to adapt to smaller workforce

While EMA’s staffing losses are in line with projections as it settles into its new Amsterdam headquarters, the agency said it plans to establish task forces to tackle key priorities such as regulatory science and...
BC Innovations | Sep 26, 2019
Emerging Company Profile

Edgewise: breaking away from dystrophin for muscular dystrophy

With a lead compound that staves off use-induced muscle damage, Edgewise thinks it can compete with dystrophin replacement therapies for muscular dystrophy. Edgewise Therapeutics emerged from stealth this month with a $50 million series B...
BC Extra | Sep 18, 2019
Financial News

Sept. 18 Financial Quick Takes: IGM gains in first trading day; plus a follow-on roundup, BenevolentAI, UCSF’s InVent Fund and Versantis

First-day pop for IGM on NASDAQ  Oncology antibody company IGM Biosciences Inc. (NASDAQ:IGMS) gained $8.30 (52%) to $24.30 in its first day of trading after raising $175 million in its IPO. IGM sold 10.9 million...
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1 - 10 of 409
BioCentury | Feb 7, 2020
Product Development

Roche, PTC provide first look at pivotal SMA data in adults

Roche and PTC reported the first pivotal data for a spinal muscular atrophy therapy in adults with established disease on Thursday when they unveiled the detailed data supporting their bid for risdiplam to treat SMA...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BC Extra | Jan 25, 2020
Politics & Policy

Court ruling favors EMA’s transparency policy

The Court of Justice of the European Union has ruled in favor of EMA in response to an appeal by PTC and Merck & Co.’s animal health unit, which were challenging the legality of agency...
BC Extra | Jan 23, 2020
Clinical News

Risdiplam hits again in FIREFISH, setting up oral option for SMA patients

As risdiplam inches closer to the market in spinal muscular atrophy, the oral candidate notched another win, hitting the primary endpoint in the Phase II/III FIREFISH study and setting up a new alternative for SMA...
BC Extra | Nov 26, 2019
Company News

Priority Review roundup: Roche-PTC, Intercept, Zogenix

FDA granted Priority Review to a trio of compounds Monday, accepting NDAs from partners Roche and PTC, as well as Intercept and Zogenix to treat neurological and hepatic diseases. Risdiplam from Roche (SIX:ROG; OTCQX:RHHBY) and...
BC Extra | Nov 12, 2019
Clinical News

Roche oral therapy hits endpoint in older SMA patients, offering advantages over Zolgensma, Spinraza

After reporting positive data earlier this year in infants with spinal muscular atrophy, Roche’s risdiplam has now met the primary endpoint in a separate pivotal trial in older patients, paving the way for the therapy...
BC Extra | Oct 19, 2019
Company News

CHMP backs Merck’s Ebola vaccine, a first

EMA’s CHMP issued its first positive opinion for an Ebola vaccine and backed AbbVie’s rheumatoid arthritis treatment. The agency recommended approving Ervebo (rVSV-ZEBOV) from Merck & Co. Inc. (NYSE:MRK), to prevent infection by the Ebola...
BC Extra | Oct 4, 2019
Politics & Policy

EMA looks to adapt to smaller workforce

While EMA’s staffing losses are in line with projections as it settles into its new Amsterdam headquarters, the agency said it plans to establish task forces to tackle key priorities such as regulatory science and...
BC Innovations | Sep 26, 2019
Emerging Company Profile

Edgewise: breaking away from dystrophin for muscular dystrophy

With a lead compound that staves off use-induced muscle damage, Edgewise thinks it can compete with dystrophin replacement therapies for muscular dystrophy. Edgewise Therapeutics emerged from stealth this month with a $50 million series B...
BC Extra | Sep 18, 2019
Financial News

Sept. 18 Financial Quick Takes: IGM gains in first trading day; plus a follow-on roundup, BenevolentAI, UCSF’s InVent Fund and Versantis

First-day pop for IGM on NASDAQ  Oncology antibody company IGM Biosciences Inc. (NASDAQ:IGMS) gained $8.30 (52%) to $24.30 in its first day of trading after raising $175 million in its IPO. IGM sold 10.9 million...
Items per page:
1 - 10 of 409