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...
BioCentury | Jan 23, 2020
Regulation

Disparities in FDA decisions on Sarepta DMD therapy raise questions about integrity of review process

Documents released Wednesday by FDA reveal unexplained discrepancies between an August complete response letter for Vyondys 53 golodirsen and December’s surprising accelerated approval of the therapy. The differences between FDA’s skepticism about the development program...
BioCentury | Jan 18, 2020
Product Development

Mapping the path to gene therapy 2.0

A series of incremental but important improvements on the existing gene therapies are starting to address some of the technology’s key limitations. But some argue it will take a major overhaul of manufacturing practices to...
BioCentury | Jan 4, 2020
Finance

All’s well that ends well

Biotech companies across all market cap tiers posted big gains in the fourth quarter of 2019, with median changes ranging from 7-18%. 4Q19 growth was enough to erase prior quarter losses, putting all tiers in...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Jan 1, 2020
Financial News

Fourth quarter rally pushes biotech to strong finish

Biotech indexes rose as much as 33% in 2019 despite gaining little value overall in the year’s first nine months, with a series of clinical catalysts and strong appetite for M&A and licensing deals fueling...
BC Extra | Dec 23, 2019
Company News

Roche’s ex-U.S. deal for Sarepta DMD programs could extend beyond micro-dystrophin gene therapy

After weathering one clinical failure in DMD this fall, Roche broadened its commitment to gene therapy by obtaining ex-U.S. rights to Sarepta’s micro-dystrophin-targeting program in a deal worth more than $1.1 billion up front. Roche...
BC Extra | Dec 16, 2019
Clinical News

Wave crashes on DMD data as investors await Huntington’s readout

Wave’s decision to discontinue its two Duchenne muscular dystrophy programs raised broader investor concerns about the company’s stereopure oligonucleotide platform and sent shares down more than 50% on Monday. Another readout for the platform in...
BC Extra | Dec 13, 2019
Company News

Sarepta wins approval for second exon-skipping DMD therapy after disputing FDA decision

FDA reversed an August decision that rebuffed Sarepta’s Vyondys 53 golodirsen, granting accelerated approval to the therapy to treat Duchenne muscular dystrophy in patients amenable to exon 53 skipping. The decision came as a surprise...
BioCentury | Dec 10, 2019
Finance

Perceptive launches $210M early-stage fund tied to Garabedian’s accelerator Xontogeny

Two and a half years after Perceptive Advisors’ Chris Garabedian launched Xontogeny to foster biotech start-ups’ growth, the firm has created a $210 million fund that will invest in companies the accelerator is nurturing through...
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1 - 10 of 697
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...
BioCentury | Jan 23, 2020
Regulation

Disparities in FDA decisions on Sarepta DMD therapy raise questions about integrity of review process

Documents released Wednesday by FDA reveal unexplained discrepancies between an August complete response letter for Vyondys 53 golodirsen and December’s surprising accelerated approval of the therapy. The differences between FDA’s skepticism about the development program...
BioCentury | Jan 18, 2020
Product Development

Mapping the path to gene therapy 2.0

A series of incremental but important improvements on the existing gene therapies are starting to address some of the technology’s key limitations. But some argue it will take a major overhaul of manufacturing practices to...
BioCentury | Jan 4, 2020
Finance

All’s well that ends well

Biotech companies across all market cap tiers posted big gains in the fourth quarter of 2019, with median changes ranging from 7-18%. 4Q19 growth was enough to erase prior quarter losses, putting all tiers in...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Jan 1, 2020
Financial News

Fourth quarter rally pushes biotech to strong finish

Biotech indexes rose as much as 33% in 2019 despite gaining little value overall in the year’s first nine months, with a series of clinical catalysts and strong appetite for M&A and licensing deals fueling...
BC Extra | Dec 23, 2019
Company News

Roche’s ex-U.S. deal for Sarepta DMD programs could extend beyond micro-dystrophin gene therapy

After weathering one clinical failure in DMD this fall, Roche broadened its commitment to gene therapy by obtaining ex-U.S. rights to Sarepta’s micro-dystrophin-targeting program in a deal worth more than $1.1 billion up front. Roche...
BC Extra | Dec 16, 2019
Clinical News

Wave crashes on DMD data as investors await Huntington’s readout

Wave’s decision to discontinue its two Duchenne muscular dystrophy programs raised broader investor concerns about the company’s stereopure oligonucleotide platform and sent shares down more than 50% on Monday. Another readout for the platform in...
BC Extra | Dec 13, 2019
Company News

Sarepta wins approval for second exon-skipping DMD therapy after disputing FDA decision

FDA reversed an August decision that rebuffed Sarepta’s Vyondys 53 golodirsen, granting accelerated approval to the therapy to treat Duchenne muscular dystrophy in patients amenable to exon 53 skipping. The decision came as a surprise...
BioCentury | Dec 10, 2019
Finance

Perceptive launches $210M early-stage fund tied to Garabedian’s accelerator Xontogeny

Two and a half years after Perceptive Advisors’ Chris Garabedian launched Xontogeny to foster biotech start-ups’ growth, the firm has created a $210 million fund that will invest in companies the accelerator is nurturing through...
Items per page:
1 - 10 of 697