BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease  FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
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...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | Apr 15, 2019
Company News

Gelesis' weight loss aid gains U.S. approval

Gelesis said Sunday it received FDA clearance for Plenity (Gelesis100), making the prescription weight loss product available to patients who are ineligible for gastric bypass surgery. Plenity is indicated for use as an aid in...
BC Innovations | Jan 11, 2019
Product R&D

PureTech turns inward

After a 15-year run of spinning out technologies into affiliate companies, PureTech Health plc is stepping away from that model in favor of an internal pipeline to advance its new platforms. Behind the structural shift...
BC Week In Review | Nov 16, 2018
Clinical News

Gelesis submits device application to FDA for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said it submitted a medical device marketing application to FDA over the summer for weight loss product Gelesis100 as an adjunct to a hypocaloric diet and moderate physical activity. The company...
BC Extra | Jun 5, 2018
Company News

Management tracks: Sarepta, Gilead

Neuromuscular disease company Sarepta Therapeutics Inc. (NASDAQ:SRPT) hired Louise Rodino-Klapac as VP of gene therapy at its newly created gene therapy unit. She will continue to serve as acting CSO at Myonexus Therapeutics Inc. (New...
BC Week In Review | Sep 29, 2017
Clinical News

Gelesis reports mixed data for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said lead candidate Gelesis100 met 1 of 2 co-primary endpoints in the pivotal GLOW weight loss trial. COO David Pass told BioCentury the company plans to submit the product for regulatory...
BC Extra | Sep 25, 2017
Clinical News

Gelesis reports mixed data for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said lead candidate Gelesis100 met one of two co-primary endpoints in the pivotal GLOW weight loss trial. COO David Pass told BioCentury the company plans to submit the product for regulatory...
BC Week In Review | Jan 4, 2016
Financial News

Gelesis withdraws IPO

Gelesis Inc. , Boston, Mass.   Business: Endocrine/Metabolic   Date announced: 2015-12-17   Type: IPO   Underwriters: Piper Jaffray; Stifel, Nicolaus; Guggenheim Securities   Note: Gelesis withdrew its IPO on NASDAQ, citing market conditions. Last April,...
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BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease  FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
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...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | Apr 15, 2019
Company News

Gelesis' weight loss aid gains U.S. approval

Gelesis said Sunday it received FDA clearance for Plenity (Gelesis100), making the prescription weight loss product available to patients who are ineligible for gastric bypass surgery. Plenity is indicated for use as an aid in...
BC Innovations | Jan 11, 2019
Product R&D

PureTech turns inward

After a 15-year run of spinning out technologies into affiliate companies, PureTech Health plc is stepping away from that model in favor of an internal pipeline to advance its new platforms. Behind the structural shift...
BC Week In Review | Nov 16, 2018
Clinical News

Gelesis submits device application to FDA for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said it submitted a medical device marketing application to FDA over the summer for weight loss product Gelesis100 as an adjunct to a hypocaloric diet and moderate physical activity. The company...
BC Extra | Jun 5, 2018
Company News

Management tracks: Sarepta, Gilead

Neuromuscular disease company Sarepta Therapeutics Inc. (NASDAQ:SRPT) hired Louise Rodino-Klapac as VP of gene therapy at its newly created gene therapy unit. She will continue to serve as acting CSO at Myonexus Therapeutics Inc. (New...
BC Week In Review | Sep 29, 2017
Clinical News

Gelesis reports mixed data for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said lead candidate Gelesis100 met 1 of 2 co-primary endpoints in the pivotal GLOW weight loss trial. COO David Pass told BioCentury the company plans to submit the product for regulatory...
BC Extra | Sep 25, 2017
Clinical News

Gelesis reports mixed data for hydrogel weight loss product

Gelesis Inc. (Boston, Mass.) said lead candidate Gelesis100 met one of two co-primary endpoints in the pivotal GLOW weight loss trial. COO David Pass told BioCentury the company plans to submit the product for regulatory...
BC Week In Review | Jan 4, 2016
Financial News

Gelesis withdraws IPO

Gelesis Inc. , Boston, Mass.   Business: Endocrine/Metabolic   Date announced: 2015-12-17   Type: IPO   Underwriters: Piper Jaffray; Stifel, Nicolaus; Guggenheim Securities   Note: Gelesis withdrew its IPO on NASDAQ, citing market conditions. Last April,...
Items per page:
1 - 10 of 31