BioCentury | Feb 27, 2020
Product Development

Feb. 26 Quick Takes: Takeda acquires PvP for celiac therapy; plus Lilly, Esperion, Supernus, Moderna, Taiho-Arcus, Twist-Sophia

Takeda gains another celiac candidate via PvP takeout   After PvP Biologics Inc. finished a Phase I trial demonstrating proof of concept of its celiac disease therapy, Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) exercised its...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Feb 22, 2020
Product Development

Regenerative medicine for hearing loss makes quiet progress

While the late-stage programs for hearing loss are designed to protect cells in the inner ear, or help them recover from trauma, a growing number of early-stage therapies is aiming for a more dramatic outcome...
BioCentury | Feb 22, 2020
Product Development

FDA approves Lundbeck's Vyepti, the first CGRP inhibitor for migraine delivered IV

FDA's approval of Vyepti eptinezumab-jjmr from Lundbeck is the first for an IV-delivered CGRP inhibitor for migraine prevention, but the therapy will face competition from established subcutaneous drugs in its class. Already on the market...
BioCentury | Feb 21, 2020
Product Development

Gilead beefing up Corp Dev with new SVP role

Gilead is creating an SVP of corporate development position, a signal to investors that the company is answering the call for increased M&A. According to a posting on several recruitment sites, Gilead Sciences Inc. (NASDAQ:GILD)...
BioCentury | Feb 20, 2020
Finance

With $88M series B, Spruce seeks short path to approval in rare endocrine disorder

Spruce Biosciences hopes two rounds of financing will be enough to deliver pivotal data for its lead program, which takes a non-steroidal approach to treating endocrine disorders such as classic congenital adrenal hyperplasia (CAH). Omega...
BioCentury | Feb 14, 2020
Finance

On heels of reimbursement, Innovent raises $303M to ready Tyvyt rollout

Within one month of its stock reaching an all-time high, Innovent priced its second follow-on offering on the Hong Kong exchange early Thursday, raising HK$2.4 billion ($303.2 million) to expand manufacturing capacity in preparation for...
BioCentury | Feb 11, 2020
Product Development

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...
BioCentury | Feb 5, 2020
Product Development

2019-nCoV drug discovery: HHS funds Regeneron mAbs and BenevolentAI deploys machine learning

Regeneron and BenevolentAI unveiled a deal and a platform, respectively, on Tuesday that could yield therapies against 2019-nCoV that go beyond anti-inflammatory drugs for other viral infections. The first nine clinical trials of medicines for...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
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1 - 10 of 5902
BioCentury | Feb 27, 2020
Product Development

Feb. 26 Quick Takes: Takeda acquires PvP for celiac therapy; plus Lilly, Esperion, Supernus, Moderna, Taiho-Arcus, Twist-Sophia

Takeda gains another celiac candidate via PvP takeout   After PvP Biologics Inc. finished a Phase I trial demonstrating proof of concept of its celiac disease therapy, Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) exercised its...
BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Feb 22, 2020
Product Development

Regenerative medicine for hearing loss makes quiet progress

While the late-stage programs for hearing loss are designed to protect cells in the inner ear, or help them recover from trauma, a growing number of early-stage therapies is aiming for a more dramatic outcome...
BioCentury | Feb 22, 2020
Product Development

FDA approves Lundbeck's Vyepti, the first CGRP inhibitor for migraine delivered IV

FDA's approval of Vyepti eptinezumab-jjmr from Lundbeck is the first for an IV-delivered CGRP inhibitor for migraine prevention, but the therapy will face competition from established subcutaneous drugs in its class. Already on the market...
BioCentury | Feb 21, 2020
Product Development

Gilead beefing up Corp Dev with new SVP role

Gilead is creating an SVP of corporate development position, a signal to investors that the company is answering the call for increased M&A. According to a posting on several recruitment sites, Gilead Sciences Inc. (NASDAQ:GILD)...
BioCentury | Feb 20, 2020
Finance

With $88M series B, Spruce seeks short path to approval in rare endocrine disorder

Spruce Biosciences hopes two rounds of financing will be enough to deliver pivotal data for its lead program, which takes a non-steroidal approach to treating endocrine disorders such as classic congenital adrenal hyperplasia (CAH). Omega...
BioCentury | Feb 14, 2020
Finance

On heels of reimbursement, Innovent raises $303M to ready Tyvyt rollout

Within one month of its stock reaching an all-time high, Innovent priced its second follow-on offering on the Hong Kong exchange early Thursday, raising HK$2.4 billion ($303.2 million) to expand manufacturing capacity in preparation for...
BioCentury | Feb 11, 2020
Product Development

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...
BioCentury | Feb 5, 2020
Product Development

2019-nCoV drug discovery: HHS funds Regeneron mAbs and BenevolentAI deploys machine learning

Regeneron and BenevolentAI unveiled a deal and a platform, respectively, on Tuesday that could yield therapies against 2019-nCoV that go beyond anti-inflammatory drugs for other viral infections. The first nine clinical trials of medicines for...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
Items per page:
1 - 10 of 5902