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 26, 2020
Product Development

Feb. 25 Quick Takes: Vanda’s Phase III miss; plus Iovance; 1st-twoXAR; app for AFib, stroke; ICER-Aetion; new-look Purple Book, and more

Vanda’s itch therapy misses in atopic dermatitis   Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares tumbled after market close Tuesday after tradipitant missed the primary endpoint in the Phase III EPIONE trial to treat atopic dermatitis in...
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

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
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...
BioCentury | Feb 15, 2020
Management Tracks

Immunomedics names Itri CMO; plus Hua, GenMark, AAM, Vividion, Sophia Genetics, Enterprise, Encoded, Palleon and more

Antibody-drug conjugate company Immunomedics Inc. (NASDAQ:IMMU) hired Loretta Itri as CMO. She was EVP of global health sciences and regulatory affairs at The Medicines Co. (NASDAQ:MDCO). Shanghai-based diabetes company Hua Medicine Ltd. (HKEX:2552) hired Fuxing...
BioCentury | Feb 14, 2020
Regulation

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...
BioCentury | Feb 13, 2020
Product Development

COVID-19 update: Gilead ramping up remdesivir production; Codagenix partners with vaccine giant

Gilead is ramping up manufacturing of remdesivir, which is being tested as a potential treatment for COVID-19, the company told BioCentury Thursday. Gilead said it has not been in contact with BrightGene, a Chinese company...
BioCentury | Feb 12, 2020
Finance

AurorA debuts to back early-stage European biotechs

A new Europe-focused investment vehicle has launched with €10 million in backing from two Italian biopharmas. AurorA Science will be managed by AurorA-TT, a tech transfer company founded in 2017 and led by co-founder, Chairman...
BioCentury | Feb 12, 2020
Politics, Policy & Law

When single-payer systems adopt innovation better than U.S. commercial payers

It is a truth universally acknowledged, to borrow from Jane Austen, that a single-payer system will say “no” to new technology. If they accept it at all, they do so only when the prices are...
Items per page:
1 - 10 of 10310
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 26, 2020
Product Development

Feb. 25 Quick Takes: Vanda’s Phase III miss; plus Iovance; 1st-twoXAR; app for AFib, stroke; ICER-Aetion; new-look Purple Book, and more

Vanda’s itch therapy misses in atopic dermatitis   Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares tumbled after market close Tuesday after tradipitant missed the primary endpoint in the Phase III EPIONE trial to treat atopic dermatitis in...
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

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
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...
BioCentury | Feb 15, 2020
Management Tracks

Immunomedics names Itri CMO; plus Hua, GenMark, AAM, Vividion, Sophia Genetics, Enterprise, Encoded, Palleon and more

Antibody-drug conjugate company Immunomedics Inc. (NASDAQ:IMMU) hired Loretta Itri as CMO. She was EVP of global health sciences and regulatory affairs at The Medicines Co. (NASDAQ:MDCO). Shanghai-based diabetes company Hua Medicine Ltd. (HKEX:2552) hired Fuxing...
BioCentury | Feb 14, 2020
Regulation

Controversy over stretching expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes. FDA’s expanded access, or compassionate use,...
BioCentury | Feb 13, 2020
Product Development

COVID-19 update: Gilead ramping up remdesivir production; Codagenix partners with vaccine giant

Gilead is ramping up manufacturing of remdesivir, which is being tested as a potential treatment for COVID-19, the company told BioCentury Thursday. Gilead said it has not been in contact with BrightGene, a Chinese company...
BioCentury | Feb 12, 2020
Finance

AurorA debuts to back early-stage European biotechs

A new Europe-focused investment vehicle has launched with €10 million in backing from two Italian biopharmas. AurorA Science will be managed by AurorA-TT, a tech transfer company founded in 2017 and led by co-founder, Chairman...
BioCentury | Feb 12, 2020
Politics, Policy & Law

When single-payer systems adopt innovation better than U.S. commercial payers

It is a truth universally acknowledged, to borrow from Jane Austen, that a single-payer system will say “no” to new technology. If they accept it at all, they do so only when the prices are...
Items per page:
1 - 10 of 10310