BioCentury | Jul 2, 2020
Regulation

Borio, Dolsten say FDA’s COVID-19 vaccine guidance hits mark

FDA has laid the groundwork for robust, randomized, placebo-controlled trials of vaccines for COVID-19, but it will be up to groups such as NIH and Operation Warp Speed to encourage coordination among developers to harmonize...
BioCentury | Jul 2, 2020
Emerging Company Profile

Bolt’s myeloid twist on ADCs charged up with $93.5M series C

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...
BioCentury | Jun 27, 2020
Product Development

BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows

A slew of therapies entered the clinic this week aimed at tamping down the immune system to treat excessive lung inflammation in COVID-19 patients, even as BARDA announced it would no longer fund the class...
BioCentury | Jun 26, 2020
Product Development

Pfizer, BioNTech on track to make hundreds of millions of COVID-19 vaccine doses this year

Pfizer and its partner BioNTech could obtain emergency use authorization for a COVID-19 vaccine as early as October, and expect to be able to produce hundreds of millions of doses in 2020 and a billion...
BioCentury | Jun 24, 2020
Finance

Expect more company creation by BGV with its €105M fourth fund

BioGeneration Ventures is the latest in a string of European early-stage VCs raising upsized funds that give them the ability to commit more capital to portfolio companies and retain larger stakes longer. The firm also...
BioCentury | Jun 23, 2020
Distillery Therapeutics

An HIV vaccine stimulating T cell and antibody responses

DISEASE CATEGORY: Infectious disease INDICATION: HIV/AIDS Adding T cell-stimulating heterologous viral vectors (HVVs) to an adjuvanted, HIV env-based HIV vaccine could improve the prevention of HIV infection. The HVVs comprise a vesicular stomatitis virus vector,...
BioCentury | Jun 23, 2020
Regulation

FDA pilot project aims to provide symptom data to cancer patients

FDA Tuesday launched a pilot version of Project Patient Voice, a website that will give patients and physicians information that isn’t on labels about patient-reported symptoms for cancer drugs. Project Patient Voice will present sponsor-provided...
BioCentury | Jun 20, 2020
Deals

Clinical scorecard for COVID-19: lessons from the first wave of controlled trials

Breaking through the noise of poor-quality clinical studies are the first clear signals of a treatment paradigm for COVID-19, indicating how and when to use the two major therapeutic approaches -- attacking the virus and...
BioCentury | Jun 20, 2020
Politics, Policy & Law

Protecting the world: global access to COVID-19 vaccines

Biopharmaceutical companies and academic scientists around the world have set aside commercial and professional rivalries to collaborate on the development of vaccines to protect against COVID-19. Technologies that have been slowly advancing for a decade...
BioCentury | Jun 19, 2020
Management Tracks

Dubovsky succeeds Fries as Novavax CMO; plus Carl June to head Ziopharm SAB, Dewpoint, FerGene, Cambrex, Adverum, Epsilen and more

Novavax Inc. (NASDAQ:NVAX), which expects Phase I data for its COVID-19 vaccine in July, hired Filip Dubovsky as SVP and CMO. He succeeds CMO Louis Fries, who has retired. Dubovsky was head of clinical engagement...
Items per page:
1 - 10 of 5983
BioCentury | Jul 2, 2020
Regulation

Borio, Dolsten say FDA’s COVID-19 vaccine guidance hits mark

FDA has laid the groundwork for robust, randomized, placebo-controlled trials of vaccines for COVID-19, but it will be up to groups such as NIH and Operation Warp Speed to encourage coordination among developers to harmonize...
BioCentury | Jul 2, 2020
Emerging Company Profile

Bolt’s myeloid twist on ADCs charged up with $93.5M series C

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...
BioCentury | Jun 27, 2020
Product Development

BARDA no longer funding immunomodulators as support for the therapeutic class to treat COVID-19 grows

A slew of therapies entered the clinic this week aimed at tamping down the immune system to treat excessive lung inflammation in COVID-19 patients, even as BARDA announced it would no longer fund the class...
BioCentury | Jun 26, 2020
Product Development

Pfizer, BioNTech on track to make hundreds of millions of COVID-19 vaccine doses this year

Pfizer and its partner BioNTech could obtain emergency use authorization for a COVID-19 vaccine as early as October, and expect to be able to produce hundreds of millions of doses in 2020 and a billion...
BioCentury | Jun 24, 2020
Finance

Expect more company creation by BGV with its €105M fourth fund

BioGeneration Ventures is the latest in a string of European early-stage VCs raising upsized funds that give them the ability to commit more capital to portfolio companies and retain larger stakes longer. The firm also...
BioCentury | Jun 23, 2020
Distillery Therapeutics

An HIV vaccine stimulating T cell and antibody responses

DISEASE CATEGORY: Infectious disease INDICATION: HIV/AIDS Adding T cell-stimulating heterologous viral vectors (HVVs) to an adjuvanted, HIV env-based HIV vaccine could improve the prevention of HIV infection. The HVVs comprise a vesicular stomatitis virus vector,...
BioCentury | Jun 23, 2020
Regulation

FDA pilot project aims to provide symptom data to cancer patients

FDA Tuesday launched a pilot version of Project Patient Voice, a website that will give patients and physicians information that isn’t on labels about patient-reported symptoms for cancer drugs. Project Patient Voice will present sponsor-provided...
BioCentury | Jun 20, 2020
Deals

Clinical scorecard for COVID-19: lessons from the first wave of controlled trials

Breaking through the noise of poor-quality clinical studies are the first clear signals of a treatment paradigm for COVID-19, indicating how and when to use the two major therapeutic approaches -- attacking the virus and...
BioCentury | Jun 20, 2020
Politics, Policy & Law

Protecting the world: global access to COVID-19 vaccines

Biopharmaceutical companies and academic scientists around the world have set aside commercial and professional rivalries to collaborate on the development of vaccines to protect against COVID-19. Technologies that have been slowly advancing for a decade...
BioCentury | Jun 19, 2020
Management Tracks

Dubovsky succeeds Fries as Novavax CMO; plus Carl June to head Ziopharm SAB, Dewpoint, FerGene, Cambrex, Adverum, Epsilen and more

Novavax Inc. (NASDAQ:NVAX), which expects Phase I data for its COVID-19 vaccine in July, hired Filip Dubovsky as SVP and CMO. He succeeds CMO Louis Fries, who has retired. Dubovsky was head of clinical engagement...
Items per page:
1 - 10 of 5983