Biotech Archives - Page 718 of 795

1 minute read

IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy in (Neo)Adjuvant Uveal Melanoma

September 6, 6:04 AM

- Investigator Sponsored Trial sites in Australia include St. Vincent's Hospital, Sydney, Alfred Health, Melbourne, and the Royal Victorian Eye and Ear Hospital, Melbourne - Preliminary signals of clinical activity

IDYA

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SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

By Bill Haddad

September 6, 6:01 AM

Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, announced that the Chilean Public Health Institute (Instituto de Salud

SVA

2 minute read

Recap Of Friday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

September 2, 5:32 PM

The U.S. Food and Drug Administration (FDA) has approved expanded use of Vertex’s (NASDAQ:VRTX) lead asset ORKAMBI (lumacaftor/ivacaftor) to…

IMRX

1 minute read

AstraZeneca Says FDA Approved Durvalumab In Combination With Gemcitabine And Cisplatin For Adult Patients With Locally Advanced Or Metastatic BTC

By Benzinga Newsdesk

September 2, 2:19 PM

- Reuters

AZN

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White House May Ask For $25B Emergency Funding For COVID-19, Monkeypox

By Vandana Singh

September 2, 1:50 PM

The White House is seeking $44.5 billion in emergency funding from Congress for Covid-19 and monkeypox and back…

AZN

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Vertex Pharma’s Flagship Cystic Fibrosis Drug Scores FDA Approval For Infants

By Vandana Singh

September 2, 1:45 PM

The FDA has approved Vertex Pharmaceuticals Incorporated’s (NASDAQ:VRTX) Orkambi (lumacaftor/ivacaftor) for expanded use to include children with cystic fibrosis (CF) ages…

VRTX

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Raymond James Initiates AnaptysBio With ~42% Upside, Despite Trial Setback

By Vandana Singh

September 2, 1:41 PM

Raymond James initiated coverage on AnaptysBio Inc (NASDAQ:ANAB) with an Outperform rating and a $35 price target. The analyst has a positive…

ANAB

1 minute read

Amylyx Pharmaceuticals Announces Posting Of Briefing Documents For Second FDA Advisory Committee Meeting On AMX0035

By Benzinga Newsdesk

September 2, 12:17 PM

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx or the "Company") today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central

AMLX

2 minute read

FDA
News

FDA Briefing Document On Amylyx Pharmaceuticals’ AMX0035 Says ‘it does not appear that this data can be considered independent confirmatory evidence as it uses the same data as the primary analysis.’

By Bill Haddad

September 2, 12:04 PM

FDA Position: This post hoc analysis is highly correlated with the primary analysis. Both change from baseline slope and pre-study slope were used in the primary analysis; thus, this is not independent data. Therefore,

AMLX

1 minute read

FDA
News

FDA Briefing Document For Amylyx Pharmaceuticals’ AMX0035 (Full document)

By Bill Haddad

September 2, 12:02 PM

https://www.fda.gov/media/161378/download

AMLX