Biotech Archives - Page 775 of 795

3 minute read

SCYNEXIS Highlights Presentation Of Data From Phase 3 CANDLE Nested Sub-Study

July 19, 8:38 AM

Data show that 71% of 24 patients with recurrent vulvovaginal candidiasis (RVVC) who failed to respond to a three-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs

SCYX

9 minute read

FDA
News

Novavax Announces Expanded Agreement With SK Bioscience To Manufacture Covid-19 Vaccine Containing Omicron Variant And Manufacture The Novavax Covid-19 Vaccine In Prefilled Syringes

By Benzinga Newsdesk

July 19, 8:36 AM

Novavax Announces Expanded Agreement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes GAITHERSBURG, Md., July 19,

NVAX

2 minute read

PharmaCyte Biotech Reports Interim Results in Malignant Ascites Mouse Model Study

By Bill Haddad

July 19, 8:33 AM

PharmaCyte Biotech, Inc. (NASDAQ:PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its signature live-cell encapsulation technology,

PMCB

1 minute read

Apellis Shares Climb As FDA Accepts Geographic Atrophy Candidate Submission Under Priority Review

By Ragothaman Srinivasan

July 19, 8:22 AM

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan. The regulatory agency has assigned target action date of November 26, 2022.

APLS

2 minute read

Allena Pharmaceuticals Announces Completion Of Enrollment Of Cohorts A And B Of ALLN-346 Phase 2a Study 202 In Patients With Gout And Stages 2 And 3 Chronic Kidney Disease

By Benzinga Newsdesk

July 19, 8:01 AM

Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class,

ALNA

1 minute read

Avadel Secures FDA Tentative Approval For Excessive Daytime Sleepiness (EDS) Candidate

By Ragothaman Srinivasan

July 19, 7:59 AM

The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

AVDL

1 minute read

Johnson & Johnson Cuts Annual Profit Outlook, Pharma Unit Cushions Fall In Medical Devices

By Vandana Singh

July 19, 7:45 AM

Johnson & Johnson (NYSE:JNJ) has reported Q2 FY22 adjusted earnings of $2.59 per share, up 4.4% Y/Y and slightly ahead…

JNJ

1 minute read

Novartis Posts Mixed Q2 Earnings, Expects Improved Earnings At Sandoz

By Vandana Singh

July 19, 6:06 AM

Novartis AG (NYSE:NVS) has reported a core EPS of $1.56 in Q2 FY22 compared to $1.66 a year ago, beating the…

NVS

3 minute read

AstraZeneca Announced Enhertu Approved in the EU for Patients With HER2-Positive Metastatic Breast Cancer Treated With One or More Prior Anti-HER2-based Regimens

By Charles Gross

July 19, 4:49 AM

Approval broadens indication for AstraZeneca and Daiichi Sankyo's Enhertu across Europe to earlier use in HER2-positive metastatic breast cancer. Based on ground-breaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1).

AZN

2 minute read

Post Mega London Stock Exchange Listing, GSK Spinoff Haleon’s Plunge Brings Valuation Concerns To The Fore

By Bhavik Nair

July 19, 4:06 AM

After GSK (NYSE: GSK) spun off its consumer health division Haleon Plc (LSE: HLN) into a separate entity, shares of the newly listed firm plunged during intraday trade, closing over 6.5% down at GBX 308.4 on the London Stock Exchange on Monday.

GLNCY