Streetbeat News

Regulatory

EXAS

Exact Sciences plans to present 15 abstracts at the ASCO Annual Meeting 2023, showcasing its approach in multi-cancer early detection (MCED) and the long-term confidence in the prognostic value of the Oncotype DX Breast Recurrence Score.

Portfolio Pulse from Benzinga Newsdesk

May 26, 2023 | 10:59 am

TSLA

Tesla customers have filed over 2,400 complaints about self-acceleration issues and 1,500 complaints about braking problems between 2015 and March 2022, according to leaked data from Tesla's IT system. The data leak also exposed weak data protection within the company, including employee salaries, customer bank details, and CEO Elon Musk's social security number.

Portfolio Pulse from Anan Ashraf

May 26, 2023 | 10:52 am

REGN

Regeneron Pharmaceuticals announced updated data from two Phase 2 expansion dose cohorts of linvoseltamab in patients with relapsed/refractory multiple myeloma, showing a 71% response rate. The LINKER-MM1 trial will form the basis of planned submissions to regulatory authorities, including the FDA, later this year. Regeneron also announced data from three independent cohorts of fianlimab and Libtayo in adults with advanced melanoma, demonstrating clinically meaningful and durable results.

Portfolio Pulse from Vandana Singh

May 26, 2023 | 10:40 am

FXI

MRNA

Moderna has confirmed the incorporation of a legal entity in China, as the company explores opportunities to bring its mRNA platform to the Chinese market.

Portfolio Pulse from Charles Gross

May 26, 2023 | 9:40 am

AZN

EWJ

AstraZeneca's Ultomiris has been approved in Japan as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with neuromyelitis optica spectrum disorder.

Portfolio Pulse from Charles Gross

May 26, 2023 | 8:50 am

BNTX

PFE

VGK

Pfizer and BioNTech have agreed to amend their COVID-19 vaccine contract with the European Union, reducing the number of vaccines the EU must purchase.

Portfolio Pulse from Charles Gross

May 26, 2023 | 8:44 am

NVO

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Novo Nordisk's once-weekly Sogroya (Somapacitan) for growth hormone deficiency in children aged 3 years and above, and adolescents.

Portfolio Pulse from Benzinga Newsdesk

May 26, 2023 | 7:37 am

IPHA

SNY

Innate Pharma announced positive Phase 1/2 safety and preliminary efficacy results for SAR'579/IPH6101, a drug for relapsed/refractory acute myeloid leukemia. The drug, developed by Sanofi, was well tolerated up to doses of 3 mg/kg QW with observed clinical benefits.

Portfolio Pulse from Benzinga Newsdesk

May 26, 2023 | 7:23 am

GILD

The European Medicines Agency's CHMP granted a positive opinion for the use of Gilead Sciences' Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission will review the recommendation.

Portfolio Pulse from Benzinga Newsdesk

May 26, 2023 | 7:16 am

BPTS

Biophytis has filed an application for Early Access Authorisation (EAA) with the French National Authority for Health (HAS) for Sarconeos (BIO101) in the treatment of severe forms of COVID-19. The application was filed through its pharmaceutical partner Intsel Chimos.

Portfolio Pulse from Benzinga Newsdesk

May 26, 2023 | 7:10 am