Streetbeat News

Regulatory

BNTX

BioNTech SE and OncoC4 have announced that the FDA has placed a partial clinical hold on their Phase 3 trial, PRESERVE-003, due to varying results in different NSCLC patient populations. Enrollment of new patients is paused, but current participants will continue treatment.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 7:28 pm

LLY

The FDA announced it will not take action against GLP-1 compounders for certain violations as it reassesses the shortage of Eli Lilly's drug, Tirzepatide, used for weight loss and diabetes treatment.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 7:10 pm

TSLA

U.S. regulators are investigating Tesla's self-driving software after a fatal crash involving a Tesla vehicle. The probe focuses on whether the software adequately prompts drivers to retake control in dangerous situations.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 6:57 pm

ACHC

Acadia Healthcare is under investigation by the Veterans Affairs Department and other federal agencies for potential insurance fraud. The company is accused of holding patients longer than medically necessary to defraud government health insurance programs. Acadia is cooperating with authorities but denies any wrongdoing.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 6:55 pm

GOOGL

A U.S. judge has granted Google's request to temporarily pause an injunction that ordered app store reforms in the Epic Games case. This development is significant for Google as it impacts their app store operations.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 6:49 pm

CTLT

NVO

NVS

SRPT

A coalition of unions and consumer groups is urging the FTC to block Novo Holdings' $16.5 billion acquisition of Catalent Inc., citing concerns over reduced competition in GLP-1 drugs and gene therapies. The acquisition could lead to vertical foreclosure, limiting access for Novo's rivals.

Portfolio Pulse from Vandana Singh

October 18, 2024 | 6:39 pm

GILD

MRK

Gilead Sciences is withdrawing the US accelerated approval for Trodelvy as a bladder cancer treatment after a failed confirmatory trial. The decision, made with the FDA, does not affect other approved uses of Trodelvy. The TROPiCS-04 study did not meet its primary endpoint, impacting Gilead's stock slightly.

Portfolio Pulse from Vandana Singh

October 18, 2024 | 6:34 pm

CVRX

CVRx, Inc. announced that the AMA has accepted new CPT Category I codes for its Barostim therapy, which treats heart failure symptoms. This decision is expected to facilitate reimbursement and broaden patient access, with implementation set for January 1, 2026.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 6:21 pm

ISPR

TLLTF

The cannabis vape industry is focusing on safety, innovation, and consumer engagement. Experts at the Benzinga Cannabis Capital Conference, including Steven Przybyia from Ispire Technology Inc. and Tim Conder from TILT Holdings Inc., discussed the importance of age-gating technology, self-regulation, and continuous innovation to ensure sustainable growth and differentiation in the market.

Portfolio Pulse from Jelena Martinovic

October 18, 2024 | 6:07 pm

VEV

Vicinity Motor Corp shares fell after PricewaterhouseCoopers resigned as its auditor. The company anticipates that the BC Securities Commission will halt trading of its stock by October 21.

Portfolio Pulse from Benzinga Newsdesk

October 18, 2024 | 6:06 pm