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The Latest Breaking News from FDA

HeartBeam, Triple Ring To Co-Develop Telehealth Solution Device For Heart Attack Monitoring

HeartBeam Inc (NASDAQ:BEAT) has signed a professional services agreement with Triple Ring Technologies Inc to assist in the design and development of its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring. The joint partnership is a five-phase expedited device development project scheduled to be completed…

Benzinga

Tiziana Life Shares Rise On Encouraging Data From Intranasal Foralumab In Multiple Sclerosis Patient

Tiziana Life Sciences Ltd (NASDAQ:TLSA) has reported clinical data in a patient with Secondary Progressive Multiple Sclerosis (SPMS) following six months of treatment with intranasally administered foralumab. In addition to being well-tolerated, both biological and clinical improvements were seen in the patient using Tiziana's immunotherapy technology, which overcame the challenge of delivering foralumab…

Benzinga

The FDA-approved, Kiwi-owned, PCR test technology the Health Ministry wouldn’t even look at

Newsroom is an independent, New Zealand-based news and current affairs site.

Newsroom.co.nz

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Medical Device Maker Merit Medical Mulls Sale: Reuters

Merit Medical Systems Inc (NASDAQ:MMSI) is exploring options that include an outright sale to a private equity firm, Reuters reported citing people familiar with the matter. The U.S. medical device manufacturer has an enterprise value of approximately $3.9 billion. The sources said that Merit Medical is working with an investment bank and…

Benzinga

FDA Backs Immutep's Eftilagimod Registrational Trial In Metastatic Breast Cancer

Immutep Limited (NASDAQ: IMMP) has

Benzinga

Intellia's CRISPR-Engineered Cell Therapy Receives FDA Orphan Drug Tag For Bone Marrow Cancer

Intellia Therapeutics Inc's (NASDAQ: NTLA) CRISPR-powered T cell therapy has

Benzinga

Truist Sees 350% Upside On This Cancer-Focused Biopharma Stock - Read Why

Truist has initiated coverage on Verastem Oncology Inc (NASDAQ:VSTM) with a Buy rating and $6.00 price target, equivalent to approximately 350% upside. Analyst Srikripa Devarakonda notes that trading at about 2-times cash, the stock is "undervalued" given its programs in two cancers. Devarakonda adds that the Verastem base case is supported by a…

Benzinga

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Amryt Pharma's Q4 FY21 Sales, FY22 Guidance Shy Of Street Consensus

Amryt Pharma Plc's (NASDAQ:AMYT) Q4 FY21 sales increased 29% Y/Y to $54.8 million, missing the consensus of $56.81 million. The growth was driven by metreleptin revenues that increased 44% to $31.9 million. Cash of $113 million at December 31, 2021 (2020: $118.8M) The Company reported a wider operating loss of $(50.5) million…

Benzinga

Renalytix Launches National Physician Access To KidneyIntelX Platform

Renalytix plc (NASDAQ:RNLX) has launched its new provider access portal, myIntelX, to provide nationwide online access for physicians to order KidneyIntelX bioprognostic testing. KidneyIntelX enables early-stage diabetic kidney disease (DKD) progression risk assessment by combining diverse data inputs, including blood-based biomarkers and personalized health data. It employs a proprietary algorithm to generate a…

Benzinga

Wednesdays With Wedbush: 3 Smid-Cap Biotech Stock Picks

Since the coronavirus pandemic began in early 2020, the FDA's plate has been full with reviews of COVID-19 vaccines and treatments. That has put the approval of many other drugs and therapies on the back burner.

Benzinga

Enforcing Abortion Bans Is Much Harder Than Passing Them

The experience in Texas shows that workarounds pose daunting obstacles to such laws.

Reason

Former Moderna Vice President Joins Psychedelics Company In Phase 3 Trials For Ecstasy

Michael Mullette, a former Moderna (NASDAQ:MNRA) vice president is taking a senior leadership position in the MAPS Public Benefit Corporation, a biotech company in the psychedelics sector. The MAPS PCB is a for-profit company wholly owned by the Multidisciplinary Association for Psychedelic Studies, a nonprofit founded in 1986 to advance patient…

Benzinga

This Microcap Pharma Stock Almost Doubled Today - Read Why

UnitedHealthcare has added Kala Pharmaceuticals Inc's (NASDAQ:KALA) Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022. Eysuvis now has coverage for approximately 118 million lives or 70% of all commercial lives. Kala also announced that Cigna Medicare had added Eysuvis as a preferred brand effective…

Benzinga

Congress Seems Poised To Let the FDA Ban E-Cigarettes Containing Synthetic Nicotine

A spending bill provision would redefine "tobacco products" to include products that have nothing to do with tobacco.

Reason

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Benzinga

Read Why Valneva's Stock Gained 7% Today

Valneva SE (NASDAQ:VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop. The removal of two subjects from the analysis increased the proportion of participants with protective…

Benzinga

Why Owlet Shares Are Trading Lower Today

Owlet Inc (NYSE:OWLT) reported FY21 sales of 75.8 million, just 0.6% higher than the $75.4 million reported a year ago. The Company noted that through the first three quarters of 2021, revenues were $78.4 million, up 44% Y/Y, but early in Q4 FY21, Owlet received an FDA Warning Letter, resulting in halting sales…

Benzinga

The Daily Biotech Pulse: Moderna Outlines Steps For mRNA Tech Advancement, Voyager-Novartis Strike Licensing Deal, Valneva Reports Positive Chikungunya Shot Readout

Here's a roundup of top developments in the biotech space over the last 24 hours:

Reason

Can the FDA's New Commissioner Save the Agency From Itself?

Robert Califf must demand transparency and accountability from the bureaucrats.

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Benzinga

FDA Gives Green Signal To Inventiva's Mid-Stage Lanifibranor Study In NASH Patients

The FDA has completed a safety review of Inventiva SA's (NASDAQ: IVA) IND application and

Benzinga

FDA Approves Axonics' Recharge-Free Sacral Neuromodulation System

The

The Hindu

Gene-edited beef cattle get regulatory clearance in U.S.

Meat from gene-edited cattle could be on the way in a few years

Benzinga

Lung-Disease Focused AN2 Therapeutics Files Plans For NASDAQ Debut

AN2 Therapeutics Inc filed plans on Friday to go public in an initial public offering in which it reportedly hopes to raise about $75 million. AN2 plans to list on the Nasdaq with the symbol of ANTX. The Menlo Park-based biotech is developing a therapy for non-tuberculous mycobacterial (NTM) lung disease, which…

Benzinga

LAVA Therapeutics Shares Interim LAVA-051 Data From Early-Stage Cancer Trial

LAVA Therapeutics NV (NASDAQ:LVTX) announced initial data from its first clinical study with LAVA-051. The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a trial, along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207. The first three dose-escalation cohorts showed LAVA-051 to be safe and…

Benzinga

Why Alpine Immune's Shares Are Falling Today

The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies. The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. The participant had choroidal melanoma previously treated with nivolumab and…

Benzinga

NOVN: A Banner Year for Novan - 2021 Results

By John Vandermosten, CFA NASDAQ:NOVN READ THE FULL NOVN RESEARCH REPORT

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