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The Latest Breaking News from FDA

FDA Clears AbbVie's Rinvoq For Moderate To Severe Active Ulcerative Colitis

The FDA approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib) for adults patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from…

Benzinga

80 Biggest Movers From Yesterday

Gainers Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) shares gained 86.7% to close at $0.5150 on Wednesday after the company announced FDA clearance of its IND for SON-1010 for the treatment of advanced solid tumors.

Benzinga

Second COVID-19 booster shot does little to stop omicron, study finds

Israeli health care workers who were boosted with a fourth shot of COVID-19 vaccine at the height of the omicron wave were only marginally more protected against reinfection than their peers who had received three jabs of vaccine, researchers reported Wednesday.

Los Angeles Times

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FDA Lifts Clinical Hold On Aprea's Relapsed/Refractory Blood Cancer Studies

Aprea Therapeutics Inc (NASDAQ: APRE) can resume testing its eprenetapopt after a string of clinical holds on the therapy in August 2021. The Company plans to study the drug in new trials across various myeloid and lymphoid malignancies.

Benzinga

Medtronic's US Trial Of GI Genius Endoscopy Module Reduces Missed Colorectal Polyps By 50%

Medtronic plc (NYSE:MDT) announced final findings from a study that confirmed the effectiveness of the GI Genius intelligent endoscopy module. GI Genius uses AI to aid in detecting colorectal polyps during colonoscopy, potentially helping to prevent colorectal cancer (CRC). The study published in Gastroenterology found that the use of GI Genius in conjunction with…

Benzinga

FDA Removes Clinical Hold On AIM ImmunoTech's Mid-Stage Ampligen Trial In Pancreatic Cancer

The FDA has lifted the clinical hold on AIM ImmunoTech Inc's (NYSE:AIM) investigational new drug (IND) application for a Phase 2 study of Ampligen for locally advanced pancreatic cancer (AMP-270). The AMP-270 clinical trial's primary objective compares the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced…

Benzinga

Adagene Shares Pop After FDA Clears Phase 1b/2 Trial For ADG126/Keytruda Combo Therapy In Solid Tumors

The FDA has cleared Adagene Inc's (NASDAQ:ADAG) Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab). The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors. The ADG126-P001 trial is expected to dose the first patients soon. The trial is…

Benzinga

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Sonnet Shares Surge As FDA Clears Its First Human Trial For Solid Tumor Candidate

The FDA has signed off Sonnet BioTherapeutics Holdings Inc's (NASDAQ:SONN) Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet's Fully Human Albumin Binding (FHAB) technology. Sonnet will initiate its First-in-Human Phase 1 trial in adult oncology patients in Q2 of 2022. The study will establish…

Benzinga

Iovance Receives FDA Allowance For IOV-4001 Study In Two Advanced Cancers

The FDA has signed off Iovance Biotherapeutics Inc's (NASDAQ:IOVA) Investigational New Drug Application (IND) first genetically modified TIL therapy, IOV-4001, for unresectable or metastatic melanoma and stage III or IV non-small-cell lung cancer (NSCLC). IOV-4001 leverages the gene-editing TALEN technology licensed from Cellectis SA (NASDAQ:CLLS). A clinical study of IOV-4001 in patients with metastatic melanoma…

Benzinga

The Daily Biotech Pulse: Pfizer-BioNTech Apply For Authorization Of 3rd Booster Shot, Sanofi-Seagen Strike Cancer Therapy Pact, Iovance Gets Nod For Cancer Study

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

Benzinga

Manufacturing Bottlenecks Hit Launch Of Talis' FDA-Approved COVID-19 Test

Talis Biomedical Corp (NASDAQ: TLIS) said that it had

Benzinga

Pfizer-BioNTech Seek FDA Approval For Second COVID-19 Booster In Elderly Population

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) filed an application with the

Benzinga

Pfizer asks FDA to clear another booster for older adults

Pfizer Inc. said it has asked U.S. regulators for clearance of an additional COVID-19 booster shot for seniors, in a bid to protect vulnerable adults as immunity provided by the first three doses wanes.

Tribune News Service

FDA Recommends At Least 15 years Of Follow-Up For Genome Editing Product Trials

The FDA has outlined new draft guidance on what should be submitted in a clinical trial application and potentially concerning safety issues to track the genome editing products.

Benzinga

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Benzinga

Smart For Life Agrees To Acquire Vitamin & Supplement Company Ceautamed For Undisclosed Sum

Smart For Life Inc (NASDAQ:SMFL) has agreed to acquire the vitamin and supplement company Ceautamed Worldwide LLC and its affiliates, Wellness Watchers Global LLC and Greens First Female LLC. The financial terms of the transaction were not disclosed. Ceautamed, based in Florida, is principally engaged in the development and distribution of nutritional products, including antioxidant…

Benzinga

Psyched: Albert Labs Goes Public, Ex-Moderna Executive Joins MAPS, Novamind and Usona Join For Phase 2 Psilocybin Trial

A new company has entered the public psychedelic markets, with an alternative drug-to-market approach. Using Real World Evidence trials, Albert Labs is expecting to legally provide psilocybin to patients in the UK much earlier than companies working with to get FDA approval.

Benzinga

FDA Issues To Class I Recall To Baxter's Spectrum Infusion Pump

In December 2021, Baxter International Inc (NYSE: BAX) issued an urgent safety communication about an issue with some of its Spectrum infusion pumps.

Benzinga

Solid Biosciences Posts Two-Year Efficacy, Safety Data From Duchenne Gene Therapy Trial

Solid Biosciences Inc (NASDAQ:SLDB) has reported two-year interim efficacy and safety data from the first three patients treated with SGT-001 in the high dose (2E14 vg/kg) cohort as part of IGNITE DMD. Results suggest durable benefit 24-months post-administration of SGT-001 compared to natural history, consistent with results reported at the 12-month and 18-month…

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Benzinga

Immunoprecise, Elektrofi To Pursue Low-Volume Injectable Formulation Of IPA's COVID-19 Antibody Cocktail

Elektrofi and Immunoprecise Antibodies Ltd (NASDAQ:IPA) have collaborated to explore a high-concentration formulation of IPA's COVID-19 antibody cocktail, PolyTope TATX-03. The collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting. The parties anticipate formulating TATX-03E…

Benzinga

FDA Extends Decision Date For Incyte's Ruxolitinib In Vitiligo Skin Disorder

The FDA has extended the review period for Incyte Corporation's (NASDAQ:INCY) supplemental application for ruxolitinib cream (Opzelura) for vitiligo. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18 from April 18. The FDA extended the PDUFA action date to review additional data from the ongoing Phase 3…

Benzinga

Wesana Health One Step Closer To Clinical Trials Of Psilocybin And CBD Based Treatment Of Brain Injury Related MDD

Wesana Health Holdings Inc. (OTCQB:WSNAF) (CSE:WESA) have received a full written response from the Food and Drug Administration regarding their pre-investigational new drug meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of traumatic brain injury related major depressive disorder.

Benzinga

FDA Declines To Approve AstraZeneca's Asthma Treatment For Chronic Nasal Condition

The FDA has declined to approve AstraZeneca Plc's (NASDAQ:AZN) asthma medicine, Fasenra (benralizumab), to treat chronic rhinosinusitis with nasal polyps, a condition characterized by benign growths that cause pain and stuffiness. The FDA has issued a complete response letter following AstraZeneca's application to extend the use of Fasenra and requested additional clinical data…

The Guardian - US

Test to Treat: pharmacists say Biden’s major new Covid initiative won’t work

Program to facilitate access to antivirals will have a limited impact because pharmacists are restricted from prescribing the pills

Chicago Sun-Times

Alzheimer’s patients divided on costly new drug: a ‘magic pill’ or ‘risk I’m willing to take’

Medicare has proposed limiting coverage of Aduhelm. Key groups representing patients and families are pressing to make it more widely available. Among people facing the disease, the outlook is more nuanced.

Benzinga

U.S. Senate Appropriations Committee Directs FDA To Regulate CBD And Study Products On The Market

Under Sec. 741 of Division A(p.120), the U.S. Senate Committee on Appropriations has requested for the U.S.

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