Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

IntelGenx submits response to CRL from FDA for RIZAPORT VersaFilm

IntelGenx (TSX:IGX; OTCQB:IGXT) responded to the complete response letter (CRL) for its 505(b)(2) NDA for RIZAPORT VersaFilm received from the FDA in March 2020. “We have been encouraged by our interactions with...

October 18, 2022

Developments

TIAP and Evotec expand LAB150 BRIDGE partnership to Include Amgen

Toronto Innovation Acceleration Partners (TIAP) and Evotec (NASDAQ:EVO; FSE: EVT) have expanded LAB150, their translational BRIDGE partnership, to include Amgen (NASDAQ:AMGN) as a strategic partner. The expansion...

October 17, 2022

Developments

IntelGenx updates atai collaboration as first-in-human study launched of an oral film psychedelic drug candidate

IntelGenx (TSX:IGX; OTCQB:IGXT) updated its collaboration with strategic partner, atai Life Sciences (NASDAQ:ATAI), which has begun a first-in-human Phase 1 study for the development of novel formulations of...

October 13, 2022

Developments

Sigyn Therapeutics to register ChemoPrep and ChemoPure as trademarks for devices to enhance cancer therapy

Sigyn Therapeutics (OTCQB:SIGY) disclosed that trademark applications to register ChemoPrep and ChemoPure have been filed with the United States Patent and Trademark Office (USPTO). The intent-to-use trademark...

October 13, 2022

Developments

Ripple Therapeutics signs licensing agreement for China with CS Pharmaceuticals

Closely held Ripple Therapeutics signed an exclusive licensing agreement for the Chinese rights to its lead product, IBE-814, with CS Pharmaceuticals, a British-based company focused on the development and...

October 11, 2022

Developments

Oramed unit posts positive preliminary Phase 1 oral COVID-19 vaccine data

Oramed Pharmaceuticals’ (NASDAQ, TASE:ORMP) subsidiary, Oravax Medical, reported positive preliminary data from its Phase 1 trial of an oral COVID-19 vaccine candidate. Oravax Medical is developing oral vaccines that...

October 7, 2022

Developments

FDA clears Boston Cell Standards’ IHControls panel in breast cancer

Closely held Boston Cell Standards received 510(k) clearance from the FDA for its IHControls panel (HER2/ER/PR) for evaluating breast cancers, representing a first-in-category regulatory approval. IHControls are the...

October 6, 2022

Developments

FDA clears Annovis Bio for Phase 2/3 AD study

The FDA approved the development plan and study protocol for Annovis Bio (NYSE:ANVS) to proceed with a Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD). In a statement, Maria...

October 6, 2022

Developments

Sigyn Therapeutics files U.S. patent entitled “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity”

Sigyn Therapeutics (OTCQB:SIGY) filed a provisional patent application entitled, “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity,” with the United States Patent and Trademark Office. Cancer is...

October 6, 2022

Developments

FDA clears Tonix IND in major depressive disorder

The FDA approved Tonix Pharmaceuticals’ (NASDAQ:TNXP) IND application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder...

October 3, 2022

Developments

VoxNeuro, CAF in study to measure training-related sub-concussive exposure

VoxNeuro, a closely-held software-as-a-medical-device (SaMD) brain health company, has partnered with the Canadian Armed Forces (CAF) to study the cognitive effects following intense military training regimens designed...

September 28, 2022

Developments

atai unit initiates Phase 1 trial for MDMA derivative EMP-01

EmpathBio, a unit of atai Life Sciences (NASDAQ:ATAI), received regulatory and ethics approval to begin enrollment of its Phase 1 study of EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment...

September 28, 2022

Developments

SAB Biotherapeutics presents new influenza and COVID-19 data

SAB Biotherapeutics (NASDAQ:SABS) presented new data at the Options for Control of Influenza conference in Belfast, showing its fully-human polyclonal antibody platform maintains its efficacy against multiple variants...

September 28, 2022

Developments

Maxim survey finds two-thirds of respondents planning to attend JMP

A survey of 150 people to a recent Maxim Group survey about the upcoming J.P. Morgan Healthcare Conference found that 69% of respondents are planning to attend the conference in person, while 52% would choose in person...

September 26, 2022

Developments

Profound Medical presents durable and stable positive 4-year trends from TACT pivotal trial

An investigator for Profound Medical (NASDAQ:PROF; TSX:PRN) presented four-year follow-up data from the TACT clinical study with Profound’s TULSA-PRO device that continue to demonstrate durable and stable safety and...

September 26, 2022

Developments

OpSens SavvyWire in first U.S. procedure

Dr. Philippe Genereux, director of the Structural Heart Program at Morristown Medical Center in New Jersey, and his team, performed the first use of OpSens’ (TSX:OPS; OTCQX:OPSSF) SavvyWire in a transcatheter aortic...

September 23, 2022

Developments

Novo Nordisk Foundation investing $200-million for first quantum computer for life sciences research

The Novo Nordisk Foundation has awarded a grant of $200-million to establish the first full-scale quantum computer for the development of new medicines as well as providing new insights into climate change and the green...

September 21, 2022

Developments

MindMed collaborators begin dosing in Phase 1 trial of MDMA-like substances

The first patient has been dosed in a Phase 1 investigator-initiated study led by MindMed (NASDAQ:MNMD; NEO:MMED) collaborator Prof. Dr. Matthias Liechti at University Hospital Basel to evaluate the effects of MDMA-like...

September 20, 2022

Developments

Zucara secures Phase 2 funding for hypoglycemia trial

Closely held Zucara Therapeutics’ positive proof-of-concept data has enabled the company to secure continued funding for a Phase 2 clinical study of ZT-01 to prevent hypoglycemia in people with Type 1 diabetes, which is...

September 19, 2022

Developments

Profound Medical realigns commercial organization to support continued growth

Profound Medical (NASDAQ:PROF; TSX:PRN) has changed its management team and structure to further position the company for continued sales success and global growth. Abbey Goodman and Hartmut Warnken have been appointed...

September 15, 2022

Developments

FDA clears OpSens SavvyWire for transcatheter aortic valve replacement

OpSens (TSX:OPS; OTCQX:OPSSF) received 510(k) regulatory clearance from the FDA for SavvyWire, its new guidewire for transcatheter aortic valve replacement procedures, or TAVR. In a statement, Louis Laflamme, president...

September 15, 2022

Developments

Sigyn Therapeutics to pursue first-In-human studies in end-stage renal disease

Sigyn Therapeutics (OTCQB:SIGY) plans to pursue first-in-human feasibility studies of its Sigyn Therapy in end-stage renal disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Sigyn Therapy is...

September 14, 2022

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