Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Atossa to acquire stake in Dynamic Cell Therapies

Atossa Therapeutics (NASDAQ:ATOS) is acquiring 19.99% of the capital stock of closely-held Dynamic Cell Therapies for $2-million, in addition to $3-million previously paid to Dynamic, “This investment in Dynamic...

November 1, 2022

Developments

Rhythm Pharma gets FDA breakthrough status in hypothalamic obesity

Rhythm Pharmaceuticals’ (NASDAQ:RYTM) setmelanotide received breakthrough therapy designation from the FDA for the treatment of hypothalamic obesity. Hypothalamic obesity is a rare, acquired form of extreme obesity that...

November 1, 2022

Developments

OpSens starts SavvyWire study in Europe

OpSens (TSX:OPS; OTCQX:OPSSF) announced the successful completion of the first cases in a clinical study, named SAFE-TAVI, studying SavvyWire left ventricular rapid pacing in transcatheter aortic valve replacement...

October 26, 2022

Developments

Hepion Pharmaceuticals Phase 2a AMBITION results published

The peer-reviewed journal, Hepatology Communications, has published a paper by Harrison et al. entitled, “Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single-blind, placebo-controlled study in...

October 26, 2022

Developments

IntelGenx receives FDA GDUFA date for partnered buprenorphine buccal film

IntelGenx’s (TSX:IGX; OTCQB:IGXT) previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated new drug application (ANDA) has been filed by Chemo Research through its agent and...

October 25, 2022

Developments

PharmaJet gets USAID contract to evaluate needle-free delivery in polio shots

Closely-held PharmaJet received a multi-year, $1.5-million grant from the United States Agency for International Development (USAID) to evaluate the impact of intradermal vaccine administration using the company’s...

October 24, 2022

Developments

AUM Biosciences going public through merger with Mountain Crest Acquisition

Closely held AUM Biosciences, which is advancing a broad portfolio of precision oncology therapeutics, entered into a definitive business combination agreement with Mountain Crest Acquisition Corp. V (NASDAQ:MCAG). The...

October 21, 2022

Developments

Hepion Pharma food effect study with rencofilstat published

The peer-reviewed journal, Clinical Pharmacology in Drug Development, published the results of a clinical trial examining the effect of food on the oral bioavailability of Hepion Pharmaceuticals’ (NASDAQ:HEPA) lead drug...

October 21, 2022

Developments

IntelGenx receives new U.S. patent on VersaFilm technology

IntelGenx Corp. (TSX:IGX; OTCQB:IGXT) received U.S. Patent No. 11,471,406 from the United States Patent and Trademark Office, with claims for modulating drug absorption in oral film dosage form designed for sublingual...

October 20, 2022

Developments

Jazz Pharma in license for Zymeworks’ HER2 zanidatamab

Jazz Pharmaceuticals (NASDAQ:JAZZ) inked an exclusive licensing agreement to acquire development and commercialization rights to Zymeworks’ (NYSE:ZYME) zanidatamab across all indications in the United States, Europe...

October 19, 2022

Developments

Ondine presents effective photodisinfection treatment research against MRSA

Ondine Biomedical (LON:OBI) presented new research at the Infection Prevention Society Conference in Bournemouth, UK showing that its Steriwave photodisinfection technology is highly effective against clinical MRSA...

October 19, 2022

Developments

LENZ Therapeutics posts positive Phase 2 presbyopia treatment data

Closely held LENZ Therapeutics reported positive topline results from its Phase 2 INSIGHT clinical trial of two investigational formulations of aceclidine to treat presbyopia, or farsightedness. Both LNZ100 (aceclidine)...

October 18, 2022

Developments

Comera reports favorable preclinical results of lead SQore excipient

Comera Life Sciences (NASDAQ:CMRA) reported favorable results from its recently completed SEQURUS-2 study. Together with the SEQURUS-1 study. the preclinical results showed that Comera’s caffeine-based SQore...

October 18, 2022

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

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