The Orphan Drug Designation strengthens LP-284’s clinical development path and provides the opportunity for additional market exclusivity and commercial protection.
Lantern is anticipating filing the IND with the FDA and initiating a first-in-human Phase 1 trial for LP-284 in B-cell non-Hodgkin’s lymphomas (NHL), including mantle cell lymphoma (MCL), by mid 2023.
In the US, MCL is diagnosed in approximately 4,500 patients each year and has an estimated annual market potential of $600 million.
Deal Strengthens Zimmer Biomet's Growing Sports Medicine Portfolio and Supports Continued Company Transformation
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced that it has reached a definitive agreement to acquire Embody, Inc., a privately-held medical device company focused on soft tissue healing, for $155 million at closing and up to an additional $120 million subject to achieving future regulatory and commercial milestones over a three year period. The acquisition is expected to be accretive to overall revenue growth and slightly dilutive to adjusted earnings per share in 2023.
https://finance.yahoo.com/news/zimmer-biomet-acquire-embody-inc-120000718.html
Vyant Bio, Inc. (“Vyant Bio” or “Company”) (Nasdaq: VYNT) is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders. The Company’s proprietary central nervous system (“CNS”) drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Today, Vyant Bio announced that it has engaged LifeSci Capital as its financial advisor to assist in exploring a range of strategic alternatives focused on enhancing shareholder value.
In addition, the Company announced that it is participating in BIO’s One-on-One Partnering event in San Francisco taking place at the same time as the annual JP Morgan Healthcare Conference.
https://finance.yahoo.com/news/vyant-bio-engages-lifesci-capital-211500071.html
ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, Inc., a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022.
The application, designated IND 161602, was approved on December 30, 2022. It contained the clinical protocol for ABV-1519 and was entitled “A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Patients.” BLEX 404, the primary active ingredient, is extracted from the Maitake mushroom (Grifola frondosa), an edible mushroom, whose immunological effects and safety have been demonstrated in two Phase I/II clinical studies performed at Memorial Sloan Kettering Cancer Center (MSKCC) with breast cancer and myelodysplastic syndromes (MDS) patients.
https://finance.yahoo.com/news/fda-approves-ind-submission-allowing-133000414.html
Breakthrough Therapy Designation for 24-Valent Investigational Pneumococcal Conjugate Vaccine Candidate Based on Positive Topline Proof-of-Concept Data Results in Adults Aged 18-64 That Suggest Potential Best-in-Class Profile --
-- Topline Safety, Tolerability and Immunogenicity Data from VAX-24 Phase 2 Study in Adults 65 and Older Expected in Q2 2023 --
-- Company Continues to Advance PCV Franchise, Including VAX-24 and VAX-31, While Progressing Early-Stage Vaccine Programs --
https://finance.yahoo.com/news/vaxcyte-vax-24-granted-fda-133000218.html
When it comes to public health, we should follow the facts and science, as opposed to political posturing. If history has taught us anything, it’s that prohibition is rarely the answer when addressing a public health problem. Outright bans of products tend to produce the opposite result of their intent, spurring more product consumption and fueling unregulated black markets. Unfortunately, this is the approach the Food and Drug Administration (FDA) is taking when it comes to adults over 21 consuming tobacco products.
Just look at the early 1920s, when the average annual per capita consumption of hard liquor shot up 11.64 percent during the national prohibition of alcohol. Not only were people consuming more, but the product they were consuming was more potent. It’s estimated that the potency of Prohibition-era products distributed by underground markets was more than 150 percent of the potency of products produced either before or after Prohibition.
So, when President Biden recently announced a plan to publish a proposed rule in May 2023 that could eliminate nearly 98 percent of the nicotine found in cigarettes, it’s difficult not to see this as a 21st-century “Prohibition.” We know it didn’t work for alcohol, so why does this administration think banning nicotine in cigarettes will be different?
No one wants kids smoking, but the most recent National Youth Tobacco Survey by the FDA and Centers for Disease Control and Prevention (CDC) shows combustion cigarette use among adolescents is trending even further downward, with only 1.5 percent of students now reporting consumption of traditional cigarettes since Congress passed a law raising the smoking age to 21 in 2019. Instead of addressing the core concern of youth e-cigarette use, this proposed rule only stands to pull the rug out from under more than 30 million adults, forcing them to essentially quit smoking cold turkey or — much like during Prohibition — get their fix through illicit markets.
In response to cigarette tax hikes in New York City alone, over half the cigarettes smoked are now smuggled. Can you imagine the impact Biden’s federal proposal would have nationwide? Surging black-market sales lead to more funding for organized crime and less for “mom-and-pop” corner stores. In addition, the illicit tobacco market has been found to fund terrorist organizations overseas — so it wouldn’t be surprising to see a cigarette ban directly correlated to more funding for terrorist groups such as Hamas and Hezbollah.
Instead of pushing for prohibition, the administration should implement harm-reduction tactics for cigarettes, similar to how they’ve addressed marijuana and opioid use. Harm reduction is proven to work. For example, when it comes to combating the HIV crisis, cities that have needle and syringe programs have an average annual decrease in HIV prevalence of 18.6 percent, compared with an annual average increase of 8.1 percent in cities without these programs.
The Biden administration could use the $712 million annually given to the Center for Tobacco Products to educate adults on alternatives to cigarettes. Countries such as Japan, Britain and Sweden have done so and have seen significant drops in cigarette consumption as adults have transitioned. Or, if Biden wants to really get serious about reducing nicotine usage, he should encourage the FDA to exercise the authority given to it by Congress to better regulate synthetic nicotine, the main ingredient in e-cigarette products such as youth-favorite Puff Bar.
Prohibition will not lead to smoking cessation, but it could spur more illicit cigarette consumption and even raise national security concerns. It’s time to enforce the laws we have on the books and apply harm reduction approaches universally.
Richard Marianos, an adjunct professor at Georgetown University, is a senior law enforcement consultant, having served more than 27 years with the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF). He was assistant director in the Office of Public and Governmental Affairs and Special Agent in Charge of ATF’s Washington Field Division.
