Proposed Sale Establishes a Pure-Play Dental Company with a Leading Implant Portfolio
Net Proceeds Will be Used to Pay Down Debt and Support Dental Growth Initiatives
Monday, December 18, 2023
Invivyd: Positive Initial Results for the Prevention of COVID-19
- VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants
- Data supportive of an immunobridging approach to the EVADE study of adintrevimab
- Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to date
- VYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against HV.1, the currently dominant variant in the U.S.
CRL for Checkpoint Therapeutics' skin cancer therapy
Checkpoint Therapeutics said on Monday the U.S. Food and Drug Administration declined to approve its experimental therapy to treat a type of advanced skin cancer, citing issues related to a third-party contract manufacturer.
The company filed the marketing application for the drug, Cosibelimab, its lead therapy in development, earlier this year.
Shares of the Waltham, Massachusetts-based company were halted for trading premarket.
Checkpoint said the FDA did not state any concerns about the data or safety on the drug in its so-called complete response letter.
"We believe we can address the feedback in a resubmission to enable marketing approval in 2024," said CEO James Oliviero said in a statement
The trial data showed the therapy helped reduce or clear cancerous tumors by 47.4%
https://finance.yahoo.com/news/1-us-fda-declines-approve-123118673.html
Oculis starts Phase 3 in Diabetic Macular Edema
- DIAMOND-1 Phase 3 trial, assessing the efficacy and safety of OCS-01 eye drops following 52 weeks of treatment in Diabetic Macular Edema (DME) patients, was initiated as planned
- Stage 1 results showed superiority of OCS-01 eye drops vs. vehicle with robust statistical significance with no unexpected adverse events observed
- Second 52 weeks Phase 3 trial of OCS-01 in DME, DIAMOND-2, is anticipated to start in Q1 2024
- If approved, OCS-01 has the potential to become the first topical eye drop and non-invasive treatment option for DME
Ebix in "Stalking Horse" Sale Agreement for Life Insurance and Annuity Business
- Company Continues to Have Robust Worldwide Operations and Strong Fundamentals
- Secures New Financing to Support Restructuring Process
- Proposed Transaction Provides Ongoing Stability for the Insurance Industry, Ensuring Continued World Class Delivery for Clients
Mirum Pharma's liver disease therapy fails in mid-stage study
Mirum Pharmaceuticals said on Monday its experimental adjuvant therapy to treat a type of liver disease did not meet main goal in mid-stage study.
https://finance.yahoo.com/news/mirum-pharmas-liver-disease-therapy-133725912.html
DEA warns Georgia to cancel plans to be 1st state to allow pharmacies to sell medical marijuana
The U.S. Drug Enforcement Administration is warning Georgia not to move forward with its plan to become the first state to allow pharmacies to distribute medical marijuana.
DEA officials told pharmacies that dispensing medical marijuana would violate federal law. The Georgia Access to Medical Cannabis Commission, which oversees the state's medical marijuana industry, said it cannot override the federal ban despite state law allowing pharmacies to sell the products.
The Georgia Board of Pharmacy began accepting applications in October for pharmacies to dispense marijuana products. Licenses have already been issued to 23 independent pharmacies in the Peach State.
The state wants pharmacists to be allowed to continue providing consultations for medical cannabis products as they do with other medication, The Georgia Access to Medical Cannabis Commission's executive director Andrew Turnage told The Atlanta Journal-Constitution.
The DEA said in a memo sent to pharmacies that none of them can lawfully possess, handle or dispense marijuana or related products containing more than 0.3% tetrahydrocannabinol, the psychoactive chemical known as THC that gives people a high.
The DEA memo was published online by the group Smart Approaches to Marijuana, which opposes marijuana legalization.
Georgia allows patients with medical needs to buy medical marijuana products with up to 5% THC, while marijuana sold for recreational use typically has a higher level.
According to the DEA, products derived from a cannabis plant with a THC content above 0.3% are illegal under federal drug law.
The state has permitted patients with certain illnesses and physician approval to possess and consume low-THC medical cannabis products since 2015, but there was no legal way for them to buy the product in Georgia until 2015.
Recreational marijuana is legal in 24 states across the country, while another 23 allow some form of medical cannabis, according to the National Conference of State Legislatures.
Ira Katz of Little Five Points Pharmacy in Atlanta told WXIA-TV that he believes pharmacies should be able to dispense marijuana products just like marijuana dispensaries do.
"It just doesn’t make any sense to me that people can go to a dispensary and not to a pharmacy," he said. "We would be buying it from the same growers."
While Katz said he understands federal law trumps state law, he believes the DEA's stance will hurt patients who rely on medical cannabis.
"We’re the most regulated industry in healthcare. That’s what shocked me. That’s what blows me away when it comes to why the DEA is not moving on this. They don’t see what we see here every single day," Katz said, referring to patients who need the medicine.
The DEA's stance could change if a recent proposal to ease restrictions on marijuana moves forward. In August, the U.S. Department of Health and Human Services proposed taking marijuana off the banned list of Schedule I substances and reclassifying it as a lower-risk Schedule III drug.
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