Posts in category: Uncategorized

Legalization of medical marijuana is associated with a reduction in opioid dispensing and pain-related hospital events among adults receiving treatment for newly diagnosed cancers, according to a study published online Dec. 1 in JAMA Oncology.

Yuhua Bao, Ph.D., from Weill Cornell Medicine in New York City, and colleagues conducted a crosssectional study using 2012 to 2017 national commercial claims data and a difference-in-differences design to examine the association between medical marijuana legalization that took effect between 2012 and 2017 and opioid-related and pain-related outcomes for patients receiving cancer treatment. Data were included for 38,189 patients newly diagnosed with breast cancer (100 percent women); 12,816 with colorectal cancer (55.4 percent men); and 7,190 with lung cancer (51.1 percent women).

The researchers found that medical marijuana legalization was associated with a reduction in the rate of one or more opioid days among patients with breast cancer with recent opioids, with colorectal cancer with recent opioids, and with lung cancer without recent opioids (difference, 5.6, 4.9, and 6.5 percentage points, respectively). Among patients with lung cancer with recent opioids, legalization of medical marijuana was associated with a reduction in the rate of one or more pain-related hospital events (difference, 6.3 percentage points).

“The findings suggest that medical marijuana could be serving as a substitute for opioids to some extent,” the authors write. “Future studies need to elucidate the nature of the associations and their implications for patient outcomes.”

Herpes zoster (HZ) is associated with an elevated long-term risk for a cardiovascular event, according to a study published online Nov. 16 in the Journal of the American Heart Association.

Sharon G. Curhan, M.D., from Brigham and Women’s Hospital in Boston, and colleagues examined the longitudinal association of HZ and long-term risk for stroke or coronary heart disease (CHD) among 79,658 women in the Nurses’ Health Study (NHS), 93,932 women in the NHS II, and 31,440 men in the Health Professionals Follow-Up Study.

The researchers found that 3,603 incident stroke and 8,620 incident CHD cases were documented during >2 million person-years of follow-up. There was a significant and independent association observed for history of HZ with higher long-term risk for stroke and CHD. Compared with those with no history of HZ, the multivariable-adjusted hazard ratios (95 percent confidence intervals) for stroke were 1.05 (0.88 to 1.25), 1.38 (1.10 to 1.74), 1.28 (1.03 to 1.59), and 1.19 (0.90 to 1.56) among those with one to four, five to eight, nine to 12, and 13 or more years since HZ, respectively. The corresponding multivariableadjus ted hazard ratios (95 percent confidence intervals) for CHD were 1.13 (1.01 to 1.27), 1.16 (1.02 to 1.32), 1.25 (1.07 to 1.46), and 1.00 (0.83 to 1.12) for one to four, five to eight, nine to 12, and 13 or more years since HZ.

“These findings suggest there are longterm implications of HZ and underscore the importance of public health efforts for prevention,” the authors write.

Several authors disclosed financial ties to pharmaceutical and medical technology companies, including GlaxoSmithKline Biologicals, which partially funded the study.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezlidhia (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

• Rezlidhia is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
• Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
• “Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, Rezlidhia may provide an effective, new treatment option with a well characterized safety profile” said Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.
• Read more… https://www.drugs.com/rebyota.html

Rebyota, a Microbiota-Based Live Biotherapeutic, (fecal microbiota, live-jslm) has been approved for the prevention of recurrence of Clostridioides Difficile Infection in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

• Ferring’s novel first-in-class Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI
• The safety and efficacy of Rebyota was studied in the largest clinical trial program in the field of microbiome-based therapeutics, including five clinical trials with more than 1,000 participants
• Recurrent CDI represents a significant burden for patients, caregivers and the healthcare system.
• Read more… https://www.drugs.com/newdrugs/fda-approves-rebyota-fecal-microbiota-live-jslm-microbiotabased-live-biotherapeutic-prevention-5934.html

Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The additional lots were distributed October 26, 2021 through April 25, 2022.

• The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts.
• Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
• Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-3321088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.
• View the full recall notice on the U.S. FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciencesllc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50

Global biotechnology leader CSL (ASX: CSL) has announced that the U.S. Food and Drug Administration (FDA) approved Hemgenix (etranacogene dezaparvovec-drlb), the first and only onetime gene therapy for appropriate adults with hemophilia B.

• Hemgenix is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes.
• Hemgenix®, etranacogene dezaparvovec-drlb is administered as a single intravenous infusion and can be administered only once.
• In the ongoing clinical trial, Hemgenix reduced the rate of annual bleeds and 94 percent of patients discontinued factor IX prophylaxis and remained prophylaxis-free.
• If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.
• The most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell.
• Read more… https://www.drugs.com/newdrugs/fda-approves-hemgenix-etranacogene-dezaparvovec-drlb-genetherapy-hemophilia-b-5931.html Tzield November 17, 2022 – Provention Bio, Inc. (Nasdaq: PRVB),

FDA Approves Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing
schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn). Rylaze is approved for use in the U.S. as a component of a multi-agent chemotherapeutic regimen for the treatment of acute
lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.

When first approved in the U.S. in June 2021, under the FDA Real-Time Oncology Review (RTOR) program, the approval had a dosing schedule of 25 mg/m2 administered IM every 48 hours met the
immediate patient need for a non-E.coli-derived asparaginase treatment option while the clinical trial was still ongoing to evaluate additional dosing and administration options.

Read more…

Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration has approved Sezaby™ (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.

• With this approval, Sezaby becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. Sezaby is expected to be available in the U.S. in Q4FY23.
• Sezaby is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures.
• Sezaby was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of Sezaby by the US FDA.
• Read more… https://www.drugs.com/newdrugs/fda-approves-sezaby-phenobarbital-sodium-powder-neonatalseizures-5932.html

Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, has announced that the United States Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for Tzield (teplizumab-mzwv), an anti-CD3-directed antibody, for intravenous use, as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D.

• TZIELD injection is supplied as a sterile, preservative-free, clear, and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. TZIELD should be administered by intravenous infusion (over a minimum of 30 minutes) once daily for 14 days.
• TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections.
• The most common adverse reactions (>10%) that occurred during treatment and through 28 days after the last study drug administration from the TN-10 study were lymphopenia), rash, leukopenia and headache.
• Read more… https://www.drugs.com/history/tzield.html

Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at our Columbus, Ohio manufacturing facility.

These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.