Lancet

VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Wednesday, August 9, 2023

VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.

Key Points: 
  • VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
  • The results of QuANTUM-First were published in The Lancet .1
    The safety of VANFLYTA was evaluated in 265 patients with newly diagnosed FLT3-ITD positive AML who received VANFLYTA once daily (35.4 mg with chemotherapy, 26.5 to 53 mg as maintenance) in the QuANTUM-First trial.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.
  • Provider and patient support and information regarding distribution, access, and reimbursement are now available through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com or calling 1-866-4-DSI-NOW (1-866-437-4669).

TAKING ON THE OPIOID OVERDOSE EPIDEMIC IN NEW JERSEY

Retrieved on: 
Thursday, August 3, 2023

HACKENSACK, N.J., Aug. 3, 2023 /PRNewswire/ -- HIKMA Pharmaceuticals, Hackensack Meridian Health (HMH) and non-profit Dispensary of Hope are teaming up to pilot a Take-Home Naloxone Program to stem the tide of opioid overdose fatalities by delivering Kloxxado® (naloxone HCl) Nasal Spray 8 mg free of charge to patients at high risk of an opioid overdose. Kloxxado® contains naloxone, an opioid antagonist that can save the lives of patients who have overdosed with an opioid.1 All three organizations share a vision of providing affordable medication access, with a particular focus on communities and individuals who are most vulnerable.

Key Points: 
  • Hackensack Meridian Health, HIKMA Pharmaceuticals and Dispensary of Hope join forces to save lives from opioid overdose.
  • Opioid overdoses are preventable and tragic.
  • 2022, "Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission," The Lancet,  399:10324, p555-604
    3 Opioid Basics: Understanding the Opioid Epidemic.
  • CDC, https://www.cdc.gov/stopoverdose/fentanyl/index.html , Accessed 2022 1006
    6 Abdelal et al., 2022, "Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders," Harm Reduction Journal, 19:49.

180 Life Sciences Provides Update on Regulatory Approval Process in the UK and US for Dupuytren’s Disease Treatment; Continues Consultations with the UK MHRA and Initiates a Type C Meeting Request With the US FDA

Retrieved on: 
Thursday, August 3, 2023

A meeting with the MHRA is anticipated to take place in late Q3 of 2023 with the written responses anticipated to be received prior to year end.

Key Points: 
  • A meeting with the MHRA is anticipated to take place in late Q3 of 2023 with the written responses anticipated to be received prior to year end.
  • The Company’s regulatory consultants have indicated that initiation of an additional clinical trial (Phase 3) may be required to obtain CMA approval, and such a trial has been designed.
  • In support of our FDA Type C meeting request, a leading pharmaceutical biosimilar manufacturer will be participating with 180 Life Sciences in the FDA advice discussion.
  • Promising data from a Phase 2b Dupuytren’s treatment trial was published in the June 2022 issue of The Lancet Rheumatology(1).

AI can help detect breast cancer. But we don't yet know if it can improve survival rates

Retrieved on: 
Wednesday, August 2, 2023

Around one in seven Australian women will be diagnosed with breast cancer in their life, with 20,000 new breast cancers diagnosed each week.

Key Points: 
  • Around one in seven Australian women will be diagnosed with breast cancer in their life, with 20,000 new breast cancers diagnosed each week.
  • Mammograms are a key detection tool for early-stage breast cancer and involve placing the breast tissue between two plates and then doing an x-ray.

How are breast cancers currently detected?

    • Breast screening using mammography was introduced in Australia more than 30 years ago to detect cancers earlier, allowing more effective and often less invasive treatments.
    • Currently, a mammogram is studied (or “read”) by two doctors (called radiologists) who decide whether the mammogram looks normal or not.
    • Most of those referred are cleared of cancer, but around one in ten are eventually diagnosed with a breast cancer.

What did the researchers test?

    • The researchers set out to test whether AI could better direct a radiologist’s attention to a suspicious, but often very subtle, abnormal area on a mammogram, using a commercially available AI-supported mammogram reading system.
    • They also looked at whether using AI could replace one of the two radiologists who normally read the mammogram.

So what did they find?

    • In those in whom AI was used, if the AI suggested a suspicious area, the mammogram was still read by two radiologists.
    • But if the AI did not see a suspicious area then only one “live” radiologist read the mammogram.
    • Overall, the AI program picked up one extra cancer for each 1,000 women screened (six per 1,000 vs five per 1,000).

Risk of overdiagnosis

    • Of course what we really want to know is can any new test improve survival from cancer – and make the burden of treatment easier.
    • Studies often use the detection of interval cancers as a surrogate for improving cancer survival.
    • But it’s unclear if AI can detect more of these interval cancers.

Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology

Retrieved on: 
Tuesday, August 1, 2023

WALTHAM, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, announces The Lancet Rheumatology has published findings from a Phase 2 study evaluating obexelimab for the treatment of patients with IgG4-Related Disease (IgG4-RD). Based on the results of this study, a Phase 3 study in patients with IgG4-RD is ongoing to further investigate the efficacy and safety of obexelimab administered as a subcutaneous injection.

Key Points: 
  • IgG4-RD is a chronic, immune-mediated fibro-inflammatory disease that can affect multiple organs including the major salivary glands, orbits, lacrimal glands, pancreas, biliary tree, lungs, kidneys, and retroperitoneum.
  • Despite its increasing recognition, there remains a need for further research and effective therapeutic options for individuals living with this debilitating disease.
  • Across the world, the use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD.
  • “Our team is honored to have our research recognized by The Lancet Rheumatology, and we are immensely grateful to the patients who participated in this groundbreaking study.”

Audicus introduces new line of hearing aids and innovative monthly subscription program that makes it easier than ever to try hearing aids

Retrieved on: 
Tuesday, August 1, 2023

Audicus was the first company to offer fully customizable hearing aids by subscription in 2020 and will retire the Audicus Plus program in favor of the company’s new, more flexible subscription offering, Audicus Premier.

Key Points: 
  • Audicus was the first company to offer fully customizable hearing aids by subscription in 2020 and will retire the Audicus Plus program in favor of the company’s new, more flexible subscription offering, Audicus Premier.
  • Audicus Premier offers a low upfront fee of $249, with monthly payments of $99 for Spirit Series 2 hearing aids and $149 for Omni Series 2 hearing aids.
  • Along with the introduction of Audicus Premier, Audicus has also introduced a new line of hearing aids, the Spirit Series 2 and Omni Series 2.
  • Hearing aids from the Series 2 line are 10 percent smaller than Audicus’ Series 1 products.

Marinus Pharmaceuticals Announces European Commission Approval of ZTALMY® (ganaxolone) for the Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder

Retrieved on: 
Monday, July 31, 2023

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the European Commission (EC) has granted approval of ZTALMY® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the European Commission (EC) has granted approval of ZTALMY® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.
  • ZTALMY may be continued in patients 18 years of age and older.
  • In the Marigold open label extension study, patients treated with ZTALMY for at least 12 months (n=48) experienced a median 49.6% reduction in major motor seizure frequency.
  • In July 2021, Marinus and Orion Corporation entered into a collaboration agreement which grants Orion the right to commercialize ZTALMY in Europe.

Osivax Announces Publication in The Lancet Infectious Diseases of Phase 2a Data for Broad-Spectrum Influenza Vaccine Candidate, OVX836

Retrieved on: 
Thursday, July 27, 2023

Applying Osivax’ proprietary oligoDOM® technology platform, OVX836 is designed to target the nucleoprotein (NP), a highly conserved internal antigen.

Key Points: 
  • Applying Osivax’ proprietary oligoDOM® technology platform, OVX836 is designed to target the nucleoprotein (NP), a highly conserved internal antigen.
  • OligoDOM® enables the transformation of the NP into a highly immunogenic antigen to trigger powerful T-cell immune responses.
  • Importantly, OVX836 provided an 84% level of protection against PCR-confirmed symptomatic influenza compared to placebo.
  • As such, we look forward to advancing OVX836 toward the next stages of clinical development as a truly universal influenza vaccine.”

Mirum’s LIVMARLI® Now Authorized in Canada for Cholestatic Pruritus in Patients with Alagille Syndrome

Retrieved on: 
Tuesday, July 25, 2023

Cholestasis in ALGS is associated with pruritus which is among the most common indications for liver transplant in ALGS.

Key Points: 
  • Cholestasis in ALGS is associated with pruritus which is among the most common indications for liver transplant in ALGS.
  • “Today’s approval in Canada furthers our commitment to ensuring patients globally have a meaningful and effective treatment option for the unrelenting burden of cholestatic pruritus impacting patients and their families living with ALGS,” said Chris Peetz, president and chief executive officer at Mirum.
  • Results from these studies showing robust and meaningful improvements for patients with cholestatic pruritus associated with ALGS were featured in several publications, including The Lancet and Hepatology .
  • Regulatory submissions outside of the U.S., Canada and Europe are being pursued by partners and distributors in key markets globally.

Elevar Therapeutics Announces Publication of Phase 3 CARES 310 Study Results in The Lancet

Retrieved on: 
Tuesday, July 25, 2023

FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.

Key Points: 
  • FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.
  • The study assessed the combination of Elevar’s drug candidate rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).
  • “As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • With efficacy results generally consistent across all subgroups, the CARES 310 data suggested the combination confers a benefit in a global uHCC population.