Search Results for “EC” – Page 75 – media

What One Medicaid Insurer Looks for From Potential Health Tech Vendors

Digital health companies often start in the commercial market and thereafter target Medicaid plans. But not all startups are suited to serve the Medicaid population, according to Dr. Pooja Mittal, vice president and chief health equity officer at Health Net. That’s why Health Net created a vetting process to understand which companies have the potential to be the most effective with Medicaid members. The California-based insurer offers health plans for individuals, families and businesses and has three million members, including those who qualify for Medi-Cal or Medicare. Mittal noted that when the company started bringing in new vendors about four or five years ago, some were very successful working with its Medicaid population, while others struggled with engagement. “What we realized was that there were a lot of companies that didn’t have experience in the Medicaid space that were trying to enter into that space without a good understanding of ...
- Source: drugdu
- 98
- November 22, 2023
Almirall granted EC approval for Ebglyss in moderate-to-severe atopic dermatitis

Almirall has announced that its IL-13 inhibitor Ebglyss (lebrikizumab) has been approved by the European Commission (EC) to treat moderate-to-severe atopic dermatitis. The regulator has specifically approved the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy. Typically referred to as eczema, atopic dermatitis is a chronic, inflammatory disease of the skin characterised by recurrent inflammation associated with intense pruritus or itching. The incidence of atopic dermatitis appears to have increased in recent decades, currently affecting an estimated 4.4% of adults in the EU. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, is supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis, as well as data ...
- Source: drugdu
- 91
- November 22, 2023
NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 93
- November 22, 2023
Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 192
- November 22, 2023
FDA pushes back decision date on BMS, 2seventy bio’s Abecma in earlier line of treatment

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting. BMS revealed on Monday that the FDA’s Oncologic Drug Advisory Committee (ODAC) will meet to discuss data from the KarMMa-3 study. The United States regulator has not identified a date for the meeting, BMS said. BMS and its partner on the drug, 2seventy bio, said in the release that they expect the meeting has been called to review overall survival (OS) data, which is a secondary endpoint of the phase 3 study. The companies added that the meeting will not impact Abecma’s approval for multiple myeloma as a fifth-line treatment. This is another blow to the CAR-T medicine, ...
- Source: drugdu
- 89
- November 22, 2023
AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
- Source: drugdu
- 124
- November 21, 2023
New York Proposes Regulations For Stronger Hospital Cybersecurity

New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The state also put aside $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules. By KATIE ADAMS If newly proposed regulations are finalized in New York, hospitals in the state will soon have to beef up their cybersecurity measures. This week, New York Governor Kathy Hochul released a proposed set of cybersecurity regulations that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. The governor’s budget for next year includes $500 million in funding to help hospitals upgrade their technology systems to comply with these new rules. Some experts think the proposed rules will serve as a blueprint for other states to draft similar sets of regulations. New ...
- Source: drugdu
- 101
- November 21, 2023
Eli Lilly Plans New $2.5B Manufacturing Site in Germany for Injectable Meds

The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs. By FRANK VINLUAN Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany. Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio. Some of Lilly’s capital investments have been closer to the ...
- Source: drugdu
- 102
- November 21, 2023
AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients. The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023. HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low ...
- Source: drugdu
- 114
- November 21, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 113
- November 20, 2023

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