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Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says

Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare’s controversial coverage policy for new Alzheimer’s treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer’s disease. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the ...
- Source: drugdu
- 121
- May 1, 2023
Roche’s Genentech opens up the world with new ad for Vabysmo

Adults facing wet age-related macular degeneration (AMD) and diabetic macular edema (DME) fear their world getting smaller due to loss of eyesight. Roche’s Genentech addresses that issue head-on in its first DTC ad for Vabysmo. The new “Open up your world with Vabysmo” campaign was developed with input from patients, caregivers, advocacy groups and the retinal community impacted by wet AMD and DME. “One of the critical insights was that many of these patients felt when they were losing their vision it made their world feel really small—they didn’t get to go out as much, they weren’t necessarily doing their daily activities of living because they felt like they were losing their sight and therefore inhibiting that ability,” Jennifer Kim, Genentech’s vice president and head of ophthalmology, said. “So that’s how we developed that concept around open up your world. The idea of the campaign is ...
- Source: drugdu
- 140
- May 1, 2023
Merck results beat expectations despite a big drop in sales of Covid antiviral treatment

Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
- Source: drugdu
- 127
- May 1, 2023
ChatGPT may have better bedside manner than some doctors, but it lacks some expertise

ChatGPT can be a useful tool for patients who are seeking medical information and guidance, but the artificial intelligence tool can’t fully replace the value of a human physician – it says so itself. “While I am a language model that has been trained on a vast amount of information, I am not a licensed medical professional and I am not capable of providing medical diagnoses, treatments, or advice,” the chatbot wrote in response to a question from CNN. Still, new research published this week suggests that physicians may have some things to learn from the chatbot when it comes to patient communication. A panel of licensed health care professionals assessed responses to about 200 different medical questions posed to a public online forum, including patient inquiries about medical diagnoses, need for medical attention and more. Responses from ChatGPT were “preferred over physician responses and rated ...
- Source: drugdu
- 144
- April 30, 2023
CDC set to stop tracking community levels for Covid-19

As the nation’s public health emergency expires on May 11, the United States Centers for Disease Control and Prevention will stop reporting its color-coded Covid-19 Community Levels as a way to track the spread of the infection. Instead, the CDC will keep tabs on Covid-19 largely by tracking hospitalizations in some areas, according to a source familiar with the agency’s plans. This is much the same way the agency tracks other respiratory infections, such as the flu. Hospitalizations are a lagging indicator: it generally takes a person a week to 10 days to be hospitalized with a Covid-19 infection. So the switch may mean that the nation is losing its capacity for the earliest warning of an uptick in spread. However, wastewater testing in communities and for air travelers will continue and is expected to close some of those early warning gaps. “We’re not ...
- Source: drugdu
- 137
- April 30, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially ...
- Source: drugdu
- 144
- April 30, 2023
Hansa Biopharma enters into collaboration with Genethon

Swedish biotech company Hansa Biopharma has entered a research and development collaboration with Genethon. The partnership will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, in a clinical trial. Imlifidase will be developed as a pre-treatment for patients with Crigler-Najjar syndrome and pre-existing neutralising antibodies (NAbs) to adeno-associated virus serotype 8 (AAV8), before administering GNT-0003, Genethon’s gene therapy product candidate. The company stated that patients with circulating NAbs will be excluded from the clinical trial of potentially curative gene therapies as well as from access to approved gene therapies. Hansa Biopharma president and CEO Søren Tulstrup said: “Genethon is a pioneer at the cutting-edge of research and development of gene therapies for rare diseases and we are thrilled to be collaborating with them. “This research collaboration further validates Hansa’s commitment in gene therapy and underscores the important role that our antibody-cleaving ...
- Source: drugdu
- 130
- April 30, 2023
Stablix, Vertex partner to develop targeted protein stabilisation therapies

Biopharmaceutical company Stablix and Vertex Pharmaceuticals have joined forces to discover and develop targeted protein stabilisation (TPS) therapies. Under the terms of the deal, Stablix will use its platform to discover new heterobifunctional small molecule drug candidates (RESTORACs) against specified targets which are involved in several diseases. Vertex will get an exclusive licence to certain molecules, which will be identified under the collaboration. Additionally, the company will handle the development and commercialisation along with research costs associated with the collaboration. As per the terms of the agreement, Stablix will get an upfront payment including a convertible note investment. The company is also eligible to receive research, development, regulatory and commercial milestones, along with the tiered royalties on future net sales of any products that are resulted from the partnership. Stablix CEO Tony Kingsley said: “We’re thrilled to partner with the outstanding scientists and ...
- Source: drugdu
- 128
- April 30, 2023
Statins Tied to Lower Stroke Risk in Atrial Fibrillation

Daniel M. Keller, PhD Among patients with atrial fibrillation (AF), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows. Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications. Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen Hospital, Shenzhen, China, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AF. “The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said. The results were presented in a moderated poster session at the European Heart Rhythm Association (EHRA) 2023 in Barcelona and are available online. Widely Prescribed Anticoagulant ...
- Source: drugdu
- 246
- April 30, 2023
AbbVie weathers first months of biosimilar challenge to top-selling Humira

Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
- Source: drugdu
- 166
- April 30, 2023

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