Search Results for “EC” – Page 81 – media

With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. Pfizer has stepped up to the plate with an update, and its effects are staggering as the company has slashed its 2023 revenue projection by $9 billion. Pfizer now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion. In delivering its update late Friday afternoon, a time often reserved by companies to reveal bad news, Pfizer chalked up most of the decline to a $7 billion decrease in its projection for sales of oral antiviral Paxlovid. The company has also cut its forecast for sales of COVID vaccine Comirnaty by $2 billion. Pfizer also sees earnings per share plummeting to between $1.45 and $1.65, down from ...
- Source: drugdu
- 115
- October 18, 2023
FDA clears next-gen image-guided therapy tech from GE HealthCare

BY SEAN WHOOLEY The Allia IGS Pulse system. [Image courtesy of GE HealthCare] GE HealthCare (Nasdaq:GEHC)+ announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system. The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless of patient size. Allia IGS Pulse provides a personalized workspace to meet the operator’s specific needs and preferences. As part of the new image chain, the system features a monopolar X-ray tube used to capture images for interventional procedures. GE HealthCare says the tube — the first of its kind — provides powerful, yet quiet imaging capabilities. Its small footprint also helps clinicians reach steep angulation for better understanding of the coronary artery anatomy. More about the GE HealthCare Allia IGS ...
- Source: drugdu
- 170
- October 18, 2023
High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. The Danish company now expects full-year sales to grow between 32% and 38% at constant exchange rates. The new projection, released on Friday, represents a 5-percentage-point increase on both ends of the range from an August estimate, which itself was 3 percentage points higher than a previous forecast from April. Novo’s share price at one point traded at around $104 on the New York Stock Exchange on Friday, a new all-time high. Huge demand for Ozempic—which is often used off-label to treat obesity—plus new discount adjustments for Ozempic and Wegovy in the U.S. drove the updated sales outlook, Novo explained in a release. Novo on Friday also dialed up its estimated profit growth rate by 9 percentage points to a range of 40% to 46%. The company released the ...
- Source: drugdu
- 192
- October 17, 2023
Almirall and EpimAb Biotherapeutics enter $210m bispecific antibody partnership

Almirall and EpimAb Biotherapeutics have announced a bispecific antibody partnership worth up to $210m. The agreement will give dermatology-focused Almirall a licence to utilise EpimAb’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to generate, develop and commercialise bispecific antibodies. Almirall will have exclusive global rights for any resulting products and, in exchange, EpimAb is eligible to receive milestone payments totalling up to $210m plus royalties on net sales. Karl Ziegelbauer, executive vice president, research and development, and chief scientific officer of Almirall, said the agreement was “an important step” towards the company’s ambition to develop new biologics in the dermatology field. EpimAb’s FIT-Ig platform generates bispecific antibodies using only the basic structural parts of monoclonal antibodies without adding any complex changes. The company has so far focused the technology within the oncology space and currently has five clinical-stage assets being evaluated for indications including non-small cell lung cancer (NSCLC), gastrointestinal cancer and multiple ...
- Source: drugdu
- 133
- October 17, 2023
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
- Source: drugdu
- 201
- October 17, 2023
Ozempic’s Pros, Cons and Correct Use Cases

By George Kramb Pictured: Man preparing Ozempic injection/iStock, imyskin Thanks to TikTok, Ozempic has emerged as this year’s go-to weight loss drug. The current debate revolves around a need to understand Ozempic’s true benefits, unmarred by the overshadowing emphasis on weight loss. Ozempic is not a weight loss drug. It is an injectable prescription medicine used “along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes,” according to its label. As such, it is crucial to recognize its multifaceted nature and the responsible approach it demands. Ozempic’s role in the evolving world of healthcare—and inadvertently weight loss—involves both medical benefits and societal perceptions. The Authentic Benefits of Ozempic Amidst the clamor surrounding Ozempic’s media coverage, it’s imperative to redirect the focus to its true advantages when employed for its designated purposes. Ozempic’s primary function lies in regulating blood sugar levels, offering crucial assistance to ...
- Source: drugdu
- 118
- October 16, 2023
Almirall and EpimAb partner to develop bispecific antibody therapies

Almirall has signed a licensing agreement with EpimAb Biotherapeutics to utilise the latter’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop up to three bispecific antibody targets. EpimAb is eligible for up to $210m (¥1.53bn) in milestone-based payments and net sale royalties. Almirall will hold exclusive global commercialisation rights over the therapies developed during the course of the partnership, based on a 12 October press release. EpimAb’s FIT-Ig platform rearranges the DNA sequences of two monoclonal antibodies to generate bispecific antibodies. “While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped,” said EpimAb’s CEOChengbin Wu in the press release. “We believe Almirall is the partner of choice for this endeavour and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for ...
- Source: drugdu
- 212
- October 16, 2023
Mount Sinai researchers receive NIH grant to compare new treatment options for sickle cell disease

The Mount Sinai Health System has received a $12,180,625 grant from the National Heart, Lung and Blood Institute to compare new treatment options for sickle cell disease and determine which work best for specific patients. Jeffrey Glassberg, MD, Director of the Mount Sinai Sickle Cell Program, said, “Sickle cell traditionally has been a neglected disease, but it benefited from a flurry of innovation over the last decade and there are now three new medications approved for the disease.” “While this is welcome news, clinicians now have a new challenge. No studies have compared the drugs to each other or looked at their use in combination, so there’s very little information to help decide which of the new drugs are best for which patients.” The study, known as REAL (Registry Expansion Analyses to Learn) Answers, is a collaboration among 10 sickle cell centers across the United States that will implement a ...
- Source: drugdu
- 159
- October 14, 2023
What to Expect

Ira Studin, PhD President Stellar Managed Care Consulting The old axiom, “The truth is somewhere in between” may be a useful lens to gauge how a new generation of obesity drugs will perform in the payer market. On one side is the school of thought suggesting that annual revenues will be in the multi-billions, with investment analysts’ tacitly assuming insurance will support demand. On the other side is the “PCSK9” school, referring to extreme barriers payers created to restrict Repatha and Praluent coverage as an alternative to statins. The discussion below will draw on conversations with payers and describe the likely payer market between these two sides. HEAVY DISCOUNT OR ELSE There is a through line from the cholesterol lowering drugs that put their stamp on the market starting in the 1990s and weight loss drugs today. Assuming Mounjaro follows Wegovy’s recently announced outcomes data, the parallel with statins centers ...
- Source: drugdu
- 179
- October 14, 2023
report

Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
- Source: drugdu
- 180
- October 14, 2023

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