PharmaFocus Today – Page 250 – media

FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
- Source: drugdu
- 207
- October 18, 2023
Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
- Source: drugdu
- 118
- October 18, 2023
Merck’s Keytruda receives approval greenlight from EU CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
- Source: drugdu
- 175
- October 18, 2023
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
- 121
- 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
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- October 18, 2023
Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
- Source: drugdu
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- 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
- 196
- October 17, 2023
GSK survey results highlight meningitis knowledge gaps among parents

GSK has announced results from a survey revealing that parents are less knowledgeable about meningitis compared to other childhood infectious diseases. The multi-country GSK-commissioned and funded survey conducted by Ipsos revealed that 72% of over 4,000 parents said they were somewhat knowledgeable or knew a lot about meningitis. However, this result was significantly lower compared to other infectious diseases, including COVID-19 (95%), influenza (94%), measles (86%), pneumonia (82%) and whooping cough (74%). Additionally, 93% of parents across the US, Brazil, Germany, France, Spain, the UK and Italy surveyed said they could not identify the three most common symptoms of the condition: fever, headache and stiff neck. Annually, 2.5 million people are diagnosed with meningitis globally, of which 1.2 million cases are invasive meningococcal disease (IMD). Despite 88% of parents considering meningitis to be a serious childhood illness, only 38% said they believed that their child was at risk of catching ...
- Source: drugdu
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- October 17, 2023
Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients. The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases. Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases. “BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval. The study, which is evaluating the combination ...
- Source: drugdu
- 121
- 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
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- October 17, 2023

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