PharmaFocus Today – Page 298 – media

Amid shortage, FDA clears several generics of Takeda’s popular ADHD drug Vyvanse

After 16 years on the market, Takeda’s blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation. On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency’s regulatory bar with their generics. It’s not clear whether any of the companies have actually launched their copycats in the U.S. Takeda’s patents on its branded version expired Aug. 24. Whenever they debut, the generics will surely be welcomed by patients. A 100-day ...
- Source: drugdu
- 142
- September 1, 2023
FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection

It is a bleak view for Outlook Therapeutics’ wet age-related macular degeneration (AMD) treatment plans after the US Food and Drug Administration (FDA) rejected a biologic licence application (BLA) for the company’s bevacizumab-vikg candidate. Shares in Outlook Therapeutics fell a hefty 80% when the market opened on 30 August. Prior to the FDA’s complete response letter (CRL), a GlobalData consensus estimated Outlook to potentially earn $989m in 2029 if the drug was approved. GlobalData is the parent company of Pharmaceutical Technology. Despite ONS-5010 (bevacizumab-vikg) demonstrating positive results in a trial – meeting safety and efficacy endpoints, the agency noted several manufacturing issues and the need for additional confirmatory clinical data. In a conference call on 30 August, Outlook Therapeutics’ CEO Russell Trenary said: “We are disappointed, and we were certainly not expecting to receive a CRL back from the FDA.” He added that the company believes the chemistry, manufacturing, and ...
- Source: drugdu
- 117
- September 1, 2023
Merck receives EC approval for Keytruda combination in gastric cancer

Merck & Co – known as MSD outside the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the European Commission (EC) as part of a combination treatment for certain gastric cancer patients. The therapy is now approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients eligible for the Keytruda regimen will also have tumours that express PD-L1 with a combined positive score of one or more, the company outlined. Gastric cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide, with nearly 1.1 million new cases diagnosed and more than 768,000 deaths from the disease globally in 2020. Most gastric cancers are adenocarcinomas, which develop from cells in the innermost lining of the stomach. As the disease ...
- Source: drugdu
- 123
- September 1, 2023
Bayer and BlueRock announce positive results from Parkinson’s cell therapy trial

Bayer and BlueRock Therapeutics have announced positive results from their phase 1 stem cell clinical trial, showing that the treatment improved symptoms of Parkinson’s disease. The trial results were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Copenhagen, Denmark. Parkinson’s disease is the fastest-growing neurodegenerative disease in the world and causes parts of the brain to become progressively damaged over many years. The condition affects around 145,000 people in the UK. As part of the trial, a total of 12 people with Parkinson’s underwent surgery to receive either a high or low dose of bemdaneprocel (BRT-DA01), an experimental therapy involving dopamine-producing cells developed from stem cells. Stem cells develop different types of specialised cells, including skin, muscle or brain cells. For years, researchers have been working to find a way to convert stem cells into dopamine-producing brain cells to be used to replace those that are ...
- Source: drugdu
- 111
- September 1, 2023
Recalls and Shutdowns Worsen Drug Shortage Crisis

By Andy Gooding-Call Pictured: Packs of birth control pills/iStock, towfiqu ahamed At the end of July, Lupin Pharmaceuticals recalled two batches of Tydemy, a birth control drug that the company produces in India, when it was found to have reduced effectiveness. It was the company’s eighth product recall in just 18 months. Lupin was also forced to stop production at one of its Indian plants in 2022 after the FDA issued a warning letter last fall. Around the same time, another generics manufacturer, Intas Pharmaceuticals, made headlines over a failed FDA inspection at a manufacturing plant in Gujarat, India, leading the company to cease operations there. At a moment when drugs already are in short supply, these disruptions are reducing availability even more, putting entire supply chains at risk and forcing doctors and patients to make difficult, life-changing treatment decisions. “It’s hard to know” how the issues at Intas and ...
- Source: drugdu
- 141
- August 31, 2023
Novocure Fails Phase III Ovarian Cancer Trial for Tumor Treating Fields Therapy

By Tristan Manalac Pictured: Magnifying glass focusing on a tumor in an ovary/iStock, Mohammed Haneefa Nizamudeen In the Phase III INNOVATE-3 trial, Novocure’s investigational ovarian cancer therapy Tumor Treating Fields was unable to significantly improve overall survival, the company announced Monday. Patients who received Tumor Treating Fields (TTFields) treatment combined with paclitaxel had a median overall survival (OS) of 12.2 months, which was only marginally higher than the 11.9-month median OS in comparators treated with paclitaxel alone. In terms of safety, TTFields remained well-tolerated and showed no new signals of concerns or systemic toxicities. Its adverse event profile in INNOVATE-3 was consistent with what had previously been reported. TTFields is an investigational oncology therapy that uses electric fields that act via many different mechanisms to kill cancer cells. Because it works via several pathways, the approach can be combined with other treatment modalities—such as PARP inhibitors and immune checkpoint inhibitors—to ...
- Source: drugdu
- 286
- August 31, 2023
US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
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- August 31, 2023
CMS

The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflation Reduction Act (IRA). The drugs that made the price negotiation cut are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel. Together, the drugs accounted for more than $45 billion in Medicare Part D spending from June 2022 to May 2023, according to a CMS fact sheet (PDF). Next up, these companies will get a chance to submit data and information on their medications to CMS by Oct. 2. Meanwhile, many of the companies are challenging the legality of the IRA in court. It remains to be seen whether any of those efforts can stop the IRA process ...
- Source: drugdu
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- August 31, 2023
New dementia risk score ‘calculator’ shown to strongly identify disease risk

A new study has revealed that a new dementia risk score ‘calculator’ can strongly predict the chances of people developing dementia within the next 14 years. Based on 11 mostly modifiable risk factors in people in the middle stages of life and onwards, the UK Biobank Dementia Risk Score (UKBDRS) outperformed three additional widely used risk sources, according to the results from the study published in the British Medical Journal. Around 50 million people are thought to be living with dementia worldwide, with numbers expected to triple by 2050. Targeting key risk factors could potentially avert around 40% of dementia cases, and various risk scores have been devised to predict a person’s chances of developing the disease while preventive measures are still possible. However, these scores have been shown to be unreliable across different age groups and geographies, and some are reliant on expensive and invasive tests. After analysing two ...
- Source: drugdu
- 124
- August 31, 2023
Study reveals gut conditions could be early sign of Parkinson’s disease

New research published in the journal Gut suggests that certain gastrointestinal symptoms could be an early warning sign of Parkinson’s disease. Symptoms including constipation, dysphagia (difficulty swallowing) and irritable bowel syndrome (IBS) are suspected to drive the development of Parkinson’s disease, along with cerebrovascular disease (CD), such as a stroke or brain aneurysm, and Alzheimer’s disease (AD). Parkinson’s is one of the fastest-growing neurodegenerative diseases in the world and affects around 145,000 people in the UK. There is currently no cure for the condition. Researchers analysed the US medical records of 24,624 people with Parkinson’s and compared them to 19,046 people with AD, 23,942 with CD, and 24,624 with healthy brains to determine whether patients with Parkinson’s experienced gut issues six years prior to diagnosis and whether they had a higher chance of developing the condition. The gastrointestinal tract possesses millions of nerve cells that communicate with the brain. Researchers ...
- Source: drugdu
- 135
- August 31, 2023

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