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Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO

By Tristan Manalac Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis Pfizer and German partner BioNTech on Monday asked the U.S. Patent and Trademark Office to reconsider, and ultimately invalidate, Moderna’s patents over core technologies of the COVID-19 vaccine, Reuters reported. In an 87-page document, the partner companies argued that the Moderna patents are “unimaginably broad” and seek to claim ownership of knowledge that had existed long before its asserted priority date of 2015. Pfizer and BioNTech contend that using injecting mRNA into cells to produce a protein—and in turn leveraging this process to produce vaccines that prime immune protection—had been demonstrated and documented in the scientific literature as early as the 1990s. Moderna’s patent claims over any mRNA sequence encoding any betacoronavirus spike protein or its subunit, as well as a lipid-based formulation for delivery, is an “attempt to coopt and entire field of mRNA technology,” Pfizer and BioNTech argued ...
- Source: drugdu
- 111
- September 1, 2023
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
- Source: drugdu
- 210
- September 1, 2023
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
- 129
- 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
- 109
- 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
- 107
- 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
- 103
- 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
- 127
- 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
- 277
- 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
- 104
- 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
- 94
- August 31, 2023

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