Feb 6, 2024
Swedish pharmaceutical company AlzeCure Pharma has announced that preclinical data on its lead drug candidate, NeuroRestore ACD856, has been accepted for presentation at the AD/PD 2024 conference. The data shows that ACD856 selectively potentiates certain signaling pathways, promoting nerve cell communication without affecting pain signaling. The drug also improves memory and synaptic plasticity. AlzeCure plans to continue developing ACD856 for Alzheimer's disease treatment.
Feb 5, 2024
Novo Holdings has agreed to acquire contract development and manufacturing organization (CDMO) Catalent for $16.5 billion. The acquisition will allow Novo Nordisk to meet the growing demand for its obesity drug Wegovy and diabetes drug Ozempic. Novo Nordisk will also acquire three fill-finish sites from Catalent for $11 billion upfront. The sites are located in Indiana, Belgium, and Italy and employ over 3,000 people. The acquisition is expected to be completed by the end of 2024, subject to regulatory approvals.
Feb 5, 2024
Manufacturers of GLP-1s are aggressively using complex patent thickets to protect their products more than older drugs, according to researchers at Harvard University. The researchers found numerous patents in the FDA's Orange Book that were unrelated to the active drug product, a strategy they claim goes beyond what has been done with other combination products like insulin pens and inhalers.
Feb 5, 2024
Amgen Inc. received both bad news and a positive development at the start of the year. The Food and Drug Administration has placed a "boxed warning" label on the drug Prolia, which is used to treat osteoporosis, due to the risk of dangerously low calcium levels for advanced kidney disease patients. On a more positive note, Amgen has partnered with Nvidia Corp. to develop artificial intelligence models for the discovery of biomarkers and precision medicine therapies. Prolia is Amgen's second highest-selling drug but is expected to face generic competition next year.
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Feb 5, 2024
Eli Lilly & Co's diabetes drug, Mounjaro, commonly used off-label for weight loss, is facing a shortage due to increased demand. Higher doses of the drug will have limited availability through early March. The company expects intermittent backorders of higher doses over the next month. Lilly and rival Novo Nordisk have been struggling to maintain supplies of their diabetes drugs amid high demand. Both companies are investing in increasing production capacity.
Feb 5, 2024
The US FDA has approved many glucagon-like peptide 1 (GLP-1) receptor agonists for treating type 2 diabetes and weight management. These drugs are typically sold as a combination of active ingredients and delivery devices, creating patent thickets and delaying generic competition.
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Feb 4, 2024
Biogen has announced that it will stop selling its Alzheimer’s treatment Aduhelm and end a study needed for full approval from the FDA. The drug, initially launched in 2021, was expected to generate billions in sales, but faced challenges due to weak evidence of its effectiveness and restricted insurance coverage. Biogen will now focus on other Alzheimer’s treatments and is helping sell another treatment called Leqembi. Patients taking Aduhelm through the commercial market can continue until November. Biogen's decision could open the door for a potential Alzheimer's drug from Eli Lilly and Co., currently under FDA review.
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Feb 3, 2024
Patients with cystic fibrosis (CF) in India have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to intervene and make CF drugs more affordable. The patients highlighted the high cost of CF drugs, such as Kalydeco, Orkambi, Symdeko, and Trikafta, which are owned by US-based Vertex Pharmaceuticals and cost anywhere from Rs. 21 lakh to Rs. 2.66 crore. They alleged that the prices are inflated due to patent protection, preventing the production of generic versions. The patients urged the DPIIT to issue government use licenses or compulsory licensing to make the drugs accessible and affordable.
Feb 2, 2024
Biogen's drug Aduhelm, initially lauded as a breakthrough in Alzheimer's treatment, will be discontinued due to its failure to meet sales expectations and controversy surrounding its FDA approval. Biogen plans to focus on other Alzheimer's treatments, including Leqembi, which has shown promise in slowing cognitive decline. The Aduhelm case highlights the complexities of drug approval and the need for transparency and evidence-based decision-making. Patients currently on Aduhelm should continue treatment until November and discuss options with their healthcare providers.
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Feb 2, 2024
The Federal Trade Commission (FTC) has challenged the validity of over 100 drug patents, focusing on drug delivery devices like inhalers and auto-injectors, as an effort to increase competition and potentially lower prices. Drug manufacturers often extend a drug's patent protection by making changes to the delivery device or method. The FTC argues that patent law protects active ingredients, not delivery methods, and is trying to eliminate so-called patent thickets to make it easier for generics to enter the market. Some companies have already withdrawn patents in response to the FTC's challenge.