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Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit

Alnylam Pharmaceuticals isn’t letting up with its COVID-19 vaccine patent allegations. Late last week, the company filed its third set of lawsuits against the two largest manufacturers of coronavirus vaccines. Once again, RNA specialist Alnylam is accusing Pfizer and Moderna of violating its lipid particle delivery technology with their lucrative COVID-19 vaccines. Specifically, Alnylam claims that Pfizer stepped on four of its patents and that Moderna infringed three. With the lawsuits, it’s seeking a “reasonable royalty” for the alleged damages. The new suits come after Alnylam originally sued the two last March, arguing that it invented the delivery tech utilized by the vaccines more than a decade ago. Then, in July, the biotech followed up with new claims. Earlier this month, Moderna hit back against the claims in a set of countersuits, alleging that Alnylam “baselessly seeks to profit” from its inventions. Moderna pointed out that the company “based its ...
- Source: drugdu
- 117
- June 1, 2023
After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit

Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. As part of the settlement, which was recorded (PDF) in a federal district court in New Jersey, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. The deal comes three months after the company said it would slash price of the type 1 diabetes treatment to the same level to “make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system.” Lilly’s initial move had come a month after President Joe Biden, in his State of the Union address, called on Congress to limit insulin costs for all patients to $35 per month. The Inflation Reduction Act already had limited insulin costs for patients on Medicare at $35 per month. The lawsuit was ...
- Source: drugdu
- 118
- June 1, 2023
UK life sciences sector to receive £650m in government funding

The UK government has announced a £650m funding package to support the continued growth of the life sciences sector. Unveiled by chancellor Jeremy Hunt, the ‘life sci for growth’ package includes £121m to speed up clinical trials and improve access to real-time data, as well as £48m to support scientific innovation in preparing for potential health emergencies. Another £154m has been committed to increase the capacity of the UK Biobank – the biomedical database containing the in-depth genetic information of half a million UK citizens. This funding will go towards a new facility at Manchester Science Park, a new hub to help small to medium sized enterprises (SMEs) collaborate with industry and academia, and better IT to accommodate multi-disciplinary data. A new call for proposals has also been released as part of the initiative that will offer £250m to incentivise pension schemes to invest in the UK’s science and technology ...
- Source: drugdu
- 112
- June 1, 2023
EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab). The recommendation follows a review by the Committee for Medicinal Products for Human Use (CHMP) that concluded the benefits of the drug, which is indicated for preventing painful crises in SCD patients aged 16 years and older, did not outweigh its risks. The CHMP’s review looked at results from the phase 3 STAND study, which compared the safety and efficacy of Adakveo with placebo. While the study did not raise new safety concerns, it showed a higher rate of severe and serious treatment-related side effects for Adakveo compared with placebo, the regulator said. The study also showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit, with patients in the Adakveo group experiencing an average of 2.5 over the first ...
- Source: drugdu
- 103
- June 1, 2023
Study identifies new genes associated with heart attack risk largely affecting younger women

Research led by the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC) and Universite Paris Cite, and supported by worldwide partners in Canada, the USA and Australia, has identified new genes that are associated with an increased risk of a type of heart attack primarily affecting young to middle-aged women. The results are published in Nature Genetics today, 29 May 2023. SCAD – or Spontaneous Coronary Artery Dissection – is when a bruise or bleed occurs in the wall of a coronary artery, cutting off the blood to part of the heart. This leads to a heart attack. Unlike other types of heart attack, SCAD is most common in women under the age of 60 and is a leading cause of heart attacks around the time of pregnancy. Furthermore, people who have had a SCAD tend to be generally healthy and SCAD can sometimes happen ...
- Source: drugdu
- 102
- May 31, 2023
FDA decisions that could be delayed if the U.S. defaults on its debt

As lawmakers trudge through debt ceiling negotiations, the possibility that the U.S. will default on its loan obligations in the coming days looms like a dark cloud over Washington. Should government coffers run dry on June 1, as Treasury Secretary Janet Yellen has warned they could, federal workers will go unpaid and agencies like the FDA could see operations come to a screeching halt. Just last week, FDA Commissioner Robert Califf said that without a bipartisan bill to raise the debt limit by June, the regulator wouldn’t have the money to pay staff and scientific reviewers, potentially delaying upcoming drug approval decisions, advisory committee meetings and regulations. And with President Joe Biden and House Speaker Kevin McCarthy scrambling to finish negotiations — while haggling over where to cut federal spending in future budget packages — it’s unclear when a deal might be struck, or how long a potential default could ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】How to ace the process of drug registration?

Drugdu.com expert’s response: Drug registration is a complex task that involves multiple steps. To do it well, you need to follow these steps: 1. Understand regulations and guidelines: Firstly, understand the related laws, guidelines, and policies of drug registration to ensure your product complies with the requirements of the country or region where it’s being registered. These laws and guidelines usually cover requirements for drug quality, safety, and efficacy. 2. Prepare registration materials: Prepare relevant registration materials according to the drug registration requirements of the country or region. These materials usually include the chemical, biological, and pharmacological properties of the drug, the drug development process, production technology, quality control, clinical trial data, drug labels, and instructions. Ensure the materials you submit are complete, accurate, and easy to understand. 3. Conduct clinical trials: In some cases, you may need to conduct clinical trials to prove the safety and effectiveness of the ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】How to improve the response rate of emails for international trade development?

Drugdu.com expert’s response: Email marketing, as one of the essential tools for medical trade marketing, can significantly influence customer responses and even determine the success of your orders. Therefore, editing emails requires attention to detail and technique, as a small detail might prompt a customer to reply to your email. So, how can you write high-response-rate emails that make customers eager to reply? Deduo Medical Trade Network shares four essential email editing tips: Five times more people read email subject lines than the email body Readers usually judge whether to continue reading an email based on the subject line’s appeal, especially for customers who receive many emails every day. If your email subject line can grab the customer’s attention, you are already halfway successful. To increase the chances of customers opening your email, consider these three subject line patterns (use with caution as they may risk being marked as spam): 1.Imitate ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】What exactly is the difference between intermediates and active pharmaceutical ingredients?

Drugdu.com expert’s response: Both intermediates and active pharmaceutical ingredients (APIs) are chemical substances used in the pharmaceutical manufacturing process, but they serve different roles and purposes. An API refers to a chemical substance used to manufacture pharmaceutical products, typically obtained through chemical synthesis or natural extraction. APIs are the foundation of pharmaceutical manufacturing and are a crucial factor in determining the quality and efficacy of the drugs. APIs usually have specified chemical structures and purity requirements, therefore, the quality control and standard requirements for APIs are relatively high. Intermediates, on the other hand, are chemical substances used in the synthesis of APIs during the pharmaceutical manufacturing process. They are typically intermediate products obtained through multiple chemical reaction steps. Although intermediates themselves usually do not possess pharmacological activity, they play a significant role in pharmaceutical manufacturing, influencing the synthesis efficiency, quality, and cost of APIs, among other factors. Intermediates generally need ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】What are the market access requirements for medical devices entering the Ecuadorian market?

Drugdu.com expert’s response: The following are the market access requirements for medical devices entering the Ecuadorian market: Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples. License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents. Customs requirements: All imports of medical devices must comply with Ecuador’s customs regulations, including providing product information, product pricing, and the identity of the importer. Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging. Ecuador’s medical device classification rules are based on ...
- Source: drugdu
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- May 31, 2023

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