PharmaFocus Today – Page 409 – media

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
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- 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
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- 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
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- 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
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- 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
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- 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
Study maps immune responses produced by COVID-19 vaccination in First Nations population

Published in Nature Immunology and Nature Briefing, the research is the first of its kind to decisively map immune responses produced by a COVID-19 vaccination in any First Nations populations. In partnership with Menzies School of Health Research, researchers at the Peter Doherty Institute for Infection and Immunity (Doherty Institute) evaluated immune responses in Aboriginal and Torres Strait Islander peoples and non-Indigenous individuals after receiving the mRNA COVID-19 vaccine. Lead author of the study and PhD candidate at the Doherty Institute, University of Melbourne’s Wuji Zhang, said the research provides strong evidence that COVID-19 vaccination triggers effective immune responses against the virus in First Nations peoples. “We found excellent antibody and T cell responses against SARS-CoV-2 in Australian First Nations peoples following COVID-19 vaccination. We saw high levels of antibodies binding to the virus following two vaccine doses,” Mr Zhang said. “T cells against the spike protein, which often recognize ...
- Source: drugdu
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- May 31, 2023
77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
- Source: drugdu
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- May 31, 2023
US and Mexico sound alarm over cosmetic surgery-linked fungal outbreak

IMAGE SOURCE,ABRAHAM PINEDA Image caption, Mexican authorities shut one of two clinics linked to the fungal outbreak By Laura Gozzi BBC News US and Mexican authorities are urging the World Health Organization (WHO) to declare a public health emergency over a fungal outbreak linked to cosmetic operations in Mexico. The Centers for Disease Control and Prevention (CDC) said two people who got surgeries involving epidural anaesthesia have died of meningitis. Almost 400 people in the US and Mexico are being monitored. Two cosmetic clinics in the Mexican city of Matamoros have been shut. Authorities in both the US and Mexico have urged people who had surgeries involving epidural anaesthesia at either the River Side Surgical Center or Clinica K-3 since January to get evaluated, even if they are currently asymptomatic. The CDC said it had already identified 25 people in the US with “suspected” or “probable” cases of fungal meningitis. ...
- Source: drugdu
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- May 31, 2023
Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in those patients who are aged 18 years and more. A serious and rare genetic disorder, CDKL5 deficiency disorder (CDD) is characterised by early‑onset, difficult‑to‑control seizures besides severe neuro‑developmental impairment. Marinus chairman and CEO Scott Braunstein said: “The CHMP’s positive opinion reinforces the safety and efficacy profile of ZTALMY and is a testament to the tireless efforts and dedication of our team and the CDD community. “This recommendation brings us one step closer to addressing a significant unmet need for CDD patients with treatment-resistant seizures ...
- Source: drugdu
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- May 31, 2023

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