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EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
- Source: drugdu
- 149
- September 18, 2023
Charles River and Related Sciences partner for AI drug platform

Charles River Laboratories International has signed a multi-programme collaboration agreement with Related Sciences (RS) for the artificial intelligence (AI)-powered drug platform, Logica. Last year, Charles River and Valo Health unveiled Logica, a solution that leverages the AI-powered Valo Opal Computational Platform, along with Charles River’s preclinical expertise. Logica will be used on multiple previously undrugged targets within the RS portfolio. RS will collaborate with the teams from both Charles River and Valo Health to deploy Logica to discover significant new medicines. These medicines will be used to meet unmet requirements across disease areas including autoimmunity, cancer immunotherapy and inflammatory diseases. Charles River senior vice-president and chief scientific officer Julie Frearson stated: “Logica’s unique platform, which combines AI/machine learning (ML)-enabled in silico discovery, high-powered DNA-encoded libraries and traditional screening techniques, has the capability to accelerate the drug discovery and development pipeline, transforming a target to a candidate in just over two ...
- Source: drugdu
- 195
- September 18, 2023
ICON partners with US Government for clinical trials of Covid-19 vaccines

US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
- Source: drugdu
- 123
- September 18, 2023
First Wave plans to repurpose Sanofi’s capeserod as GI therapy

First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy. Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m. The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively. Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development. Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis. Sanofi had previously evaluated capeserod in Alzheimer’s disease and urinary incontinence but had since terminated the drug development. However, Fist Wave ...
- Source: drugdu
- 216
- September 18, 2023
Moderna and Immatics announce oncology collaboration worth over $1.7bn

Moderna and Immatics have announced a collaboration agreement aimed at developing ‘novel and innovative’ cancer therapies, with the deal potentially worth over $1.7bn. The multi-platform partnership will combine Moderna’s mRNA technology with Immatics’s T-cell receptor platform and cover various therapeutic modalities such as bispecifics, cell therapies and cancer vaccines. The companies outlined in a statement that their research will focus on three main pillars, including applying the mRNA technology for in vivo expression of Immatics’s half-life extended TCR bispecifics (TCER) targeting cancer-specific HLA-presented peptides. They will also leverage Moderna’s mRNA experience alongside Immatics’s tumour and normal tissue data included in its Xpresident target discovery platform and Xcube bioinformatics and AI platform to develop mRNA-based cancer vaccines, as well as evaluate Immatics’s IMA203 TCR-T therapy targeting preferentially expressed antigen in melanoma (PRAME) in combination with Moderna’s investigational PRAME mRNA-based cancer vaccine. Under the terms of the agreement, Immatics will receive an ...
- Source: drugdu
- 172
- September 16, 2023
Gilead Sciences opens a new chapter, publishes the world’s ‘hardest book to read’ to reveal patients stuck in the margins

Depicting the plight of patients with chronic and potentially fatal diseases is always a challenge for pharma companies, but Gilead Sciences has quite literally found a novel way forward.Teaming up with British historian, presenter and writer Professor David Olusoga, OBE, Gilead is launching “From the Margins,” (PDF) in what is intended to be one of the most difficult books to read. That’s because the book has every word printed entirely in the margins of the pages in what Gilead and Prof. Olusoga see as a direct inversion of a normal book. The idea is simple: “To tell the profoundly moving personal stories of marginalized people living with HIV, Hepatitis C and cancer,” according to a statement sent to Fierce Pharma Marketing. Gilead markets drugs for all three diseases. The book is specific to Britain and being run to “to raise awareness of the issue of marginalization and health inequality in ...
- Source: drugdu
- 116
- September 16, 2023
Alnylam’s RNA interference drug wins favour of FDA AdCom

The US Food and Drug Administration (FDA) voted nine to three in favour of expanding the label of Alnylam Pharmaceuticals’ Onpattro (Patisiran) at a 13 September Advisory Committee (AdCom) meeting. A possible approval would allow the drug to be used to treat cardiomyopathy caused by a wild-type or hereditary transthyretin-mediated amyloidosis (ATTR/ ATTR-CM). At a Cardiovascular and Renal Drugs AdCom meeting, a panel reviewed results from the Phase III (NCT03997383) APOLLO-B trial. In the study, the drug showed favourable effects on functional capacity and quality of life. The drug also demonstrated a good safety profile through the 18 months of treatment with most adverse events being mild or moderate, as per May 2023 interim results. The AdCom discussed if the results from the APOLLO-B study were enough to prove a clinically meaningful benefit for the drug in the new indication. Dr Eric Peterson, a professor of internal medicine at the ...
- Source: drugdu
- 185
- September 16, 2023
NICE recommends use of Vydura for acute migraines on the NHS

Adults in England and Wales with acute migraines will now have access to a new treatment after the National Institute for Health and Care Excellence (Nice) recommended Pfizer’s Vydura for use on the NHS. In May, NICE recommended the drug – with the generic name rimegepant – for the prevention of migraines. At the time, NICE said up to 145,000 people would benefit from the treatment, though the drug was only permitted for use as a fourth-line treatment option. As per the most recent draft guidance, the drug has now been recommended for adults who do not respond to two previous migraine medicines, called triptans. Although this means Vydura is still not recommended for primary use, the move will help an additional 13,000 people access the treatment, NICE said. Patients who do not benefit from taking nonsteroidal anti-inflammatory drugs or paracetamol have also been endorsed to take the treatment in ...
- Source: drugdu
- 113
- September 16, 2023
Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff

Recent research shows that about two-third of clinicians have felt physically unsafe at their job. This week, lawmakers introduced bipartisan legislation to address this concerning trend of violence waged against healthcare workers by giving them federal protections that mirror those for aircraft and airport workers. The bill, called the Safety from Violence for Healthcare Employees Act, would make it a federal crime to assault hospital workers. It was introduced by Sens. Marco Rubio (R-Florida) and Joe Manchin (D-West Virginia). The legislation can be thought of as the Senate’s rendition of the SAVE Act — the SAVE Act is a 2019 bipartisan bill that was reintroduced in Congress this year by Reps. Madeleine Dean (D-Pennsylvania) and Larry Bucshon (R-Indiana), but it has failed to advance. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital ...
- Source: drugdu
- 126
- September 16, 2023
Insulin pump-makers grapple with questions about GLP-1s

Insulin pump-makers face questions about whether a new category of weight loss drugs will affect their long-term growth prospects. Companies including Insulet and Tandem Diabetes Care saw their stock prices fall after a small study showed that GLP-1 agonists — which include the branded drugs Ozempic, Wegovy and Mounjaro — allowed people with Type 1 diabetes to reduce or stop insulin injections. Shares of Insulet have declined 22% in the last month to $173.90, and shares of Tandem have declined 20% to $23.14. However, physicians surveyed by analysts were skeptical the drugs would change the long-term outlook for diabetes, noting that the study only included 10 patients who started GLP-1s within three months of being diagnosed. William Blair analyst Margaret Kaczor cited interviews with three physicians, including Insulet Medical Director Trang Ly, who all said there was no evidence GLP-1s reverse damage to the insulin-producing beta cells in the pancreas. ...
- Source: drugdu
- 104
- September 16, 2023

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