PharmaFocus Today – Page 306 – media

EU grants full marketing authorisation for Novavax’s Covid-19 vaccine

US-based Novavax received its first full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) in the EU. Nuvaxovid is now fully authorised as a primary series vaccine for general Covid-19 prevention for individuals aged 12 years and older and as a booster dose in adults aged 18 years and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2023, surrounding the vaccine’s full approval. The full authorisation comes a few years after the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, in December 2021. At the time, Nuvaxovid was the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets worldwide. Nuvaxovid is a novel Matrix-M adjuvant protein-based vaccine that has received a US Food and Drug Administration (FDA) emergency use authorisation but has not yet received full ...
- Source: drugdu
- 106
- July 10, 2023
Genentech CEO Hardy warns of ‘unintended consequences’ from the Inflation Reduction Act

It’s been almost one year since Congress and the Biden administration passed the Inflation Reduction Act (IRA), and so far leaders in the biopharma industry have not been shy in voicing their complaints. As some drug companies and trade groups take to the courts with their arguments, Genentech CEO Alexander Hardy is publicly warning about the “unintended consequences” of the IRA. In a recent interview with Fierce Pharma, the Genentech chief described his concerns with measures included in IRA, which particularly affects the oncology sector, he says. Under the IRA, small molecule drugs are subject to Medicare drug-pricing negotiations after 9 years, while biologics get 13 years on the market before they’re included in the program. Regardless of a drug’s classification, Hardy noted that those timelines squeeze companies as they work to study their drugs in additional indications and reach more patients. Companies like Genentech regularly work to move their ...
- Source: drugdu
- 105
- July 10, 2023
Takeda and F-star announce immunotherapy partnership worth over $1bn

Takeda and F-star Therapeutics have announced a strategic collaboration and licence agreement focused on developing next-generation multi-specific immunotherapies for patients with cancer, with the deal potentially worth over $1bn. Though few details of the partnership were disclosed, the two companies said they will jointly research and develop antibodies for new immuno-oncology targets using F-star’s proprietary fully-human Fcab and tetravalent mAb2 platforms. Takeda will then have an exclusive option to take select candidates arising from the collaboration forward, with F-star retaining the rights to research, develop,and commercialise antibodies incorporating certain other Fcab domains. F-star will receive an undisclosed upfront payment and research funding for the period of the collaboration and will also be eligible to receive future payments of up to $1bn “if all milestones across multiple programmes are reached during the term of the agreement” plus royalties. The agreement marks the third deal between the two companies, with licence agreements ...
- Source: drugdu
- 107
- July 10, 2023
BrainTale Has Presented at the European Academy of Neurology and the World Parkinson Congress the Interest of Its Digital Biomarker Platform for the Early and Differential Diagnosis of Parkinson’s Disease

STRASBOURG, France–(BUSINESS WIRE)– BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, presented preliminary results during the European Academy of Neurology (Budapest, July 1 – 4, 2023) and the World Parkinson congress (Barcelona, July 4 – 7, 2023) demonstrating the interest of its digital biomarker platform for the early and differential diagnosis of Parkinson’s disease. Vincent Perlbarg, co-founder, scientific director and president of BrainTale, has presented the results supporting the interest of BrainTale’s digital biomarker platform for the care of patients suffering from the disease and the development of new therapies. Long underestimated in neuroscience, white matter, which represents 60% to 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, since its creation in 2018, BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools ...
- Source: drugdu
- 104
- July 10, 2023
Cipla Issues Voluntary Nationwide Recall of Six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to Container Defect

WARREN, N.J., July 6, 2023 /PRNewswire/ — Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. Sr. No Product Name Batch No Expiry Date 1 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20045 Nov.2023 2 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20055 Nov.2023 3 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20056 Nov.2023 4 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20057 Nov.2023 5 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20059 Nov.2023 6 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20072 Nov.2023 Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and ...
- Source: drugdu
- 96
- July 10, 2023
Not eating enough of these six healthy foods is associated with higher cardiovascular disease and deaths globally

A study led by McMaster University and Hamilton Health Sciences researchers at the Population Research Health Institute (PHRI) has found that not eating enough of six key foods in combination is associated with a higher risk of cardiovascular disease (CVD) in adults. Consuming fruits, vegetables, legumes, nuts, fish and whole-fat dairy products is key to lowering the risk of CVD, including heart attacks and strokes. The study also found that a healthy diet can be achieved in various ways, such as including moderate amounts of whole grains or unprocessed meats. Previous and similar research has focused on Western countries and diets that combined harmful, ultra-processed foods with nutrient-dense foods. This research was global in scope and focused on foods commonly considered to be healthy. The World Health Organization estimates nearly 18 million people died from CVD in 2019, representing 32 percent of all global deaths. Of these deaths, 85 percent ...
- Source: drugdu
- 130
- July 9, 2023
How dietary restraint could significantly reduce effects of genetic risk of obesity

Obesity risk genes make people feel hungrier and lose control over their eating, but practicing dietary restraint could counteract this. New research by University of Exeter, Exeter Clinical Research Facility, and University of Bristol published in the International Journal of Epidemiology found that those with higher genetic risk of obesity can reduce the effects that are transmitted via hunger and uncontrolled eating by up to half through dietary restraint. Psychology Ph.D. student, Shahina Begum, from the University of Exeter is lead author and said, “At a time when high calorie foods are aggressively marketed to us, it’s more important than ever to understand how genes influence BMI. We already know that these genes impact traits and behaviors such as hunger and emotional eating, but what makes this study different is that we tested the influence of two types of dietary restraint—rigid and flexible—on the effect of these behaviors.” “What we ...
- Source: drugdu
- 125
- July 9, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 107
- July 9, 2023
Antidepressant prescriptions continue to steadily grow in England

The number of antidepressant drugs being prescribed on the UK’s National Health Service (NHS) rose again, according to a quarterly report by the NHS Business Services Authority (NHSBSA). The report, which covers the months from October 2022 to December 2022, lists the number of mental health medicines prescribed in England according to the five British National Formulary (BNF) drug groups. This includes drugs that could have been dispensed in England, Scotland, Wales, Isle of Man of the Channel Islands. The British National Formulary classifies mental health medications into different groups based on their use. They are antidepressants, hypnotics and anxiolytics, central nervous system (CNS) stimulants and attention-deficit/hyperactivity disorder (ADHD) drugs, dementia medication, and antipsychotics. In the Q3 2022-2023, period antidepressant drugs were the most prescribed drug class, totalling nearly 22 million items, a 2.67% increase compared to the same period in the previous year. The rise is part of an ...
- Source: drugdu
- 111
- July 9, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 101
- July 9, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.