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Indian authorities have cancelled or suspended licences of some domestic drug companies as part of action taken against 76 pharmaceutical firms this month for selling adulterated or fake products, a government source said on Thursday. India is known as the 'pharmacy of the world' and its pharmaceuticals exports have more than doubled over the past decade to $24.5 billion in 2021-22. But that image has been dented by the death of at least 70 children in Gambia and 19 children in Uzbekistan in Uzbekistan last year linked to drugs made by India-based pharmaceutical companies. Health Minister Mansukh Mandaviya confirmed a crackdown but did not give details of companies against which action had been taken. "There are more than 10,500 pharma companies in the country. Companies who make spurious medicine will not be spared," Mandaviya told reporters at an event. Licences of some Indian drug companies have been cancelled, some were suspended while others have been put on notice during the past 15 days, the source, who had direct knowledge of the matter, told Reuters news agency.

Hundreds of children in England are set to benefit from a treatment for cystic fibrosis - Kaftrio, after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed an extension to its licence. With the licence extension, more than 1,300 children in England with cystic fibrosis, aged six to 11, are newly eligible for this treatment, which improves lung function and improves overall quality of life of patients. Earlier, Kaftrio was only licensed for those aged 12 and above. British patients were the first in Europe to benefit from Kaftrio, when NHS England secured a landmark deal in June 2020. NHS chief executive Amanda Pritchard said: "Since NHS staff delivered one of the fastest rollouts of Kaftrio in the world just over a year ago, the lives of thousands of patients with cystic fibrosis have been transformed. "Innovative treatments like Kaftrio are life-changing for patients and their families, and that is why the NHS has done all it can since we secured the deal for Kaftrio to ensure patients benefit as soon as possible.

Pharmanovia, the lifecycle management company has signed a licence and supply agreement with Aquestive Therapeutics for its patented diazepam buccal film formulation across the EU, UK, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA)- up to 48 markets in total. Aquestive Therapeutics has been granted tentative approval by the US Food and Drug Administration (FDA), for its diazepam buccal film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. Pharmanovia will be responsible for seeking appropriate regulatory approval across EU and MENA. Pharmanovia CEO, James Burt commented: "Pharmanovia and Aquestive are aligned in our mission to find new and innovative ways to enhance and revitalise iconic medicines. We have extensive experience with diazepam through the Valium brand and, together with Aquestive's unique PharmFilm technology, we're intending to bring a novel alternative diazepam delivery option to caregivers and patients at a time of critical need."

British drug discovery company C4X Discovery said AstraZeneca had signed a licence worth up $402 million to develop an oral therapy for the treatment of inflammatory and respiratory diseases using its NRF2 Activator programme. The Manchester-based company said on Monday (November 28) it would receive pre-clinical milestone payments worth up to $16 million ahead of the first clinical trial, including $2 million upfront. In addition, C4XD said it would receive a further potential $385.8 million in clinical development and commercial milestones and tiered mid-single digit royalties upon commercialisation of any treatment.

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."