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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."

The US Food and Drug Administration has approved a US clinical trial of a lung cancer vaccine developed in Cuba. Already produced in Cuba for $1 per dose...

The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity.

The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.

There has been extensive national media coverage today (August 11) on how medicine shortages have forced patients to visit multiple pharmacies to get their prescriptions filled or return to their GP to be prescribed alternative drugs. These media reports have been based on a survey involving more than 1,500 pharmacists in the UK, in which over a half of those polled said that their patients' health had been put at risk in the last six months. In response to a query from Pharmacy Business, the Department of Health and Social Care (DHSC) said it monitors the medicines supply chain closely to prevent any shortages and acts swiftly when any issue arises. A DHSC spokesperson told Pharmacy Business: "We take patient safety extremely seriously and we routinely share information about medicine supply issues directly with the NHS so they can put plans in place to reduce the risk of any shortage impacting patients, including offering alternative medication.

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

The Scottish Medicines Consortium (SMC) has accepted AbbVie's RINVOQ (upadacitinib) for use within NHS Scotland for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). Upadacitinib offers an additional treatment choice in the therapeutic class of janus kinase inhibitors. "Daily life with ulcerative colitis is difficult due to the debilitating and unpredictable nature of its symptoms", said Dr Jonathan Macdonald, Consultant Gastroenterologist at NHS Greater Glasgow and Clyde. "Clinical trials have shown that upadacitinib as a once daily pill controls symptoms in eight weeks for many patients and provided sustained responses at one year. The SMC's decision is good news for people with ulcerative colitis in Scotland as it provides an additional treatment option to help them gain control of their condition." The SMC decision is based on data from the induction studies U-ACHIEVE and U-ACCOMPLISH, as well as the Phase 3 U-ACHIEVE maintenance study, which demonstrated the efficacy of upadacitinib versus placebo in its ability to achieve clinical remission. The SMC's decision follows the granting of Marketing Authorisation for upadacitinib in UC in July 2022.

An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death. The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB). Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year. The results drove Lilly's shares to a record high, up more than 6% at $429.85. Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory. "It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful." Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.

The drug, alpelisib, which is the 100th cancer drug that has being fast-tracked to patients under the NHS Cancer Drugs Fund (CDF) will be used in combination with the hormone therapy, fulvestrant, to target the gene that causes fast-growing tumours. Up to 3,000 people a year with a certain type of secondary breast cancer will benefit from the treatment. The approach has contributed to people in England having access to nearly one third more cancer drugs compared to the European average. The drug which is manufactured by pharmaceutical company Novartis, is part of a growing number of precision treatments that target a tumour based on mutations in its DNA and that the NHS is rolling out. John Stewart, NHS National Director for Specialised Commissioning said, "In just over five years, more than 80,000 people have benefitted from earlier access to a range of cancer drugs, with people in England having access to nearly one third more cancer drugs compared to the European average, and this latest innovative new treatment will help up to 3,000 more to live a better quality of life.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving an oral therapy to treat myelofibrosis patients with moderate to severe anaemia. Myelofibrosis is a rare blood cancer that affects the body's normal production of blood cells, and the affected patients are likely to develop anaemia over the course of the disease. British drugmaker GSK, the manufacturer of the oral therapy known as momelotinib, said that it can be used to treat "both newly diagnosed and previously treated myelofibrosis patients." The medicine helps address disease-related splenomegaly (enlarged spleen) or symptoms in adult patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib, as stated by the company. Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, said that receiving the positive CHMP opinion "is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer."

The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates. It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for drug development. The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies. Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies." "Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," he added.

The American healthcare company, CVS Health, has decided to remove the cold and cough pills containing phenylephrine from the drug stores. The following decision comes after the health regulator, the US Food and Drug Administration (FDA) determines the decongestant is ineffective towards flu if taken orally. However, when ingested in pill or tablet form, this ingredient fails to reach its destination from the stomach to the nasal passages. CVS Health spokesperson told USA Today, "We are removing a small number of oral decongestant products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores but will continue offering many other oral cough and cold products to meet consumer needs." They almost run more than 9,000 stores in the US whereas their rival, Walgreens has not yet taken the step to remove over-the-counter medications from their shelves.

The US Food and Drug Administration (FDA) has approved the Novartis drug, Cosentyx, (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. HS is a chronic, progressive and painful disease which affects one in 100 people worldwide, and has limited treatment options. "Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS," said the Swiss company. The FDA approval was based on robust Phase III data (SUNSHINE and SUNRISE studies) in which Cosentyx showed rapid relief from HS symptoms as early as Week 21.

The National Institute for Health and Care Excellence (NICE) has recommended faricimab as treatment option for adults with wet age-related macular degeneration or diabetic macular oedema. Thousands of people in England could benefit from the recommendation of a new drug that helps to treat two leading causes of sight loss and visual impairment. Faricimab is administered as an eye injection and is being recommended as an option for treating some adults with wet age-related macular degeneration (AMD) or with diabetic macular oedema (DMO). In the key clinical trials, aflibercept, another eye injection drug used to treat AMD and DMO, was administered every 8 weeks, while faricimab dosing, based on assessments of the disease activity, allowed for an interval of up to 16 weeks between doses, and was found to be equally effective. Up to 300,000 people in England with wet age-related macular degeneration (AMD) could be eligible to receive faricimab as part of their treatment alongside just over 28,000 people with diabetic macular oedema.

Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States. The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease. Nearly all previous experimental drugs using the same approach have failed. The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27 per cent, compared with a placebo. Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.

The Royal Pharmaceutical Society (RPS) has confirmed that the recall of blood pressure drugs amlodipine and olmesartan by the Food and Drug Administration is only for the US market and will not have any impact in the UK. MHRA also clarified that the manufacturer of these drugs, Macleod Pharmaceuticals, does not supply amlodipine medicines in the UK. It was published online in both the Daily Record and Daily Express on the morning of Monday, March 21, that the drugs had been recalled in the US by the FDA due to deviations from standard manufacturing protocols by the manufacturer. RPS intervened to ensure the articles were edited to make clear that this is not an issue in the UK after confirmation from the MHRA. Amlodipine tablets from Macleod Pharmaceuticals aren't available for wholesale distribution in the UK.

Pfizer's oral Covid-19 therapy will be evaluated as a potential treatment for patients hospitalised with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world. The world's largest randomised study of potential medicines for Covid-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment. "Paxlovid is a promising oral antiviral drug but we don't know if it can improve survival of patients with severe Covid-19," said Peter Horby, a professor at the University of Oxford and joint chief investigator of the RECOVERY trial. The scientists said they aim to mainly find whether Pfizer's Paxlovid reduces the risk of death among patients admitted to hospitals with Covid-19.

The National Institute for Health and Care Excellence (NICE) has recommended Enhertu for people with advance breast cancer. "There is not enough evidence yet to show how much longer people live with Enhertu compared with trastuzumab emtansine because the clinical trial is still ongoing. This means the cost-effectiveness estimates are highly uncertain and Enhertu cannot be recommended for routine use in the NHS," said NICE. The independent appraisal committee concluded that Enhertu could be cost-effective if further evidence from the ongoing trial and from NHS practice can show how much longer people live with treatment. Helen Knight, director of medicines evaluation at NICE, said: "Today's draft guidance is good news for people with this type of advanced breast cancer, who often experience severe and debilitating symptoms.

In a recent announcement, Mundipharma, a leading global pharmaceutical company, has announced its acquisition of all assets and rights related to rezafungin from Cidara Therapeutics. This solidified Mundipharma's dedication to managing infectious diseases and specialty care therapeutic areas, especially invasisve candidiasis which over the 15 years has seen no new therapeutic developments underscoring for alternative options. The FDA and MHRA approved rezafungin is a groundbreaking once-weekly echinocandin antifungal drug specifically designed for the treatment of invasive candidiasis in adults. While Mundipharma will oversee global commercialization efforts, Melinta Therapeutics will retain commercialization rights for rezafungin in the United States. Moreover, the acquisition empowers the pharmaceutical company with global ownership of rezafungin, encompassing its ongoing development and distribution.