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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

Britain has approved a new coronavirus vaccine by the Austrian-French drugmaker Valneva. "An approval has been granted after the Valneva Covid-19 vaccine was found to meet the required safety, quality and effectiveness standards," the Medicines and Healthcare products Regulatory Agency said in a statement on Thursday (April 14), adding: "It is also the first, whole-virus inactivated Covid-19 vaccine to gain regulatory approval in the UK." In vaccines such as Valneva's VLA2001, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response. It is seen by some as having the potential to win over people wary of some which use new mRNA technology. Valneva CEO Thomas Lingelbach said that "this authorisation could pave the way for the availability of an alternative vaccine solution for the UK population."

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.

American biotechnology company Novavax said on Monday (February 28) it would pursue full approval of its Covid-19 vaccine in the second half of this year and forecast total revenue of between $4 billion and $5 billion for 2022. "We expect to gain additional authorizations where we have already filed, including in the US. We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022," CEO Stanley Erck said during a post-earnings call. Novavax late last month filed for emergency use authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems. Novavax said it has completed delivery of around nine million vaccine doses to Indonesia, 6 million to Australia and two million to South Korea and expects to supply 69 million doses to Europe in the first half of this year.

Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus. Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults. The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said. The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. "The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."

Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients. The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and weight-related health issues. The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings. The injection helps individuals lose 20 per cent of their body weight, and are advised to follow a reduced-calorie diet and increase physical activity simultaneously. Although it is not authorised to use on the NHS as yet but future approvals can be predicted.

Following a period of prolonged uncertainty, the Competition and Markets Authority has given its approval to Bestway Healthcare's acquisition of Lexon UK and Asurex. The company expects the transactions to be finalised in the upcoming months. In April, Bestway, the owner of Well Pharmacy, acquired Asurex Limited and Lexon UK Holdings, along with the 44-community pharmacy chain Norchem Group, known as Knights Pharmacy. However, in June, the CMA raised competition-related concerns about the transaction, citing worries that the acquisition could lead to a significant decrease in competition among retail pharmacies across 12 areas in Liverpool and the northeastern region of England. The CMA had asked undertakings from Bestway Healthcare due to competition concerns affecting specific branches of Knights Pharmacy within the acquisition. In July, the CMA indicated its readiness to approve the deal, contingent upon Bestway's completion of the required divestments. According to Bestway Healthcare, This matter has been successfully resolved, as Bestway Healthcare has consented to the sale of seven pharmacies in Liverpool and the northeastern region of England. "The impacted Well pharmacies are situated in Seaham, Bishop Auckland, Kenton, High Howden, Stockton, Moreton, and Pensby. Buyers for all seven branches have been identified and contracts have been signed."

The first big breakthrough in 30 years of Alzheimer's research is providing momentum for clinical trials of "cocktail" treatments targeting the two hallmark proteins associated with the mind-robbing disease, according to interviews with researchers and pharmaceutical executives. Drugmakers Eisai and Biogen reported in September that their therapy lecanemab could slow progress of the disease by 27% over 18 months compared with a placebo. The finding validates the theory that clearing the amyloid protein that forms clumps in the brains of Alzheimer's patients could slow or halt the disease and has strengthened the support from some scientists for simultaneously targeting another notorious protein linked to Alzheimer's: tau. Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. The U.S. Food and Drug Administration is expected to make a decision by early January on the companies' application for accelerated approval. If approved on an accelerated basis, the companies said they would immediately apply for full U.S. regulatory approval which could help secure Medicare coverage.

Britain's Covid booster campaign is set to kick off this September, after the country became the first in the world to approve an Omicron-adapted shot. Around 26 million people in Britain are estimated to be eligible for an autumn Covid-19 booster, having had at least two Covid vaccine doses already, a UK Health Security Agency (UKHSA) spokesperson said. The preference is to deploy what is known as a "bivalent vaccine" that targets both the original virus and the Omicron variant through the autumn campaign, but that will depend on the health regulator (MHRA) approving such shots and the state of vaccine supplies. The UK's Joint Committee on Vaccination and Immunisation (JCVI) has advised boosters should be given to over-50s, individuals in clinical risk groups, frontline workers and care-home staff ahead of the winter, when respiratory viruses are typically at their peak. On Monday (August 15), the MHRA gave Moderna's bivalent shot conditional approval. The endorsement of the vaccine is based on data that showed it produced a marginally better immune response against some Omicron variants, versus the original novel coronavirus - although whether that translates into stronger protection against serious disease is unclear.

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 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.

British pharmaceutical giant GSK said on Saturday (April 15) its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults and adolescents met the main goals in late-stage trials. The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for the treatment of uUTIs, the company said. GSK plans to submit results of the trials to the United States Food and Drug Administration for review later in the second quarter. The drug, if approved, could become the first new type of antibiotic, which is critically important for countering drug-resistant infections, to treat uUTIs in 20 years, the company said. "Gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI," Chris Corsico, senior vice president of development at GSK, said.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

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 Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Anastrozole in a new use to prevent the disease. The off-patent drug has been used as a breast cancer treatment for many years. Clinical trials have shown that it can reduce the incidence of breast cancer in post-menopausal women with increased risk by almost 50 per cent. Health Minister Will Quince expressed his happiness on the approval of the drug that can help to prevent this "cruel disease". He said: "We've already seen the positive effect Anastrozole can have in treating the disease when it has been detected in post-menopausal women and now we can use it to stop it developing at all in some women.

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."

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 Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.