Group items tagged

Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four drug candidates intended for use as licensed pain medications. The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome. The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to confirm its value as a potential drug. Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.

Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday (May 10), the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks. Paola Casarosa, head of therapeutic areas at Germany's Boehringer Ingelheim told Reuters the partners are in discussion with regulators about the design of a planned follow-up trial in the third and last phase of testing. The enormous demand for weight-loss treatments such as Novo Nordisk's Wegovy, or potentially Eli Lilly's Mounjaro, could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said. Lilly said about a year ago that Mounjaro was shown to reduce up to 22.5% in weight after 72 weeks of treatment in a much larger late-stage trial.

The Digital Medicines Transformation Portfolio (DMTP) was able to deliver the electronic prescription service (EPS) in Wales - just 20 months after starting the project - with support from key partners in the NHS and industry. Patients in Rhyl were the first to benefit from the new service, which allows GPs to send prescriptions electronically to the patient's choice of community pharmacy, without the need for a paper form. The new EPS service is currently in a live testing phase, with a phased roll out across Wales expected from January 2024. DMTP, which is hosted by Digital Health and Care Wales (DHCW) has worked closely with NHS England, who provided the core EPS platform that has been developed for use in Wales. NHS Wales Shared Services Partnership has also made a major contribution in the project, incorporating digital reimbursement to pharmacies and putting security measures in place.

Initial weeks are very hectic for the newborns and their mothers, because in this phase, infants are trying to adapt the new things from the surrounding.

Initial weeks are very hectic for the newborns and their mothers, because in this phase, infants are trying to adapt the new things from the surrounding.

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.

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.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

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.

Pregnancy is a phase that makes the women complete and opens the doorway for her to relive her childhood again. A newborn child in the home brings lots of happiness and everyone in home forgets their pain when they see the child smiling, playing, sleeping or even crying too. A child is a warehouse to positive energy and happiness but only when it is conceived from your partner or lover with your complete consent...

The Department of Health and Social Care's (DHSC) response to the 2019 consultation on community pharmacy drug reimbursement reform has paved the way for the second phase of consultation with the pharmacy negotiator. The second round of the consultation will focus on eight proposals: Changes to the way Category A prices are set Changes to how medicine margin is distributed in Category M drugs Changes to how Category C prices are set for drugs with multiple suppliers Inclusion of non-medicinal products in the Drug Tariff Changes to the way prices of drugs in non-Part VIIIA are set Changes to arrangements for reimbursement and procurement of 'specials' Changes to reimbursement of generically prescribed drugs and appliances dispensed as 'specials' Changes to the discount deduction scale The Pharmaceutical Services Negotiating Committee has been discussing these proposals with the DHSC and the outcome was featured in the final package of the 'Community pharmacy in 2016/17 and beyond' document.

The Royal Pharmaceutical Society (RPS) has been on the lookout for innovative ideas and suggestions that could transform the future of pharmacy practice in England over the next decade. The society's new project with the King's Fund to transform the future of pharmacy practice in England is at a consultation phase, seeking views and opinions of pharmacy teams from all areas of practice including primary, secondary, social and community care to ensure that the system gets the best out of pharmacy and the public receives seamless, joined-up care. "We want to build a vision that sets out the role of and value of pharmacists and pharmacy teams working across systems, providing patient care and NHS services," said RPS in a statement. "Transforming the future of pharmacy practice recognises the urgent need to build on new ways of working established across health and care systems during the pandemic to meet the increasingly complex health needs of people and improve patient outcomes."

Lapses in strategies to tackle COVID-19 this year continue to create the perfect conditions for a deadly new variant to emerge, as parts of China witness a rise in infections, the head of the World Health Organization said on Friday (December 2). The comments by WHO Director-General Tedros Adhanom Ghebreyesus mark a change in tone just months after he said that the world has never been in a better position to end the pandemic. "We are much closer to being able to say that the emergency phase of the pandemic is over, but we're not there yet," Tedros said on Friday. The global health agency estimates that about 90% of the world's population now has some level of immunity to SARS-COV-2 either due to prior infection or vaccination. "Gaps in testing … and vaccination are continuing to create the perfect conditions for a new variant of concern to emerge that could cause significant mortality," Tedros said. COVID-19 infections are at record highs in China and have started to rise in parts of Britain after months of decline.

Amgen's experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year, company officials said ahead of a data presentation on Saturday (December 3). The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as AMG133. Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight loss of 14.5%. At 150 days after the last dose, maintained weight loss had dropped to 11.2% below original weight at the start of the trial, according to findings detailed at a meeting of World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles. Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose, Amgen said.

The Pharmaceutical Services Negotiating Committee (PSNC) has announced the margin delivery rates will increase from October as the agreed £100m write off is implemented. "The baseline margin allowance will remain £800m per year in 2022/23 and 2023/24," said PSNC. "Margin levels in the last two full years (2020/21 and 2021/22), as measured by the Margin Survey of independent pharmacies, were in excess of the baseline allowance, meaning that an excess was accrued." As new services have been introduced and take up of these has accelerated, the amount of unallocated funding left in the CPCF is now less than it previously was. As such, the value of the Transitional Payments will decrease from its current level. Some of the unallocated funding remaining in 2023/24 will be repurposed into a Flat Payment for all contractors (see details below). Over the course of the second half of 2022/23, the value of the Transitional Payments will be phased down. This will start in October 2022 with a reduction in payment levels to approximately 85% of the current level, as shown in the following table:

Sun Pharma has announced that it will acquire all outstanding shares of Concert Pharmaceuticals through a tender offer for an upfront payment of $8.00 per share of common stock in cash, or $576 million in equity value. The upfront payment of $8.00 per share of common stock in cash represents a premium of approximately 33% to Concert's 30-day volume weighted average price as of January 18, 2023, the last trading day prior to today's announcement. Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate deuruxolitinib - an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease - which is in late-stage development. It has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3 clinical program and two open label, long-term extension studies are ongoing in North America and Europe. Sun Pharma's immediate focus would be to follow Concert's plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2023.

The Pharmaceutical Services Negotiating Committee (PSNC) has refused to accept the Department of Health and Social Care (DHSC)'s decision to get rid of 'transitional payments' from February 2023. The pharmacy negotiator said that 'any reductions in payments at this point will be impossible for community pharmacy contractors to manage financially.' "We are also continuing to be clear with officials and ministers that CPCF funding needs an urgent uplift to help businesses to cope with soaring costs being driven by inflation and the workforce crisis. We put a comprehensive business case to the government for this uplift in the last CPCF negotiations." The latest 'transitional payments decision' by the Department follows the announcement last year that the value of the these payments would be phased down over the second half of 2022/23 and will be based on the latest monitoring and analysis of funding delivery. PSNC says it submitted a fully-costed bid for a 'Pharmacy First' service in its last round of negotiations alongside the case for an uplift to core CPCF funding. Both of these were refused.

Bestway operates approximately 750 pharmacies nationwide in the UK under the Well brand. In April 2023, it completed its acquisition of Lexon, which operates 46 pharmacies in the UK under the Knights Pharmacy brand, and Asurex, a wholesale perfume supplier. On 26th May 2023, CMA announced the launch of its merger inquiry. A fast-track Phase 1 investigation found that the merger could lead to a significant lessening of competition between retail pharmacies in 12 local areas located in Liverpool and North East England. The merging businesses conceded that the deal raises competition concerns in these areas and have submitted proposals to sell pharmacies within these areas to restore the competition that would otherwise be lost as a result of the deal. Colin Raftery, CMA Senior Director of Mergers, said: "Pharmacies are essential public health services, and it's vital that the loss of competition brought about by a deal like this shouldn't leave people with reduced choice or worse services when they need medical support. The CMA will now carefully consider whether the remedy put forward by Bestway will address its concerns and ensure that customers in the affected areas continue to have access to good quality chemists.

The Competition and Markets Authority (CMA) has announced on Tuesday (20 June) that it may consider undertakings offered by Bestway Panacea Holdings, a parent company of Well Pharmacy, which involves divesting seven pharmacy stores under the merger deal with Lexon UK. The Authority said: "CMA considers that there are reasonable grounds for believing that the undertakings offered by Bestway, or a modified version of them, might be accepted by the CMA under the Enterprise Act 2002." Last week, the Authority had announced that the merger of Bestway, and independent pharmacy owner Lexon UK could "lessen the competition between retail pharmacies" in England. On 26th May 2023, CMA announced the launch of its merger inquiry. A fast-track Phase 1 investigation found that the merger could lead to a significant lessening of competition between retail pharmacies in 12 local areas located in Liverpool and North East England. The merging businesses conceded that the deal raises competition concerns in these areas and have submitted proposals to sell pharmacies within these areas to restore the competition that would otherwise be lost as a result of the deal.

The General Pharmaceutical Council (GPhC) has initiated the evaluation of its five-year strategy for changing the way it manage concerns about pharmacy professionals. It has urged people to share their experience of fitness to practice. The evaluation will look at how the strategy has improved the experience of people involved in fitness to practice (those who raise concerns, professionals, witnesses etc.); impacted the culture amongst pharmacy professionals and their attitudes to openness and honesty; improved the process and made it fairer and changed perceptions of fitness to practice. The first phase of the evaluation process will take place from July to September 2023. The council said: "We are committed to making our ambitions a reality for the benefit of everyone involved and your contribution will help us to make sure patients and the public continue to be protected while being fair to pharmacy professionals." In June 2021, GPhC published its five-year strategy- Managing concerns about pharmacy professionals: Guided by its 2030 vision and commitment to equality, diversity and inclusion, the strategy outlines a programme for change.

The NHS Business Services Authority (NHSBSA) has published the Drug Tariff Category M price list for July which reflects an increase in reimbursement level of approximately £5m per quarter. An adjustment of -£23.8m was announced, in light of the results of the margin survey (latest result up until end of December 2022), and the phasing down of the additional £100m agreed across years 4 and 5 as part of the Community Pharmacy Contractual Framework and uplifts for underlying market prices (between January - March 2023). Community Pharmacy England has agreed the adjustments based on the analysis of margin delivery and on current projections for 2023/24. It said: "The objectives are to ensure full delivery of agreed margin and smooth delivery as much as possible. As always, the impact on individual pharmacies will vary depending on dispensing mix."