Group items tagged

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."

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.

Arrowhead Pharmaceuticals on Monday (November 22) entered a drug development deal with GlaxoSmithKline (GSK) under which the British drugmaker will develop and market Arrowhead's potential treatment for patients with fatty liver disease NASH. Under the pact, Arrowhead said it would get an upfront payment of $120 million and is eligible for additional milestone payments including up to $190 million at first commercial sale of the product, and up to $590 million in sales-related milestone payments. The drug candidate, ARO-HSD, is currently in an early-to-mid stage trial for nonalcoholic steatohepatitis (NASH), a fatty liver disease. It is based on RNA interference technology, where genes that contribute to disease are silenced.

GSK is helping pharmacists to tap into Self Care Week this November, and remind patients how they can adopt a more proactive approach in looking after their health. This includes treating ailments, such as joint pain, over the counter to take pressure off GPs where possible. Joint pain complaints take up a significant amount of general practice resource with 57 per cent of pain presentations reported relating to joint pain[1], as well as 23 per cent of sufferers feeling as though their pain impacts their quality of life[2]. Many of these complaints and ailments could be addressed with treatment recommendations from a pharmacist with support from Voltarol. GSK, manufacturer of Voltarol (the market leader in the pain relief topic category[3]), offers support through both its products and resources in hopes to advocate over-the-counter treatments.

GlaxoSmithKline on Tuesday (May 31) snapped up US biopharmaceutical firm Affinivax for up to $3.3 billion, expanding further into vaccines before the demerger of its consumer health care arm. The London-listed company has agreed to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones for Affinivax. "GSK plc today announced that it has entered into a definitive agreement to acquire Affinivax, Inc," it said in a statement. "Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines," it added. The Cambridge, Massachusetts-based firm specialises in vaccines for diseases including meningitis, pneumonia and bloodstream infections. "The proposed acquisition further strengthens our vaccines research and development (R&D) pipeline, provides access to a new, potentially disruptive technology, and broadens GSK's existing scientific footprint in the Boston area," said GSK's chief scientific officer Hal Barron.

GSK submits sNDA for Promacta to FDA for severe aplastic anaemia treatment

PBR Staff Writer Published 22 April 2014 Swiss pharmaceutical firm Novartis has entered into a definitive agreement to acquire the oncology unit of Britain's GlaxoSmithKline (GSK) for about $14.5bn and up to $1.5bn contingent on a development milestone. As part of the deal, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.

Covid-19 has accelerated a culture change for community pharmacists. Throughout the pandemic, they have been the first line of advice, treatment and referral for common illnesses, and they have Successfully prevented countless unnecessary visits to A&E. The commitment of the profession to patient care has been widely recognised by both the government and the public. Despite immense pressure, pharmacy teams have risen to the challenges posed by a Global pandemic. "The extent to which pharmacists went over and above the call of duty, acting outside of their licences from a humanity point of view was extraordinary," said Tess Player, vice president and global head of expert and health influencers at GSK Consumer Healthcare, calling them the "unspoken heroes" of Covid-19. Pharmacy teams from around the world have shared with her their experiences. Pharmacists in China remained open round the clock and sourced face coverings for their community and metered out the short supply for their patients.

Consumer healthcare group Haleon on Thursday announced that it has entered into a binding agreement for the sale of the ChapStick brand to Suave Brands Company, a company owned by American private equity firm Yellow Wood Partners. The British consumer healthcare company has agreed to sell its lip balm brand to Suave for about $430 million in cash and a minority interest in the buyer, valued at around $80 million. Haleon, which was spun off from the GSK Group in July 2022, said that cash proceeds from the sale would be used to pay down debt. ChapStick generated £112 million ($142.5 million) in revenue in 2023, said Haleon, adding that the sale is likely to close in the second quarter of 2024. Brian McNamara, Chief Executive Officer, Haleon, said: "Today's announcement is consistent with Haleon being proactive in managing our portfolio, and being rigorous and disciplined where there are opportunities for divestment. "While ChapStick is a great brand, much loved by consumers around the world, it is not a core focus for Haleon.

PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

Consumer health company Haleon, formerly known as GSK, claims that pain's emotional and life impact has grown by nearly 25 per cent in the past decade. The company has launched a campaign #ListenToPain to personalise patients' pain management through a series of practical tools and resources. The campaign was introduced on 28 September which focused on enabling the HCPs to maximise their time with patients and understand their pain experience - providing them with an effective treatment plan. The new data has been obtained through the fifth edition of the Haleon Pain Index (HPI). This social study measured the impact of individuals' everyday lives, their health, their feelings, their emotions, motivations and behaviours. They have spoken to more than 87,000 people around the world since their first edition in 2014 - HPI 1 (The State of Pain), which later progressed over the years from HPI 2 (Impact of Pain) in 2017, then HPI 3 (Managing Pain) in 2018, to HPI 4 (Treatment Journey), and finally HPI 5 (Pain and Inclusivity) in 2023.

Despite a 13 per cent increase from last year, less than a quarter (21%) of pharmacy teams recommend Proton Pump Inhibitors (PPIs) as a first line of treatment for frequent heartburn. There has been a 4% decrease in pharmacy teams considering 'frequent heartburn' as a condition that occurs more than once a week 8-in-10 said a larger pack size would be useful to their patients who suffer from frequent heartburn. Haleon, formerly part of GSK, has recently commissioned research to better understand how pharmacy teams help patients to treat frequent heartburn. Comparing with data captured last year, there has been a been a +13% increase in the number of pharmacy teams recommending Proton Pump Inhibitors (PPIs) (21% in 2022 vs 8% in 2021). Nexium Control, the UK's number one heartburn product for 24-hour protection, aims to use this research to provide better support for pharmacists and their teams and encourage the recommendation of PPIs, where appropriate for frequent heartburn, over other heartburn remedies.

Pfizer's plan to sell its Haleon stake is not a surprise, the consumer health company's finance chief Tobias Hestler told Reuters on Wednesday (3 May). London-listed Haleon was carved out as an independent company in July and comprises consumer health assets once owned by GSK and Pfizer. Pfizer, which has a 32% stake in the maker of Sensodyne toothpaste and Panadol painkillers, told the Financial Times on Tuesday that it intends to offload that stake in a "slow and methodical" manner within months. Hestler said Pfizer has long been clear about its intention to sell off the stake, suggesting that the reason the potential of the selloff has gained traction is because the selling window opens around the time that Haleon's results are announced. "This will happen every quarter from now until they're sold off…this is just what's expected," he said, adding: "If I get a courtesy call the evening before they do it then that would be nice, but they don't even have to do that." Shares of the world's biggest standalone consumer health business were down more than 3% in early trading.

An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights for Covid-19 interventions between the pharmaceutical industry and developing nations endures. At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected. In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck. The declaration is not legally binding. However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.

The issues related to race and ethnicity are common across the sectors, but the problem is not unsolvable, said panelists in a discussion on Race, Identity and Belonging In The Workplace, held during the Pharmacy Business Diversity Conference on Thursday (December 9). Creating safe and comfortable spaces and allowing authentic conversations is a precursor to resolving this big challenge, said Zaheer Ahmad MBE, global head of Inclusion and Diversity at GSK Consumer Healthcare. The session, moderated by the conference chair BBC presenter Clive Myrie, also had Asif Sadiq MBE, senior vice president at WarnerMedia for Equity and Inclusion, International, and Sathya Bala, founder & CEO of True Change and My Skin My Story, a growing global community for women of colour. Ahmad said encouraging open conversations is important as there is great discomfort and stigma attached to talking about it, and many times senior leaders fall short in their efforts not because they have racist views or they don't believe in advancing race and ethnicity, but because they are not aware.

GSK has received approval from FDA for its Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adult patients with type 2 diabetes.

GlaxoSmithKline (GSK) announced the expansion of its manufacturing facility in Boronia, in the outer eastern suburbs of Melbourne, Australia, in November 2014. The expansion will introduce the latest machinery, which will be used for manufacturing advanced aseptic packing of sterile pharmaceutical liquids.

Otrivine brings the world's first air-purifying "Air Bubble" to Glasgow in a bid to raise awareness of the devastating effect of air pollution on children's health. Air pollution is considered the world's largest environmental health threat, with 93 per cent of children breathing polluted air every day according to the World Health Organisation (WHO). The Air Bubble, launched to help bring this invisible crisis to the top of the agenda, is an educational architecture, using biotechnology to purify the air. The nose is one of our first lines of defence when it comes to filtering out particle pollutants from the air we breathe. As a world leader in nasal health, Otrivine is demonstrating how innovative nature-based technology can expand the functionality of our nose to 'clean' the air we breathe in polluted urban environments.

Global consumer healthcare company Haleon has launched a new centre of excellence for a global leader in consumer health which will bring together world leading academics in human behaviour and frontline healthcare professionals including community pharmacists. Unveiled at the International Pharmaceutical Federation (FIP) Congress in 'sunny' Seville, Spain on September 20, the Centre will operate as a community of healthcare professionals and specialists in behavioural science, health psychology and the social sciences to solve some of the most pressing everyday health challenges. Named the Centre for Human Sciences (CHS) the initiative will be the first major programme for healthcare professionals since the Haleon's launch on July 18 as an independent, global leader in consumer health. The Centre's mission is to support practising health professionals - pharmacists, pharmacy assistants and dental professionals - in serving their patients and communities. Combining science with deep human understanding, CHS will bring expertise in physiology together with human sciences to deliver real world-solutions and tangible interventions, resulting in measurable improvements in health outcomes through sustained behavioural change. The Centre is facilitated by Robert Horne, professor of Behavioural Medicine at UCL School of Pharmacy, who started his career as a practising pharmacist but later chose to become a behavioural scientist when he saw an opportunity to address issues around psycho-social factors that acted as a hindrance in pharmacy practice. Speaking to me in an exclusive three-way conversation alongside Tess Player, the global head of healthcare professional & health influencer marketing at Haleon, on the sidelines of the FIP Congress 2022, Prof Horne expanded on what the Centre was all about and how it would work. "We've got some good ideas, but it's not a pre-filled prescription that we're going to deliver at scale from the start. What Haleon is t

Pfizer on Thursday said a single dose of its new respiratory syncytial virus (RSV) vaccine Abrysvo maintained its ability to protect against the illness through a second year of respiratory disease season. The company said in a press release that the vaccine's efficacy against RSV-associated lower respiratory tract disease with three or more symptoms was 77.8 per cent through season two, compared with efficacy of 88.9 per cent after the first RSV season, which led to the shot's US approval. The data is from a late-stage trial of more than 37,000 participants being conducted in both the Northern and Southern hemispheres. Cumulative efficacy over both seasons after around 16.4 months of disease surveillance was 81.5 per cent, Pfizer said. The data is similar to the efficacy of GSK's rival RSV shot Arexvy over two seasons, which was released in June.