Capitalising on strong demand for its obesity therapies, Novo Nordisk's growing appetite for deals has fuelled a bet on a U.S. gene-editing company called
Life Edit Therapeutics.
The Danish drugmaker's collaboration with Durham, North Carolina-based Life Edit Therapeutics - owned by ElevateBio, a cell and gene therapy company in Waltham - is
focused on up to seven programs for rare genetic disorders as well as cardiometabolic diseases.
At the heart of the tie-up is Life Edit's technology, called base editing, which is designed to make precise changes to the human genome by tweaking one base - or
letter - into a different one without affecting other letters.
Single-letter mistakes, called point mutations, can give rise to genetic diseases.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed
by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients
in the UK from early 2024.
Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo
Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available
in a 150 mg in 1 mL pre-filled syringe.
According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an
initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week.
"We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our
commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and
Ireland at LEO Pharma.
The Royal Pharmaceutical Society (RPS) has called for a 'firm commitment' to prosecuting those making profits through the sale of DNP (2,4-Dinitrophenol).
It has also urged the social media companies to 'remove content promoting or selling DNP to further reduce harm'.
Legislation to regulate DNP will come into effect on 1 October 2023. On Monday (23 January) it was announced that DNP will be included in the 1972 Poisons Act.
President of RPS Professor Claire Anderson said: "DNP is unfit for human consumption and its main use is in the manufacture of explosives and pesticides. It is
sold by unscrupulous dealers to vulnerable individuals wanting to lose weight but has a dangerous effect on the metabolism and has led to 32 deaths since 2007 in
those taking it as a 'diet drug'.
"Including DNP in the Poisons Act is a positive move as it will restrict its availability, but what's really needed is an outright ban to reduce the risk to the
public. Australia has already classified DNP as a substance of such a danger to health as to warrant prohibition of sale and we'd like the UK to follow suit.
A physically active lifestyle offers numerous benefits, including better cardiovascular fitness, healthy body weight, management of chronic illnesses like
diabetes and arthritis, and improved bone health and muscular fitness. However, like the cliché statement that every action attracts an adverse reaction, physical
activity has its fair share of risks, including injuries.
Some common body injuries while engaging in various levels of physical activity or active sports include wrist, knee, and ankle injuries. The most common injuries
are bruises, strains, and sprains, and this article focuses on the latter.
A sprain is an acute soft tissue injury when ligaments get torn or stretched excessively. Ligaments are tough fibrous tissues made of collagen that connect the bones
and form the different joints found in human bodies. Therefore, sprains are joint injuries, with ankles taking the giant share of most sprain injuries.
It's also important to note that sprains are often confused with strains. However, they're distinctly different because the former are injuries to the ligaments in a
joint, while the latter are injuries to the muscles.
Are you interested in a career helping others improve their overall health and wellbeing through nutrition? Becoming a nutritionist is an excellent way to
make a positive impact on the lives of your patients. Nutritionists are experts in understanding how food affects our bodies, so they can provide advice on healthy
eating habits, dietary requirements for certain medical conditions, and more.
However, it takes more than just interest to become a successful nutritionist - there are specific qualifications and experience that you need to have before you
can practice as one. In this blog post, we will look at what it entails so that you can start planning your journey toward becoming a certified professional
nutritionist. We'll cover the education needed for certification, any licensing or registration requirements necessary for practicing in different states or
countries, what kind of skillset potential employers might be looking for when hiring nutritional professionals, and finally some tips on gaining practical
experience while working towards full accreditation. So if you are serious about becoming a nutritionist, let's get started!
FORMAL EDUCATION REQUIREMENTS
The first step towards becoming a certified professional nutritionist is often completing an accredited program in either dietetics or nutrition. A Bachelor's degree
in Nutrition Science, Food Science, and Human Nutrition or Dietetics would be the minimum qualification for entry-level positions as a nutritionist. However, there
are many advanced courses available that can take you further in this field such as Master of Nutrition programs and postgraduate degrees.
Danish drug developer Novo Nordisk on Wednesday (February 1) warned of supply constraints on its best-selling drug.
The company, which develops diabetes and obesity drugs, said it expected "periodic supply constraints" this year, partly driven by higher than expected demand for
its blockbuster diabetes drug, Ozempic, and manufacturing constraints.
"Supply of Ozempic cannot keep up with demand in some markets," Novo's Chief Financial Officer Karsten Munk Knudsen told journalists on Wednesday, but said Ozempic
was available in the United States, the firm's biggest single market.
Shortages of human growth hormone would also cause sales in its rare disease franchise to drop by a "mid-single digit" percentage in 2023, as its Norditropin drug
would be out of stock in certain markets, Knudsen said.
Researchers at at an Australian university have developed a new form of antibiotic that can be swiftly re-engineered to avoid resistance to dangerous superbugs.
The antibiotic, which was developed by PhD candidate Priscila Cardoso and major supervisor Dr Celine Valery from RMIT's School of Health and Biosciences, has a basic
architecture that allows it to be generated quickly and cheaply in a lab. The antibiotic, Priscilicidin, has tiny amino acid building blocks that allow it to be
tailored to combat various types of antimicrobial resistance.
With the World Health Organization calling antimicrobial resistance "one of the top ten global public health threats facing humanity", developing new antibiotics has
become more urgent than ever.
Professor Charlotte Conn, one of Cardoso's PhD supervisors, said given that urgency, Priscilicidin was an exciting breakthrough for public health.
Priscilicidin is a type of antimicrobial peptide. These peptides are produced by all living organisms as the first defence against bacteria and viruses.
Insuman Comb 50 100units/ml suspension for injection 3ml cartridges has been discontinued with stocks being exhausted imminently, notified Department of Health
and Social Care (DHSC).
The department has issued a medicine supply notification for Insulin isophane biphasic human 50/50 (Insuman Comb 50) 100units/ml suspension for injection 3ml
cartridge.
"Humolog Mix 50 remains available, as do other biphasic insulin preparations, and the manufacturers can support a full uplift in supply," said DHSC.
A copy of this medicine supply notification, including further information, has been sent to all pharmacy NHS email addresses.
DHSC and NHSE/I's newly launched online Medicines Supply Tool provides up to date information about medicine supply issues. The contents of these MSNs can now be
viewed on the Tool.
Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines
and Healthcare products Regulatory Agency (MHRA).
The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as
dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period
for at least one year.
The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public
consultation.
The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists,
the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.
The message of Diwali - a festival of new beginnings and the triumph of good over evil and light over darkness - seems to take on new layers of meaning every
year.
At the height of the Covid pandemic, it brought to mind the importance of togetherness, as we all struggled through lockdowns and missed the human contact that is
so important to us all.
In 2022, sadly, it feels like there's a lot of darkness in the world. Diwali is so full of hope for the future and we certainly need some of that that right now. In
troubled times, both in the UK and across the globe, Diwali provides an opportunity to reflect and hope for better times ahead.
In their own way, pharmacies bring light to the communities they serve - giving help and reassurance to many vulnerable people. As chair of the NPA it is truly a
privilege to support pharmacy teams to deliver this vital work all year round. Diwali is a family feast - at the NPA we like to think of ourselves as the family
of family-owned pharmacies.
It's time for pharmacists to get their technology forecasting hats on and be selective in choosing digital technologies, commented Prof James Woudhuysen, of
London South Bank University, at the National Pharmacy Association (NPA) Conference, Pharmacy Odyssey, held on Thursday (13 October).
In a session on 'Healthcare in tomorrow's digital environment', hosted by Fergus Walsh, Prof Woudhuysen opined that digitisation has its merit, but it's quite tricky,
and slower than we imagine.
"Mechanisation has a digital component that we can look to as a way out of the gloom of the moment. And in dispensing, labelling, prescribing, and many other features
of the conventional retail pharmacist, there's a lot that could be done for productivity and automation," he said.
Replying to a question on 'where are we at the digital front now and where can it go', Woudhuysen replied: "It's taken 20 years for the electronic prescription. It
was Tony Blair, who wanted every prescription electronic. The mishaps on repeat prescriptions and all the rest of it are still quite intense. So, we need to remember
that electronics is only as clever as software and then human input into it. There're still many mistakes.
The World Health Organization called for caution on Tuesday (May 16) in using artificial intelligence for public healthcare, saying data used by AI to reach
decisions could be biased or misused.
The WHO said it was enthusiastic about the potential of AI but had concerns over how it will be used to improve access to health information, as a decision-support
tool and to improve diagnostic care.
The WHO said in a statement the data used to train AI may be biased and generate misleading or inaccurate information and the models can be misused to generate
disinformation.
It was "imperative" to assess the risks of using generated large language model tools (LLMs), like ChatGPT, to protect and promote human wellbeing and protect public
health, the U.N. health body said.
As a human being, you should know that everyone has a different body type, and no diet can be perfect for everyone. Hence, An efficacious diet is significant to maintain after thoroughly researching what foods to eat during IVF to avoid severe complications of negativity and miscarriage in an IVF process.
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 National Health Service England (NHSE) aims to eliminate cervical cancer by 2040 by making the lifesaving Human Papillomavirus (HPV) vaccination
easily accessible to people and increasing cervical screening uptake.
In addition to the campaign, the NHS is expanding the outreach of cervical screening more than ever before.
Last year, the health service invited over five million people aged 25 to 64 for the screening, out of which 3.5 million were tested.
Moreover, self-sampling will be trialled to see if the service can introduced as part of national screening.
England is among the first countries in the world to set this elimination ambition, which could save thousands of lives every year in the country.
Amanda Pritchard, chief executive of Officer of NHS England, announced the health service's new goal and how to achieve it at the NHS Providers' annual conference
today (15 November).
The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally
traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester.
Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of
Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012
and money laundering."
They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants,
as well as unlicensed versions of erectile dysfunction drugs.
The Department of Health and Social Care (DSHC) has launched a consultation to seek views on changes to pharmacy supervision, which is being considered as
part of the Primary Care Recovery Plan.
Plans set out in the consultation include making better use of pharmacies, improving access to primary care and maximising the contribution of pharmacy
professionals across healthcare.
In the consultation, the DSHC has set out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012.
The proposals aim to allow pharmacists to authorise registered pharmacy technicians to carry out the preparation, assembly, dispensing, sale and supply of
pharmacy and prescription only medicines in their absence. Currently, these services can only be carried out by, or under the supervision of, a pharmacist.
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 MHRA's Criminal Enforcement Unit (CEU), working with other law enforcement partners, has seized more than two million "illegally traded medicines" this
year, with a total value of £5 million.
The products confiscated in the UK were prescription-only medicines including anti-depressants, pain medication and human growth hormones.
The MHRA launched an initiative, Operation Pangea, 15 years ago to combat "illegal internet trade in medical" products.
Andy Morling, the Deputy Director of Criminal Enforcement of MHRA, spoke about Operation Pangea's 15-year anniversary.
"Fifteen years ago, the MHRA started Operation Pangea, combining our knowledge and resources with those of international partners to disrupt and bring to justice
the criminal gangs responsible for selling medicines illegally and causing harm around the world.
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.