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The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new drug today (1 November) to treat severe alopecia areata. Litfulo is the new hard capsule medicine with a recommended dosage of just 50 mg per day. It contains an active ingredient, ritlecitinib, an enzyme inhibitor treatment for patients over 12 years. Ritlecitinib works by reducing the activity of enzymes in the body called JAK3 and TEC kinases that cause hair follicle inflammation. This reduction in inflammation leads to hair regrowth in patients with alopecia areata. Alopecia areata is an autoimmune disease, where the body's own immune system attacks hair follicles leading to hair loss on the scalp and other parts of the body.

British scientists said on Thursday (December 30) they would be studying whether higher doses of a cheap and widely used steroid called dexamethasone could work better for patients with severe Covid-19 compared to the standard low doses. Last year, the same scientists conducting the large trial, dubbed RECOVERY, showed that dexamethasone was able to save the lives of Covid-19 patients in what was called a "major breakthrough" in the coronavirus pandemic. They had found that a 6 mg daily dose of dexamethasone, which is used to reduce inflammation in diseases such as arthritis, cut death rates by around a third among the most severely ill Covid-19 patients in hospitals. "Given how quickly the Omicron variant is spreading, we can expect to see patients admitted to hospital with severe Covid-19 for a while to come," said Peter Horby, an Oxford University professor co-leading the trial.

NICE has recommended use of tucatinib as an option to treat HER2-positive breast cancer that has spread in people who have already tried 2 or more anti-HER2 treatments. The move is set to benefit around 400 people with advanced breast cancer. Tucatinib works by blocking a specific area of the HER2 gene in cancer cells, which stops the cells from growing and spreading. The medicine is taken as two 150 mg tablets twice daily along with anti-cancer medicines trastuzumab and capecitabine. Helen Knight, programme director in the NICE Centre for Health Technology Evaluation, said: "Unfortunately there is no cure for breast cancer that has spread to other parts of the body. There is also a lack of additional anti‑HER2 treatments which can postpone the need for chemotherapy, especially for people whose cancer has spread to their brain because their treatment options are even more limited.

Kelso Pharma, the growing UK based specialty pharma business, has announced its first product launch with the release to the UK prescription medicines market of Acepiro (Acetylcysteine) 600mg effervescent tablets. Acepiro 600 mg effervescent tablets are indicated in adults only and are being made available to hospital and community prescribers in 20 and 30 day packs, with the 30 day pack consistent with monthly prescribing. The NHS List Price for the 30 day pack is £4.40, with the 20 day pack priced at £3.65. Acepiro is being launched by Stirling Anglian Pharmaceuticals (SAP), which was acquired by Kelso Pharma one year ago, providing a new UK platform and springboard for future sales growth for the business. The new product complements SAP's existing portfolio of three medicines: CosmoCol (macrogol 3350 plus electrolytes) powder for oral solution - an osmotic laxative indicated for the treatment of chronic constipation and faecal impaction. Stirlescent (naproxen) 250mg effervescent tablets - containing naproxen, which is a non-steroidal anti-inflammatory drug (NSAID).

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 latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

Aspire Pharma Limited has solidified its position as a leading specialty generics enterprise by adding leuprorelin acetate as a branded generic to its oncology portfolio. Leuprorelin acetate is hormone therapy recommended for patients with high-risk localised, locally advanced, and metastatic prostate cancer, serving as an alternative to surgical castration for locally advanced cases. Used as an alternative to surgical castration for locally advanced prostate cancer, a pre-filled syringe containing 11.25mg of leuprorelin acetate (equivalent to 10.72 mg leuprorelin) is injected subcutaneously into the abdomen. The British pharmaceutical company noted that one of its primary objectives is to seek "new investment opportunities" that brings products and companies into its portfolio, aligning closely with Aspire values and therapeutic focus areas. Prostate cancer is the most common cancer among men in the UK, with an average of over 52,000 men receiving a diagnosis of prostate cancer annually, as per Prostate Cancer UK.

Aspire Pharma Limited has reaffirmed its commitment to combating prostate cancer by adding leuprorelin acetate as a branded generic to its oncology portfolio. This move solidifies Aspire's position as a leading specialty generics enterprise. Leuprorelin acetate is a hormone therapy recommended for patients with high-risk localized, locally advanced, and metastatic prostate cancer. It serves as an alternative to surgical castration for locally advanced cases. A pre-filled syringe containing 11.25mg of leuprorelin acetate (equivalent to 10.72 mg leuprorelin) is injected subcutaneously into the abdomen, providing a vital treatment option for patients.

New Lamotrigine Desitin 10mg/ml Oral Suspension is the first licensed Lamotrigine oral liquid medicine available in the UK, offering simple, accurate and flexible dosing for vulnerable patient groups with epilepsy and bi-polar disorder. Accurate dosing and slow titration are essential when initially prescribing for patients with epilepsy. This helps minimise the risk of potentially life-threatening side effects such as Stevens-Johnson syndrome (an acute, rare, and occasionally fatal skin reaction). Dose escalation is required every 2 weeks until the optimal dose is achieved to reach the desired maintenance level. Lamotrigine Desitin 10mg/ml Oral Suspension helps simplify complex prescribing and dispensing regimes, as all dosing requirements are covered in a single product. The supplied dosing syringe and cup make it simple for patients to use and carers to administer. The licensed Oral Suspension is likely to be of benefit when prescribing for children (over 2 years), older people (particularly patients with dysphagia) and also those with learning disabilities. The 10mg/ml strength simplifies accurate dosing for children and offers complete flexibility when dosing is based on mg/kg body weight.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight. Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support. The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants. The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.

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The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately. Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing. "Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA. The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.

The Department of Health and Social Care has issued a Serious Shortage Protocol (SSP) in response to a significant ongoing disruption to the supply of Paracetamol 120mg and 240mg suppositories. Effective from Tuesday (Jan 25), SSP015 provides that for every Paracetamol 120mg or 240mg suppository originally prescribed, one Paracetamol 125mg or 250mg suppository must be supplied. SSP015, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing either of these suitable alternative products to help reduce the number of patients having to return to their prescriber for a replacement prescription. The SSP may be amended or revoked at any time but currently expires on 18 February 2022 - PSNC will update contractors on any changes.

The NHS on Thursday (May 5) said it has rolled out the arthritis drug baricitinib for seriously ill Covid patients. The Recovery trial, conducted by the NHS and University of Oxford, found that 13 per cent fewer severely ill patients died of Covid when treated with the drug compared to existing treatment options. Typically used to treat arthritis to reduce pain and inflammation, baricitinib can now be given to hospitalised Covid patients in addition to current treatments, and clinical studies show that this can provide benefits on top of existing treatment. The NHS has led the rollout of Covid medicines, from the discovery of dexamethasone as the world's first effective treatment, to the first vaccination outside of a clinical trial in December 2020. The NHS said baricitinib works by reducing inflammation caused by Covid-19 by blocking signals to the immune system that are causing it to attack the body.