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A Phase 3 study comparing Samsung Bioepis' SB8 with Avastin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) demonstrated equivalent efficacy in terms of risk ratio of overall response rate (ORR).

The advantages of randomization are various. It guarantees against the inadvertent bias in the investigation and creates similar groups in all the regard.

Aspen has committed not to charge more for its six generic cancer drugs for the next 10 years in the UK, according to the Competition and Markets Authority (CMA). The CMA also clarified that "although these commitments were offered while the UK was a part of the European Union" they remain "legally binding". It added: "The CMA has now assisted the NHS to secure binding undertakings from Aspen, under the law of England and Wales, which enshrine the UK elements of the commitments and are enforceable by UK courts, including in relation to the supply of these drugs in Northern Ireland and Scotland." This allows NHS to monitor and ensure compliance by Aspen following the UK's exit from the EU. In 2017, the European Commission began an investigation into Aspen over concerns that the company had engaged in excessive pricing for 6 off-patent cancer medicines.

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year. It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost. One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year. "Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer. Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

Vial is a technology enabled Contract Research Organization (CRO) that delivers faster, higher quality trial outcomes.

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

BioNTech and Pfizer are to start tests on humans of next-generation vaccines that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations. In presentation slides posted on BioNTech's website for its investor day, the German biotech firm said its aim was to "provide durable variant protection". The two companies are currently discussing with regulators enhanced versions of their established shot to better protect against the Omicron variant and its sublineages. The virus' persistent mutation into new variants that more easily evade vaccine protection, as well as waning human immune memory, have added urgency to the search by companies, governments and health bodies for more reliable tools of protection. As part of a push to further boost its infectious disease business, BioNTech said it was independently working on precision antibiotics that kill superbugs that have grown resistant to currently available anti-infectives.

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.

The drug, 'durvalumab', can double the overall time someone can survive with an aggressive form of lung cancer from two-and-a-half to five years. It has been approved by the National Institute for Health and Care Excellence (NICE) and the NHS has sealed a deal with manufacturer AstraZeneca to begin rolling it out. The new treatment will be offered to more than 550 patients a year with advanced non-small-cell lung cancer (NSCLC) who have already undergone both chemotherapy and radiotherapy concurrently. NHS said: "The drug can stop the cancer from getting worse for more than two years - significantly longer than treatment with a combination of chemotherapy and radiotherapy, which can only hold the disease at bay for around six months. This increases overall survival time and gives patients more precious moments with their loved ones." Dame Cally Palmer, national cancer director for NHS England, said: "We are resolute in our ambition to fight the devastating effects of cancer and new pioneering treatments like durvalumab are a vital lifeline for people living with cancer - giving them more precious time with family and friends.

The Association of the British Pharmaceutical Industry (ABPI) has proposed a Voluntary Scheme for Pricing, Access and Growth (VPAG) that aims to deliver a sustainable approach to medicines provision and maximise the growth potential of the UK life sciences industry. It has published the industry's vision for a new agreement with the government which will deliver for patients, the NHS and the economy. VPAG also includes measures to ensure rapid patient access and adoption of new medicines, as well as opportunities to improve health outcomes and productivity for the whole country. The association's proposals consist of four key areas: restoring an internationally competitive commercial environment for life sciences; supporting UK clinical research and R&D; ensuring rapid patient access and uptake of new medicines; and improving population health and productivity through health innovation. The proposal would deliver over £1bn a year to the NHS - around £300m more than the average delivered under the old scheme before 2023, and comfortably more than the highest contributions ever made before the pandemic.

The Association of the British Pharmaceutical Industry (ABPI) has suspended the membership of Novo Nordisk for two years due to serious breaches of its Code of Practice. The action was taken by the ABPI Board following an investigation and appeals process conducted by the Prescription Medicines Code of Practice Authority (PMCPA) which found Novo Nordisk to be in breach of the ABPI Code of Practice, including Clause 2 which deals with actions "likely to bring discredit on, or reduce confidence in, the pharmaceutical industry". Having considered the case and requesting a further detailed audit of Novo Nordisk's compliance processes, the ABPI Board decided to suspend Novo Nordisk from ABPI membership. Susan Rienow, President-Elect, ABPI, said: "The ABPI Board has carefully considered the PMCPA's case report into Novo Nordisk and the subsequent audit of their compliance procedures. "The Board expressed significant concern about Novo Nordisk's compliance activities and the very serious issues identified. As a result, the ABPI Board have taken the decision to suspend Novo Nordisk from ABPI membership.

The European Union's health regulator on Friday said it had recommended granting a conditional marketing authorisation for a gene therapy by Australian drugmaker CSL Ltd and partner uniQure N.V. , to treat haemophilia B, a rare bleeding disorder which is caused by genetic anomalies. About one in 40,000 people are affected by the inherited disorder, caused by a gene mutation that hampers the body's ability to make clotting protein factor IX. If approved, the treatment, branded Hemgenix, will be the first gene therapy in the European Union for the condition that is usually treated by regular injections of factor IX, the European Medicines Agency said. CSL had acquired exclusive global rights to Hemgenix in May last year from uniQure N.V.

Many people with advanced Parkinson's disease are currently required to take more than 20 pills a day to manage their symptoms, while some necessitate treatment through a permanent feeding tube. Soon, patients will only be required to wear a portable kit to get a continuous dose of the medication delivered into their bloodstream 24 hours a day. This innovative treatment, called Produodopa, will now be made available on the NHS, providing benefit to nearly 1,000 people with advanced Parkinson's disease, according to a BBC report. James Palmer, NHS England's medical director for specialised services, told the publication that the drug's rollout will offer "a vital new option on the NHS for those who aren't suitable for other treatments such as deep brain stimulation." He added that the new therapy will help patients manage their symptoms "more effectively" and improve their quality of life.