Diabetes tablet passes Phase III clinical trial

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As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative.

In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

Novo Nordisk’s semaglutide however permanently lowers blood glucose levels by increasing insulin production and could also treat obesity, a major underlying cause of diabetes. A recent study showed that the drug controls appetite and food cravings and could therefore generate significant weight loss.

First developed in 2012, an injectable version of semaglutide is already approved for use in the US. Now, an oral version of the drug has now passed its first Phase III clinical trial.

Semaglutide works by mimicking the action of a hormone (GLP-1) which increases insulin secretion. It can be taken orally once daily and in this 6-month trial was delivered in 3, 6 and 14 mg doses to over 700 people with type 2 diabetes.

The drug showed significant reductions in long-term blood glucose levels compared to placebo at all doses, while the highest dose also led to significant weight loss. People treated with 14mg semaglutide experienced a weight loss of over 4 kg on average.

The drug was also safe and well tolerated, causing only nausea, which reduced over time. Chief Science Officer of Novo Mads Krogsgaard Thomsen said he was encouraged by the results of the trial, adding “[The results] confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes”.

There are nine additional trials running for semaglutide with over 9000 participants, results for which will be provided later this year. Novo Nordisk plan to apply for regulatory approval for the drug in 2019.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

The FDA commissioner just laid out how ‘everybody wins’ in the US healthcare system except the patients

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  • FDA Commissioner Dr. Scott Gottlieb put the pressure on health insurance companies and pharma middlemen about the high drug prices patients are facing at a health insurance conference on Wednesday. 
  • “Sick people aren’t supposed to be subsidizing the healthy,” Gottlieb said. “That’s exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance.”
  • Gottlieb’s interested in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far. 

FDA Commissioner Dr. Scott Gottlieb has health insurers in his crosshairs.

Speaking at a policy conference hosted by America’s Health Insurance Plans, the lobby that represents health insurers, Gottlieb called out the practices insurers and pharmaceutical middlemen use that keep prices high for patients.

The Food and Drug Administration, which Gottlieb oversees, is responsible for regulating food and drugs, as well as medical devices, blood donations, veterinary products, cosmetics, and tobacco. While he has oversight into whether or not a drug is approved, the agency does not play a role in determining how much the medication costs once it’s on the market.

Even so, he did not mince words when it came to pointing out the shortcomings of the way those prescriptions get paid for.

“The top three PBMs control more than two-thirds of the market; the top three wholesalers more than 80%; and the top five pharmacies more than 50%,” he said, referring to pharmacy benefits managers, which negotiate lower prices for brand-name medications. “Market concentration may prevent optimal competition. And so the saving may not always be passed along to employers or consumers.”

That’s putting pressure on patients when they show up at the pharmacy counter.

“We continue to see a backlash against these Kabuki drug-pricing constructs — constructs that obscure profit taking across the supply chain that drives up costs; that expose consumers to high out of pocket spending; and that actively discourage competition.”

That can lead to those with chronic conditions paying more for their medication, often close to the list price if they have a high deductible health plan that leaves them on the hook for paying a certain amount before insurance kicks in. And because the rebates drug companies pay to insurers and middlemen are still getting paid, that cost gets absorbed into lowering premiums for everyone who’s insured, healthy and sick alike.

“Sick people aren’t supposed to be subsidizing the healthy,” he said. “That’s exactly the opposite of what most people thought they were buying when the bought into the notion of having insurance.”

The insurers and the pharmaceutical middlemen need to own their role in the pressure it’s putting on patients, Gottlieb said.

“Now I understand that there’s a perverse incentive to use that rebated money to lower premium costs, since most health plans compete on the sticker cost of their premiums,” he said. “But we’re living in a world where financial toxicity is a real concern for patients. And every member of the drug supply chain needs to take responsibility for addressing it.”

Gottlieb’s bringing this responsibility up due to his interest in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far.

Because of how rebates get paid out, there’s not a lot of incentive to use a cheaper version of the biologic drug, which keeps costs high.

“Everybody wins. The health plans get the big rebates. The PBMs get paid on these spreads. And branded sponsors hold onto market share,” he said. “Everyone that is, but the patients, who in the long run, don’t benefit from the full value of increased competition Congress intended.”

On Tuesday, the biggest health insurer in the US, UnitedHealthcare, said that starting in 2019, some of its members on high deductible plans would be eligible to get rebates for their medications. So, for example, if a patient went to the pharmacy for a medication that under their high deductible cost $600, that might get lowered to $300 after factoring in the rebate the insurer receives. Gottlieb called the move a “potentially disruptive step.”

“This could make the difference between patients affording their medicines and remaining adherent, or stopping effective therapy to save on out of pocket costs,” he said.

“Payors are going to have to decide what they want: The short-term profit goose that comes with the rebates, or in the long run, a system that functions better for patients, providers, and those who pay for care.”

SOURCE: www.http://uk.businessinsider.com

Green Leaf Farms receives expanded cultivation site approval

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US manufacturer of cannabis products has begun operations in a state-of-the-art facility.

Green Leaf Farms, a US-based manufacturer of medical and recreational cannabis products, has received approval for expansion of its state-of-the-art facility and commencement of operations in an additional cultivation site.

Both sets of permits were tied together, the company said, due to the complexity of the structural and mechanical engineering that was needed to integrate the operations.

Based in Denver, Green Leaf Farms is a Division of Player’s Network (PNTV). The company took home the approved building permits for Phase Three development of its production and cultivation build-out, and officially began operations in an 8000 ft2 cultivation room. The site was completed last November.

According to PNTV, the expanded building has been designed to develop new products that will differentiate Green Leaf Farms in the emerging legal marijuana industry.

The expansion includes a state-of-the-art cleanroom, genetics lab, development laboratory, an extraction facility, a commercial kitchen, product development space, automated water purification including custom dosage and nutrient centre, a bio-testing facility, curing, packaging, and media centre.

“These design approvals will allow Green Leaf Farms to complete its build-out and become what I believe will be among the most advanced marijuana production and cultivation facilities in the world,” said Mark Bradley, CEO at PNTV.

“We have combined technology with an amazing, creative workspace that will encourage innovation, product development, differentiation and operating efficiencies.”

Green Leaf Farms has announced that further details of the expanded cultivation and manufacturing facility will be disclosed in due course.

SOURCE: www.manufacturingchemist.com/news

The third wave of AI in pharma R&D

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The capabilities of artificial intelligence are advancing and its ‘third wave’ offers the ability to analyse enormous sets of data, identify patterns, and generate algorithms to explain them, to the benefit of researchers.

The digital revolution vastly accelerated the research, development, and production of new drugs. Digital technology has augmented the natural capabilities of researchers and scientists in a variety of ways. Now, artificial intelligence (AI) is poised to take this augmentation to the next level.

One of the most significant ways in which AI technology augments human capacity – particularly in an R&D context – is by automating repetitive, lower-level cognitive functions that once had to be carried out manually. This liberates drug researchers to focus on higher-level thinking. This advantage was identified early in the development of AI technology by J C R Licklider, who wrote back in 1960 in Man-Computer Symbiosis:

“About 85% of my ‘thinking’ time was spent getting into a position to think, to make a decision, to learn something I needed to know. Much more time went into finding or obtaining information than into digesting it.”… “Several hours of calculating were required to get the data into comparable form. When they were in comparable form, it took only a few seconds to determine what I needed to know.”

A related idea was expressed by Herbert A Simon with the concept of ‘bounded rationality. He wrote that humans’ decision making can be optimised when they are provided with a limited quantity of relevant, focused information and sufficient time to process it.

With the advent of contemporary AI technologies, the bounds of human rationality have been expanded. AI provides drug researchers with a greater breadth and depth of data that is simultaneously more focused and relevant than the data sets of the past, enabling researchers to optimise their decision-making capacities.

The continued advancement of AI will augment humans’ power of critical thinking in three key areas that are relevant to the medical and pharmaceutical industries: computing advanced mathematical problems, analyzing complex statistics, and generating novel hypotheses. These areas correspond to the ‘three waves’ of AI development throughout the 20th and 21st centuries.

The first and second waves

The first wave of AI development brought us ‘knowledge engineering’ optimisation programs, which solved real-world problems efficiently.

While applications specific to the pharmaceutical industry were scarce, the broader medical field benefits from first-wave AI technologies every day. Take the Framingham Risk Score Calculator, which utilises AI to predict the heart disease risk of any patient.

Machine learning programs were brought along by the second wave of AI. These solve complex pattern recognition problems using statistical analysis. Unlike their first-wave predecessors, second-wave AI programs perceive and learn – often as well as humans do.

Clinical decision support systems use second-wave pattern-recognition programs to analyse and evaluate medical test results. Similar machine-learning programs are beginning to be used by leading pharma firms in a variety of research and development contexts to predict drug effectiveness, to discover new compounds with pharmaceutical qualities, and to develop new combinations of existing drugs.

Second-wave AI is powerful, but it demands well-organised, consistently-coded, and complete data sets in order to accurately conduct its analyses. This limitation is now being overcome by the third wave of AI.

The third wave

We have now entered the third wave of AI development. Third-wave AI programs have the capacity to analyse enormous sets of data, identify patterns, and generate algorithms to explain them. These programs normalise the context of disparate data points and generate original, novel hypotheses at a faster rate and with greater accuracy than human researchers can.

Only in this third wave have AI programs reached a sufficiently advanced state to effectively analyse the vast and complex web of unstructured biological data. Until recently, biological data had to be manually cleaned and organised through extensive and costly human effort. Now, AI programs use a combination of machine learning, natural language processing, and text analytics to analyse unstructured data in real-time.

Through context normalisation, third-wave AI technology dramatically increases the quantity of data that can be analysed in the course of the drug discovery and testing process. Furthermore, it enables the simultaneous generation and testing of new hypotheses at a rate that would be impossible without such immense computing power.

Aided by this technology, drug researchers can arrive at a higher quantity of more accurate hypotheses and can test these hypotheses with unprecedented speed. The result is a significantly faster, and less expensive, discovery process, with lower risk and more effective results. Firms such as Pfizer and Johnson & Johnson are employing such methods to great effect.

Given that R&D consumes as much as 20% of pharma firms’ revenues, and that the total price of developing a new drug has ballooned by 250% in the last 30 years, it’s not surprising that firms are eager to embrace third-wave AI as a means of accelerating drug development.

SOURCE: www.pharmaphorum.com

Amryt looking to expand rare disease franchise

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UK-based specialist Amryt Pharma is looking to expand in 2018 after acquiring two rare disease treatments.

A relative newcomer to the niche rare disease market, Amryt Pharma was founded by former Astellas medical director Joe Wiley and financier Rory Nealon in August 2015, who spotted an opportunity to develop products in under-served orphan disease therapy areas.

The Irish duo in-licensed their first product, Lojuxta from Aegerion in December 2016, and have since increased its revenues by more than 50%, as well as building a corporate team and European operations.

Lojuxta is licensed to treat the rare, life-threatening disease called Homozygous Familial Hypercholesterolemia (HoFH), and Amryt has marketing rights for the drug in the EEA region, as well as Israel, Turkey and MENA markets.

The company also has in its pipeline AP101, a promising product candidate currently in a pivotal trial for epidermolysis bullosa, a rare and debilitating skin condition.

Amryt expect to bring the product to the US and European markets by 2020, and believe the global market to treat the condition is worth around $1 billion annually.

“This is an exciting time of growth and expansion for us. Rare disease companies often start up in the US and then enter the European market, but our origins mean we have a deep understanding of what’s required and the nuances of doing business in the pharmaceutical space in Europe,” said Joe Wiley.

“I believe we’re proving this with the significant growth we have delivered in the space of one year with Lojuxta.”

The privately-held company is expected to look for further growth this year, and this includes interest in further in-licensing deals.

Meanwhile, the company is planning a paediatric study for Lojuxta and is currently awaiting sign off for its study design from the EMA.

The company is also pursuing additional licences for AP101.

“We’re planning to study other severe partial thickness wound conditions, such as Toxic Epidermal Necrolysis (TENs) / Stevens Johnson Syndrome (SJS), a rare, serious disorder of skin and mucous membranes. These are being planned in parallel in order to maximise the potential value of the AP101 asset for Amryt, our shareholders and most importantly for patients.”

Plans to enter US market

As for expansion into the US, the company says it already has its first “boots on the ground” in the US and in Latin America, its teams there establishing the opportunities in the market and meeting with relevant stakeholders.

“The EB market is particularly appealing in the US – there are approximately 20 centres focusing on EB, therefore it makes it easier for a small, agile company like Amryt Pharma to work closely with them,” says Wiley.

“We can offer patients what they need as we seek to improve their quality of life, with more effective wound care.”

The design of the global trial for AP101 has already been agreed with the FDA, and the company is currently completing the pre-clinical package and preliminary safety data set the US regulator has requested in order to open the IND specific to the US.

Amryt won’t have the EB market to itself, however, and a number of companies are developing novel treatments for the condition.

These include US-based Fibrocell Science, which has just got the green light to begin phase 2 trials of its gene therapy candidate FCX-007 for recessive dystrophic epidermolysis bullosa (RDEB).

Another company in the field is Netherlands-based ProQR Therapeutics, which is working on an RNA-based therapy for dystrophic epidermolysis bullosa (DEB).

Interim analysis of the data from Amryt’s EASE trial will be available later in 2018, followed by top-line analysis.

The company expects to compile its submissions to the FDA and EMA shortly thereafter, with marketing authorisation in Europe and US anticipated late 2019, or possibly early 2020.

SOURCE: www.pharmaphorum.com/news

EMA accepts Marketing Authorisation Variation for Forxiga in adults with type-1 diabetes

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First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes.

AstraZeneca has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D. The short-term (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-relevant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5 mg and 10 mg doses.

The safety profile of Forxiga in the DEPICT clinical programme to date is consistent with its established profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in dapagliflozin-treated patients versus placebo in these T1D studies. DKA is a known complication for patients with diabetes that affects those with T1D more frequently than with T2D.

Forxiga has the potential to become the first selective SGLT-2 inhibitor approved in Europe for the treatment of T1D as an oral treatment adjunct to insulin, helping to address a significant unmet need in this patient population. Forxiga is not currently licensed for use in T1D.

About the DEPICT Clinical Programme

The DEPICT clinical programme consists of two clinical trials, DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1 and DEPICT-2 are 24-week, randomised, double-blind, parallel-controlled trials designed to assess the effects of dapagliflozin 5 mg or 10 mg on glycaemic control in patients with T1D inadequately controlled by insulin. All patients will be evaluated at week 24 and after a 28-week extension (52 weeks in total).

About Forxiga (dapagliflozin)

Forxiga is a first-in-class selective inhibitor of human sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated as both monotherapies and as part of combination therapy to improve glycaemic control, with the added benefits of blood pressure reductions and weight loss in adult patients with type-2 diabetes (T2D).

AstraZeneca continues to push the boundaries of science with Forxiga through the largest and broadest, patient-centric clinical programme. The DapaCare clinical programme currently will enrol nearly 30,000 patients in randomised clinical trials, including a wide range of mechanistic studies, and is supported by a multinational real-world evidence study (CVD-REAL). DapaCare and complementary clinical research will generate first-in-class data for Forxiga across a spectrum of people with T2D, type-1 diabetes (T1D), established CV disease, CV risk factors and varying stages of renal disease, both with and without T2D, providing healthcare providers with the evidence needed to improve patient outcomes. DapaCare underscores our commitment to following the science with Forxiga, as the first SGLT-2 inhibitor to be studied in these diverse patient populations, pursuing a holistic patient approach to address the multiple risk factors associated with CV, metabolic and renal diseases.

SOURCE: www.europeanpharmaceuticalreview.com/news/73381s

Blood test could predict response to breast cancer drug early

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A new study has found that a blood test for cancer DNA could predict if a woman is responding to the new breast cancer drug palbociclib, months earlier than current tests.

Scientists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, say the test could detect in two to three weeks whether the drug is working, although they caution that the results need replicating before they are used clinically.

The research, published today in the journal Nature Communications, was largely funded by the Medical Research Council (MRC). The researchers tested women with oestrogen receptor positive breast cancer – the most common kind – who were taking part in a clinical trial of palbociclib for advanced breast cancer.

In November 2017, palbociclib was approved for use on the NHS by NICE for women with previously untreated advanced breast cancer.

Currently, women must wait two to three months to find out if palbociclib is working, via a scan.

The new blood test instead looks for circulating tumour DNA – fragments of DNA shed by the cancer that have entered the bloodstream. The DNA mutations associated with the cancer can be detected in these samples.

The researchers found that they could predict if the palbociclib treatment would work by comparing the amount of a gene PIK3CA detected in a blood test before treatment and 15 days after starting treatment. In the study, 73 women had the PIK3CA mutation and were given blood tests before and after starting palbociclib treatment.

In these women, the researchers found that those who had a small decrease in PIK3CA circulating DNA at 15 days had a median progression-free survival (the length of time the patient survived and the cancer did not get worse) of only 4.1 months, compared to women with a large decrease in PIK3CA, who had a median progression-free survival of 11.2 months.

The test could allow the women in the first group for whom the treatment is not as effective to be identified early, so that they could consider altering their treatment.

Professor Nicholas Turner, senior author and Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Palbociclib is one of a new class of drugs that delays cancer progression for patients with advanced breast cancer, but it’s not effective for everybody. The problem is we have to wait for two to three months before doing a scan to see if the therapy is working.

“Our new study found that a blood test for cancer DNA in the first two weeks of treatment indicated whether the drug was likely to be effective. Having an early indication of how likely a treatment is to work might allow us to adapt treatment – switching some patients to an alternative drug that is more likely to benefit them.”

Dr Nathan Richardson, Head of Molecular and Cellular Medicine at the MRC, said: “This study provides early evidence that might help us understand sooner when a drug is successfully treating breast cancer, and if not, it can be discontinued and better approaches pursued.”

The research also received funding from the charity Breast Cancer Now and the pharmaceutical company Pfizer.

SOURCE: www.pharmafield.co.uk/Pf-Fox-News/General/2018/03

Migraine maven Lilly finds ‘understanding gap’ between patients, nonpatients in new survey

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Disconnects still exist in perceptions around migraines.

Surveying both migraine sufferers and average consumers, Eli Lilly found significant understanding gaps between the two.

For instance, migraine patients estimated their pain episodes lasted an average of 31 hours, while nonsufferers guessed the average fell around 21 hours. Migraine patients also rated the pain they felt much higher than the average person’s rating of what they imagined the pain to be.

“There is a huge stigma in migraine,” said Sheena Aurora, a physician who has treated migraine patients and is now a medical fellow at Eli Lilly. “… Sometimes even people with migraines don’t realize the impact of their disease. When I treated patients with migraines, I would ask them how many migraine headache days did they have, and they would have to stop and think about it.”

Lilly undertook the survey to determine migraine perceptions among three groups of people: migraine sufferers, caregivers and loved ones, and consumers who didn’t know anyone who suffers from migraines.

Other poll findings included that migraine patients feel stressed and that they’re missing out on life. Patients reported that migraines had prevented them from doing what they wanted in their lives for an average 7 days out of the previous 30 days.

During the previous year, the migraines had been severe enough to force them to miss an average of 7.4 important events, such as birthday or holiday gatherings. And an overwhelming majority—82%—agreed that it is stressful to have an unpredictable disease like migraine.

“By highlighting their unmet needs and continuing to do that, then we can help patients talk to their physicians, help physicians recognize their impact and perhaps even help payers understand the impact of migraines,” Aurora said.

She noted that the survey and other studies around migraines are important as new treatments created specifically for migraines come to market. Of the four currently FDA-approved drugs, none were designed exclusively for migraines, a fact that is often seen in low adherence when patients can’t take the side effects or don’t get enough relief, Aurora said.

Lilly is currently working to bring a new class of migraine therapy to market. The Indianapolis drugmaker has already filed a Biologics License Application with the FDA for its CGRP inhibitor maintenance drug galcanezumab, which is eventually expected to go up against contenders from companies including Amgen and Teva.

Meanwhile, Lilly’s first-in-class acute migraine candidate lasmiditan is in late-stage trials with expectations for FDA filings this year.

SOURCE: www.fiercepharma.com/marketing

Gilead takes ‘HIV eradication’ combo into clinic

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Gilead has become a victim of its own success in hepatitis C, as it has pioneered a series of blockbuster combination drugs that are eradicating the disease, but are depleting the revenue-creating pool of infected patients.

Faced with pressure from competitors such as Merck & Co in hepatitis C, the company is now turning back to its old stomping ground – HIV, for which it has developed an arsenal of drugs that can stay the disease’s progression into full-blown AIDS.

Unlike hepatitis C, HIV is currently incurable, as drugs from Gilead and competitors like GlaxoSmithKline and Pfizer can only suppress it so that infected people can live much longer lives than in the past.

HIV creates a latent reserve within a patient’s body, lying dormant within infected CD4 cells, which can become activated and lead to the disease progressing into AIDS.

Only by tackling this reserve of infected, but dormant, T-cells can the disease be cured – and scientists have been trying for years to find ways to do this.

Gilead thinks it may have found a solution to the complex problem of tackling the infected dormant T-cells so that patients can control the disease without need for drugs.

Data from a trial in rhesus monkeys infected with simian-human immunodeficiency virus (SHIV) show that an oral toll-like receptor 7 (TLR7) agonist antiviral drug, and a broadly neutralising antibody (bNAb) could be an effective HIV eradication strategy for tackling this latent reserve.

Data from a subset of SHIV infected monkeys on suppressive antiretroviral therapy (ART) demonstrated a combination of a TLR7 called GS-9620, and a bNAb called PGT121, resulted in viral suppression after ART therapy stopped.

In the proof-of-concept study, 45% – five out out of 11 – of animals receiving both GS-9620 and PGT121 did not demonstrate viral rebound for at least 168 days after stopping ART. The other six animals rebounded but then began re-suppressing the virus without ART.

The data published at the Conference on Retroviruses and Opportunistic Infections showed that in a placebo arm 11 out 11 animals rebounded, nine out of 11 treated with only PGT121 rebounded and 10 out of 11 treated with GS-9620 rebounded.

Gilead is calling the combination therapy an “HIV eradication strategy” and will test it in phase 1 trials, in people who are HIV suppressed on approved ART therapies.

Gilead’s chief scientific officer, Norbert Bischofberger, said: “GS-9620 is currently in a phase 1b dose-escalation study in ART-suppressed people living with HIV and we have advanced GS-9722, a derivative of PGT121, into phase 1 testing.”

Gilead licensed in PGT121 from Theraclone Sciences under an agreement signed in 2014, although details of the deal were not disclosed at the time.

It was part of a portfolio of broadly neutralising antibodies discovered in collaboration with the International AIDS Vaccine Initiative and The Scripps Research Institute, Florida.

SOURCE: www.pharmaphorum.com/news

Amazing wireless cancer detection device gets extended US approval

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Endomag celebrate more FDA clearance.

A Cambridge company’s novel wireless device to help locate cancer tumours has been approved for wider use.

Endomag has received approval from the US food and drug administration (FDA) to extend the indication of its Magseed magnetic marker to include both the marking of soft tissue and long-term implantation.

The Magseed marker has already been used to locate thousands of breast cancer lesions, and this FDA clearance makes it the world’s only wire-free localisation device that can be implanted into any soft tissue with no restrictions on the length of time that the marker can remain in the body.

Magseed is a tiny magnetic seed, smaller than a grain of rice, that can be detected using the Sentimag probe. In order to support its extended indication, the Magseed marker was evaluated in a number of soft-tissue models including lymph nodes, lung and thyroid tissue. The Magseed marker is at least 60 per cent smaller than competing non-radioactive localisation devices and is made from low-nickel stainless steel. It’s safe to be imaged under ultrasound, X-ray and can be safely scanned with MRI under indicated conditions. It is also impossible to break or damage during deployment, implantation or surgery.

Eric Mayes, CEO at Endomag, said: “Our team’s ability to innovate for the benefit of clinicians and their patients continues to strengthen, and it’s great to be able to deliver another ‘world first’ with this extended indication for Magseed.”

SOURCE: www.cambridge-news.co.uk/business