Type 2 diabetes drugs linked to deadly ketoacidosis

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A new class of drugs, SGLT2 inhibitors, used to treat type 2 diabetes have been linked to diabetic ketoacidosis which can be deadly if left untreated.

A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns.

These prescription drugs are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine.

The drugs are sold under the brand names:Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin).

Between March 2013 and June 2014, the FDA received 20 reports of the drugs triggering ketoacidosis, in which levels of blood acids called ketones are too high. If untreated, ketoacidosis can lead to a diabetic coma or even death, according to the American Diabetes Association.

All 20 patients had to go to an emergency department or were hospitalised, the FDA said.

Ketoacidosis typically affects people with type 1 diabetes, but all of these cases involved people with type 2 diabetes and the condition manifested itself slightly differently than in people with type 1 diabetes, the FDA said in a news release.

The agency said it’s investigating the issue to see if changes are needed in the prescribing information for . The drugs are approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Patients taking SGLT2 inhibitors should monitor themselves for any signs of ketoacidosis and seek immediate medical attention if they develop symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness, the FDA said.

Testing for ketones

Ketones can be detected with a simple urine test using a test strip, similar to a blood testing strip, and you should ask your health care provider about when and how to test for ketones, according to the diabetes association.

Patients shouldn’t stop or change their diabetes medications without first talking with their doctor. If ketoacidosis is confirmed in a patient, doctors should take the patient off SGLT2 inhibitor, take appropriate action to correct the condition and monitor sugar levels, the FDA advised.

Taken from Health24 / HealthDay

Synthetic Drugs: Evidence That They Can Cause Cancer

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Almost weekly, a new synthetic psychoactive drug comes onto the market somewhere in Europe that can be ordered legally and easily, for example as an incense blend, via the Internet.

Synthetic cannabinoids are difficult to identify chemically and the possible unwanted toxic effects that can occur following their consumption have so far barely been investigated. As part of the international EU project “SPICE II Plus”, which is now coming to an end, scientists from the MedUni Vienna’s Institute for Cancer Research have now also found evidence that synthetic substances damage the DNA of human cells and can therefore possibly have cancer-causing effects.

Synthetic cannabinoids, similar to tetrahydrocannabinol (the psychoactive ingredient of marijuana), bind to cannabinoid receptors in the human brain, triggering similar neurophysiological effects. These synthetic cannabinoids are marketed in incense mixtures as “legal highs” via the Internet and are “flooding the market”, as Siegfried Knasmüller from the Institute for Cancer Research at the MedUni Vienna warns.

“The substances are directly active, in other words they are not activated via enzymes that metabolise foreign substances”, explains Knasmüller. “The respiratory organs and the digestive tract especially are subjected to increased concentrations of these drugs. Our investigations on human cell lines in the laboratory have shown that synthetic cannabinoids, in the high concentrations found in cells in the oral cavity or in the lungs, for example, are likely to trigger damage to the DNA that may have significant consequences for the consumers of such substances. They damage chromosomes, and this is directly associated with cancer.”

Effects on consumers cannot be quantified

Synthetic cannabinoids bind very differently and some have an effect even in very small quantities. Consumers have absolutely no information about the varying levels of effect, since they are unaware of the detailed composition of synthetically manufactured drugs. Even with “known” products, the type and quantity of ingredients added change constantly. The risk of an unwanted overdose is correspondingly great. As a result, there have been repeated cases of damage to users’ health or poisoning, and in some cases users have even died.

Between 2005 and 2012, the European Union’s early warning system registered just under 240 new psychoactive substances that were disguised as incense blends, bath salts or plant fertiliser, and around 140 of them contained synthetic cannabinoids.

Source: Medical University of Vienna 

Sun Pharma and Technion form oncology research pact

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Mumbai-based Sun Pharmaceuticals Industries is teaming up with the Israel Institute of Technology Technion to develop new oncology drugs.

This agreement aims at the development of a joint project, based on new findings by Nobel Prize laureate Professor Aaron Ciechanover, Dr Gila Maor and Professor Ofer Binah – that can potentially lead to the development of novel anti-cancer drugs.

“We are very excited about this new endeavour between Sun Pharma, with the Technion. We are confident that this collaboration will help us move rapidly forward with our research” note Ciechanover and Binah. “We explored several collaboration alternatives, but Sun Pharma’s market leadership and its long term commitment have made this collaboration a very high priority for us.”

Whilst no financial details have been unveiled, the news leads to an unusual pairing between Sun Pharma as the world’s fifth largest speciality generic pharma company and India’s top drug firm – with the oldest university in Israel’s Technion, that was founded back in 1912.

Sun Pharma just recently closed its mega merger deal with fellow Indian giant Ranbaxy and began the integration of the two businesses. The firm says the combined force will now allow it to expand its R&D capabilities, increase its presence in emerging markets, and ‘strengthen its M&A bandwidth’.

Both Sun and Ranbaxy have provoked the ire of regulators over the past year with escalating manufacturing woes, as well as claims of insider dealing that almost brought the merger to an end. The deal was signed off by the US Federal Trade Commission in February.

This latest move sees the company aiming towards fruitful ties however, as its senior VP of business development Kirti Ganorkar notes: “This collaboration is part of the various initiatives that Sun Pharma is taking to enhance its specialty pipeline. Mutually beneficial partnerships with independent research institutes, especially world renowned institutes, such as the Technion, is our preferred route to bring to the market, innovative products for unmet medical needs.”

By Brett Wells, Pharmafile online

AZ and Takeda diabetes drugs get FDA safety update

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An FDA advisory committee has said that the labels of two type 2 diabetes drugs should be changed to warn of the risk of heart problems.

The panel discussed trial results suggesting that both AstraZeneca’s Onglyza (saxagliptin) and Takeda’s Nesina (alogliptin) – from the DPP-4 inhibitor class of diabetes treatments – could increase risk of hospitalisation due to heart failure.

Both drugs were found to have an increased risk of lower than 30% – the level defined as unacceptable by the trials – and were voted to have an acceptable safety profile. However, the panel recommended that the treatments’ labels should now include data from these trials to inform patients of the potential risk.

“Patients with diabetes are at an increased risk of cardiac related comorbidities such as heart disease and stroke, as well as hospitalised heart failure and cardiac death,” says Professor William White, on behalf of the steering committee and investigators for Nesina’s trial.

“Today’s advisory committee recommendation provides important information about Nesina that may be useful for prescribing physicians as they consider appropriate treatment options for patients with type 2 diabetes.”

The safety of diabetes drugs has been an area of increasing concern for the FDA, and in 2008 it requested pharma firms to conduct trials to assess the risk of cardiovascular problems in treatments such as these.

Results from Onglyza‘s SAVOR trial were analysed earlier this week, and suggested a 27% increase in hospitalisation due to heart failure in patients taking the drug. The committee voted 13 to one, with one abstention, that this was an acceptable risk.

There were also concerns that that the medicine may ‘significantly’ increase all-cause mortality, although analysis of the results from the FDA found no clear reason for the higher number of deaths compared to patients taking placebos.

In a statement AstraZeneca says it will conduct further investigations to better understand the hospitalisations arising out of the SAVOR results.

The FDA is not obliged to follow the advisory committee’s recommendations, but is likely to do so.

The US regulator is awaiting results from a similar study into Merck’s Januvia (sitagliptin) – another DPP-4 inhibitor – which are expected in June. These could show whether cardiovascular risks are a problem with the entire drug class or just individual treatments.

By George Underwood – Pharmafile online

FDA lifts ban on Pfizer Lilly pain study

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Pfizer and Eli Lilly will resume Phase III clinical trials of tanezumab following the FDA lifting a ban on trials of this class in pain medicines.

As a result, Pfizer will receive a $200 million payment from Lilly under the terms of a collaboration agreement between the two companies to jointly develop and sell the drug.

The companies had been conducting late-stage trials of tanezumab in 11,000 patients with chronic pain. But in 2012 the US regulator placed a hold on these studies after nervous system side effects emerged during studies of similar drugs – monoclonal antibodies that block a protein called nerve growth factor (NGF) – conducted by other companies. Trials of tanezumab and other NGF receptor blockers for terminal cancer pain were allowed to continue.

The FDA has now lifted the hold on studies of tanezumab for chronic pain “after a review of a robust body of non-clinical data characterising the sympathetic nervous system response to tanezumab”, the regulator says.

In 2010 Pfizer had suspended late-stage trials of tanezumab, despite showing initially promising results as a treatment for knee and lower back pain in people with osteoarthritis after reports that patients’ osteoarthritis had worsened – although the FDA later recommended that the osteoarthritis trials could continue if patients taking other non-steroidal anti-inflammatory drugs were excluded.

“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” says Steve Romano, senior vice president and head of global medicines development at Pfizer’s global innovative pharmaceuticals business.

And David Ricks, Lilly senior vice president and president of Lilly bio-medicines adds: “We’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions.”

It is estimated that nearly one in five adults suffer from chronic pain. Should tanezumab be approved, it could reach sales of $100 million in 2020, according to financial services company Cowen and Co. This could rise if the drug is approved for other pain conditions including terminal cancer pain and diabetic neuropathy.

By Lilian Anekwe, Pharmafile online

Baxter’s haemophilia drug performs

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Baxter International has reported positive Phase III [BW1] clinical trial results for its investigational haemophilia drug BAX 817.

The recombinant factor VIIa (rFVIIa) treatment for people with haemophilia A or B who develop inhibitors – a molecule that binds to an enzyme and decreases its activity – was tested for its safety and efficacy in male patients ages 12 to 65.

The study met its primary endpoint with an overall success rate of 92%, 98% and 85% in each dosing group respectively. Furthermore, almost 90% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.

“The development of inhibitors remains one of the most significant challenges in treating haemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes,” comments John Orloff, who is the vice president and global head of R&D at Baxter’s BioScience division.

He adds: “These positive results reflect our commitment to addressing the complex treatment of haemophilia patients with inhibitors, and reinforce our legacy of advancing haemophilia care worldwide.”

Haemophilia A is a rare condition which affects one in 10,000 males, according to The Haemophilia Society. B on the other hand affects around one in every 50,000, and only 20% of people with haemophilia have type B. There are approximately 6,000 people living with the condition in the UK.

Both types have the same symptoms but they are caused by problems with different clotting factors. Both are inherited conditions that affect the blood’s ability to clot – typically meaning someone with haemophilia will bleed for longer than usual.

US-based Baxter recently announced its plans to split into two independent firms. Later this year its BioScience division will branch out with a focus on addressing unmet medical needs in niche areas of oncology.

Moreover, Baxter’s medical products business will remain as it is, but with more of an effort on developing new healthcare solutions in hospital and home based therapies.

Full data from the BAX 817 trial, including additional efficacy and safety outcomes, will be presented at a medical meeting later in 2015.

By Tom Robinson, Pharmafile online

Drug development contracts: can lessons be learned from healthcare delivery?

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There is a very good question to ask at the beginning of every project: “What does success look like?” If it’s not possible to define the required outcome, we should not be doing the project.

The outcome will be necessarily at the end of the project, so the next question is: “What do I need before I can work on the final outcome?” and so on to the beginning of the project, defining deliverables as we go.

I’ve planned clinical trials using a whiteboard and lots of sticky notes bearing the names of deliverables in just this manner, linking them all into a logical network by starting at the end and working forwards.

Traditionally however, contracts awarded to contract research organisations (CROs) are structured on a unitised basis, rather than as a network of deliverables.

For those not well versed in contracting, this means that projects are built up from libraries of activities, each of which has a unit cost attached, and sometimes a standard duration.

CROs with long histories have good experience of how much each activity costs. Bids can thus be generated quickly, and at the bid defence stage much of the horse trading comprises slotting activities in and out of the model.

The business development specialists in CROs will complain at my simplistic description, but I am reflecting my own experience of consulting for sponsors who have asked me to support them when commissioning major studies.

That experience has told me that unitised contracts can create a number of advantages for the CRO and not many for the sponsor; let’s have a look at some of these.

An expensive business

A global CRO confided to me not very long ago that change orders were more profitable than the baseline contract. It’s not too difficult to see why. Once the study is under way the sponsor is heavily committed, because changing the contractor is going to be highly disruptive and expensive.

So there is an incentive for the CRO to inflate the cost of any change. But also, plugging in extra activities is a cheap thing to do for CROs, because most of the negotiation was done at the bid stage.

To put it simply (again), if for example the project is running late it will require more periodic site monitoring visits. The cost per visit was negotiated and agreed at the outset so the sponsor has no option but to accept the agreed unit cost.

It is often not fully appreciated just how expensive this process can be for a sponsor. In my contract management support role, for multiple sponsors, much of my time was taken up with checking claims by CROs for additional costs.

To return to the site visit example, this meant that someone had to check that the visits being claimed had actually happened. But a site visit wasn’t a single activity; as well as the visit itself, there was writing the report, getting it reviewed, and signing it off.

So before approving the cost, all these items had to be verified by someone, and that someone has to be paid to do it. I have known sponsors to be quite sanguine about the expectation that costs will escalate.

Indeed, at the bid stage both parties expect this, but it’s really an elephant in the room. Yes, the contract wording does cater for project change, but without estimates of how much extra cost and lateness are likely.

I suspect this is because sponsors don’t like to face the possibility that anything can go wrong, but deep down they know it usually does. In my example of the unit cost of a periodic site visit, I missed out an important element – that of expenses.

Years ago sponsors became paranoid at the possibility that CROs were ripping them off by inflating expenses (as some of them probably were). So the practice of separating them as ‘pass-through’ costs became the norm.

You can see how this entails more cost for the sponsor, because all the expenses have to be checked against the pass-through element on the invoice.

The sponsor has to employ someone to do that. But the CRO is not going to handle expenses for free either, so there is usually an activity in the budget called ‘administration’ or more commonly ‘project management’, typically 15% of the whole. We end up with double-checking of expenses at double the cost.

Cost per outcome

All this stems from a focus on work done rather than on results achieved. But a sponsor surely isn’t interested in the effort expended by the CRO; only the results have any business benefit.

Indeed, one of the big current themes in the projects fraternity is benefits management. If you can’t define the benefit of any activity, don’t do it.

We could take that a stage further – if we are OK with the expected benefit, do we really care about the split between effort and pass-through expense? Well I don’t. I am, though, critically interested in the package cost for the item of benefit in the plan. In other words, the benchmark is cost per outcome.

This argument of course doesn’t only apply to drug development; it applies to any industry, and not just to R&D either. To my mind, a sponsor who insists on micro-managing a contractor by tracking every task and every expense is making their life unnecessarily difficult.

Yet sponsors have paid me to set up systems to do just that. They had to do this because by the time I came on board they were well down the road of a unitised contract with no chance of going back.

There can be no doubt that healthcare delivery is also an industry, albeit a largely public sector one in the UK. Social media are currently seething with the widely-held belief that the Conservative party intends to privatise the National Health Service.

I don’t propose to get into a political argument here, but I do want to look at how contracts work in the NHS, to see if there is anything for us to learn in pharma.

In reality, outsourcing in the NHS is not new. It has always been obliged to buy in certain services. But the Health and Social Care Act 2012 places the onus on commissioners to invite tenders from any qualified provider.

As I say, nothing new in this, other than the pressure to do it, and the NHS ‘internal market’ goes back decades. Hence there should be reasonably long experience of negotiating contracts.

The said Act is quite heavily reliant on outcomes, although rather vague as to how they will be achieved. Evidence-based clinical practice is not mentioned anywhere. We should expect that the outcomes for both the pharmaceutical R&D contract and the healthcare delivery contract are closely aligned.

Both sectors are striving to be patient-centred. For a clinical trial, the desired outcome is to verify a patient benefit from the medicine. For healthcare delivery, the patient outcome may be assessed via quality of life instruments, although of course more specific measures are also used.

Making care integration work

I have identified some progress towards a more modern type of contract in the NHS, as reported by the King’s Fund. Their Commissioning and Contracting for Integrated Care report highlights “holding providers to account for outcomes” as one of three main ambitions for contract managers.

To make care integration work, the author Rachel Addicott also identifies outcomes as comprising one of the three underlying principles of organisational integration, along with service integration and alignment of currencies, to streamline payments between providers.

There is some evidence that this is not just an academic exercise from a health-related think tank. The Oxfordshire Clinical Commissioning Group has issued a work programme on outcomes-based commissioning that apparently has attracted attention from several other CCGs.

It initially aims at care for mental health and for older people, both identified as having especially heavy demands on services. A wide range of advantages is expected to accrue, but I am particularly taken with the prediction that things will be simpler to implement.

A focus on the outcome will – it is said – mitigate against the high degree of fragmentation that prevails at present. With clinical trials becoming immensely complex, this struck a chord. I’m not suggesting that the more modern contract format will make trial protocols simpler, but it could signal a move away from the need to model every protocol item in the contract.

I also like the idea that the Oxfordshire CCG model releases providers to design services “to suit the needs of patients, under a single contract, with fewer process targets”. We have seen cases of suboptimal clinical trials resulting from unimaginative protocols, such as the notorious TG1412 disaster, and much of the time these have been dictated by sponsors.

Why not cut the brief to the CRO right down to the outcomes required, and ask for their ideas? This approach is very close to the project definition process that I taught to trainees for many years. The problem was that most of them had no scope to do that, and just had to conduct protocols that had already been set in stone.

So what type of contract is the norm among CROs these days? Ronald Openshaw, chief executive of Simbec-Orion, doesn’t see any significant trend towards an outcomes basis. He gives the example of a single study in a relatively uncommon condition, where the sponsor company was certain that it could be carried out with five investigator sites.

Simbec-Orion, with their experience in that therapeutic area, knew that 15 sites would be needed. The gap could not be bridged.

I suggested that both parties were not going to agree on the number of sites, but could agree on the outcome, so that should have been the basis of the negotiation. Openshaw feels it would be ‘wonderful’ if a client were to come to him with just a desired outcome, but nobody ever does.

He points out that a purely outcomes-based contract would not work as a business proposition as all CROs need cash flow – nobody can wait until the end before getting paid. I think this is a given, and contracts would ideally be structured with a mix of outcomes and interim deliverables as milestones.

Where there’s a will there’s a way

There is a way though in which a CRO can buy into the results of a trial, by accepting equity in lieu of some fees.

Sponsors seem to be constrained by the fear of delegating too much responsibility, and indeed they are legally responsible under medicines legislation. A profit-sharing deal should allay some of that fear, and of course is not new in the pharmaceutical industry. But I think it only really affects the financial clauses of the contract.

Sponsors and CROs of course have different objectives. TranScrip Partners supports many pharma companies in the management of R&D projects (among other activities), and senior partner Dr Mark Watling alludes to the CROs’ love affair with the item-of-service contract.

Perhaps they rely on sponsors’ carelessness or naiveté when signing off a contract – anything they have missed immediately triggers a change order, at higher cost. Because both parties are so risk-averse, Watling doesn’t see the unitised contract disappearing.

Maybe it can be improved by building in rigorous timelines, but whatever its structure it depends critically on the quality of project management within both client and contractor (a recurring theme of mine!). Not that CROs are always comfortable with the escalating complexity of contracts these days, made much worse by the increasing influential involvement of legal departments.

Nevertheless, I have not detected a clear refusal by CROs to consider outcomes as contract targets, contrary to my expectation. Any reluctance seems to stem more from sponsors, who are fearful of relying on the experience of CROs who have an appropriate specialism.

It does appear that there are some learnings available from what is going on in the NHS, although healthcare delivery is not the same as R&D. Making things simpler is usually good, and outcomes can help towards that.

The hurdles to be jumped seem to be rather more mental than methodological ones.

With R&D costs continuing to sound alarm bells around the world, it behoves pharmaceutical companies to be creative and explore innovation not just in the drugs themselves, but in the way they are developed.

Les Rose is a freelance clinical science consultant and medical writer

Pharmafile online

NICE recommends hep C and bowel treatments

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Three drugs to treat chronic bowel condition ulcerative colitis and one for hepatitis C will be funded by the NHS following final guidance recommendations by NICE.

The UK health watchdog says Merck’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Merck’s Simponi (golimumab) should be recommended as an option for treating moderate to severe ulcerative colitis.

Professor Carole Longson who is NICE’s health technology evaluation centre director, says: “This recommendation will benefit tens of thousands of people who live with this debilitating condition. We are very pleased that we can recommend all three drugs to treat ulcerative colitis. Those with the condition will have more options available to them and a greater chance of controlling their symptoms, so they can have a much better quality of life.”

An estimated 146,000 people in the UK live with ulcerative colitis in which the large intestine becomes inflamed. Symptoms vary, but may include bloody diarrhoea, abdominal pain, weight loss, fatigue and an urgent need to go to the toilet.

Sporadic in nature, the condition disappears for months or even years at a time, but it is thought that half of people with ulcerative colitis will relapse at least once a year – and whilst it can develop at any age the peak age appears to be between 15 and 25-years-old.

On these approvals, Chris Probert who is a Professor of gastroenterology at the University of Liverpool and vice-chair of the clinical advisers committee for Crohn’s and Colitis UK, says: “This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis.”

Remicade, Humira and Simponi are all licensed to treat moderate to severely active ulcerGilead’sative colitis in adults who have had an inadequate response to conventional therapy, or are unable to take such treatments. Remicade is also licensed to treat children and adolescents aged 6-17 years.

This drug has also been in the news of late for its biosimilar version Remsima, which was just launched by Napp in the UK for the treatment of a range of illnesses including Crohn’s disease ­– which followed Hospira’s biosimilar monoclonal antibody launch just prior.

Meanwhile NICE has been extra busy of late, as along with its final guidance this week approving Sovaldi for hepatitis C, it has also given the final nod to Johnson & Johnson’s fellow hep C offering Olysio (simeprevir).

Olysio has UK marketing authorisation for use along with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C, but this latest guidance recommends its use in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

Olysio was in fact one of the stars in J&J’s full-year sales results, and the drug has seen the introduction of a novel ‘pay if you clear’ pricing agreement with the NHS, whereby NHS England will only pay for Olysio if patients are effectively cured of the virus after 12 weeks of treatment, with Janssen (J&J’s pharma wing) refunding the cost for those who aren’t.

By Brett Wells – Pharmafile online

FDA approves Eisai thyroid drug, fast-tracks Novartis heart pill

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The FDA has approved Eisai’s thyroid cancer drug Lenvima and also granted Novartis heart pill LCZ696 a priority review.

Lenvima (lenvatinib) has been approved in the US to treat the most common type of thyroid cancer – differentiated thyroid cancer (DTC) – and is for patients whose disease has progressed despite receiving radioactive iodine therapy.

DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” says Richard Pazdur, who is the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

Lenvima was evaluated under the FDA’s priority review programme, and the drug also received orphan product designation because it is intended to treat a rare disease.

The firm is now trialling the drug for other tumour types, and Lenvima is undergoing regulatory review worldwide and the EU (where it was also granted accelerated assessment).

Speedy FDA review for Novartis 

Meanwhile there’s good news for Novartis too as the FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF).

For LCZ696 this means a welcome reduction in the total review time from 12 to 8 months, meaning the FDA could make a decision on approval as early as in August this year.

David Epstein who is the division head at Novartis Pharmaceuticals, says: “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”

In the EU the Committee for Medicinal Products for Human Use (CHMP) has also granted accelerated assessment for the heart pill.

Nearly six million people that live with heart failure in the US alone. The twice a day medicine is said to work by reducing the strain on failing hearts, and acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).

By Brett Wells, Pharmafile online

Apple hails health benefits of new watch

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Users of the upcoming Apple Watch will be prompted to be more active because ‘sitting is the new cancer’ according to Apple boss Tim Cook.

The California-based company’s chief executive told delegates at a recent Goldman Sachs Technology and Internet Conference that the device will “tap you on the wrist to remind you to get up and move”.

He explained that the gadget’s latest trick is to give you a small vibration encouraging the user to be more energetic and keep fit.

The long-awaited ‘smartwatch’ – set for release in April – will be able to calculate all kinds of data including heart rate, calories burned whilst also counting steps. Additionally it will send and receive messages, play music and make calls.

Cook explained that: “One of the biggest surprises for Apple Watch will be the breadth of what it can do.” Acknowledging that there are competitors already out there he said: “None have changed the way people live their lives.”

Apple has been pioneering its launch into healthcare for some time now, it was boosted late last year after new figures released by the Department of Health found that NHS England has spent over £1.2 million on its products since 2012.

Furthermore, a pilot programme for Apple’s mobile health platform HealthKit was rolled out across a number of US hospitals this month to help doctors monitor patients with chronic conditions.

The tech company also announced plans in early 2014 to manufacture a new health-monitoring device that will be built into a pair of headphones. The gadget will be able to track user activity during exercise and record various biometric data.

No better than smartphones?

New wearable technology benefits aside, recent work by the University of Pennsylvania investigated just how accurate the tools really are. One study got 14 participants to trial six wearables and six smartphones laden with gadgets to see how they compared.

Results found that the activity tracking systems of wearables are no better than that of smartphones. Nike’s Fuelband device was found to be the most inaccurate tracker followed by the Jawbone’s UP24, and Flex by Flitbit.

Any firms making exaggerated health claims of its wearable devices face scrutiny following new FDA guidelines on how the gadgets for medical purposes could be regulated. The rules will define what separates a healthcare device from a consumer offering.

The potential for this type of technology in the industry will only be realised if Apple and others engage effectively with consumers and healthcare authorities, and pharma will no doubt be following the developments closely.

By Tom Robinson – Pharmafile online