The first regulatory approval for a manufactured drug based on stem cells has been received for a drug to support bone marrow transplants.

Canadian regulators have approved Prochymal from Osiris Therapeutics to treat children suffering from the rare graft-versus-host disease.

The drug is prepared from stem cells obtained from the bone marrow of healthy young adult donors and replicated in culture.

A clinical trial showed the drug was effective in 60% of children suffering from the condition in whom steroid treatment had failed.

Graft-versus-host disease following bone marrow transplant is a form of transplant rejection, and can cause severe damage to the host tissues.

According to Dr Joanne Kurtzberg, director of the pediatric blood and marrow transplant program at Duke University Medical Center, the drug has saved a number of children’s lives and could increase the success rate of bone marrow transplants.

C. Randal Mills, CEO of Osiris, commented: “It’s really a good day for the concept and the hope behind stem cell therapies becoming a reality.”

The company intends to submit Prochymal for FDA approval in the same indication later this year, when it has gathered more data.

The use of adult stem cells avoids the ethical controversies surrounding the use of embryonic stem cells, offering a potential breakthrough for regenerative medicine.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Healthcare corporation 3M has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence.

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome claimed by both sides as a success.

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M in 2007 and then abandoned as having failed the necessary clinical trials to support its marketing in the EU and the US.

The MoD, its spin-out company Ploughshare Innovations and private equity firm the Porton Group together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The High Court in London found that 3M was in material breach of its obligation “actively to market” BacLite in the EU, the US, Canada and Australia, including its obligation to seek regulatory approval in the US.

However, it did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

While the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

Merck Serono has launched its easypod Connect, which monitors injection data collected by the easypod auto-injector in patients receiving growth hormones, in Europe.

The medical software is designed to display patients’ injection history from the easypod electronic auto-injector on a secured online database.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “easypod Connect is a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient.”

easypod Connect provides healthcare professionals with reports and data from the patient’s injection history, which both monitors and analyses patients treatment adherence.

The easypod Connect Observational Study (ECOS) has already been in use since its launch at the end of 2010, offering the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data.

Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono, said: “By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes.”

easypod Connect has already been launched in Canada and Australia. The medical device has not been submitted for use in the US.

Oxford, a division of patient lift provider Joerns Healthcare, has launched an online Sling Selector to help healthcare professionals select the best sling option for patients.

The online tool takes account of patient specifics, the transfer task, the safe working load and the lift to be deployed.

The Oxford Sling Selector (pictured) was demonstrated at the National Back Exchange (NBE) Conference and Exhibition 2011 in Hinckley.

The tool comes with an on-screen guide to answer any queries that arise during the selection process. It provides detailed sling information and has an account history to track patient sling usage.

Tom Bulpitt, Marketing Manager for Joerns Healthcare, said: “Selecting the most appropriate sling is crucial since it ensures a safe, dignified and comfortable patient transfer while reducing the risks associated with manual handling.

“The Oxford Sling Selector will be of particular help to those clinicians less familiar with sling equipment such as junior or trainee occupational therapists, physiotherapists and back care advisors.”

During the NBE conference Joerns demonstrated the educational tool on its exhibition stand in the main hall and during an in-depth training workshop.

The Oxford Sling Selector is free to access by all professionals and can be located at its own dedicated website or via the Resources section on the main Joerns UK website.

Oxford is an established supplier of patient handling and rehabilitation products and a division of Joerns Healthcare, an international brand with offices in the UK, the US, Canada and the Netherlands.

Popular painkillers or non-steroidal, anti-flammatory drugs (NSAIDs) can increase the risk of heart attack or stroke by a third, a study has found.

Researchers from the NHS, Hull York Medical School (HYMS), and the Institute for Clinical Evaluative Sciences in Canada found that patients with heart problems who used NSAIDs, including diclofenac and indomethacin, had a significantly higher risk of serious cardiovascular events compared to patients who did not.

Dr Patricia McGettigan, lead researcher of the study at HYMS said: “NSAIDs provide pain relief for millions of patients with chronic inflammatory disorders. The cardiovascular risk is well described but often overlooked.”

Even OTC drugs such as diclofenac were linked to serious cardiovascular risks, however, other common NSAIDs, including naproxen and low doses of ibuprofen do not appear to increase any risks.

The team of researchers based its results after reviewing 51 large scale studies of NSAIDs conducted in Europe, USA, Canada and Australia.

Dr McGettigan commented: “In choosing which one of the many available NSAIDs to use, patients and doctors would benefit from knowledge of the balance between benefit and harm for individual NSAIDs.”

Many people use NSAIDs in both OTC and prescription form for pain relief and for their anti-inflammatory effects to treat pains and aches.

In 2010, GPs prescribed 17 million NSAIDs in England alone, accounting for one in three people in the country. Of these, nearly 6 million were for diclofenac, 5 million were for ibuprofen and 3 million for naproxen, all of which can be bought without prescription.

The CHMP has recommended Astellas Pharma and Optimer Pharmaceuticals’ Dificlir (fidaxomicin) to treat adults with colon disease.

The drug specifically targets the bacteria causing the infection in the colon whilst avoiding ‘friendly’ bacteria in the gut of patients with the disease, which is also known as Clostridium difficile-associated diarrhoea (CDAD).

Ken Jones, President and CEO of Astellas Pharma Europe, said: “European patients with this potentially fatal disease can take encouragement from the positive CHMP opinion for Dificlir that a new medication for clostridium difficile infection may soon be available.”

Dificlir’s active substance is fidaxomicin, which belongs to the macrocyclic class of antibacterials and inhibits RNA synthesis by bacterial RNA polymerase.

Dr Xavier Luria, Head of Safety and Efficacy at the EMA, said: “This is a promising step forward in the Agency's drive for addressing patients' needs in infectious diseases.”

The positive opinion is based on Phase III clinical research data comparing fidaxomicin with oral vancomycin on patients in the US and Canada. Results of the studies showed that clinical cure was achieved at the end of ten days of treatment with both treatments. Furthermore, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin.

Dificlir, known as Dificid in the US, was approved by the FDA in May for the treatment of CDAD in adults.

The European Commission will deliver its final decision within three months.

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.

UK-based Astellas Pharma Europe manufactures and distributes pharmaceuticals globally with the intention to improve lives through the introduction of innovative and reliable pharmaceutical products.

Optimer Pharmaceuticals, is a biopharmaceutical company focused on developing and commercialising hospital specialty products to treat serious infections and address unmet medical needs.

Orexo AB has appointed Nikolaj Sørensen as its new Chief Commercial Officer.

He will be responsible for commercial operations, as well as development of the company’s commercial strategies, and brings a wealth of international commercial experience.

Anders Lundström, President and CEO of Orexo AB, says the company is “particularly pleased” to recruit Mr Sørensen whose “background suits the company’s strategy”.

Mr Sørensen has previously worked at Pfizer where he was a Director and Brand Team Leader for pain treatment product in Europe and Canada. He also worked as Head of Business Development and Director of Strategic Planning, plus Business Area Director for primary care products, and as Managing Director and Chairman of the board for Pfizer AB.

For the past few years, he has also been a member of the Board of the Swedish Pharmaceutical Industry Association (LIF).

The company currently has four commercialised products and several projects developed in partnership, plus three further proprietary development programs. Its new Chief Commercial Officer says he has followed the progress of the company for a number of years.

“Orexo is an exciting company that I have followed for several years,” said Mr Sørensen. “The company has a very interesting product portfolio that provides a solid foundation for a commercial organisation. I look forward to developing and executing Orexo’s strategy for sales and marketing of the company’s own products.”

He will commence his role on 1 October.

Pregnant women have been told not to take ibuprofen after new research claimed it can more than double the risk of miscarriage.

The Canadian Medical Association Journal said that the popular painkiller can increase the risk of miscarriage by 2.4 times if taken in the first 20 weeks of pregnancy.

The report stated: “Women who were exposed to any type and dosage of non-aspirin NSAID during early pregnancy were more likely to have a spontaneous abortion.”

Clinicians discovered that 7.5% (352) of 4,705 miscarriage cases were linked to a dose of nonsteroidal anti-inflammatory drugs (NSAIDs) and 2.6% of 47,050 women who did not lose their babies had taken the same drugs.

However, it has also been claimed that women may take painkillers after suffering early signs of miscarriage where no connection has been found to the drug.

Dr Virginia Beckett, spokesman for the Royal College of Obstetricians and Gynaecologists, added: “This study adds to the research base surrounding miscarriage however, it does not look at other factors which may increase a woman’s chance of having a miscarriage such as smoking and weight gain."

Previous research has suggested that NSAIDs, such as ibuprofen containing naproxen and diclofenac, may increase the risk of miscarriage because they reduce the production of vital chemicals called prostaglandins, which are necessary to implant fertilised eggs in the womb.

The findings support NHS advice that pregnant women should use paracetamol as a form of pain relief, particularly in the first and final trimesters of their pregnancies.

Janet Fyle, Professional Policy Adviser at the Royal College of Midwives, said: “We need to advise women, as midwives often do, to avoid buying over the counter medication for pain relief.”

Approximately one in five pregnancies end in miscarriage, with the highest risk in the first few weeks when many women may be unaware that they are expecting.