A new quadrivalent (four-strain) vaccine for seasonal influenza has been approved by the MHRA for use in the UK.

Fluarix Tetra from GSK, which has also been approved for use in Germany, is the first vaccine of this type to gain regulatory approval in Europe.

The vaccine is approved by the MHRA for the immunisation of adults and children aged over three years, and was approved in the US in December 2012.

It offers protection against two subtypes of the influenza A virus and two of the B virus, widening the scope of the trivalent flu viruses currently in use.

GSK commented: “As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine.”

The new vaccine is expected to be available to the NHS by autumn 2013, the start of the flu vaccination season.

Sanofi Pasteur and Novartis are both working on quadrivalent flu vaccines, while AstraZeneca has one on the market in the US.

AstraZeneca has lost its appeal to the European Court of Justice against a €52.5m fine for its tactics to delay generic versions of Losec (omeprazole).

The company was fined by the European Commission in 2005 for manipulating regulatory approval in order to block generics.

According to the Commission, AZ launched a tablet version of the ulcer drug in 2001 and asked for the capsule’s authorisation to be withdrawn.

As a result, generic companies planning to launch their own capsule versions of omeprazole were blocked.

The Commission also claimed that AZ had deceived patent offices, courts and lawyers in several EU states over the date of Losec’s authorisation.

Losec, a proton pump inhibitor, was the world’s best-selling drug in 2000, but its European patent expired in 2001.

The European Commission commented that the appeal decision would prevent other companies from misusing drug regulatory procedures in order to protect their drug patents.

According to Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, “This case exposed some of the strategems that pharma companies have used to delay the launch of cheaper generic versions of their drugs.

“By upholding the ruling, the court confirmed that pharma companies have to stamp out these practices or risk a substantial fine.”

Jonas Koponen of London law firm Linklaters commented that the decision was representative of “the European Commission’s policy of removing obstacles to competition from generics”.

The restrictions on use of existing drugs in pharmaceutical R&D could be lifted under new laws proposed by the Intellectual Property Office (IPO).

The IPO’s proposed amendments to the Patents Act would rule that the use of a branded drug in a clinical or field trial does not infringe copyright.

This would make it easier for companies to compare a new drug to a branded product that is not their own, or to test a combination of the two drugs.

Current UK law allows limited use of patented drugs in tests required for the regulatory approval of generic drugs, but not of new brands.

The aim of the proposals, now out for consultation, is to create a better environment for pharmaceutical R&D in the UK.

IPO Chief Executive Sean Dennehey said: “Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials.

“This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.”

The consultation will run for eight weeks, until 19 December.

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.

GlaxoSmithKline (GSK) has reported successful phase III trials of its new diabetes drug albiglutide, which it intends to file for regulatory approval.

The injectable drug, taken weekly, outperformed a rapid-acting insulin when used in combination with a daily insulin to manage type 2 diabetes.

Analysts predict the drug will earn GSK $250m per year by 2016 – not a potential ‘blockbuster’, but a robust product in the diabetes market.

Albiglutide – awaiting a new brand name after GSK dropped the name Syncria – is the latest product in the class of glucagon-like peptide-1 (GLP-1) diabetes drugs that includes Victoza from Novo Nordisk and Byetta from Amylin and Lilly.

GLP-1 drugs stimulate insulin release when glucose levels are high, a flexible property that makes them a potential alternative to insulin in patients with severe type 2 diabetes.

They have the further advantage of stimulating weight loss, which is of clinical value to most people with type 2 diabetes.

The first phase III trial of albiglutide, reported in November 2011, found it to be less effective than daily Victoza in reducing blood glucose levels – a disappointing result for GSK.

However, armed with top-line results from seven of eight phase III studies, GSK said that the cumulative data support an application for the drug’s approval as a treatment for type 2 diabetes.

One trial tested albiglutide against Lilly’s rapid-acting insulin Humalog when used in combination with Sanofi’s daily insulin Lantus.

The patients taking albiglutide experienced a 0.82 reduction in HbA1c, compared to 0.66 in the Humalog group. In addition, The albiglutide patients also lost an average of 0.73 kg in weight, whereas the Humalog patients gained 0.81 kg.

GSK expects to have all the data it needs to apply for regulatory approval by the end of 2012.

US-based contract research firm Cetero has filed for bankruptcy protection after being put on notice by the FDA for alleged “misconduct and violations”.

The North Carolina company, which carries out early-stage clinical research and bioanalytics for a number of US pharmaceutical companies, was accused last year of faking research documents and manipulating drug samples.

The FDA has warned Cetero’s clients that they may need to repeat or confirm any studies Cetero carried out in support of their applications for regulatory approval between 2005 and 2010.

In July 2011, the FDA said it had uncovered “significant instances of misconduct and violations” at Cetero’s Houston facility.

According to Cetero’s bankruptcy filing, the FDA’s warning caused the company’s financial position to become “severely constrained” due to creditors declaring an event of default.

As part of the bankruptcy process, Cetero has reached a deal with certain lenders for the sale of the company’s assets, and has also secured Debtor-in-Possession financing of $15m to finance this process.

Over the first two months of 2012, Cetero’s revenue totalled $11m while the company had liabilities of $248 million and assets up to $10 million.

The European Medicines Agency (EMA) has piloted an electronic application form for regulatory submissions from pharmaceutical companies.

The four-month pilot will enable companies to file applications for marketing authorisation using an interactive PDF form.

This represents a step towards making the use of the Electronic Common Technical Document (eCTD) standard in submissions for EMA approval.

While companies have been able to use the eCTD for submissions to the EMA since 2003, paper submissions have remained the norm due to the complexity of the electronic process.

According to the EMA, the new process will “simplify and speed up the application process” by enabling companies to submit data in XML format, improve the quality and consistency of the data, and integrate it with controlled vocabulary lists.

The new electronic application forms for human medicines are supported by Data Exchange Standards documentation, XML schema definitions and user guidance.

A second pilot will provide access to electronic forms for veterinary medicines.

The new forms were developed by the EMA in collaboration with the European Commission services and national medicines regulatory authorities in the EU.

The Food and Drug Administration (FDA) is considering making medications for some long-term conditions available without prescription.

The US regulatory agency will hold a public meeting to discuss whether to reclassify drugs for high blood pressure, high cholesterol, asthma and migraine in order to ease patient access.

The FDA is also considering ways to accelerate the approval of drugs for Alzheimer’s disease and rare conditions, and to improve the targeting of antibiotics to specific patient groups.

FDA Commissioner Margaret Hamburg commented: “As the science is unfolding in new and exciting ways that will give us new tools, I think we are in a position to do things differently than we have historically.”

The shifting of some long-term condition medications to OTC status would require drug companies to carry out consumer use studies in order to show that customers are able to use the medicines correctly.

Despite this hurdle, the new policy could create a new OTC market opportunity for ‘blockbuster’ branded drugs such as Lipitor, which is facing a major drop in sales due to patent expiry.

This could create a new medical model for long-term condition management where the patient consults with a pharmacist rather than a doctor.

According to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, the FDA intends to expand its accelerated approval programme – currently limited to AIDS and cancer drugs – to drugs for Alzheimer’s disease and rare conditions.

Woodcock also said that in order to counter the spread of antibiotic resistance, which has “reached crisis proportions”, the FDA plans to allow companies to test new antibiotics on smaller patient groups, and to restrict prescribing to more closely defined patient populations.

These changes, which have implications for many pharmaceutical companies selling into the US market, are intended to address urgent unmet medical needs in the US population.

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.