Mylan has launched its Rivastigmine capsules to treat dementia in Alzheimer’s patients, the first generic version of Novartis’ Exelon in the UK.

Robert J. Coury, Mylan’s Chairman and CEO, said that the drug is Mylan’s second recent first-to-market generic to be launched in the UK, following the company's launch of Modafinil tablets, the generic version of Cephalon's Provigil, earlier this year.

He said that the launch marks the company’s continued “commitment of providing high quality and affordable medicines to patients around the world”.

Mylan provides global generic and specialty pharmaceuticals in 150 countries and territories.

The FDA has approved Accuray’s Dose Control System (DCS), a new feature of the company’s TomoTherapy System.

The equipment is the first dose servo-controlled helical delivery system of its kind, providing accuracy in dose stability through complex rotational treatments.

Dr Euan S. Thomson, President and CEO of Accuray, said that the device’s clearance by the FDA “is a positive step toward improving TomoTherapy System performance and customer satisfaction.”

The system introduces helical delivery to radiation therapy, providing accurate dose applications whilst sparing healthy tissue. Static delivery through the TomoDirect option provides a consistent dose rate at any angle. 

The DCS technology ensures a stable output over longer duration treatments, offering improved patient experience and overall system performance.

Based in Sunnyvale, California, is a radiation oncology company that develops, manufactures and markets personalised treatment solutions.

Pfizer has agreed to pay $14.5 million for illegally marketing overactive bladder drug Detrol, for males with benign prostatic hypertrophy.

The settlement resolves the last of ten whistleblower suits that were filed by the government against Pfizer, under which the company agreed to pay $2.3 billion dollars to resolve multiple civil claims and criminal charges.

Carmen Ortiz, US Attorney for the District of Massachusetts, said: “We hope and expect that this is indicative of a commitment to move forward in compliance with the law, and we will continue to watch vigilantly to ensure that Pfizer complies with the law in its sales and marketing of drugs sold to the public.”

It was filed that the company illegally marketed Detrol for treatments not approved by the FDA, marketing it for use in men suffering from benign prostatic hypertrophy and several allied conditions, including lower urinary tract symptoms and bladder outlet obstruction.

Tony West, Assistant Attorney General of the Justice Department's Civil Division, said: “Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse.”

The $14.5 million fine will be divided between the US and participating state Medicaid programs, with nearly $12 million going to the federal government and $2.5 million going to state Medicaid programmes.

“Settlements like this one help maintain the integrity of FDA's drug approval process and support important federal and state health care programs,” added Mr West.

This settlement is part of the government scheme to combat healthcare fraud through the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was established in May 2009.

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement to develop and commercialise a potential fixed-dose combination single pill for the treatment of HIV.

The combination would include BMS’ protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s pharmacoenhancing agent cobicistat.

Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, R&D, BMS, says the pill has the potential “simplify HIV therapy” and address unmet needs for innovative treatment options.

The combination is currently being studied in Phase II and Phase III studies in HIV-1 treatment-naive patients.

Reyataz is a prescription medicine used in combination with other medicines to treat people aged 6 years of age and older who are infected with HIV. Gilead’s cobicistat is a boosting agent that increases blood levels of certain strains of the virus.

Under the terms of the agreement, BMS will be responsible for the worldwide formulation, manufacturing, development, registration, distribution, and commercialisation. It will pay Gilead an undisclosed royalty based on the annual net sales of the product when released.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Mr Sigal.

Gilead will retain the sole rights for the manufacturing, development and commercialisation of cobicistat as a stand-alone product and for any future combinations with other agents.

Eli Lilly has withdrawn Xigris (drotrecogin alfa) from all markets due to it showing no gain in 28-day survival of septic shock patients in the PROWESS-SHOCK study.

New results showed that the drug failed to meet its primary endpoint and question the overall benefit-risk balance of Xigris for patients with severe sepsis.

Timothy Garnett, Senior Vice President and Chief Medical Officer of Lilly, said that the results were unexpected to the company. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”

Xigris was approved in the US by the FDA in November 2001, and in the EU in 2002 under exceptional circumstances for septic shock patients with multiple organ failure, in addition to best standard care.

As a condition for continued market authorisation in Europe, Eli Lilly established the placebo-controlled PROWESS-SHOCK study in March 2008, to assess the benefit-risk profile of the product.

Aside from failing its primary aim, the study also failed its secondary endpoint of reducing mortality in patients with severe protein C deficiency. The small difference in the 28-day mortality of the overall population (26.4% in the Xigris arm versus 24.2% in the placebo arm) was not statistically significant.

Xigris is administered as a continuous intravenous infusion, in one dose for a total duration of 96 hours.

The CHMP will assess the issue during its plenary meeting in November 2011.

Pharmaxis has received a positive opinion from the CHMP for Bronchitol to treat adults with cystic fibrosis (CF) in Europe.

The drug’s indication is to help clear mucus, improve lung function and reduce exacerbations in CF patients over the age of 18, which represents approximately two thirds of those who could benefit from the therapy.

Dr Alan Robertson, CEO of Pharmaxis, said that the positive opinion “is good news for the CF community, which has supported us throughout the development of Bronchitol”.

The treatment consists of mannitol administered as a dry powder in a hand-held inhaler and is to be used as an add-on therapy to standard medications already in use.

Professor Stuart Elborn, President of the European Cystic Fibrosis Society, said that the medication will be the first approved therapy in Europe to improve both lung function and reduce exacerbations when added to standard medications in use today.

“Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies,” he added.

Bronchitol’s approvals in Australia and Europe are based on two Phase III clinical trials involving more than 600 CF patients.

Bronchitol was developed in Australia and will be commercialised through the EU in collaboration with the company’s marketing partner, Quintiles.

Pharmaxis plans to undertake a clinical trial in children aged 6-17, with a view to extend the drug’s licence.

Pharmaceutical company Pharmaxis researches, develops and commercialises therapeutic products for chronic respiratory disorders.

The EMA has issued an immediate recall of certain batches of Astellas’ Advagraf (tacrolimus) after increased levels of the active substance tacrolimus were found.

The recall from pharmacies and wholesalers across the European Union (EU) is a precautionary measure after information suggested the defect does not result in a clinical adverse event.

Doctors have now been told to consider the potential impact on blood tacrolimus levels when monitoring patients who may have taken capsules from the defective batches, especially those taking maintenance therapy.

Advagraf is used as a treatment option to prevent organ rejection in adults who have had a kidney or liver transplant or to treat organ rejection.

Astellas found the defect during a routine test. It found that during the first stages of dissolution testing, an average of 70% of the tacrolimus in the capsules was released above the permitted range of 48% to 68%.

Affected batches were distributed to a number of countries across the EU, with Romania and the UK believed to have the most stock of affected capsules remaining.

The recall is not expected to affect the overall supply of the medication and Astellas has informed that EMA that replacement batches are available.

Krka, d.d., Novo mesto has formally withdrawn its marketing application for Desloratadine Krka (desloratadine) with the EMA.

The generic of Aerius was intended to be used for the relief of symptoms associated with allergic rhinitis and urticaria.

In its official letter, Krka, d.d., Novo mesto said the withdrawal was down to a change in marketing strategy.

At the time of withdrawal, the tablets were awaiting marketing authorisation by the European Commission.

The application for a centralised marketing application was submitted to the EMA in February after Aerius was authorised for use in the EU in January. Prior to its application being pulled, the CHMP issued a positive opinion at its September meeting.

Takeda Pharmaceutical has called a halt on big deals following its recent $13.7 billion buyout of Nycomed.

Takeda’s President, Yasuchika Hasegawa, has said that the company will hold back on big mergers and acquisitions to “focus on integration for the next year or two”, adding that Japanese companies have been typically poor at integrating foreign acquisitions in the past.

Hasegawa said that domestic deals are even harder to get right, and told the Wall Street Journal that “it’s not worth it”.

He commented that acquisitions outside Japan tend to work better when companies are looking to fill in gaps, such as Takeda’s plans to develop products and pipeline projects to make up for loss of patent protection on its leading drug, Actos.

Eli Lilly’s diabetes injection Bydureon, exenatide prolonged release suspension, has been preliminarily recommended by NICE.

The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE says the Institute is “pleased” to recommend another treatment option for people with the condition.

The injection improves glycaemic control by lowering the rise in blood sugar from eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors are contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimen should only be continued if a beneficial metabolic response has been proven.

Final guidance is likely to be published in February 2012.

Eli Lilly expects the drug’s increasing approval to create jobs at its US manufacturing facility in West Chester.

Bydureon was approved by the European Commission to treat type 2 diabetes in June 2011.