Pharma gossip archive : February 06 - August 10
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AstraZeneca pulls plug on Recentin filing for colorectal cancer
Pharmatimes - 28 May 2010
AstraZeneca has suffered a setback after its investigational oncology agent Recentin failed in a second late-stage trial for colorectal cancer.
The Anglo-Swedish drugmaker has announced the top-line results this morning of a Phase III study evaluating Recentin (cediranib) for the first-line treatment of metastatic colorectal cancer. The drug met the co-primary endpoint of the Horizon II study, namely improving progression-free survival, but showed no improvement in overall survival.
A couple of months ago, Recentin failed in another mCRC tstudy, Horizon III, which was a head-to-head trial with Roche’s blockbuster Avastin (bevacizumab) plus chemotherapy. As a result of these two trials, AstraZeneca says it does not intend to file regulatory submissions in first-line mCRC.
This is not the end of the road for Recentin, however, as the results of a Phase III study evaluating the drug for the treatment of recurrent glioblastoma are expected soon. The company added that it “currently examining whether cediranib may have applications in a number of different tumour types”.
Complete data from the two Horizon trials will be submitted to a forthcoming medical congress, AstraZeneca added.
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FDA panel backs Theratech drug for excess fat in HIV patients
Pharmatimes - 28 May 2010
Canada’s Theratechnologies and partner Merck KGaA are celebrating after advisors to the US Food and Drug Administration gave a unanimously positive recommendation to the former’s Egrifta for the treatment of excess abdominal fat in HIV-infected patients.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 that Egrifta (tesamorelin) should be granted marketing approval to help HIV-infected patients with lipodystrophy, for which there is currently no approved treatment. The compound is a growth hormone-releasing factor analogue and will be Theratechnologies’ first drug to hit the market if the FDA gives the thumbs-up; the agency will complete its review by July 27.
Visceral abdominal tissue in HIV-infected patients, which affects about one-third of those on antiretrovirals, is different from the type of visceral fat in people who are obese. Experts have said that excess abdominal fat has a significant negative impact on quality of life and can lead to HIV patients discontinuing their treatment.
Theratechnologies chief executive Yves Rosconi said the committee’s recommendation “reinforces our belief that the tesamorelin benefit-risk profile seen in clinical trials in HIV-patients with excess visceral abdominal fat supports approval for this indication”. The Montreal-headquartered company licensed the US rights for Egrifta in October 2008 to Merck’s EMD Serono under a deal potentially worth $215 million, plus royalties.
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Queen’s Speech unveils new Health Bill and vision for NHS
Pharmatimes - 27 May 2010
The Queen has outlined the new coalition government’s plans for introducing a Health Bill that will cement its vision for a National Health Service run by clinicians and free from political meddling.
Unveiling plans for the Health Bill in her speech to Lords and Members of the House of Commons earlier this week, Her Majesty said “the voice of patients and the role of doctors will be strengthened in the NHS to improve public health alongside actions to reduce health inequalities”.
Broadly speaking, the Bill, to be put before parliament within the next 18 months, is designed to support a patient-led NHS that is focused on outcomes as well as deliver on the government’s commitment of slashing unnecessary bureaucracy, which it sees a major drain on resources.
As previously announced, a flagship component of the Bill is the creation of an independent NHS Board that will take on responsibility for dishing out resources and providing commissioning guidance, as well as allow GPs to purchase services for their patients.
Also under the plans, the role of the Care Quality Commission will be ramped up and Monitor will be assigned new powers as an economic regulator “to oversee aspects of access and competition in the NHS”, as a means of improving service efficiency.
Furthermore, the Bill also takes forward the government’s intention to significantly trim the number of health quangos, in a bid to cut administration costs in the NHS by a third.
According to the government, the Bill will foster a new environment for the NHS, one in which patients and clinicians will have a much greater say in the direction of services and care and one in which resource waste is eliminated, under the ultimate goal of achieving outcomes “that are amongst the best in the world”, said Health Secretary Andrew Lansley.
According to Anna Dixon, Director of Policy at think-tank The King’s Fund, the Bill and other announcements in the Queen’s Speech “confirm that the NHS is embarking on a period of significant change”.
“Strengthening the role of doctors and the voice of patients will create some difficult dilemmas,” she said, and added: “In setting up an independent NHS board, careful thought will need to be given to the relationship between its responsibilities and those of ministers, who will remain accountable to parliament for NHS expenditure”.
GPs’ ‘critical’ role
Dixon welcomed the government’s acknowledgement of the critical role played by family doctors within the NHS and that changes are essential to boosting the quality of general practice. “If, as expected, these changes include transferring budgets to GPs, it will be important to learn from the previous experiences of GP-led commissioning in the UK and other countries to ensure it delivers benefits for patients and efficiency savings across the health system while ensuring accountability for public expenditure,” she said.
Also commenting on the Speech, Dean Arnold, head of the health care practice at Deloitte, said: “Putting patients first is always a positive thing to do, so too is empowering clinicians”. But he also warned that this requires “some caution as clinicians are not specialists in cost management – a skill that will increasingly be important as we seek to maximise the benefit received out of every pound spent on health”.
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ICON firms up imaging capabilities with Timaq acquisition
Pharmatimes - 27 May 2010
Underlining the growing importance of medical imaging technology to cost-efficient drug development, Irish contract research organisation (CRO) ICON has acquired Timaq Medical Imaging, a leading European provider of advanced imaging services to the pharmaceutical and biotechnology industries, for an undisclosed sum.
Clinical trials have increasing recourse to medical imaging, whether for inclusion criteria, safety assessment or as secondary and surrogate endpoints that support early ‘go/no-go’ decisions. ICON itself is already a leader in the use of core imaging laboratories, having conducted more than 500 imaging trials on behalf of clients worldwide, the company notes.
Based in Zurich, Switzerland, Timaq was co-founded in 2003 by Dr Gustav von Schulthess, chairman of radiology and director of the Nuclear Medicine Department at the University Hospital of Zurich.
As ICON pointed out, Professor von Schulthess is one of the pioneers of combined PET/CT (positron emission tomography/computed tomography) imaging, which can show metabolic or chemical activity in the body, as well as the body’s anatomical structures, as a single, fused image.
According to Ted Gastineau, president of ICON Medical Imaging, Timaq will complement the CRO’s existing US Medical Imaging operations by giving ICON a European base for the business.
“Alongside the immediate access to an experienced imaging team, Timaq’s strong links to leading medical institutions gives us access to important scientific expertise in the imaging field that will bring significant benefits to our clients,” Gastineau commented.
ICON’s global footprint will enable the combined resources to support “even the largest multi-country imaging studies”, von Schulthess added.
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Irish pharma output soars
Pharmatimes - 27 May 2010
Pharmaceutical output in Ireland soared 22% in the first quarter of 2010 over the same period last year, reaching a record high, while production in March was up 15.6% on March 2009’s levels, say new government statistics.
In comparison, this March’s output of computer, electronic and optical products was down 34.7% compared to March 2009, says the data, from the Central Statistics Office (CSO).
Pharmaceutical industry leaders are upbeat about prospects for the sector, but are calling on the government, its agencies and the research community to provide it with “active support.” The industry in Ireland is well-placed to address the challenges facing global pharma, which include upcoming patent expiries, diminished volume in research pipelines, a rising cost base, increasing competition and stringent regulatory requirements, says Matt Moran, director of PharmaChemical Ireland (PCI), a business association within the Irish Business and Employers Confederation (IBEC).
Speaking at the group’s annual general meeting this month, Mr Moran said that PCI has identified a blueprint for the type of operation that will survive into the future. “It is our aim to drive the industry in Ireland towards this ‘factory of the future’ model that combines high-quality, cost-effective manufacturing with process and product development,” he said.
“Leading international countries are grappling with the challenge of stimulating genuine collaborative initiatives between international and indigenous companies and research centres to develop and commercialise new products and services. Ireland’s small size and flexibility is a definite advantage in this regard, as it is an ideal development test bed for the global industry to experiment and scale up new product and services,” said Mr Moran.
And this week, Gerald Farrell, president of the Irish Pharmaceutical Healthcare Association (IPHA), pointed out that the industry is the largest contributor to corporation tax in Ireland and that pharmaceuticals, with chemicals and medical products, account for more than 50% of the country’s exports.
The international research-based pharmaceutical industry has been a key driver of the Irish economy over the last forty years and it sees, in Ireland, a country which is open for business and responsive to its needs, said Dr Farrell, speaking at the launch of the latest annual Pharmaceutical Healthcare Facts and Figures publication produced by the IPHA, which represents the international research-based pharma industry in Ireland.
However, he added that while in 2008 the Irish industry was producing nine of the world’s top 15 medicines, by the following year this had dropped to just five out of the top 12, as a result of patent expiries and subsequent generic competition.
“In order that the industry can play a full role in Ireland’s economic recovery it is crucial that Ireland maintains its reputation as a country that understands and values innovation and the contribution of the pharmaceutical industry,” said Dr Farrell. Referring to the government’s desire to create an “Innovation Island,” which it believes will be central to Ireland’s economic recovery, he stressed that achieving this goal will depend on efforts to ensure that the industry maintains its competitive rate of corporation tax, improve the existing R&D tax credit “and, most important of all, that Irish patients continue to have timely access to innovative medicines.”
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FDA wants more preclinical data on GSK/XenoPort RLS drug
Pharmatimes - 27 May 2010
Regulators in the USA have told GlaxoSmithKline and partner Xenoport that they want additional preclinical data on Horizant, a potential treatment for restless legs syndrome.
In February this year, GSK received a complete response letter from the US Food and Drug Administration about Horizant (gabapentin enacarbil) extended-release tablets for the treatment of moderate-to-severe primary RLS. In the letter, the agency said the firms’ New Drug Application “provides substantial evidence of effectiveness” and the FDA “had not identified a clinical safety concern that would prevent approval”.
However, a preclinical signal of pancreatic acinar cell tumours in rats was “determined to be of sufficient concern to preclude approval of the Horizant NDA” in its current form. Therefore, a week ago, XenoPort and GSK conducted an end-of-review meeting with the agency where the latter “suggested additional preclinical data and data analyses that may be useful in the evaluation of the resubmission”.
The companies are evaluating this additional work and noted that no new clinical trials “are expected at this time”. XenoPort expects the file to be resubmitted in the second half of 2010.
Orlistat label updated to include liver risk
Meantime, the FDA has approved label changes for the weight loss drug orlistat, marketed under prescription by Roche as Xenical and sold over the counter by GSK as Alli, to include safety information about cases of severe liver injury “that have been reported rarely with the use of this medication”.
The label update is based on a review which identified 12 reports of severe liver injury among people taking Xenical and one report in Alli users between April 1999 and August 2009. This is out of an estimated 40 million people worldwide who have taken the drug.
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Novartis’ patupilone fails as ovarian cancer treatment
Pharmatimes - 27 May 2010
Novartis has suffered a setback with the news that a late-stage trial of its investigational prostate cancer treatment patupilone has failed to meet its primary endpoint.
The Swiss major says that patupilone, also known as EPO906, did not show a significant overall survival advantage in a Phase III trial of patients with advanced ovarian cancer who were refractory or resistant to platinum-based therapy The comparator arm in the study was Johnson & Johnson’s Doxil/Caelyx (pegylated liposomal doxorubicin).
The study, conducted in 168 sites in 22 countries, saw 829 patients randomly assigned to intravenous patupilone (10 mg/m2) once every three weeks or Doxil (50 mg/m2) once every four weeks and were evaluated for disease status by scans every eight weeks until disease progression. Novartis did not give any details about secondary endpoints included progression-free survival, safety and overall response rate but noted that no new or unexpected serious adverse events in the patupilone arm were identified in the trial.
However, the company said it does not plan to proceed with regulatory filings based on these data. Still, this may not be end of the road for the compound, which belongs to a class of microtubule stabilisers called epothilones. It is still being evaluated in ongoing trials in multiple tumour types, including metastatic colorectal cancer, brain metastases in non-small cell lung cancer and hormone-refractory prostate cancer.
Analysts had not held out any great hopes for patupilone but Novartis had expected to file the drug for ovarian cancer this year, giving special mention to the compound at a presentation of its oncology pipeline in December.
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Genzyme celebrates US approval for Lumizyme
Pharmatimes - 26 May 2010
At last Genzyme Corp has received some good news after it emerged that the US Food and Drug Administration has given the green light to the troubled company’s Pompe disease treatment Lumizyme.
The regulator has approved Lumizyme (alglucosidase alfa), which is produced in 4,000-litre bioreactors at its facility in Geel, Belgium, not at the Allston Landing, Boston plant which was temporarily shut down after a bioreactor was contaminated with a virus. Then, in November, the FDA warned of the potential for foreign particle contamination in a number of Genzyme therapies, including another Pompe disease therapy, Myozyme (also alglucosidase alfa).
Genzyme had originally filed to manufacture the drug in Allston Landing but following the manufacturing woes at the site, the FDA rejected that idea. Therefore the company, which has spent more than 10 years and $1 billion developing Lumizyme, needed to come up with another approach, including the plan to make it in Belgium.
The FDA approval now means Genzyme will be able to sell Lumizyme to about 200 adults in the USA who have been receiving it for free under a charitable programme and to another 1,000 people who also have Pompe disease but are not yet being treated; the cost of the treatment is about $300,000 per year.
Genzyme chief executive Henri Termeer noted that the approval came ahead of the scheduled Prescription Drug User Fee Act date of June 17. The company noted that patients must be enrolled in a risk evaluation and mitigation programme and the drug will carry a boxed warning reflecting the risk of life-threatening anaphylactic reactions, severe allergic and immune-mediated reactions.
The news has gone down well with analysts, coming as it does just a day after Genzyme said it would give the US government $175 million from the sale of products that were made at the Boston facility as part of a consent decree agreed with FDA. Christopher Raymond at Robert W Baird issued a research note saying that the approval gives the firm a “much-needed credibility boost after a steady stream of bad news”.
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Lundbeck to file Lennox-Gastaut syndrome drug soon
Pharmatimes - 26 May 2010
Lundbeck says it expects to file clobazam, a compound for the treatment of one of the most severe forms of epilepsy, in the USA after presenting postive late-stage data.
The Danish drugmaker, which got hold of the rights to clobazam last year with the acquisition of the USA’s Ovation Pharmaceuticals has announced “highly statistically significant positive findings” from a Phase III study. Data from the 238-patient trial demonstrated that the two highest doses of clobazam tested (0.5 and 1.0 mg/kg) versus placebo, showed a significant reduction in the number of drop seizures in patients suffering from Lennox-Gastaut syndrome from the four-week baseline time to the 12-week maintenance period.
Clobazam was generally well tolerated and “the overall safety profile in this study was consistent with that described in literature”, Lundbeck says. The company is now “initiating interactions with the FDA as well as scientific advisors” to discuss the study outcome and the plans for submitting a New Drug Application.
LGS is characterised by multiple seizure types and represents up to 10% of all childhood epilepsies. Sudden drop attacks are a central feature of LGS and frequently result in injury, Lundbeck noted, and up to 90% of children with the syndrome are affected by "developmental delay or regression and commonly experience behavioural and sleep disturbances as well”.
Currently, clobazam is available in more than 100 countries for various uses including the treatment of epilepsy and anxiety, although it is not currently approved for any use in the USA. As for LGS, the Copenhagen-headquartered company said no one antiepileptic drug provides satisfactory relief for all or most patients; ombination treatments are often required and many LGS sufferers are refractory to standard anti-epilepsy medicines.
"There is a clear need for new treatment options [and] we are delighted to see these encouraging data,” said Anders Gersel Pedersen, head of drug development at Lundbeck, He added that “clobazam has the potential to contribute, in a significant manner” to the firm’s growth in the years to come."
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FDA revises labels on stomach drugs over bone break risks
Pharmatimes - 26 May 2010
Regulators in the USA have issued a warning that proton pump inhibitors such as AstraZeneca’s Nexium and Pfizer’s Protonix can increase the risk of fractures if used for a year or more.
The US Food and Drug Administration has changed the labels on PPIs, to include the possible increased risk of fractures of the hip, wrist and spine with high doses or long-term use of the drugs. They are used to treat gastroesophageal reflux disease, stomach and small intestine ulcers, and inflammation of the esophagus, as well as over-the-counter treatments for frequent heartburn.
The FDA noted that drugs which will be affected by the label change include Protonix (pantoprazole), Nexium (esomeprazole) and AstraZeneca’s older treatment Prilosec (omeprazole), as well as Takeda’s Dexilant (dexlansoprazole) and Prevacid (lansoprazole), plus Johnson & Johnson’s Aciphex (rabeprazole).
Joyce Korvick, deputy director for safety at the FDA’s Division of Gastroenterology Products, said that “because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk”. She added that doctors should consider “whether a lower dose or shorter duration of therapy would adequately treat the patient's condition”.
PPIs are indeed big-sellers for young and old; earlier this week, according to a eport published by pharmacy benefit manager Medco, during 2001-9, the number of children on the drugs, which are also sometimes prescribed for colic in infants - increased 147%. IMS figures for 2009 showed that sales of PPIs fell 2% to $13.6 billion, but they became the second top-selling class of medications in the USA, moving ahead of lipid regulators and coming in behind antipsychotics.
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