« Older Entries

AZ given more time to settle Seroquel suits

Thursday, September 2nd, 2010

AstraZeneca has been given more time by judges to settle 6,000 outstanding Seroquel lawsuits.

The US Judicial Panel on Multidistrict Litigation said the return of thousands of consolidated cases to judges’ home courts would delay settlement negotiations. The cases are currently in federal court in Florida.

“A remand at this juncture would likely disrupt the settlement dialog,” US District Judge Anne Conway told the panel. Returning the cases would “stall negotiations altogether,” she added.

The pharma company still faces at least 8,000 cases in both state and federal courts alleging Seroquel causes diabetes. AZ has already agreed to pay nearly $200 million to 17,500 plaintiffs.

AstraZeneca officials said they were ‘committed’ to resolving the remaining lawsuits despite the multi-million payouts.

“We remain committed to a strong defence effort, but will continue to participate in the court-ordered mediation process,” said Tony Jewell, a US spokesperson for AZ.

Seroquel is the pharma company’s second-biggest seller.

Tags: ,
Posted in Home Page News | No Comments »

Pfizer agrees deal for FoldRx

Thursday, September 2nd, 2010

Pfizer has acquired drug discovery and clinical development company FoldRx Pharmaceuticals.

FoldRx’s portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding.

Its lead product tafamidis meglumine, a disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), is currently being considered for marketing authorisation by the European Medicines Agency.

Richard Labaudiniere, President and CEO of FoldRx, said the expertise of Pfizer would help bring tafamidis to patients.

“Pfizer’s strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease,” he said.

Although no specific financial terms were disclosed for the deal, Pfizer will make an upfront payment and contingent payments if milestones are achieved.

The completion of the transaction is subject to regulatory approval in the US, which is expected later this year.

Tags: ,
Posted in Home Page News | No Comments »

Swine Flu vaccine under review

Thursday, September 2nd, 2010

GSK’s swine flu vaccine Pandemrix is to be reviewed by the European Medicine Agency (EMA) on the request of the European Commission.

The investigation will study whether there is a link between cases of narcolepsy and the vaccination after a number of reported instances, mainly in Sweden and Finland.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) will assess all available data and consult experts across the EU to determine whether there is evidence for a causal association.

Pandemrix has been used since September 2009 for vaccine against H1N1 influenza in more than 30 million Europeans.

Narcolepsy causes an individual to fall asleep suddenly and unexpectedly. Although cases have been reported in temporal association with the use of Pandemrix, it is not known if the vaccine causes the disorder.

The CHMP will also consider the so-called background rate for narcolepsy to assess possible safety concerns and any impact on the benefit-risk balance of Pandemrix.

The EMA is also liaising with the European Centre for Disease Prevention and Control (ECDC), international regulatory partners and the World Health Organization (WHO) before considering at its September meeting the need for any provisional measures to complete the review.

Tags: , , , , ,
Posted in Home Page News | No Comments »

Drug reduces mortality risk by a quarter

Thursday, September 2nd, 2010

Thousands of patients’ lives with heart failure could be saved each year by a drug which costs less than £10 a week, research has shown.

Findings from the SHIfT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) trial showed how the use of Procoralan (ivabradine) over a two-year period reduced the risk of death by more than a quarter. Results also showed a similar impact on the number of hospital admissions.

Professor Martin Cowie, the UK lead investigator for the study, said the evidence represents a “significant clinical breakthrough”.

Patients in the UK suffering with angina can be proscribed Procoralan, but currently only one in ten uses the drug.

The trial involved more than 6,500 patients in 37 countries already on standard treatments with chronic heart failure and a high heart rate of 70 beats per minute or more. Those randomly assigned additional varying doses of ivabradine saw their risk of death reduced by 26%.

“We now know that more lives can be saved and improved simply by adding ivabradine to their current treatment in order to take some of the strain off the heart,” said Professor Cowie. “It is vital that the results of this study are implemented and ivabradine is used as part of standard heart failure treatment as soon as possible.”

The Consultant Cardiologist and specialist in heart failure at the Royal Brompton Hospital added he will now prescribe patients the drug “as soon as possible”.

More than 700,000 people over the age of 45 live with heart failure, with an estimated 68,000 new cases each year. Around 40% of those affected are dead after a year. Heart failure accounts for up to 2% of the total NHS budget, with direct medical costs amounting to £625 million a year.

Procoralan costs the NHS £1.40 per day.

Tags: ,
Posted in Home Page News | No Comments »

Brinavess secures EU approval

Thursday, September 2nd, 2010

The first new medicine for recent onset atrial fibrillation (AF) in more than a decade has been approved for use in Europe.

The intravenous (IV) formulation of Brinavess (vernakalant) has been given the green light in the EU, Iceland and Norway for the conversion of recent onset atrial fibrillation to sinus rhythm in adults.

The drug is manufactured by MSD and Cardiome Pharma, and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU.

“Brinavess is the first and only agent that acts preferentially in the atria. This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease,” said Patrick Magri, Senior Vice President, General Manager, Cardiovascular Franchise, Merck.

Doug Janzen, President and CEO of Cardiome, added: “This success was made possible through the commitment and hard work of our employees and our partner Merck, the support of our shareholders, and the efforts of many dedicated medical professionals and patients who have taken part in the clinical program.”

Tags: , , , ,
Posted in Home Page News | No Comments »

EC approves innovative cancer pain treatment

Wednesday, September 1st, 2010

The European Commission has approved a new nasal spray treatment for breakthrough cancer pain (BTCP) that has been proven to provide relief within 10 minutes.

Archimedes Pharma’s PecFent, an innovative fentanyl nasal spray, has been granted a marketing authorisation to treat BTCP in adults who are already receiving maintenance opioid therapy for their chronic cancer pain.

Breakthrough cancer pain affects 24% to 95% (average 62%) of all cancer patients despite background pain medication, and many of these experience several episodes a day. In clinical trials, PecFent demonstrated onset of pain relief as early as five minutes, as well as clinically meaningful pain relief within 10 minutes.

Prof. Marie Fallon, St Columba’s Hospice Chair of Palliative Medicine, Edinburgh Cancer Research Centre (CRUK) Western General Hospital, commented: “The availability of this significant innovation is very important. Being a nasal spray, its ease of use allows patients to treat their breakthrough cancer pain episodes conveniently, wherever they are, and its unique delivery system provides fast onset of pain relief meaning so they can manage these episodes effectively. This is absolutely crucial for cancer patients and PecFent offers real hope for an improvement in their quality of life.”

Fentanyl is a highly potent opioid analgesic, which is delivered in a rapid but controlled manner using a delivery system called PecSys.

Jeffrey H. Buchalter, President and Chief Executive Officer of Archimedes Pharma, added: “The grant of European marketing authorisation for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain. This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months.”

Tags: , ,
Posted in Home Page News | No Comments »

New centre will speed therapies from ‘bench to bedside’

Tuesday, August 31st, 2010

A new drug discovery centre in Aberdeen will support the development of research findings to become new therapies.

The Kosterlitz Centre for Therapeutics will be officially opened by the University of Aberdeen next month.

The Centre will offer various kinds of support to researchers and clinicians, from helping with grant applications and filing patents, to approaching industry, pharma companies, investors and philanthropists for financial backing.

Centre Director Professor Ruth Ross, Chair in Molecular Pharmacology at the University, said: “Scientists and clinicians can be working on research or be involved in patient care when they discover something that might suggest a possible new way of treating a medical condition. However the journey from what is called ‘bench to bedside’ is a laborious one, which is incredibly time consuming, may involve expertise that the scientist or clinician does not have, and will certainly require funding.”

The Centre is named after one of the University of Aberdeen’s most famous scientists, Professor Hans Kosterlitz, who joined the University in 1933 and co-discovered how endorphins affect humans.

Dr Iain Greig, Deputy Director of the Kosterlitz Centre and a medicinal chemist at the University, added: “We want to ensure that ‘eureka moment’ a scientist or clinician may have in the lab or in a medical setting, perhaps when they identify a new receptor or pathway, doesn’t fizzle out because they don’t have the support to translate that finding into a new therapy that could help patients.

“We have already got several pharma companies on board for projects in the pipeline which we hope will pave the way for the development of new therapies for cancer, heart disease, infection and pain. We are also looking at obesity and neurodegenerative diseases.”

Tags: ,
Posted in Home Page News | No Comments »

New EU drug approved for rare disease

Monday, August 30th, 2010

The European Commission has approved a new orphan medicine for the long-term treatment of type 1 Gaucher disease.

Marketing authorisation has been granted for Shire’s VPRIV (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT).

The approval was based on data from the largest ever clinical data set for this Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints.

“Gaucher disease is a rare and often debilitating condition,” said Professor Tim Cox from the Department of Medicine, University of Cambridge, and founder of the largest UK Gaucher clinic at Addenbrooke’s Hospital.

“The European approval of VPRIV is important in that we now have an alternative, licensed therapeutic enzyme. For type 1 patients the availability of VPRIV provides further opportunities to individualise treatment options for this complex disorder.”

Due to high demand, Shire has implemented a program to monitor demand and manage requests from physicians and patients to ensure long-term, uninterrupted treatment with VPRIV.

“The marketing authorisation for VPRIV in the EU is an important milestone for Shire,” said Sylvie Gregoire, President, Shire Human Genetic Therapies. “Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the US months ahead of schedule.”

VPRIV was approved by the US Food and Drug Administration in February 2010.

Tags: , , ,
Posted in Home Page News | No Comments »

NICE backs ARBs for heart failure

Friday, August 27th, 2010

NICE has supported the use of angiotensin receptor blockers (ARBs) in its recent partial update of the chronic heart failure guidelines.

ARBs are recommended as an alternative first line therapy in patients with chronic heart failure (CHF) who are unable to tolerate an ACE inhibitor (ACE-I). For patients who are still symptomatic despite first line therapy with an ACE-I and beta-blocker it is also recommended that an ARB licensed for heart failure is added in.

Currently available angiotensin receptor blockers include candesartan, eprosartan, irbesartan, telmisartan, valsartan, losartan and olmesartan.

Dr Alan Begg, Montrose, commented, “This partial update brings NICE guideline CG5 into line with the SIGN guideline 95 published in February 2007, confirming the first line use of ARBs as an alternative to ACE-Is if the latter are not tolerated and for additional use if not controlled with a ACE-I and beta-blocker.

“If using an ARB in heart failure, candesartan stands out as the obvious choice when taking into account the CHARM Alternative and CHARM Added trials, data that is also discussed in the guideline.”

Candesartan (brand name Amias, manufactured by Takeda) is the only ARB licensed to treat CHF both as an add-on therapy to ACE-Is or in patients who are ACE-I intolerant and also taking concomitant beta-blocker therapy.

In the CHARM-Alternative study, in 2028 CHF patients who were ACE-I intolerant, treatment with candesartan resulted in a 23% reduction in the risk of death from a cardiovascular cause. The CHARM-Added study, in 2548 CHF patients who were already taking an ACE-I, showed that the addition of candesartan resulted in a further risk reduction of 15%.

Tags: , , , , ,
Posted in Home Page News | No Comments »

Duo recommended in draft guidance

Friday, August 27th, 2010

NICE has recommended two treatments for multiple myeloma in draft guidance.

Celgene’s Thalidomide (thalidomide) and Velcade (bortezomib), manufactured by Janssen-Cilag, have both been recommended by the independent Appraisal Committee.

The Committee heard from experts how the clinical effectiveness of the two regimens were equivalent; but Thalidomide regimens were more cost effective than Velcade.

Dr Carole Longson, Health Technology Evaluation Centre Director of NICE, said the Institute was ‘pleased’ to recommend the duo and help prolong patients’ lives.

Thalidomide in combination with an alkylating agent and a corticosteroid is recommended for first-line treatment when high-dose chemotherapy with stem cell transplantation is inappropriate.

Velcade in combination with an alkylating agent and a corticosteroid is recommended as a treatment option if patients are unable to tolerate or have contraindications to Thalidomide.

“We are pleased to be able to provisionally recommend these two treatments for people with multiple myleloma,” Dr Longson said. “The evidence clearly showed that both thalidomide and bortezomib regimens are more effective at delaying disease progression and improving patients’ life expectancy than the current treatment of an alkylating agent and corticosteroid alone.”

Approximately 3,600 cases of multiple myeloma are diagnosed every year in the UK.

Final guidance is expected to be published in October.

Tags: , , , ,
Posted in Home Page News | No Comments »

« Older Entries