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Pharmaceutical
UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) sustained a double dose of bad news yesterday, after the UK' drugs watchdog the National Institute for Health and Clinical Excellence (NICE) rejected approving the firm's Revolade (eltrombopag) for use under the National Health in England and Wales because it is too expesnive, and its antidepressant drug candidate, under development with the USA's Neurocrine Biosciences (Nasdaq: NBIX), failed in a Phase II study. 15 September 2010
Pharmaceutical
The UK's National Health Service drug watchdog the National Institute for Health and Clinical Excellence (NICE) has asked US drug major Bristol-Myers Squibb and Japan's Otsuka Pharmaceuticals to provide more data on the effectiveness of their product Abilify (aripiprazole), as a treatment for schizophrenia in people aged 15 to 17 years. 14 September 2010
Pharmaceutical
The US Federal District Court has ruled in favor of Danish drugmaker H Lundbeck (LUND: DC) and found no violation of the antitrust laws in the company's acquisition of NeoProfen (ibuprofen lysine) Injection (10mg/mL), a drug used in premature infants with patent ductus arteriosus (PDA), a condition in which a blood vessel in the heart fails to close after birth. 13 September 2010
Pharmaceutical
As far as its pharmaceutical market in concerned, the Czech Republic retained its pole position, which it climbed to the previous quarter surpassing Greece, according to Business Monitor International's third-quarter 2010 environment ratings for emerging markets. 13 September 2010
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE), issued its Final Appraisal Determination (FAD) today, supporting the use of Danish insulin giant Novo Nordisk's Victoza (liraglutide) for patients with type 2 diabetes under the National Health Service. This is not a surprise as an earlier preliminary opinion from the NICE also favored approving the drug (The Pharma Letter June 15). 10 September 2010
Pharmaceutical
Governments around the world must work with pharmaceutical companies to create the right policy environment for research into urgently-needed new antibiotics, says Medicines Australia chief executive Brendan Shaw. 8 September 2010
Pharmaceutical
The human and financial cost from cancer is rising by the day in Turkey where 155,000 people get the disease, 60,000 of them fatally, every year. Difficulties mark bringing medicines to Turkish patients on time to treat cancer, an area of medicine where new discoveries are made and novel medicines developed incessantly, reports the local research-based pharma industry association the AiFD. 3 September 2010
Pharmaceutical
In what has been a busy week for the agency, draft guidance published yesterday (26 August), by the UK National Health Service watchdog the Institute for Health and Clinical Excellence (NICE) has recommended two treatments for multiple myeloma and reversed an earlier negative decision on .on an atrial fibrillation product. 27 August 2010
Generics
Retail prices for some of the most widely used brand-name prescription drugs in the USA shot up more than 8% in 2009, even as inflation plummeted to a record low, according to a new analysis of retail drug price trends released yesterday by the seniors lobby group AARP. 26 August 2010
Pharmaceutical
Egypt has received a grant of over half a million dollars from the USA that will fund a study on how to decrease the price of pharmaceuticals and increase their availability in the local market, reports Zawya, Daily News Egypt. US Ambassador to Egypt Margaret Scobey and Kamal Sabra, Assistant Minister of Health for pharmaceutical affairs, recently signed a cooperative agreement for the $557,704 grant. 26 August 2010
Pharmaceutical
People in England and Wales with rheumatoid arthritis will benefit from two new pieces of guidance from the drug watchdog the National Institute for Health and Clinical Excellence (NICE) published this morning, which recommends use of: Roche's MabThera (rituximab) and Abbott Laboratories' Humira (adalimumab). In addition, Pfizer's Enbrel (etanercept), Bristol-Myers Squibb's Orencia (abatacept) and Merck & Co's Remicade (infliximab) were also recommended for patients who failed other treatments. 25 August 2010
Pharmaceutical
The UK's drug use watchdog the National Institute for Health and Clinical Excellence (NICE) has rejected Roche's Avastin (bevacizumab) for the second time for use in patients with colorectal cancer that has spread because of the drug's cost relative to the benefits it provides. 24 August 2010
Pharmaceutical
A new analysis has found that short-term and long-term costs of prostate cancer care vary considerably based on which treatment strategy a man initially receives. Published early on-line in Cancer, a peer-reviewed journal of the American Cancer Society, the study finds that treatments that may be less expensive in the short-term may have higher long-term costs. 24 August 2010
article
Just ahead of the tightly fought and as of going to press still undecided Australian election which took place on August 21, an agreement was announced between the pharmaceutical trade group Medicines Australia and the Commonwealth Government that will reduce the price of hundreds of medicines on the Pharmaceutical Benefits Scheme (PBS), Medicines Australia told a Senate inquiry. 23 August 2010
Pharmaceutical
The USA's Centers for Medicare & Medicaid Services (CMS) announced last week that average 2011 Medicare prescription drug plan premiums will remain similar to rates beneficiaries are currently paying this year. This, coupled with new discounts for brand-name drugs through the Affordable Care Act, will help make medications more affordable for Medicare beneficiaries in 2011 and beyond. 23 August 2010
Generics
The prescription pharmaceutical market in Italy was valued at $24.9 billion in 2009 in a new report from Datamonitor. Key growth drivers for branded pharmaceuticals include the growing use of chronic high-value innovative treatments driven by a growing elderly population, the high proportion of the healthcare budget spent on pharmaceuticals, and a high level of brand loyalty among Italian patients. 18 August 2010
Pharmaceutical
The UK's drug use watchdog the National Institute for Health and Clinical Excellence (NICE), in a final appraisal document issued yesterday, has again stated that Swiss drug major Novartis' asthma drug Xolair (omalizumab) should not be recommended for the treatment of severe persistent allergic asthma in children aged under six to 11 under the National Health Service. The decision is, however, open to appeal. 13 August 2010
Pharmaceutical
Following ongoing advocacy campaigns spearheaded by the USA-based AIDS Healthcare Foundation (AHF) that targeted several of the largest AIDS drug companies over their pricing and rebate policies for the nation's AIDS Drug Assistance Programs (ADAPs), the federally funded, state run programs that supply lifesaving AIDS drugs to low-income Americans in need, that the last remaining major AIDS drug company, Bristol-Myers Squibb this week announced an agreement that will provide additional cost savings to cash-strapped ADAPs nationwide (The Pharma Letter July 28). 13 August 2010
Pharmaceutical
US Department of Health and Human Services Secretary Kathleen Sebelius announced yesterday that the third round of one-time, tax-free $250 rebate checks have been mailed to eligible Medicare beneficiaries whose drug costs are so high they have reached the Medicare Part D prescription drug coverage gap known as the 'donut hole.' 11 August 2010
Generics
India's Parliamentary Standing Committee on Health and Family Welfare has proposed a series of measures to make drugs more affordable and accessible to ordinary people, such as increasing the number of drugs under price control, a blanket cap on profit margins of all medicines and promoting the use of generic drugs, reports the Times of India, which notes that the measures, which seek to tackle the problem of the rising price of drugs, that now account for up to 80% of total health care costs, 'are bound to raise the hackles of the pharmaceutical industry.' 10 August 2010
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
UK pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2 polyneuropathy across England and Wales. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
Pharmaceutical
“The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable,” says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: “That is good news from a social perspective.” 21 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
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