Pricing, reimbursement and access
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Biotechnology
US biotech firm InterMune (Nasdaq: ITMN) says that the board of the Italian Drug Agency (AIFA) has approved the pricing and reimbursement conditions for Esbriet (pirfenidone), and that the agreement has been published in the Official Gazette, the official journal of the government. 17 June 2013
Pharmaceutical
In draft guidance published today (June 14) by UK drugs watch dog the National Institute for Health and Care Excellence (NICE) it is recommending US ophthalmic biopharma specialist Alimira Sciences (Nasdaq: ALIM) Iluvien (fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies, reversing a prior draft guidance last summer (The Pharma Letter August 8, 2012). 14 June 2013
Pharmaceutical
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) this morning (June 13) issued final draft guidance not recommending US drug major Eli Lilly's Alimta (pemetrexed) for the maintenance treatment of non-small-cell lung cancer (NSCLC) following induction therapy with pemetrexed and cisplatin. 13 June 2013
Pharmaceutical
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance proposing to recommend Abilify (aripiprazole), from Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder. 10 June 2013
Generics
UNITAID's approach to transform health product markets has delivered price reductions of up to 80% for HIV/AIDS, tuberculosis and malaria medicines and diagnostics for the world's poor, according to the just released Results Beyond Investment, its 2012 Annual Report. 30 May 2013
Generics
Sales of essential and vital drugs in Russia rose by 16% to 37.85 billion roubles ($1.21 billion) in the first quarter of the current year, according to data provided by IMS Health Russia during the recent Russian pharmaceutical forum organized by the Adam Smith Institute. 29 May 2013
Generics
The value of Italy's pharmaceutical market will continue to fall in the foreseeable future, due to government support of generics and a stringent drug pricing policy, states the latest report from research and consulting firm GlobalData. 22 May 2013
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to decline the application from USA-based drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) for funding its drug Solaris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening disease of the blood. 21 May 2013
Pharmaceutical
Under the rules of the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information to studies for two drugs, US pharma behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) and Drug major Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN) Onglyza/Komboglyze (saxagliptin). 14 May 2013
Pharmaceutical
US Senator Chuck Grassley (Republican, Iowa) is looking into how hospitals are using a discount prescription drug program, known as 340B. Certain hospitals appear to be making sizeable profits from the program at the expense of Medicare, Medicaid and private health insurance, he noted. Sen Grassley asked the federal agency in the charge of the program, the Health Resources and Services Administration, about its oversight of the program. 9 May 2013
Pharmaceutical
The increasing cost of treatments for chronic myeloid leukemia (CML) in the USA has reached unsustainably high levels and may be leaving many patients under- or untreated because they cannot afford care, according to a Blood Forum article supported by nearly 120 CML experts from more than 15 countries on five continents and published on-line in Blood, the Journal of the American Society of Haematology (ASH), reported by EurekAlert. 26 April 2013
Pharmaceutical
Much to the disappointment of the company, this morning (March 27), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it does not recommend global drugs behemoth Pfizer's (NYSE:PFE) Xalkori (crizotinib) for use on the National Health Service. 27 March 2013
Biotechnology
assessing the full value of medicines when new pricing arrangements are introduced in 2014, the Ministry of Health announced March 21. 21 March 2013
Pharmaceutical
US Senator Ron Wyden (Democrat, Oregon) has released a letter written to National Institutes of Health Director Francis Collins regarding concerns about achieving a reasonable balance between getting breakthrough pharmaceuticals to market quickly, making sure patients can afford these medicines and protecting the interests of taxpayers. 20 March 2013
Pharmaceutical
Almirall (ALM: MC), Spain's largest pharma company and the licensee for UK-based GW Pharmaceuticals' (AIM: GWP) cannabis-based prescription multiple sclerosis spasticity drug Sativex, has indicted that it might withdraw the product from the German market because of an unacceptable price decision from the country's authorities. 20 March 2013
Pharmaceutical
The independent drugstore lobby is again seeking special antitrust exemptions (HR 1188) that would empower independent drugstores to charge consumers, employers, unions, and government agencies higher prescription drug prices, says the USA's Pharmaceutical Care Management Association (PCMA). 18 March 2013
Pharmaceutical
The pressure on the prices of medicines by Spanish government has seen the pharmaceutical market in Spain declined more than 7% in 2012, according to recent IMS Health's data. Moreover, the Spanish public health system debt owed to pharmaceutical suppliers stands at some 3.0 billion euros ($3.89 billion) according to trade group Farmaindustria's data, is forcing national companies to look abroad to maintain profitability, says Francisco Rosa, a journalist with Spanish newspaper El Global in an exclusive article for The Pharma Letter. 13 March 2013
Pharmaceutical
Due to repeated failures on the government's part, the health care sector in Greece has reached a definite impasse, it was agreed during the Greek pharmaceutical industry association (SFEE) annual meeting held last week. The SFEE said that the provision of pharmaceutical care is at breaking point, getting closer by the day to hitting rock bottom, and there is a risk that many medicines, including several of vital importance, will soon become unavailable to Greek patients. 11 March 2013
Biotechnology
In an early benefit assessment under Germany's Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether the fixed combination of the drugs saxagliptin and metformin, marketed by US drugmaker Bristol-Myers Squibb (NYSE: BMY) and Anglo-Swedish pharma firm AstraZeneca (LSE: ANZ) as Komboglyze and Onglyza, offers an added benefit versus the current standard treatment for diabetes. The agency also examined Cell Therapeutics' (Nasdaq: CTIC) non-Hodgkin lymphomas treatment Pixuvri (pixantrone). 4 March 2013
Biotechnology
USA-based Gilead Sciences (Nasdaq: GILD), the leading maker of HIV/AIDS drugs, yesterday posted financial results, showing that total revenues for the fourth quarter of 2012 increased 18% to $2.59 billion, exceeding analysts' expectations of $2.43 billion, according to Thomson Reuters I/B/E/S. 5 February 2013
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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