Pricing, reimbursement and access
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Pharmaceutical
Amid the ever growing competition in the Russian pharmaceutical market, the world's largest pharmaceutical giants are gradually losing ground to local competitors, while blaming them for the use of unfair methods of competition, and expressing dissatisfaction with the actions of the Russian government to protect their interests. 28 September 2012
Pharmaceutical
Pharmaceutical brand teams eager to maximize the price of the drugs establish intricate product launch sequencing strategies to target markets more favorable to higher value assessments, according to a new study published by Cutting Edge Information. 27 September 2012
Pharmaceutical
In final guidance issued this morning (September 26), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended National Health Service use of German family-owned drug major Boehringer Ingelheim's Actilyse (alteplase) for the treatment of acute ischemic stroke. 25 September 2012
Generics
The All India Organization of Chemists and Druggists (AIOCD) - the single largest body of the drug traders in India - has written to Sharad Pawar, Chairman, Group of Ministers, at the National Pharmaceutical Pricing Policy (NPPP), to urgently finalize the new drug-pricing policy that seeks to determine prices at which pharmaceutical companies sell essential medicines in the retail market. This will dispel the uncertainty presently prevailing in the market and benefit the patient fraternity and the industry at large. 19 September 2012
Generics
The Chinese pharmaceutical industry is experiencing serious losses, due to overproduction, and decreased competitiveness of domestic drugs in the global market, which is caused by the intensive pressure from Indian rivals, says China's Chamber of Commerce for Import and Export of Drugs. 17 September 2012
Generics
A new survey shows 75% of Australians believe that the government should offer a price discount to consumers who choose generic medicines, which drive significant savings to the economy, over branded medicines. 17 September 2012
Pharmaceutical
The USA's Common Patient Assistance Program Application (CPAPA), announced by Health and Human Services (HHS) Secretary Kathleen Sebelius at the International AIDS Conference in July, went into effect this week. This single common application allows uninsured individuals living with HIV to use one application to apply for multiple assistance programs that together provide an entire course of antiretroviral therapy. 13 September 2012
Pharmaceutical
USA-based InterMune (Nasdaq: ITMN) says that French regulator the Comite Economique des Produits de Sante (CEPS) has granted reimbursement for Esbriet (pirfenidone), making it the first medicine for the treatment of idiopathic pulmonary fibrosis (IPF) to be reimbursed in France. 12 September 2012
Pharmaceutical
Swiss drug major Roche (ROG SIX) says it is "extremely disappointed" that the Scottish Medicines Consortium (SMC) has decided not to make Zelboraf (vemurafenib) available for the treatment of BRAF mutation positive unresectable or metastatic melanoma. However, there was better news for Swiss rival Novartis (NOVN: VX0, with the SMC approving use of the company's multiple sclerosis drug Gilenya (fingolimod). 11 September 2012
Pharmaceutical
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) confirmed this morning that it will reconsider its Final Appraisal Determination (FAD) not to recommend National Health Service funding of pharma giant GlaxoSmithKline's (LSE: GSK) Benlysta (belimumab) for use in adult patients with active autoantibody positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy. 7 September 2012
Pharmaceutical
New Zealand's national pharmaceuticals funding agency, PHARMAC, has announced changes to the listings for leflunomide, French drug major Sanofi's (Euronext: SAN) arthritis drug Arava. 4 September 2012
Pharmaceutical
The majority of US surveyed primary care physicians (PCPs) and pain specialists indicate that they have experienced reimbursement restrictions when prescribing Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Nucynta ER (tapentadol), for chronic low back pain, according to the latest findings of advisory firm Decision Resources. 28 August 2012
Pharmaceutical
Pharmaceutical companies, which have previously been allaying the growing fears and concerns of their investors regarding the seemingly inevitable reduction in revenues upon patent expiry, may want to slow down and avoid making unrealistic promises, suggests a new report from GlobalData. 28 August 2012
Pharmaceutical
Indirect comparison based on the RE-LYtrial (for family owned German drugmaker Boehringer Ingelheim's Pradaxa; dabigatran etexilate) and the Rocket AF trial (for German major Bayer's [BAYN: DE] Xarelto; rivaroxaban) suggests advantages of Pradaxa in stroke prevention in patients with atrial fibrillation, according to a Boehringer press statement. 27 August 2012
Pharmaceutical
Mature pharmaceutical markets such as the USA and European Union countries are showing relatively little change, in contrast to the rapidly evolving health care markets of large emerging nations, China and India, states a new report by health care experts GlobalData. 23 August 2012
Pharmaceutical
Coverage of injectable type 2 diabetes therapies by public programs for pharmaceutical assistance in Brazil is limited to regular and NPH (neutral protamine Hagedorn) insulin and does not include any insulin analogues or Glucagon-like peptide 1 (GLP-1) analogues, notes a new report from health care advisory firm Decision Resources. 22 August 2012
Pharmaceutical
The European Union faced further fallout from the global financial crisis this year, and the region's health care industry has seen pricing changes to reflect this, claims a new report by health care experts GlobalData. 22 August 2012
Biotechnology
The latest and final guidance from the UK's drug watchdog the National Institute for Health and Clinical Excellence (NICE) does not recommend Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) treatment (when used in combination with the chemotherapy drug, capecitabine) for the first-line treatment of metastatic breast cancer in people for whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. 21 August 2012
Biotechnology
In what may be an unprecedented move on drug pricing and access, advocates from the AIDS Healthcare Foundation (AHF), the USA-based global AIDS organization, are calling on state AIDS and Medicaid directors as well as a number of private medical insurers nationwide asking them to place Gilead Science's (Nasdaq: GILD)new Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate), a four-in-one, once-daily HIV/AIDS combination tablet - on "prior authorization" status on their respective drug formularies. 19 August 2012
Pharmaceutical
In India, an inter-ministerial group formed in 2007 and tasked with regulating prices of patented drugs has recommended using a per capita income-linked reference pricing mechanism, a proposal that may reduce prices of several patented medicines by up to one-third, reports the Economic Times of India. 19 August 2012
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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