The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
The National Institute for Health and Care Excellence (NICE) today published final draft guidance recommending Forxiga (dapagliflozin) for treating type 2 diabetes in ‘triple therapy’. 7 October 2016
The USA’s Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, has awarded Sanofi a $37.6 million contract to supply and manage inventory for Leukine (sargramostim), for potential public health emergencies. 7 October 2016
All the drugs presenting on the Russian market will have to be labeled by a QR-code with the aim of preventing counterfeiting, according to recent statements of Denis Manturov, Russia’s Minister of Industry and Trade, reports The Pharma Letter’s local correspondent. 6 October 2016
The US Centers for Medicare and Medicaid Services (CMS) has shared its concerns with the 463% price increase charged by Netherlands-incorporated drugmaker Mylan on its EpiPen Auto-Injector (epinephrine injection, USP) over the course of four years. 6 October 2016
To better understand current and emerging trends in pediatric oncology drug development, the USA-based Tufts Center for the Study of Drug Development (CSDD) recently convened a roundtable discussion of senior leaders from drug companies, government agencies, and academia. 6 October 2016
The US Food and Drug Administration is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. 5 October 2016
Following its deliberations, the pan-Canadian Oncology Drug Review (pCODR) recently announced its decision not to recommend for provincial reimbursement for Lynparza (olaparib). 5 October 2016
Swiss pharma giant Roche has moved closer to gaining an additional indication for its rheumatoid arthritis drug Actemra (tocilizumab) – this time for giant cell arteritis (GCA). 5 October 2016
The National Institute for Health and Care Excellence (NICE) has published an evidence summary of Truvada, from US biotech major Gilead Sciences for pre-exposure prophylaxis (PrEP). 5 October 2016
The National Institute for Health and Care Excellence (NICE) today issued draft guidance not recommending US pharma giant Merck & Co’s Keytruda (pembrolizumab) to treat advanced non-small-cell lung cancer (NSCLC). 4 October 2016
UK-based Mundipharma International and Swedish drug developer Orexo have announced a European Union regulatory submission for the opioid dependence drug Zubsolv (buprenorphine and naloxone). 4 October 2016
South Korean drug developer Samsung Bioepis is closer to bring another biosimilar to the European market – this time referencing the breast and gastric cancer drug Herceptin (trastuzumab). 4 October 2016
Swiss pharma giant Roche has received a second Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration for its ALK inhibitor, Alecensa (alectinib). 4 October 2016
CPhI Worldwide, organized by UBM EMEA, today announces the findings of part iii of the 2016 CPhI Annual Report, which focuses on growth opportunities over the next five years – specifically generics consumption and approval process, the use of big data in pharma and the potential of 3D printed formulations. 4 October 2016
The European Union and the USA risk being locked into higher drug prices and a failed model of pharmaceutical innovation during negotiations for the Transatlantic Trade and Investment Partnership (TTIP), according to a joint report released today by consumer advocacy groups Health Action International (HAI), the Commons Network and Public Citizen. 4 October 2016
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance which says Tagrisso (osimertinib) from Anglo-Swedish pharma major AstraZeneca should be made available to some people with lung cancer through the Cancer Drugs Fund (CDF). 4 October 2016
Serious concerns have been raised by pharmaceutical companies in India over proposed incentive cuts to bulk drug manufacturers. With the government slashing support from a proposed outlay of $750 million to $90 million, drug manufacturers insist they would be forced to continue to depend on China for raw materials, reports The Pharma Letter’s India correspondent. 3 October 2016
The European Medicines Agency and the US Food and Drug Administration have set up a new ‘cluster’ on rare diseases to share experiences and best practices on each other’s regulatory approach to the development of medicines for these diseases. 3 October 2016
The number of people dying from opioid or heroin overdoses has nearly quadrupled in the US since the beginning of century leading to increased scrutiny of laws around prescription opioids and calls on the pharma industry to take more responsibility. Joel Levy takes an in-depth look at the issue. 3 October 2016
In response to a sharp increase in the number of patients now looking for treatment outside of FDA-approved circles, the US Food and Drug Administration has been keen to remind the public that it has a reasonable motive behind this stance, writes DR Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 3 October 2016