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
As a result of lack of commercial interest, pharmaceutical companies operating in Brazil have withdrawn from the market old and cheap medications, some of them essential and without substitutes. 12 July 2017
What is claimed to be the world's first cell and gene therapy for degenerative arthritis has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS). 12 July 2017
Californian biotech firm Amgen now has full marketing approval in the USA for Blincyto in a particular kind of acute lymphoblastic leukemia. 12 July 2017
As well as acting as the regulator to make sure therapies are safe and effective, the US Food and Drug Administration (FDA) is helping to bring precision medicine to people living with diseases that have specific genetic features. 12 July 2017
The US Food and Drug Administration (FDA) has changed its stance on a Fabry disease drug being developed by US biotech Amicus Therapeutics, paving the way for the company to submit a New Drug Application (NDA) later in 2017. 12 July 2017
The National Institute for Health and Care Excellence (NICE) today published guidance recommending approval of three drugs for the treatment of plaque psoriasis in children and young people. 12 July 2017
Ocular Therapeutix says it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its resubmission of a New Drug Application (NDA) for Dextenza. 12 July 2017
Bristol-Myers Squibb has announced that the US Food and Drug Administration will review the company’s application to broaden the label for Sprycel. 12 July 2017
The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and granted it a Priority Review designation. 11 July 2017
Financial analyst Morningstar has expressed confidence in the strength of the US healthcare market, as “continued abatement of concerns over branded drug prices helps valuations.” 11 July 2017
USA-based Concert Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its CTP-543 Phase IIa clinical trial for alopecia areata, a type of hair loss. 11 July 2017
Consumers and health professionals are advised that Danish diabetes care giant Novo Nordisk, in consultation with Australia’s Therapeutic Goods Administration (TGA), is recalling six batches of NovoPen Echo insulin cartridge holders after detecting that there is a risk that they may crack or break if exposed to chemicals in certain cleaning agents. 11 July 2017
Serving the twin purposes of creating a globally competitive biopharmaceutical industry that addresses India's major concerns around barriers to affordable healthcare, India's Department of Biotechnology (DBT) is set to roll out biosimilar drugs for diseases such as cancer, diabetes and rheumatoid arthritis, reports The Pharma Letter’s India correspondent. 11 July 2017
When plans were announced for a cap on the cost of new drugs in England made available on the National Health Service (NHS) in March, pharma companies were roundly critical of the proposals. 10 July 2017
Indian drugmaker Biocon closed 4% down at 322.05 Indian rupees on Monday after news emerged in relation to the company’s marketing authorization applications (MAAs) to sell biosimilar versions of three big-selling drugs. 10 July 2017
In a reversal of a negative draft guidance in February, the medicines cost-effectiveness watchdog for England and Wales has today issued final guidance recommending cabozantinib for some kidney cancer patients. 10 July 2017
The Hong Kong Alliance of Patients' Organizations and representatives from numerous cancer concern groups have met with physicians and politicians to discuss ways of improving cancer care in the territory. 10 July 2017
US biotech major Biogen has received approval from Japan’s Ministry of Health, Labor Welfare (MHLW) for its orphan drug Spinraza (nusinersen) to treat infantile-onset spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent Wang Fangqing. 10 July 2017
Isodiol International, a specialist in cannabis-derived pharmaceuticals, has received approval from the Brazilian medicines regulator to market Isoderm, a treatment for epilepsy and Parkinson’s disease. 10 July 2017