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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 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), the cost-effectiveness watchdog for England and Wales, has today published provisional guidance, within its Appraisal Consultation Document, on aflibercept (Eylea). 8 June 2016
The European Commission has approved the use of Swiss pharma giant Roche’s Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with epidermal growth Factor Receptor (EGFR)-activating mutations. 8 June 2016
US Food and Drug Administration advisory panels yesterday voted 14 to three to recommend approval of Vantrela ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 8 June 2016
US-based Adamis Pharmaceuticals (Nasdaq: ADMS) has suffered a share-busting setback in its New Drug Application (NDA) for its epinephrine injection pre-filled single dose syringe (PFS) product for emergency treatment of acute anaphylaxis, a severe allergic reaction. 7 June 2016
A pilot study has shown the huge differences in retail prices of cancer drugs in different countries, and highlighted the burden the cost puts on patients in many parts of the world. 7 June 2016
US RNA-based drug developer Sarepta Therapeutics says that the US Food and Drug Administration has requested additional data relating to its regulatory approval for its much delayed Duchenne muscular dystrophy drug candidate. 7 June 2016
Privately-held Swiss biotech Novimmune has announced that its lead program, NI-0501, has been declared eligible for the PRIME (PRIority MEdicine) scheme of the European Medicines Agency (EMA) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH). 6 June 2016
The US Food and Drug Administration has approved marketing of a new fixed-dose combination of two FDA-approved blood pressure lowering agents. 6 June 2016
In Russia, pharma patents account for a large share of patent portfolios. In 2015 the government considered a draft bill on compulsory licensing of patented medicines, writes Vladimir Biriulin of law firm Gorodissky & Partners on the International Law Office site. 6 June 2016
The progress that has been made globally in developing treatments for rare diseases in the last 20 years is enormous. At the end of the 20th century there were just eight medicines approved in Europe for diseases compared to around 200 today. But there is still a long way to go. 6 June 2016
Plucky US microcap Celator Pharmaceuticals has rewarded its investors this morning with a 70% stock price rise after agreeing to a $1.5 billion all-cash takeout offer from Jazz Pharmaceuticals over the holiday weekend. 5 June 2016
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 2016
Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval. 3 June 2016
The US Food and Drug Administration's streamlining of the process for physicians to seek ‘compassionate use’ of investigational treatments for their patients could make it more unlikely that Sarepta Therapeutics drug eteplirsen will gain accelerated approval. 3 June 2016
UK pharma major GlaxoSmithKline and its US partner Innoviva have brought forward the proposed date for their filing of a New Drug Application (NDA) in the USA for the closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol, for chronic obstructive pulmonary disease (COPD). 2 June 2016
Rare disease drug developer BioMarin Pharmaceutical has withdrawn its European Marketing Authorization Application (MAA) for Kyndrisa (drisapersen), an experimental drug for Duchenne muscular dystrophy (DMD). 2 June 2016
The European Medicines Agency (EMA) has accepted aducanumab, an investigational treatment for early Alzheimer’s disease being developed by US biotech major Biogen, into its Priority Medicines (PRIME) program. 2 June 2016
A flexible approach towards pharmaceutical intellectual property (IP) protection and adaptive pricing is making drugs more affordable and accessible in poorer countries, according to Vlerick business school. 2 June 2016