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
Swiss pharma giant Roche has edged closer to gaining approval from the US Food and Drug Administration (FDA) for a second bladder cancer indication with Tecentriq (atezolizumab). 9 January 2017
US-based AcelRx believes that its lead investigational compound ARX-04 has the potential to produce over $1 billion in revenue in the US. 9 January 2017
Last week, the Spanish trade group Farmaindustria, the Ministry of Finance and Public Function and Health and the Ministry of Social Services and Equality signed the Agreement that renews, for 2017, the Protocol of Collaboration agreed back in November 2015 with the common objective to ensure the sustainability of the National Health System (NHS) and the access of citizens to pharmaceutical innovations. 9 January 2017
The biopharmaceutical industry's desire for inorganic growth is expected to intensify an already heated mergers and acquisitions (M&A) environment in 2017. 9 January 2017
Shares of biotech Innocoll Holdings tumbled as much as 65% on December 30, after the US Food and Drug Administration issued a refusal to file letter for the company's product candidate for a treatment for post-surgical pain Xaracoll. 8 January 2017
The US Office of Congressional Ethics (OCE) and the US Securities and Exchange Commission (SEC) should look more closely at the stock trading activity of US Representatives Tom Price (Republican, Georgia.) and Chris Collins (Republican, New York) for conflicts of interest and possible insider trading, consumer advocacy Public Citizen said in a letter yesterday. 6 January 2017
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC, or kidney cancer) versus the established comparator therapy. 5 January 2017
Wockhardt on Wednesday revealed that it had received another US Food and Drug Administration warning letter for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat. 5 January 2017
Pharmaceutical companies are increasingly using social media as a platform for their communications and advertising, enabling them to engage more actively with consumers and healthcare professionals, notes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 5 January 2017
Ocular Therapeutix will submit a New Drug Application (NDA) to the US Food and Drug Administration for Dextenza (dexamethasone) in the first quarter of 2017. 5 January 2017
Bayer has announced that its Supplemental New Drug Application (sNDA) for Stivarga (regorafenib) will be reviewed under the US Food and Drug Administration’s priority review scheme. 4 January 2017
Swedish Orphan Biovitrum has received approval from Health Canada for its Orfadin (nitisinone) capsules for hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4 January 2017
Ireland-incorporated drugmaker Allergan finished Tuesday’s trading 3% up at $216.19 as markets and analysts reacted to drug price rises which the company limited to single figures – but only just. 4 January 2017
Russian drugmakers will be allowed to produce one drug under different brand names, which should help to accelerate the process of import substitution in the industry, according to a recent decision of the Russian government. 3 January 2017
China's first oral antiviral drug, dubbed danoprevir (ASC08), for treating hepatitis C virus (HCV) has been accepted for review by the Chinese Food and Drug Administration (CFDA). 1 January 2017
The US Food and Drug Administration has issued a Refusal to File letter for Xaracoll (bupivacaine HCl collagen-matrix implants), a product candidate for the treatment of postsurgical pain. 30 December 2016
The UK’s system for assessing the cost-effectiveness of medicines has long been criticized and the latest to slam the negations between drugmakers and the National Health Service (NHS) is AstraZeneca chief executive Pascal Soriot. 30 December 2016
Shares of US antibiotics developer Cempra (Nasdaq: CEMP) slumped 53.4% to $2.85 in early trading this morning, following news late Thursday of a significant delay in the development of its pneumonia drug candidate. 29 December 2016
Our quarterly Special Report from experts at QuintilesIMS provides scientific and practical insights on Post Authorization Safety Studies based on the first three years since implementation of the new European Union legislation, offering forecasts for likely advances in 2017. 29 December 2016