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
Aralez Pharmaceuticals reports Health Canada approval of Blexten (bilastine) for the treatment of the symptoms of seasonal allergic rhinitis (SAR) and chronic spontaneous urticaria (CSU) (such as itchiness and hives). 25 April 2016
Data from the Spanish Ministry of Health, Social Services and Equality shows that in January, public pharmaceutical expenditure at pharmacies experienced a growth of 1.67%, compared to the registered accumulated figure of January 2015. 25 April 2016
The Ukraine Association of Pharmaceutical Research and Development (APRaD), uniting the largest world leading pharmaceutical companies active in the research and development of new medicines with a presence in Ukraine, will disclose the information on transfers of value to healthcare professionals and organizations. 25 April 2016
Cannabis has had a long, difficult and often contradictory relationship with the pharmaceutical world but it is making something of a resurgence and the companies that specialize in it are full of confidence for the future. 24 April 2016
Gilead Sciences stock has risen sharply in the last 10 weeks, as a result of analysts upgrading the company. There was one up revision during the last seven days and five earnings per share up revisions during the last thirty days. 24 April 2016
Lundbeck said on Friday that the US Food and Drug Administration has accepted for review the resubmission of the New Drug Application (NDA) for intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. 23 April 2016
A new fast-track system to get the most innovative and transformative drugs to patients more quickly could be introduced in England and Wales, a conference has heard. 22 April 2016
Sarepta Therapeutics has suffered a further share-busting setback over its attempts to gain accelerated US Food and Drug Administration approval for eteplirsen as a treatment for certain patients with Duchenne muscular dystrophy (DMD). 22 April 2016
Cost-effectiveness watchdog for England and Wales the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending cabazitaxel, which is marketed as Jevtana by French pharma major Sanofi, for some prostate cancer patients. 22 April 2016
based Actelion reported net income for the first quarter of 2016 was 178 million Swiss francs ($184 million), up 12% from 159 million francs a year ago but below the poll average of 188 million francs. 22 April 2016
What is behind hepatitis C virus (HCV) drug Harvoni (ledipasvir/sofosbuvir) coming top of a list showing the medicines which accounted for the highest cumulative spending by US patients in 2015? 21 April 2016
Merck & Co says that its Keytruda (pembrolizumab) has received conditional approval for the treatment of Canadians living with metastatic non-small cell lung cancer (NSCLC). 21 April 2016
Some 88.6% of doctors know what biosimilar medicines are and 59% have already prescribed biosimilar medicines as a high quality treatment for their patients, according to EuropaBio paper on physician preference regarding biosimilar labels (SmPC). 21 April 2016
20 civil society associations are urging European Union member states to support the Dutch EU Presidency’s vision on access to affordable medicines. The call for backing comes as Health Ministers meet in Amsterdam this week, according to posting on the website of the European Public Health Alliance. 20 April 2016
Physicians in Europe would like to have more information in the biosimilar label than is currently available for these biological copy drugs. 20 April 2016
US biopharma company Chiasma suffered a share price collapse, after it revealed the news that the US Food and Drug Administration would require further clinical evidence in order to approve its Mycapssa (octreotide). 20 April 2016
After its assessment in 2013, the German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed the added benefit of Xalkori (crizotinib) in comparison with the appropriate comparator therapy, concluded that an added benefit of crizotinib for the first-line treatment of advanced bronchial carcinoma is not proven. 19 April 2016
Israeli biotech firm RedHill Biopharma has announced that its RHB-105 combination for the treatment of H. pylori infection has taken steps closer to approval in the USA. 19 April 2016