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 US Food and Drug Administration has lifted its clinical hold on a Phase I/II trial of CGF166, a treatment for patients with severe to profound hearing loss which is being developed by Swiss pharma giant Novartis under a licensing agreement with US-based GenVec. 25 July 2016
The Irish Pharmaceutical Healthcare Association (IPHA) has agreed a new four-year “Framework Agreement” with the government for an economic and secure supply of medicines for patients. The Agreement will see total savings of 785 million euros ($862 million) from IPHA member companies, an average of nearly 200 million euros a year. 25 July 2016
Sanofi Pasteur MSD UK says that the UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved its quadrivalent influenza vaccine (split virion, inactivated), which contains two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata) of the influenza virus. 25 July 2016
The US Food and Drug Administration has told Canada-based Valeant Pharmaceuticals International that an inspection has identified deficiencies in the manufacturing of Vesneo (latanoprostene bunod), an ophthalmic solution for open angle glaucoma or ocular hypertension. 25 July 2016
The challenges facing the pharmaceutical healthcare system and industry, in Greece as well as the urgent need to design and implement a sustainable pharmaceutical policy framework were the subject of a joint meeting held last week at the Ministry of Health. 25 July 2016
The Venezuelan government has established automatic distribution centers as part of a project to improve medical supplies in the South American country. 25 July 2016
The European Medicines Agency has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, a contract research organization (CRO) with an analytical and a clinical site located in Bangalore, India. 24 July 2016
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Lonsurf (trifluridine–tipiracil hydrochloride) for the treatment of patients with metastatic colorectal cancer who have received previous treatment. 23 July 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its July meeting. 23 July 2016
Brexit has sent shockwaves through the pharmaceutical and life science industries and although the exact extent of the fallout is not yet known, the impact is sure to be felt for many years to come. Exactly a month on from one of the most significant votes in British history, the Pharma Letter takes a look at the immediate aftermath of the decision and some of the potential long term implications. 23 July 2016
The European Medicines Agency has recommended granting marketing authorizations in the European Union for two medicines for the treatment of advanced renal cell carcinoma (kidney cancer). 22 July 2016
Puma Biotechnogy has released encouraging interim five-year invasive disease free survival results from the company's Phase III trial of PB272 (neratinib) and announced a regulatory filing. 22 July 2016
US biotech Spark Therapeutics and pharma giant Pfizer have been granted Breakthrough Therapy designation from the US Food and Drug Administration for their hemophilia B treatment SPK-9001. 22 July 2016
US pharma giant Merck & Co says that the US Food and Drug Administration has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab. 22 July 2016
Belgium’s UCB and biotech major Amgen have submitted a Biologics License Application (BLA) to the US Food and Drug Administration for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. 22 July 2016
The Association of the British Pharmaceutical Industry (ABPI) has hit back after the leader of the Labour Party said pharmaceutical companies should not be allowed to become ‘too dominant’ over the NHS. 21 July 2016
Sales of mid- and high-priced drugs in Russia are steadily declining, due to the ongoing economic stagnation in the country and the consequences of the financial crisis, reports The Pharma Letter’s local correspondent. 21 July 2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union, is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. 21 July 2016
With the swearing-in of the new Australian federal ministry this week, it is anticipated that work will resume to deliver the National Innovation and Science Agenda. 21 July 2016
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has recommended Translarna (ataluren), from US pharma company PTC Therapeutics, for children with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation, after reaching a ‘managed access agreement’. 20 July 2016