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
US clinical-stage biotech Sage Therapeutics was trading 7% higher after Tuesday’s trading at $55.68 following news from its development plan for its SAGE-547 program in postpartum depression (PPD). 7 December 2016
The US Food and Drug Administration has approved Avastin (bevacizumab) for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 7 December 2016
Over the past half-century, the prescription medication industry has witnessed phenomenal growth. To combat sharp increments in drug costs during the 1970s, states deployed laws and developed guidance material with the help of the Food and Drug Administration, writes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 7 December 2016
Changes in the way that NHS England commissions specialized treatments have been called for by a charity working to improve the lives of patients and families affected by genetic conditions. 6 December 2016
Global drugmakers operating their plants in Russia have criticized the latest state initiative to introduce new restrictions on the participation of foreign drug manufacturers in tenders for the public procurement of drugs for state needs, reports The Pharma Letter’s local correspondent. 6 December 2016
Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, even as annual growth moderates from the record pace set in 2014 and 2015. 6 December 2016
A New Drug Application has been filed with the US Food and Drug Administration for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes. 5 December 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC has announce a major funding package following an agreement with the local subsidiary of Swiss pharma giant Roche for funding nine medicines covering 10 different medical conditions with changes implemented from January 1, 2017. 5 December 2016
A rolling submission with the US Food and Drug Administration of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT) has been initiated. 5 December 2016
Some 344 fixed dose combination (FDC) medications that have been off chemists' shelves in India for some time now, are to make a reappearance, with the Delhi High Court setting aside the Indian government’s decision to ban the FDC drugs. 5 December 2016
The US Food and Drug Administration on Friday approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. 5 December 2016
A Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 215, a biosimilar candidate to Swiss pharma major Roche’s blockbuster cancer drug Avastin (bevacizumab). 3 December 2016
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Relvar Ellipta (fluticasone furoate/vilanterol 100/25mcg) for the relief of various symptoms with chronic obstructive pulmonary disease. 2 December 2016
At its meeting over the November 28-December 1 period, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one. 2 December 2016
A domestically-developed, long-acting injectable HIV drug has been put forward for approval by the China Food and Drug Administration, and will become the first of its kind to be generally available if approved, according to the state news agency Xinhua. 2 December 2016
Legislation introduced to Parliament on the final sitting day of 2016 will enable faster access to certain new medicines for Australian patients and help to cut unnecessary red tape for industry too. 2 December 2016
A recent safety review from medicines regulatory Health Canada has found that patients infected with both hepatitis B and hepatitis C viruses who are being treated for hepatitis C with direct-acting antivirals may experience a reactivation of their hepatitis B. 2 December 2016
The National Institute for Health and Care Excellence (NICE) has issued draft guidance that recommends new drug pembrolizumab for some people with advanced non-small-cell lung cancer. 2 December 2016
ViiV Healthcare, a global specialist HIV company, today confirmed that its distributor in Brazil has finalized an agreement with the Brazilian Ministry of Health (MoH) for the supply of Tivicay (dolutegravir). 1 December 2016