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
Allergan has received a Complete Response Letter from the US Food and Drug Administration for its Prior Approval Supplement for its Restasis (cyclosporine ophthalmic emulsion) container. 15 March 2016
A small notification by Indian drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has ensured that drug formulations under price control have risen to over 800, reports The Pharma Letter’s India correspondent. 15 March 2016
The US Food and Drink Administration has granted Roche’s cancer immunotherapy atezolizumab (anti-PDL1; MPDL3280A) priority review for advanced bladder cancer. 15 March 2016
Increases in anti-depressant usage by children have come about because of the decisions of the general practitioners (GPs) and other health professionals prescribing them, pharma companies have said. 15 March 2016
KemPharm says that a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has been scheduled for May 5, to review its New Drug Application for KP201/APAP. 14 March 2016
PTC Therapeutics says it intends to submit the results of the recently completed Phase III ACT DMD study for review by drugs regulatory Health Canada as part of the New Drug Submission (NDS) for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). 14 March 2016
Global drugmakers operating in Russia may totally refuse to supply imports of cheap drugs to the country, due to unprofitability and economic futility, according to recent statements of Veronika Skvortsova, Russia’s Ministry of Health. 14 March 2016
Following the AIDS crisis in the 1980s, the US FDA, in response to criticism of slow drug approvals, introduced the first of its expedited approval processes – Accelerated Approval, writes Dr Nicola Davies in her monthly exclusive article for The Pharma Letter. 14 March 2016
The European Medicines Agency has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), following concerns over serious adverse events in ongoing clinical trials. 12 March 2016
The US Food and Drug Administration on Friday approved pharma giant Pfizer’s Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. 12 March 2016
Pharma companies in China who wish to register chemical drugs in the country need to follow the new registration policy released by China’s Food and Drug Administration (CFDA) on March 4, effective immediately, reports The Pharma Letter’s local correspondent Wang Fangqing. 11 March 2016
Médecins Sans Frontières (MSF) has, for the first time ever, filed a ‘patent opposition’ in India to prevent US pharma giant Pfizer from getting a patent on the pneumococcal conjugate vaccine (PCV13). 11 March 2016
The pharma market in Poland will develop at the average annual growth rate of 4.8% between 2016 and 2021, according to a new report from Poland-based market research firm PMR. 11 March 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list cinacalcet (Sensipar) on the Pharmaceutical Schedule through a provisional agreement with the local subsidiary of US biotech major Amgen. 11 March 2016
Sarepta Therapeutics shares were up on Thursday, after the US Food and Drug Administration announced that the Peripheral and Central Nervous System Drugs Advisory Committee will hold a meeting on April 25, to review the company’s Duchenne muscular dystrophy (DMD) drug candidate eteplirsen. 11 March 2016
The Indian government will not take any decision on drug price control without holding discussions with the pharmaceutical industry and other stakeholders, Union Minister of State for Chemicals and Fertilisers, Hansraj Gangaram Ahir, said at an ASSOCHAM (The Associated Chambers of Commerce & Industry of India) event held in New Delhi today. 10 March 2016
The European Commission has approved under the EU Merger Regulation the proposed acquisition of the generics business of Ireland-incorporated Allergan by Israel’s Teva Pharmaceutical Industries, subject to conditions. 10 March 2016
AstraZeneca and its biologics R&D arm, MedImmune, have been granted Orphan drug designation by the US Food and Drug Administration for the investigational anti-CD19 monoclonal antibody, MEDI-551. 10 March 2016
Shares of US biotech firm Medivation fell 2.48% to $38.16 yesterday, despite the company reporting positive news on the development of its blood cancer drug candidate. 10 March 2016
Yesterday, the US Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate) for the treatment of erectile dysfunction. 10 March 2016