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
Hikma Pharmaceuticals has revealed receipt of a complete response letter (CRL) from the US Food and Drug Administration in relation to its Abbreviated New Drug Application (ANDA) for VR315, its generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 11 May 2017
Figures from pharma are used to attempt to explain the complexities of an industry where public perception does not always reflect the reality, and such was the evident motivation in a letter written by Richard Torbett, the Association of the British Pharmaceutical Industry (ABPI) executive director, UK commercial. 10 May 2017
Olivier Brandicourt, the chief executive of French pharma major Sanofi, has written an open letter promising to limit the company’s US price rises. 10 May 2017
Direct-to-consumer (DTC) genetics company 23andMe was recently granted approval by the Food and Drug Administration to market their tests providing information on gene variants for certain debilitating diseases, says Dr Nicola Davies in her monthly FDA blog for The Pharma Letter. 10 May 2017
The leading pharma lobby group in the USA has been working to defend drug prices at home in recent months amid President Donald Trump’s tough talk about targeting drugmakers, but with a patriotic tone that could have come from the man himself, it has now criticized other countries for not paying adequately for US innovation. 10 May 2017
Biopharmaceuticals accounted for 35% of all new drug approvals in the USA from 2006 through 2016, and a robust development pipeline suggests that the recent increased pace of biotech approvals will continue for the next decade. 10 May 2017
Johnson & Johnson revealed in a filing with the Securities and Exchange Commission (SEC) that the US Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought its drugs. 9 May 2017
UK-based specialty pharmaceutical company EUSA Pharma has received European approval for the immunotherapy dinutuximab beta for the treatment of high-risk neuroblastoma in patients over the age of one. 9 May 2017
The Australian government has reached a major agreement with the pharmaceutical industry related to drug prices and the Pharmaceutical Benefits Scheme (PBS). 9 May 2017
Shares in women’s healthcare specialist TherapeuticsMD fell by 10.5% on Monday following news that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) relating to its vaginal pain drug TX-004HR. 9 May 2017
Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past week. 9 May 2017
The US Food and Drug Administration (FDA) has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. 9 May 2017
The pan-Canadian Oncology Drug Review (pCODR) has issued a positive clinical recommendation of the reimbursement of Tagrisso (osimertinib), a novel, targeted treatment for a subset of non-small cell lung cancer (NSCLC) patients. 9 May 2017
At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC), part of the European Medicines Agency, has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with hemophilia A who have not previously been treated with these medicines. 8 May 2017
Doctors and public health groups in India have come up with the suggestion that the government should work for the gradual phasing out of branded drugs in a calibrated manner along with the abolition of differential pricing under different brands to give a push to generic drug prescriptions. 8 May 2017
The Greek pharma industry, via its trade group the SfEE, has expressed its strong discontent and deep concern about the new across-the-board measures announced by the Ministry of Health (in particular the unified volume rebate, which puts an additional burden of 25% on new on-patent medicines). 8 May 2017
As we continue to make remarkable strides to treat our most costly and challenging diseases, there is a renewed focus on ensuring patients have access to the most innovative medicines, wrote Holly Campbell on the Pharmaceutical Research and Manufacturers of America (PhRMA) Catalyst on May 5. 8 May 2017