US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
The USA’s Institute for Clinical and Economic Review (ICER), a non-profit organization, has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. 14 May 2017
The Food and Drug Administration has expanded a previously granted Breakthrough Therapy designation (BTD) for setmelanotide, a novel melanocortin-4 receptor (MC4R) agonist from Boston, USA-based biotech firm Rhythm Pharmaceuticals. 13 May 2017
The World Health Organization (WHO) has held a forum on the cost of medicines in a stated attempt to facilitate discussion leading to ‘fairer price setting and a system that is sustainable for health systems and for innovation’. 12 May 2017
A clinical trial has found that the oncology drug Avastin (bevacizumab) is about as effective as Eylea (aflibercept) in treating central retinal vein occlusion (CRVO), an eye condition. 11 May 2017
The National Institute for Health and Care Excellence (NICE) has issued a second Appraisal Consultation Document (ACD) not recommending the routine National Health Service use of Venclexta (venetoclax) for patients with certain types of difficult-to-treat relapsed and refractory chronic lymphocytic leukemia (CLL). 11 May 2017
The European Medicines Agency’s 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. 11 May 2017
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
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024