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
Takeda has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy. 24 September 2024
Japan’s Ministry of Health, Labor and Welfare of Japan (MHLW) has approved New Drug Application (NDA) for Quviviq (daridorexant; ACT-541468) 25mg and 50mg for the treatment of adult patients with insomnia, submitted by Nxera Pharma. 24 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
A jointly-issued notice from the US FDA and Federal Trade Commission (FTC) warns the marketers and distributors of 12 opioid cessation products regarding the illegal marketing of unapproved products. 24 January 2018
USA-based Puma Biotechnology has said it is unlikely to receive the nod from the European medicines regulator for its breast cancer therapy Nerlynx when the agency votes on its application next month. 24 January 2018
The European Medicines Agency is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health. 24 January 2018
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD), developed by Swedish drugmaker Camurus. 23 January 2018
The European Medicines Agency has today published an overview of its key recommendations of 2017 regarding the authorization of new medicines and the safety monitoring of medicines, which shows that its tally of novel drug approvals was well below that achieved by its US peer. 23 January 2018
German pharma major Bayer received good news from the UK on Tuesday in the shape of positive guidance from the National Institute for Health and Care Excellence (NICE) that underlines the value of Eylea (aflibercept solution for injection) as a treatment for people with wet age-related macular degeneration (AMD). 23 January 2018
A lobbying disclosure form filed by The Pharmaceutical Research and Manufacturers of America (PhRMA) reveals the leading industry trade body spent about a third more lobbying Washington last year, compared with 2016. 23 January 2018
An analyst at GlobalData affiliate PharmSource has poured cold water on the prospects for a newly-announced not-for-profit pharma company founded by hospital groups in the USA. 23 January 2018
The USTR’s 2017 report on China’s compliance with World Trade Organization rules has found certain deficiencies with regards to intellectual property protection in the area of pharmaceuticals. 22 January 2018
With the opioid abuse situation now spreading to many countries beyond the USA, Australia's medicines' regulator, the Therapeutic Goods Administration (TGA), has issued a discussion paper on the use and misuse of prescription strong opioids such as oxycodone and whether there is a need for specific regulatory responses. 22 January 2018
The US Department of Justice announced on Friday that a federal court in New Jersey has imposed a $5 million civil penalty and entered a consent decree of permanent injunction against the US subsidiary of India’s Dr Reddy’s Laboratories. 22 January 2018
For years, China has been viewed with a mixture of excitement, optimism and suspicion by western pharmaceutical firms, with nervous investors wary of the relatively opaque political and economic environment in the country. 22 January 2018
Regulatory decisions from the US Food and Drug Administration featured in the news last with, with a negative advisory panel vote on Aradigm’s antibiotic candidate Linhaliq and news of acceptance of a Biologicals License Application for a Humira (adalimumab) by Novartis subsidiary Sandoz. On the research front, Eiger Pharmaceutical’s pulmonary arterial hypertension drug ubenimex failed. There was strong speculation that Celgene was planning a takeover bid for CAR-T cell therapy specialist Juno Pharma. Also there was disappointment for Johnson & Johnson with the revocation of Johnson & Johnson’s Zytiga patent. 21 January 2018
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the new drug application for elobixibat for the treatment of chronic constipation in Japan, according to the drug’s developer, Albireo Pharma. 20 January 2018
In a move that expresses healthcare providers’ frustration with generics pricing and allegations of price gouging, a consortium of hospitals in the USA have hit on a radical solution - starting their own pharmaceuticals company. 19 January 2018
AstraZeneca has won two new approvals in Japan, for Lynparza, the first PARP inhibitor to be approved in the country, and for asthma drug Fasenra. 19 January 2018
The cost of prescription drugs is at the forefront of discussions among patients, advocacy groups, prescribers, payers, pharmaceutical companies, and policy makers. One factor – though not the only factor – in driving the cost of prescription drugs is the availability of competing products. 19 January 2018