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
From today (February 7), children aged two to five in Australia will have immediate and free access to Kalydeco (ivacaftor) – a life-changing drug that addresses the causes of cystic fibrosis rather than just the symptoms. 7 February 2017
Over the past 20 years, more than 700 New Active Substances (NASs) - new small and large molecular entities - have been successfully discovered, developed and authorized by regulatory bodies for use with patients. 7 February 2017
Express Scripts, the USA’s largest pharmacy benefits management firm, has put the blame for rising prices of medicines in the USA at the door of drugmakers. 6 February 2017
Australian Minister for Health Greg Hunt has said that his government’s backing of the country’s researchers and scientists will help them to make the next major medical breakthrough. 6 February 2017
Belgian drug developer Ablynx was up by 1.5% at 12.20 euros as Monday’s trading neared its end after announcing news on caplacizumab, its anti-von Willebrand factor (vWF) nanobody for acquired thrombotic thrombocytopenic purpura (aTTP). 6 February 2017
Taiwan-based Foresee Pharmaceuticals has announced progress in filing for European approval for its investigational prostate cancer drug. 6 February 2017
The Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108 (hydrocodone, acetaminophen, promethazine). 6 February 2017
Intarcia Therapeutics says the US Food and Drug Administration has accepted for active review its New Drug Application (NDA) for ITCA 650 (exenatide), an investigational therapy for the treatment of type 2 diabetes (T2D). 6 February 2017
As the US President Donald Trump rally fades away, such anxiety weighs heavy on investors’ minds. But underperforming drug company Pfizer may yet profit from the President’s contradictions, wrote Financial Times Lex writer Christopher Thompson. 5 February 2017
The US Food and Drug Administration has approved multi-billion dollar selling immuno-oncology treatment Opdivo (nivolumab) for use against urothelial carcinoma, the most common kind of bladder cancer. 3 February 2017
Drug prices in Russia may increase by 20%-25% this year, due to the implementation of the latest state initiative for the introduction of mandatory QR-labelling on drugs in the local market. 3 February 2017
The National Institute for Health and Care Excellence (NICE) has today published draft guidance which does not recommend breast cancer drug Ibrance (palbociclib) for routine funding on the NHS. 3 February 2017
Teva Pharmaceutical Industries says that it is seeking approval to market the generic version of Victoza (liraglutide) injection, in the USA. 2 February 2017
US drugmaker MannKind Corp today announced the launch of a new titration pack containing 60 – 4 unit cartridges, 60 – 8 unit cartridges and 60 – 12 unit cartridges of Afrezza (insulin human) inhalation powder. 1 February 2017
How new US President Donald Trump’s meeting with pharma bosses went on Tuesday was always going to be a matter of interpretation, with the industry, the new administration and its critics all likely to put their own spin on the discussions. 1 February 2017
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals have received marketing authorization in Canada for Kevzara (sarilumab). 1 February 2017
From Wednesday, Australians have subsidized access to new drugs for ovarian and lung cancer which will reduce the price they pay by nearly 100%. 1 February 2017
The European Commission has approved Keytruda (pembrolizumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50% or more) with no EGFR or ALK positive tumor mutations. 1 February 2017
Mylan might have had some share-boosting news with a court victory over a rival on Tuesday, but the shadow of a Federal Trade Commission (FTC) investigation continues to hang over the Netherlands-incorporated company. 31 January 2017