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
UK pharma major GlaxoSmithKline is hopeful that new data on its systemic lupus erythematosus (SLE) treatment will prompt new approvals in parts of Northeast Asia. 14 November 2016
Even as a key regulatory agency that decides the list and prices of essential drugs in India is set to take on a new avatar (form) with the government looking to disband the National Pharmaceutical Pricing Authority (NPPA), US pharma giant Pfizer has received a major fillip in India by securing two Indian process patents related to its blockbuster drug etanercept. 14 November 2016
Investors in the beaten down biotech sector finally got an unexpected reprieve this week, thanks mainly due to the unexpected "clean sweep" of the US Congress and the presidency by the Republican party. 13 November 2016
The European Commission on Friday approved the first treatment advance for secondary hyperparathyroidism, as well as the first interleukin-12/23 inhibitor licensed for Crohn’s disease. 12 November 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) completed its scientific assessment of the annual renewal of the conditional marketing authorization for Translarna (ataluren) and recommended that this be renewed. 12 November 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines and three biosimilars for approval at its November meeting. 12 November 2016
US pharma major Eli Lilly has received conditional marketing authorization in Europe for Lartruvo (olaratumab injection, 10 mg/mL) in combination with doxorubicin, for advanced soft tissue sarcoma (STS). 11 November 2016
The US Food and Drug Administration has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 11 November 2016
Biotech giant Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for its new treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. 11 November 2016
The National Institute for Health and Care Excellence (NICE) has today issued draft guidance rejecting use on the National Health Service of a treatment for multiple myeloma. 11 November 2016
The UK’s Court of Appeal has ruled that National Health Service (NHS) in England has the power to fund Pre-Exposure Prophylaxis (PrEP) for HIV. 10 November 2016
The European Commission has today granted Marketing Authorization for Pfizer’s first-in-class metastatic breast cancer treatment, but the company has expressed worries about getting the drug to patients in the UK. 10 November 2016
The US Food and Drug Administration should strongly limit – not extend – off-label marketing practices for medicines and devices because it endangers patients, a leading consumer advocacy has said. 10 November 2016
The US Food and Drug Administration has put a full clinical hold (ie, no further dosing of patients) has been placed on the current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma. 10 November 2016
Draft guidance has been published today recommending two cancer drugs for routine use on the UK’s National Health Service as part of its program to appraise treatments that were first made available on the Cancer Drugs Fund before it was reformed earlier this year. 10 November 2016
Rather than uncertainty about what the Presidency of Donald Trump might mean for drug prices, many pharma and biotech stocks jumped considerably after the Republican nominee gained a shock election victory over Democrat Hillary Clinton. 9 November 2016
French biotech Nicox is confident that – together with its partners – it can overcome the concerns of the US Food and Drug Administration (FDA) in relation to its key products, latanoprostene bunod and AC-170. 9 November 2016
The cost-effectiveness watchdog for England and Wales has today issued another draft guidance recommending that a cancer treatment not be made available on the National Health Service. 9 November 2016
A biologics license application (BLA) has been submitted to the US Food and Drug Administration (FDA) for a proposed biosimilar version of Herceptin (trastuzumab), a branded drug from Swiss pharma major Roche’s Genentech unit to treat certain HER2-positive breast and gastric cancers. 8 November 2016
Payments which the pharmaceutical industry made to doctors, hospitals and other aspects of Ireland’s healthcare framework have been laid bare by a new investigation. 8 November 2016