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
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
Stephen Ubl, president and chief executive of Pharmaceutical Research and Manufacturers of America (PhRMA), is meeting with President Donald Trump on Tuesday morning. 31 January 2017
The European Commission has approved Votubia (everolimus) dispersible tablets as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). 31 January 2017
Mindful that the next two years will be massively important for the company and how closely pharma will be watching its progress, it is not surprising that Realm Therapeutics has been keen to let the world know its plans for 2017. 31 January 2017
Teva Pharmaceutical Industries has received US Food and Drug Administration approval for its own branded versions of two asthma treatments sold by UK pharma major GlaxoSmithKline. 31 January 2017
uniQure says that AMT-060, its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the US Food and Drug Administration. 30 January 2017
As of now, collaborations between healthcare professionals and pharma in Spain are to be published individually, following an update to Code of Good Practice on the pharmaceutical industry. 30 January 2017
Donald Trump’s warnings on drug prices and the tougher stance being taken by governments in Japan and Europe on paying for medicines make this a worrying time for pharma companies, as they nervously keep an eye on leaders’ pledges, policy changes and payer decisions in these mature markets. 30 January 2017
The pharmaceutical sector in India is set to gain rather than be impacted with the new US President Donald Trump's decision to reduce drug prices, given that the country's generic medicines are already affordable. 30 January 2017
The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. 30 January 2017
In the run-up to last year’s referendum on the UK’s membership of the EU, commentators and analysts warned that the country’s healthcare and pharmaceutical industries would suffer should the country turn its back on Europe. 30 January 2017
Italian drugmaker Recordati has been granted marketing authorization by the European Medicines Agency for its orphan medicinal product Cystadrops (mercaptamine). 30 January 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. 28 January 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