Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
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Pharmaceutical
US gastrointestinal (GI) and rare diseases specialist Ironwood Pharmaceuticals was trading 34% lower early Monday. 14 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 April 2025
Biotechnology
US sequencing firm PacBio is cutting jobs and reducing spending across its business as it braces for the financial impact of new global tariffs and growing uncertainty around federal research funding. 14 April 2025
Pharmaceutical
The Dutch Healthcare Authority (NZa) has published a report entitled From patent to competition – Analysis of expenditure and use of seven expensive medicines in hospital treatments. 14 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Biotechnology
Shares in US biotech Novavax fell more than 20% before the weekend, following remarks from health and human services secretary Robert F Kennedy Jr, who questioned the scientific basis of the company’s COVID-19 vaccine in a televised interview. 14 April 2025
Pharmaceutical
New regulations for running clinical trials in the UK have now been signed into law, the Medicines & Healthcare products Regulatory Agency (MHRA) announced on Friday. 14 April 2025
Pharmaceutical
According to the country’s trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 April 2025
Pharmaceutical
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Biotechnology
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
Pharmaceutical
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025
Pharmaceutical
The first comprehensive analysis of clinical trials in the UK has found the country remains a global leader in medical research but highlights the need for broader disease focus and better trial representation. 10 April 2025
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (CER), in collaboration with researchers from Brown University, has published a new white paper that provides clear policy and market solutions to help manage affordable and equitable access to GLP-1 obesity medications. 10 April 2025
Biosimilars
South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025
Biotechnology
Licensing agreements for Chinese drug candidates hit a record high in 2024, with large pharma in-licensing 28% of innovator drugs from Chinese biopharma companies. 9 April 2025
Pharmaceutical
The European Commission (EC) has granted marketing authorization to Rinvoq (upadacitinib; 15mg, once daily), from US pharma major AbbVie , for the treatment of giant cell arteritis (GCA) in adult patients. 9 April 2025
Pharmaceutical
US gastrointestinal (GI) and rare diseases specialist Ironwood Pharmaceuticals was trading 34% lower early Monday. 14 April 2025
Generics
A Texan drug compounder cannot rely on federal law to avoid a lawsuit over copycat sales of a rheumatoid arthritis treatment, clearing the way for Zyla Life Sciences to pursue claims under state competition laws. 14 April 2025
Biotechnology
US sequencing firm PacBio is cutting jobs and reducing spending across its business as it braces for the financial impact of new global tariffs and growing uncertainty around federal research funding. 14 April 2025
Pharmaceutical
The Dutch Healthcare Authority (NZa) has published a report entitled From patent to competition – Analysis of expenditure and use of seven expensive medicines in hospital treatments. 14 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Biotechnology
Shares in US biotech Novavax fell more than 20% before the weekend, following remarks from health and human services secretary Robert F Kennedy Jr, who questioned the scientific basis of the company’s COVID-19 vaccine in a televised interview. 14 April 2025
Pharmaceutical
New regulations for running clinical trials in the UK have now been signed into law, the Medicines & Healthcare products Regulatory Agency (MHRA) announced on Friday. 14 April 2025
Pharmaceutical
According to the country’s trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 April 2025
Pharmaceutical
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Biotechnology
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
Pharmaceutical
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025
Pharmaceutical
The first comprehensive analysis of clinical trials in the UK has found the country remains a global leader in medical research but highlights the need for broader disease focus and better trial representation. 10 April 2025
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (CER), in collaboration with researchers from Brown University, has published a new white paper that provides clear policy and market solutions to help manage affordable and equitable access to GLP-1 obesity medications. 10 April 2025
Biosimilars
South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025
Biotechnology
Licensing agreements for Chinese drug candidates hit a record high in 2024, with large pharma in-licensing 28% of innovator drugs from Chinese biopharma companies. 9 April 2025
Pharmaceutical
The European Commission (EC) has granted marketing authorization to Rinvoq (upadacitinib; 15mg, once daily), from US pharma major AbbVie , for the treatment of giant cell arteritis (GCA) in adult patients. 9 April 2025
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