Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
The UK risks losing £11 billion ($14 billion) in pharmaceutical R&D investment by 2033 unless urgent reforms are made to high and unpredictable clawback payments imposed on medicine sales to the National Health Service, according to a new report commissioned by the Association of the British Pharmaceutical Industry (ABPI). 3 June 2025
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Pharmaceutical
A new report from Washington DC-based group No Patient Left Behind argues that foreign governments are underestimating the value of innovative medicines — a claim that adds fuel to the ongoing transatlantic debate on drug pricing and access. 2 May 2025
Pharmaceutical
May 2, 2025
Clinical-stage biopharma company Satsuma Pharmaceuticals and its corporate parent, Shin Nippon Biomedica, announced that they have received US Food and Drug Administration (FDA) approval for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101. 2 May 2025
Pharmaceutical
The US Department of Health and Human Services has announced a sweeping change to the way new vaccines are evaluated, saying it will now require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 2 May 2025
Pharmaceutical
The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Vimkunya, a vaccine used to prevent disease caused by the chikungunya virus in people 12 years of age and older. 2 May 2025
Pharmaceutical
Shortly after Robert F Kennedy Jr was sworn in as Secretary of Health and Human Services (HHS), US President Donald Trump issued an executive order establishing the Make America Healthy Again Commission. 1 May 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s Opdivo (nivolumab) in a new formulation associated with a different route of administration (subcutaneous use), an alternative pharmaceutical form (solution for injection) and a new strength (600mg/vial). 1 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG), from US healthcare giant Johnson & Johnson. 1 May 2025
Biotechnology
UK investment firm Aviva Capital Partners is supporting a major new life sciences expansion in south London, which aims to transform Sutton’s London Cancer Hub into one of the world’s leading centers for oncology research and treatment. 1 May 2025
Biotechnology
UK pharma major GSK has published results from its Phase III MATINEE trial evaluating Nucala (mepolizumab) in patients with chronic obstructive pulmonary disease, as it awaits a US decision on whether the drug can be approved for this use. 1 May 2025
Biotechnology
UK regulators are set to review a proposed label update for Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), potentially opening the door to a once-monthly maintenance dosing option. 1 May 2025
Biotechnology
US biotech firm Stealth BioTherapeutics is facing renewed uncertainty after the American medicines regulator failed to deliver a decision on the company’s new drug application for elamipretide, its potential treatment for Barth syndrome, by the expected April 29 deadline. 30 April 2025
Biotechnology
Chicago-based drugmaker AbbVie has announced the US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), 15mg, once daily, for the treatment of adults with giant cell arteritis (GCA). 30 April 2025
Pharmaceutical
Danish drugmaker Novo Nordisk has announced that it is expanding patient access to Wegovy (semaglutide) injection 2.4 mg in the USA. 30 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, from US gene therapy developer Abeona Therapeutics. 30 April 2025
Pharmaceutical
US-Ireland drugmaker Shorla Oncology has received approval from the US regulator for a new multi-dose vial of Tepylute (thiotepa), a chemotherapy treatment for breast and ovarian cancers. 30 April 2025
Pharmaceutical
The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan). 29 April 2025
Pharmaceutical
AstraZeneca posted a 10% rise in first-quarter revenue to $13.6 billion, supported by strong sales of cancer drugs and biopharmaceuticals. Core earnings per share climbed 21% to $2.49, while reported EPS advanced 34% to $1.88. Pre-tax profits increased 21% year-on-year to $3.4 billion. 29 April 2025
Biotechnology
Regeneron Pharmaceuticals today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma. 28 April 2025
Pharmaceutical
The USA faces a serious risk of measles becoming endemic again, according to a new study modeling the impact of declining childhood vaccination rates, published in JAMA. 28 April 2025
Biotechnology
Shares of French speciality vaccines developer Valneva were down 8.4% at 2.89 euros by early afternoon, after it announced a negative decision by France’s national public health agency. 28 April 2025
Biotechnology
The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). 5 June 2025
Biotechnology
German genetic medicine company ViGeneron has announced a rebrand to become VeonGen Therapeutics. 5 June 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics revealed that its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the US Food and Drug Administration. 5 June 2025
Pharmaceutical
China’s National Medical Products Administration approved its first domestically-developed nine-valent human papillomavirus (HPV) vaccine on Thursday. 5 June 2025
Pharmaceutical
A sweeping legislative package backed by US President Donald Trump could strip health insurance from more than 16 million Americans over the next decade, according to a new analysis from the Congressional Budget Office. 5 June 2025
Pharmaceutical
The NHS Business Services Authority (NHSBSA) has published the annual Prescription Cost Analysis (PCA) for 2024/25. 5 June 2025
Biosimilars
Germany’s Formycon has announced that the Brazilian regulatory authority Anvisa has granted marketing authorization for FYB201/Ranivisio, a Lucentis (ranibizumab) biosimilar. 5 June 2025
Pharmaceutical
The European Commission has granted market authorization for Japanese ophthalmic drugmaker Santen Pharmaceutical’s Ryjunea, a low-dose atropine eye drop (0.1mg/ml), that slows the progression of pediatric myopia, marking a significant advance in pediatric eye care. 5 June 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to women taking popular medicines for weight loss and diabetes, sometimes referred to as “skinny jabs,” to use effective contraception while taking these medicines and, in some cases, for up to two months between stopping the medicine and trying to get pregnant. 5 June 2025
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published the UK’s first official guidance to support the safe development and use of phage therapies - treatments that use viruses to target and destroy harmful bacteria. 4 June 2025
Pharmaceutical
The European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal muscular atrophy (SMA), Swiss pharma giant Roche revealed today 4 June 2025
Pharmaceutical
The American medicines regulator has committed to reviewing the safety of the abortion pill mifepristone, amid renewed political scrutiny and pressure from conservative lawmakers. 4 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
Sogroya (somapacitan injection) has been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) as a treatment for people aged 3 to 17 years with pediatric growth hormone deficiency, the UK subsidiary of Denmark’s Novo Nordisk revealed yesterday. 4 June 2025
Pharmaceutical
The American medicines regulator has approved Bayer’s Nubeqa (darolutamide) for broader use in patients with metastatic castration-sensitive prostate cancer (mCSPC), marking a step forward for the drugmakeFood and Drug Administraton,r’s prostate cancer franchise. 4 June 2025
Pharmaceutical
The UK risks losing £11 billion ($14 billion) in pharmaceutical R&D investment by 2033 unless urgent reforms are made to high and unpredictable clawback payments imposed on medicine sales to the National Health Service, according to a new report commissioned by the Association of the British Pharmaceutical Industry (ABPI). 3 June 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) for adults with non-small cell lung cancer (NSCLC). 3 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Biotechnology
Shanghai-based Mabwell Bioscience has secured approval from the Chinese regulator for its first locally developed novel biologic, marking a pivotal moment in the company's ambitions to expand its oncology pipeline and strengthen its commercial presence in Asia and beyond. 3 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
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