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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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
Biotechnology
Japanese pharma major Takeda announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Vonvendi [von Willebrand factor (Recombinant)] for investigational routine prophylactic use in adults (age 18 years and older) with von Willebrand disease (VWD), including those with Type 1 and 2 disease, and on-demand and perioperative use in children with VWD. 15 May 2025
Pharmaceutical
The US Food and Drug Administration approved Welireg (belzutifan), from US pharma giant Merck & Co, for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). 15 May 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical has obtained regulatory approval from the domestic regulator for Elevidys Intravenous Infusion (delandistrogene moxeparvovec) as a regenerative medicine product for the treatment of Duchenne muscular dystrophy (DMD) under the conditional and time-limited approval pathway. 15 May 2025
Pharmaceutical
US President Donald Trump released an executive order on May 12 calling for a 30-day negotiation period between the Department of Health and Human Services (HHS) and the biopharma industry, with the threat of a rule from the Centers for Medicare and Medicaid Services (CMS) to lower US drug prices if no deal is reached. 14 May 2025
Biotechnology
UK-based Kaerus Bioscience, a biopharma created by European investment firm Medicxi for the development of therapeutics for rare genetic syndromes of neurodevelopment, has announced that its lead candidate KER-0193 has been granted both Orphan Drug Designation and Rare Pediatric Drug Designations for the treatment of Fragile X syndrome (FXS) by the US Food and Drugs Administration (FDA). 14 May 2025
Generics
India has declined the UK's request to include a 'data exclusivity' clause in the proposed Free Trade Agreement (FTA), as announced on May 6, underscoring its commitment to protect its robust domestic generic drug industry. India's generic drug industry is valued at over $30 billion. 13 May 2025
Pharmaceutical
US pharma stocks regained ground Monday after Donald Trump signed an executive order aiming to slash prescription drug prices, a move that initially rattled investors but left many analysts unconvinced about its impact. 13 May 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; rADAMTS13), the first UK treatment to treat congenital thrombotic thrombocytopenic purpura (CTTP) in patients of all ages. 13 May 2025
Pharmaceutical
US President Donald Trump sent shivers through the pharmaceutical industry as he vowed to dramatically reduce the high drug prices that have long been a feature of the US market. 12 May 2025
Pharmaceutical
A sustainable healthcare system requires holistic approaches. However, the counterproposal to the cost-control initiative, which was rejected by the people, demonstrates once again that the Swiss healthcare system is still characterized by silo thinking: Although Parliament deliberately removed separate cost targets for each cost block from the proposal, the Federal Department of Home Affairs (FDH) and Federal Office of Public Health (FOPH) blatantly disregarded this decision and reinstated the silo mentality, according to a posting on the website of Interpharma, the association of the research-based pharmaceutical industry in Switzerland. 12 May 2025
Pharmaceutical
UK-based pharma major AstraZeneca has started construction on a new manufacturing site for small molecule drugs in Wuxi, a city in East China's Jiangsu province, underscoring its deepening investment in the country. 12 May 2025
Pharmaceutical
New figures from European industry group EFPIA paint a stark picture of the growing divide in access to innovative medicines across the EU, with patients in some countries waiting more than seven times longer than others for the same treatment. 12 May 2025
Biotechnology
American health officials have recommended temporarily halting the use of Ixchiq (chikungunya vaccine) in people over 60 years old while investigations into reported serious adverse events continue. 12 May 2025
Pharmaceutical
The UK government has announced a trade agreement with the USA. The UK-US Economic Prosperity Deal was agreed on Thursday May 8 with further details released on Friday May 9. 9 May 2025
Pharmaceutical
UK pharma major AstraZeneca has suffered a setback in its legal fight to block the US government's efforts to lower prescription drug prices, after a federal appeals court dismissed its challenge to Medicare’s negotiation powers. 9 May 2025
Biotechnology
Belgium’s largest drugmaker UCB today revealed that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for at-home self-administration with infusion pump or a new manual push syringe method for Rystiggo (rozanolixizumab). 9 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy, Boston, said USA-based. Verastem Oncology, whose shares rose 3.7% to $6.94 on the news. 9 May 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
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