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
Pharmaceutical
Belgium’s General Association of the Pharma Industry, known as pharma.de, has emphasized the importance of intellectual property (IP) in stimulating creativity and innovation in the pharmaceutical industry. 28 April 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late Friday announced it has granted a conditional marketing authorization for the Aucatzyl (obecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 28 April 2025
Pharmaceutical
Seeking to ensure the quality and safety of pharmaceutical products, India's regulatory bodies have intensified their crackdown on substandard and spurious drugs. The move comes at a crucial juncture as the country inches closer to establishing a comprehensive regulatory framework for over-the-counter (OTC) medications, reports The Pharma Letter’s India correspondent. 28 April 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Beyonttra (acoramidis), from Germany’s Bayer, to treat adult patients with cardiomyopathy (damage to the heart muscle) caused by variant or wild-type transthyretin amyloidosis (ATTR-CM). 26 April 2025
Pharmaceutical
The European Medicines Agency’s (EMA)) human medicines committee (CHMP) has recommended seven novel medicines for approval at its April 2025 meeting. A final decision from the European Commission is usually issued in about two months. 26 April 2025
Biotechnology
The European Commission (EC) has approved a marketing authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 25 April 2025
Pharmaceutical
A new analysis by Charles River Associates, commissioned by European industry group EFPIA, suggests that a proposed reward system for antibiotic developers could be significantly cheaper for EU governments than previously estimated by the European Commission. 25 April 2025
Biotechnology
The US Food and Drug Administration (FDA) approved penpulimab-kcqx, from little known Chinese biotech Akeso Biopharma, with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). 25 April 2025
Biotechnology
US biotech Equillium’s shares fell by 3% to $0.47 after the company announced that the US Food and Drug Administration (FDA) declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for its drug itolizumab, intended for the treatment of acute graft-versus-host disease (aGVHD). 25 April 2025
Biotechnology
US biopharma Novavax closed 20% higher on Wednesday after announcing an update on its COVID-19 vaccine. 24 April 2025
Pharmaceutical
An Expert View from Omar Ali, head of payers, Verpora. 24 April 2025
Pharmaceutical
Shares in Eli Lilly shot up last Thursday after the US pharma major announced positive top-line Phase III results from ACHIEVE-1, comparing orforglipron to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. 23 April 2025
Pharmaceutical
Denmark-based allergy immunotherapy specialist ALK Abello today announced that its Itulazax (tree pollen sublingual allergy immunotherapy tablet) has been approved by the European regulator for treatment of young children and adolescents aged five to 17. 23 April 2025
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has issued positive final guidance recommending Joenja (leniolisib), from Dutch biopharma company Pharming, for reimbursement and use within the National Health Service (NHS) in England and Wales. 23 April 2025
Biotechnology
A new report highlights disparities in access to CAR T-cell therapies across Europe, with eligible patient treatment rates as low as 11% in some countries. The analysis suggests that complex care pathways and inconsistent funding models are key barriers to broader use of the treatment. 23 April 2025
Pharmaceutical
The Trump administration is reportedly revisiting a contentious drug pricing strategy that would tie US medicine prices to those paid in other developed nations, according to a Reuters report citing multiple industry sources. 23 April 2025
Generics
The Russian pharma trade group Innovative Pharma (Inpharma) has sent an official letter to the Ministry of Industry and Trade of Russia with proposals for revising the criteria for including drugs in the list of strategically important drugs, The Pharma Letter’s local correspondent reports. 23 April 2025
Biotechnology
US biotech major Regeneron Pharmaceuticals has announced a significant expansion of its manufacturing capacity through a new agreement with Fujifilm Diosynth Biotechnologies to manufacture and supply bulk drug product of its commercial biologic medicines at its Holly Springs, North Carolina, campus. 22 April 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending the reimbursement of Opdivo (nivolumab) in combination with Yervoy (ipilimumab). 22 April 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Hympavzi (marstacimab) to prevent or reduce bleeding in patients 12 years of age and older weighing at least 35kg with hemophilia A and B. 22 April 2025
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