Latest Pharma and Biotech News
Pharmaceutical
18 June 2025 A controversial proposal to change the Inflation Reduction Act’s pricing framework for rare disease drugs has been dropped from the Senate’s reconciliation package, marking a win for patient advocacy groups that lobbied against it. The ORPHAN Cures Act, which sought to shield some rare disease drugs from Medicare price talks, was notably absent from the text released this week by the Senate Finance Committee.
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Biotechnology
A report published by the Cell & Gene Collective, based on the findings of an expert commission, has offered recommendations to ensure the UK’s leadership in cell and gene therapies (CGTs) and urgently remove barriers to their adoption. 19 June 2025
Biotechnology
Sanofi has signed a strategic agreement with health authorities in Abu Dhabi to accelerate vaccine development and manufacturing in the United Arab Emirates. 19 June 2025
Biotechnology
The benefits from Eli Lilly’s Kisluna (donanemab) remain too small to justify the additional cost to the National Health Service (NHS), said the UK health technology assessor the National Institute for Health and Care Excellence (NICE), which also rejected Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) for the same reason. 19 June 2025
Biotechnology
Symbiotic.blue, the UK’s newest Techbio company has launched to innovate a next-generation artificial intelligence-driven drug discovery (AIDD) platform by combining the power of generative AI with brain-inspired methodologies. 19 June 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Gilead Sciences Yeztugo (lenacapavir) - the company’s injectable HIV-1 capsid inhibitor - as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. 19 June 2025
Biotechnology
Spanish skincare specialist Almirall has promised a key contribution at the International Congress of Dermatology (ICD), currently taking place in Rome, Italy. 19 June 2025
Biotechnology
The US Food and Drug Administration has approved US biotech Incyte’s Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 19 June 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has announced that Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) has not been recommended for use in the National Health Service (NHS) in England. 19 June 2025
Pharmaceutical
Israel-based Medison, a creator of a first-of-its-kind unified global commercialization platform that accelerates the launch of breakthrough therapies, has announced two key additions to its global leadership team: Shay Tamari as chief business officer (CBO) and Tali Mirsky as chief legal and compliance officer (CLCO). 19 June 2025
Biotechnology
The biopharmaceutical industry is grappling with a complex mid-year outlook in 2025, as accelerating innovation collides with mounting policy and market uncertainty. From US drug pricing reforms to global tariff tensions, sentiment has taken a hit - reflected in a 16% drop in industry optimism. 19 June 2025
Biotechnology
Scholar Rock has unveiled encouraging Phase II data for its experimental therapy apitegromab, showing the drug can reduce the amount of lean mass lost during weight reduction with Eli Lilly’s (NYSE: LLY) weight-loss drug Zepbound (tirzepatide). 19 June 2025
Pharmaceutical
Australian biotech PolyActiva has brought in seasoned pharma executive Jerry St Peter as chief executive, in a leadership shake-up timed with a fresh $25 million financing round and a push to commercialize its lead eye implant therapy in the USA. 19 June 2025
Pharmaceutical
US biotech Actio Biosciences has raised $66 million in a series B round topport its pipeline of genetically targeted therapies, with new funding led by Regeneron Ventures and repeat backing from Deerfield Management. 19 June 2025
Biotechnology
SunRock Biopharma has teamed up with China’s Escugen to co-develop SRB123, a first-in-class antibody-drug conjugate (ADC) targeting CCR9, an antigen which is tied to particularly hard-to-treat cancers, including pancreatic, ovarian and lung. 18 June 2025
Biotechnology
Chinese biotech start-up BioTroy Therapeutics has raised over 200 million renminbi ($28 million) in series A financing to advance clinical trials for its experimental immunotherapy targeting CD3L1, a novel immune checkpoint aimed at tough-to-treat tumors. The company also plans to expand its early-stage pipeline and grow its Shanghai-based R&D team. 18 June 2025
Biotechnology
US pharma major AbbVie today announced positive top-line results from its Phase III TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (trade name Aquipta, 60mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100mg/day) in adult patients with a history of four or more migraine days per month. 18 June 2025
Pharmaceutical
US biopharma Mineralys Therapeutics has announced positive top-line data from its Phase II Explore-CKD trial evaluating the safety and efficacy of 25mg of lorundrostat in subjects with hypertension and comorbid chronic kidney disease (CKD). 18 June 2025
Biotechnology
EY today released its 35th annual Biotech Beyond Borders Report. This finds that the biopharma industry is currently at an inflection point – grappling with a unique environment of macroeconomic uncertainty and constrained access to capital, including high interest rates, inflation, shifting regulatory policies and tariff turmoil. 18 June 2025
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has today recommended Spevigo (spesolimab) for the treatment of generalized pustular psoriasis (GPP) flares in adults in England and Wales. 18 June 2025
Biotechnology
Cambridge, USA-based Immuneering Corporation late yesterday announced positive data from its ongoing Phase IIa clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients. 18 June 2025
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Pharmaceutical
Pharmasyntez, one of Russia’s leading drugmakers, plans a significant expansion of its portfolio of innovative drugs in the short-term, according to recent statements, made by representatives of the company, reports The Pharma Letter’s local correspondent. 21 May 2025
Pharmaceutical
Swiss reproductive and women’s health medicines specialist ReproNovo today announced the successful closing of a $65 million Series A financing round, which will be used to advance its pipeline of multiple Phase II programs. 21 May 2025
Pharmaceutical
North Carolina, USA-based vTv Therapeutics has announced that screening has been reinitiated in the company’s CATT1 Phase III trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D). 21 May 2025
Biotechnology
US biotechs Protagenic Therapeutics and Phytanix Bio have entered into a definitive share exchange agreement pursuant to which the two entities will combine in an all-stock transaction. 21 May 2025
Biotechnology
UK-based Juvenescence, a clinical stage AI-enabled biotech company, has secured a total of $76 million in the first-close of a Series B-1 round, led by cornerstone investor M42, with follow-on investments from existing investors. 21 May 2025
Live
Welcome to The Pharma Letter’s real-time coverage of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3 in Chicago. This feed will deliver concise updates as they happen—check back here regularly for headline trial results, regulatory milestones, practice updates and more. 21 May 2025
Pharmaceutical
UK-based PureTech Health delivered a late-breaking, oral presentation at the 2025 American Thoracic Society (ATS) International Conference in San Francisco. 21 May 2025
Pharmaceutical
US biotech Tourmaline Bio has reported topline data from a Phase II trial of its lead asset, pacibekitug, in people with chronic kidney disease (CKD) and elevated inflammation levels associated with cardiovascular risk. 21 May 2025
Pharmaceutical
US biotech company SparX Biopharmaceutical has signed a research agreement with Mitsubishi Tanabe Pharma America aimed at advancing a new antibody-drug conjugate (ADC) that targets a novel immune cell protein. 21 May 2025
Biotechnology
German antibody drug conjugate (ADC) specialist Tubulis announced that the first program from its 2023 licensing accord with pharma major Bristol Myers Squibb has entered clinical development, triggering a significant milestone in the ongoing collaboration to develop next generation antibody drug candidates (ADCs) for the treatment of cancer. 21 May 2025
Pharmaceutical
US healthcare giant Johnson & Johnson presented long-term findings from the 24-month open-label extension of the A DUE trial of Opsynvi (macitentan and tadalafil) in pulmonary arterial hypertension (PAH) during a late-breaking oral session at the American Thoracic Society (ATS) Conference. 21 May 2025
Biotechnology
South Korean vaccine maker SK Bioscience has secured a final court victory over US pharma major Pfizer in a long-running patent dispute concerning exports of its 13-valent pneumococcal conjugate vaccine, SKYPneumo (pneumococcal 13-valent conjugate vaccine). 21 May 2025
Biotechnology
A panel of experts convened by the US regulator has given a cautious nod to Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients. 21 May 2025
Pharmaceutical
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
Pharmaceutical
German drugmaker Grünenthal has named Maren Thurow as its new vice president and head of global communications, stepping into the role at a time of significant business expansion and leadership change. She succeeds Florian Dieckmann, who had led the company’s communications function since 2021. 20 May 2025
Pharmaceutical
Australia’s digital health sector is poised for steady expansion, with the market forecast to grow at a compound annual growth rate of around 8% through 2034, according to research from data and analytics group GlobalData. 20 May 2025
Biotechnology
Shares in Prime Medicine, a US biotech seeking to develop one-time curative genetic therapies, closed 16% lower Monday. 20 May 2025
Pharmaceutical
Cambridge, USA-based Apnimed today announced positive top-line results from its pivotal Phase III SynAIRgy clinical trial evaluating the efficacy and safety of its lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. 20 May 2025
Biotechnology
German vaccine pioneer BioNTech today revealed that its UK subsidiary has signed a grant agreement with the UK government to broaden the company’s R&D activities for innovative medicines in the UK. 20 May 2025
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