In Brief
Refine Search
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Immatics’ IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types. 24 October 2023
Biotechnology
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics and Kurma Partners, a European venture capital firm in healthcare and biotechnology, today announced a strategic partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies. 23 October 2023
article
US pharma major Eli Lilly has agreed to acquire Mablink Bioscience, a French biotech focused on antibody-drug conjugates for cancer, according to Endpoints News, citing Lilly’s chief scientific officer Dan Skovronsky. 18 October 2023
Biotechnology
Soliris (eculizumab), one of UK pharma major AstraZeneca’s top selling drugs, has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). 18 October 2023
Biotechnology
Chinese gene therapy company Gritgen Therapeutics has announced the launch of operations at its commercial GMP facility in Suzhou Industrial Park. 18 October 2023
Biotechnology
The European Commission (EC) has approved Keytruda (pembrolizumab), Merck & Co’s $20 billion+ anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy. 16 October 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk on Friday announced that the sales and operating profit growth at constant exchange rates (CER) for the first nine months of 2023 and the full-year sales and operating profit outlook at CER have been raised. 14 October 2023
Biosimilars
Canadian trade group Biosimilars Canada has announced a new switching policy for the province of Prince Edward Island (PEI). 13 October 2023
Pharmaceutical
India’s Sun Pharmaceutical Industries has presented Phase IV data on its Cequa (cyclosporine ophthalmic solution) showing sustained improvement in dry eye disease signs and symptoms in patients switched from AbbVie’s Restasis (cyclosporine ophthalmic emulsion) 0.05%. 12 October 2023
Biosimilars
South Korea’s Samsung Bioepis today released the Fourth Quarter 2023 Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the USA. 10 October 2023
Pharmaceutical
French pharma major Sanofi is exploring a potential acquisition of cancer drugmaker Mirati Therapeutics, according to Bloomberg, citing people familiar with the matter, and other media reports. 6 October 2023
Biotechnology
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Swedish biotech Calliditas’ application for orphan drug designation in the European Union for setanaxib in Alport syndrome. 5 October 2023
Biosimilars
US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to AbbVie’s mega-blockbuster Humira (adalimumab). 5 October 2023
Pharmaceutical
Japan’s largest drugmaker Takeda revealed that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization has recommended the use of its Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003). 5 October 2023
Pharmaceutical
Novo Nordisk’s American traded shares rose 1% after the Danish diabetes care giant won two patent challenges related to semaglutide, its best-selling weight-loss therapy, Wegovy, also marketed as Ozempic for diabetes. 3 October 2023
Biotechnology
UK-based Mogrify has announced an additional $10 million closing of its Series A financing, bringing the total raised in the round to $46 million. 2 October 2023
Biotechnology
Chugai Pharmaceutical says that it launched Enspryng (satralizumab) in Taiwan on October 1 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent over 12 years old patients who are anti-aquaporin-4 (AQP4) antibody positive” as the first indication in Taiwan. 2 October 2023
Pharmaceutical
With the threat of a federal government shutdown looming in America, the operations of the US Food and Drug Administration (FDA) may be impacted creating some potential application delays for pharmaceutical and medical device companies. 30 September 2023
Pharmaceutical
The US Food and Drug Administration announced it has awarded 10 new clinical trial studies, funded by Congress through the Orphan Products Grants Program, to support the development of medical products for rare diseases. 30 September 2023
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
Pharmaceutical
The US Food and Drug Administration has announced the Commissioner’s National Priority Voucher (CNPV) program aimed at enhancing the health interests of Americans. 18 June 2025
Pharmaceutical
Draig Therapeutics, a clinical-stage company based in Cardiff, UK, and aiming to transform the treatment of neuropsychiatric diseases, today launched from stealth having raised a total of $140 million (£107 million) in the last nine months. 18 June 2025
Pharmaceutical
US pharma firm Lisata Therapeutics has teamed up with tech-bio company GATC Health in a strategic alliance aimed at using artificial intelligence to streamline drug development and improve success rates. 18 June 2025
Biotechnology
US biotech Dyne Therapeutics has revised its regulatory approach for DYNE-101, a treatment in development for myotonic dystrophy type 1 (DM1), after discussions with the American medicines regulator. 18 June 2025
Pharmaceutical
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. 18 June 2025
Pharmaceutical
Japanese companies NEC Corporation and Chugai Pharmaceutical have entered a collaboration to conduct an experiment using AI to predict drug combinations that can possibly enhance the effectiveness of certain cancer treatments. 18 June 2025
Pharmaceutical
Japanese companies Axcelead and A2 Healthcare Corporation announced that they will enter a strategic partnership to promote pharmaceutical research and development in Japan.
Axcelead operates a global business built on two core pillars: drug discovery services and mRNA CDMO services. 18 June 2025
Biotechnology
A strategic partnership has been announced to develop Saudi Arabia’s first fully integrated, modular advanced therapy medicinal product (ATMP) manufacturing campus. 17 June 2025
Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Pharmaceutical
Pharma majors AbbVie and Roche were both trading lower early Tuesday after top-line results were announced from the global Phase III VERONA trial. 17 June 2025
Pharmaceutical
Some 55 attorneys general (AGs), representing all eligible states and US territories, have agreed to sign on to a $7.4 billion settlement with Purdue Pharma and its owners, the Sackler family. 17 June 2025
Biotechnology
US pharma major Eli Lilly (today announced a definitive agreement to acquire Verve Therapeutics, a Boston-based clinical-stage company developing genetic medicines for cardiovascular disease, sending Verve’s shares up 77.7% to $11.15 in premarket trading. 17 June 2025
Biotechnology
Australian biotech CSL has announced that the US Food and Drug Administration (FDA) has approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. 17 June 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze