Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
Spanish plasma-derived medicines company Grifols announced with the Andorran government the cancellation of the immunology research center planned for the parish of Ordino. 29 July 2024
The US Food and Drug Administration (FDA) approved Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp] to include initiation of treatment, up-dosing and maintenance in individuals ages one through three years. 27 July 2024
Vividion Therapeutics, a wholly-owned subsidiary of Germany’s Bayer, today announced it will expand its global innovation capabilities with a new research and development (R&D) center and corporate headquarters in San Diego, California. 23 July 2024
US pharm major Eli Lilly on Friday revealed via a social media posting that it has been granted approval from the Chinese National Medical Products Administration (NMPA) to sell tirzepatide for weight loss in the country. 20 July 2024
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
The Association of the British Pharmaceutical Industry (ABPI), the trade group representing the UK’s pharma sector, has praised parts of the manifestos proposed by Labour, the Liberal Democrats and the Conservatives. 18 May 2017
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
German life sciences company Merck KGaA today posted first-quarter 2017 financial results, showing that profit was down year on year, though net sales were up 5.3% to 3.86 billion euros ($4.30 billion). 18 May 2017
Singapore-based Specialised Therapeutics Asia (STA) has signed an agreement to market lurbinectedin (PM1183), a marine-based anti-tumor compound being developed by Spanish drugmaker PharmaMar (MC: PHM), in Australasia and much of Asia. 18 May 2017
Australia’s Pharmaxis has announced that it now expects to receive milestones from its collaboration with German family owned pharma major Boehringer Ingelheim on PXS-4728A, a potential treatment for non-alcoholic steatohepatitis (NASH). 18 May 2017
Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. 18 May 2017
New post-hoc data from the SCALE maintenance clinical trial showed that after 16 weeks of treatment with Saxenda (liraglutide 3mg), participants who lost an additional 5% or more of their body weight (defined as ‘early responders’) were more likely to maintain weight loss. 17 May 2017
The cost of the clinical trial process today is upwards of $100 million. So how can drug developers with robust research and development (R&D) pipelines but a limited operating budget make the most of their portfolios and get as many promising new therapies to market in the narrow window before patents expire, asks Ben van der Schaaf, principal at management consulting firm Arthur D. Little in an expert view piece. 17 May 2017
US regulators have granted Priority Review designation to copanlisib, a non-Hodgkin lymphoma candidate under development by Germany's largest drugmaker Bayer. 17 May 2017
The US Food and Drug Administration says that canagliflozin, marketed by Johnson & Johnson as Invokana, causes an increased risk of leg and foot amputations. 17 May 2017
One of the most pressing unmet needs in the human immunodeficiency virus (HIV) market, which is set to reach $22.5 billion by 2025, lies in the current lack of long-acting and safer treatments, a new study states. 17 May 2017
The non-alcoholic steatohepatitis (NASH) space across the seven major markets of the USA, France, Germany, Italy, Spain, the UK and Japan, is set to rise from $618 million in 2016 to around $25.3 billion by 2026, representing a very rapid compound annual growth rate of 45%, a new study indicates. 17 May 2017
To maintain its position as the world’s top biopharmaceutical innovator, the US biopharmaceutical industry needs predictable and reliable intellectual property protections. 17 May 2017
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
Another New York county has filed a lawsuit against pharma companies and physicians over what it calls ‘aggressive and fraudulent marketing of prescription opium-like painkillers.’ 16 May 2017