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
The US Food and Drug Administration (FDA) issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). 19 July 2024
Japanese drugmaker ONO Pharmaceutical said today that it has submitted an application on its Onoact (landiolol hydrochloride) for intravenous infusion, a short-acting selective β1 blocker for the additional indication of tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) associated with sepsis in Japan. 8 August 2019
As a result of conditions imposed by the US Federal Trade Commission regarding Boston Scientific’s proposed $4.2 billion acquisition of UK-based BTG announced last November, which would violate federal antitrust law, the US medical device maker has agreed to divest certain assets to Varian Medical Systems. 8 August 2019
Pharma and other health companies are buying big into the artificial intelligence (AI) space, and the UK’s Health Secretary has now given this technology a major vote of confidence too. 8 August 2019
The South Korean pharmaceutical market’s value is set to increase from nearly $19.5 billion in 2018 to more than $23.2 billion by 2022, according to a GlobalData report. 7 August 2019
Edavarone, from Mitsubishi Tanabe Pharma, has been approved in China as an intravenous treatment for amyotrophic lateral sclerosis (ALS). 7 August 2019
US pharma major Eli Lilly announced several leadership changes in the company's corporate business development, oncology R&D, and managed healthcare services organizations before markets opened this morning. 7 August 2019
While non-steroidal anti-inflammatory drugs (NSAIDs) can help to control the pain and inflammation in individuals with osteoarthritis (OA), a new study suggests that NSAIDs contribute to cardiovascular side effects in these patients. 7 August 2019
UK pharma major GlaxoSmithKline and the Sabin Vaccine Institute (Sabin) today announced exclusive agreements for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and the closely related, but lesser known, Marburg virus. 6 August 2019
Privately-owned US drugmaker Alvogen and Swiss firm Covis Pharma have entered into an exclusive partnership and distribution agreement for the commercialization of Alvesco (ciclesonide), a treatment of persistent asthma. 6 August 2019
USA-based Akebia Therapeutics’ Keryx Biopharmaceuticals subsidiary has entered into a settlement and license agreement with Par Pharmaceutical. 6 August 2019
The Russian pharmaceutical market may face a steep decline in the second half of the current year, due to the ongoing slumping of drug sales in the country, according to recent statements by some senior state officials and industry’s analysts, reports The Pharma Letter’s local correspondent. 6 August 2019
Hungary's largest drugmaker Gedeon Richter today posted financial results, showing that consolidated sales at 241,522 million forint ($819.5 million; 753.9 million euros), increasing 7.6% in forint terms and up 5.6% in euros during the first six months to June 2019 when compared with the first half of 2018. 6 August 2019
The global pharmaceutical industry has spent well over a trillion dollars on research and development in the last ten years, and analysts expect annual investment levels to grow by around 3% annually, reaching up to $200 billion per year by 2022. 5 August 2019
The AstraZeneca type two diabetes drug Foxiga (dapagliflozin) has had its label updated for the European Union to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial. 5 August 2019
The first meeting of the Hellenic Association of Pharmaceutical Companies (SFEE) with the new leadership of the Ministry of Health took place today at the ministry’s premises last month. 5 August 2019
How will US Democratic presidential candidates lower drug prices for seniors if they become President? This is a question many will be asking ahead of the US elections. 2 August 2019
Amid fears that the UK’s departure from the European Union (EU) will likely be disruptive to trade, the British government has said it will provide funding to “accelerate preparations at the border, support business readiness and ensure the supply of critical medicines.” 2 August 2019
Arguably the biggest news of the month from an M&A perspective was the merger of Netherlands-incorporated Mylan and the off-patent business of New York-based pharma giant Pfizer, creating a generics powerhouse. 2 August 2019
Ahmedabad-based Zydus Cadila has reported positive top-line results from a Phase III trial of Lipaglyn (saroglitazar) for treating type 2 diabetes. The therapy has been approved in India to treat diabetes-related conditions since 2013. 2 August 2019
Following the news that Bayer and Orion’s Nubeqa (darolutamide) has gained US Food and Drug Administration approval for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC) in only five months, GlobalData’s healthcare director Heather Leach offers her views on the impact of the drug on the prostate cancer market. 2 August 2019