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
It’s been an important week for clinical research, with two important documents published which should go a long way in helping to support clinical research as the UK leaves the European Union, writes Dr Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry (ABPI). 9 August 2018
Synergy Pharmaceuticals traded up 7.06 % to $1.76 yesterday, when the company announced a licensing deal for its best selling gastrointestinal drug in China. 8 August 2018
In an Expert View piece, Mark Davison, head of operations in the European Union for software company RFXCEL, outlines everything marketing authorization holders need to know and what you need to do for a seamless serialization process – before regulators remove your right to trade. 8 August 2018
Glenmark Pharmaceuticals today announced that the US Food and Drug Administration has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris. 8 August 2018
Droves of investors shed Bellerophon Therapeutics stock on Tuesday, after monitors suggested stopping the Phase III INOvation-1 study early due to a lack of results. 8 August 2018
Yesterday, delivering on proposals in President Trump’s American Patients First blueprint, the USA’s Health and Human Services (HHS) Department announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients. 8 August 2018
Shares in the world’s leading diabetes drug producer were down by 4% on Wednesday lunchtime after the company revealed its latest financial results and details on its US prices for next year. 8 August 2018
Danish CNS specialist Lundbeck saw its shares fall as much as 10% early this morning, after reporting what appear to be strong financial results for first-half 2018, that beat analysts’ expectations but which nevertheless failed to impress investors. 8 August 2018
I-MAK, a pressure group composed of lawyers, health professionals and academics, has published a report excoriating pharma giants for allegedly exploiting patent laws in order to drive up prices. 7 August 2018
The China National Drug Administration (CNDA) has granted approval of Ibrance (palbociclib), the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. 7 August 2018
Following on from a series of measures aimed at challenging the ongoing opioid addiction epidemic in the USA, the US Food and Drug Administration announced new action on Monday, with a set of revised scientific recommendations. 7 August 2018
The University of Texas MD Anderson Cancer Center and Ireland-incorporated Jazz Pharmaceuticals late Monday announced a five-year collaboration agreement with a goal of evaluating therapies for multiple hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes. 7 August 2018
Indian drug major Sun Pharmaceutical Industries has launched Kapspargo Sprinkle (metoprolol succinate) extended-release capsules in the USA. 7 August 2018
Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application (NDA) for the abuse-deterrent opioid drug Remoxy ER (oxycodone) extended-release capsules CII. 6 August 2018
Daiichi Sankyo published a report on Monday, identifying Lixiana (edoxaban) as an appropriate alternative to current standard of care Fragmin (dalteparin), in patients with venous thromboembolism (VTE) but raising a red flag for those with gastrointestinal cancer. 6 August 2018
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has released an update on clinical trials regulations following the UK’s exit from the European Union, so-called “Brexit”. 6 August 2018
The Institute for Clinical and Economic Review has issued a final report for AbbVie’s Orilissa (elagolix), raising serious questions over the affordability of the product. 6 August 2018
Alzheon, a privately-held American biopharmaceutical company, has announced its hiring of former IVAX president Neil Flanzraich as vice chairman of the board. 6 August 2018
Menarini Ricerche, a part of Italian family-controlled drugmaker Menarini Group, announced today that the sponsorship of the ongoing Phase I/II study that is investigating MEN1703/SEL24 for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) in the USA has been transferred from Poland’s Selvita to Menarini Ricerche on June 30, 2018. 6 August 2018