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
The Office of the US Trade Representative (USTR)’s 2019 Special 301 Report – scheduled to be released this spring – brings critical attention to overseas intellectual property (IP) and market access challenges that harm American innovators, patients and workers. 15 March 2019
At the Annual Meeting of the Global Chagas Disease Coalition in Barcelona, Spain, Swiss pharma giant Novartis said that it is joining the Coalition as a member contributor. 15 March 2019
Daiichi Sankyo’s European subsidiary and Esperion Therapeutics announced that positive results from the 2,230 patient, 52-week, Phase III long-term safety study of bempedoic acid were published in NEJM. 14 March 2019
In a change of policy, Italian children have been told not to turn up to school unless they can prove they have been properly vaccinated. The decision follows months of national debate over compulsory vaccination. 14 March 2019
Reflecting its growing standing as an opinion leader on all things drug price-related, the Institute for Clinical and Economic Review (ICER)—in collaboration with the Office of Health Economics (OHE) —has published a white paper looking at alternative models for pharmaceutical rebates in the USA. 13 March 2019
As the UK government struggles to retain some semblance of an orderly Brexit, the city that houses the headquarters of the European Union (EU) has offered British-based businesses a route to allow them to operate seamlessly across the UK and European Union (EU) post-Brexit. 13 March 2019
Researchers have warned that counterfeit and substandard medicines are associated with tens of thousands of deaths, with young children in poorer countries being particularly affected. 13 March 2019
Even if the UK parliament votes against ‘no deal’ on Wednesday, in the wacky world of Brexit, this cliff-edge scenario is still possible – so Stevens & Bolton partner Charlotte Tillett and senior associate Paula Harris, consider the potential implications for pharma in an Expert View piece. 13 March 2019
Following the unexpected resignation of incumbent Dr Scott Gottlieb earlier this month, the Trump administration on Tuesday announced that National Cancer Institute (NCI) Director Norman (Ned) Sharpless will serve as acting Commissioner of the US Food and Drug Administration. 13 March 2019
More positive Phase III data for Eli Lilly’s Cyramza (ramucirumab) will support a mid-2019 regulatory push into non-small cell lung cancer (NSCLC). 13 March 2019
Smith & Nephew has agreed to acquire Osiris Therapeutics,, a fast growing company delivering regenerative medicine products, including skin, bone graft and articular cartilage substitutes. 12 March 2019
Medical products and generic drugmaker Covidien has agreed to pay just under $17.5 million to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians located in California and Florida to induce purchases of Covidien’s vein ablation products, the US Department of Justice announced on Monday. 12 March 2019
As lawmakers in the UK Parliament prepare to vote, again, on the Prime Minister’s EU withdrawal deal, the impact of Brexit is already being felt in the pharmaceutical industry. 12 March 2019
Johnson & Johnson has announced new results from a real-world meta-analysis of therapies, including Xarelto (rivaroxaban), for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). 12 March 2019
Johnson & Johnson has won a positive reimbursement decision in the UK with regards to the triple combo therapy Darzalex (daratumumab) plus Velcade (bortezomib) and dexamethasone, a corticosteroid medication. 12 March 2019
Heron Therapeutics has announced results of a multi-center postoperative pain management study in which 31 patients undergoing bunionectomy surgery received the investigational agent, HTX-011, together with a regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). 11 March 2019
Shares in AMAG Pharmaceuticals slipped by nearly 18% on Friday after a drug that was approved by the US Food and Drug Administration (FDA) in 2011, failed in a confirmatory study. 11 March 2019
Following swiftly on a Japanese filing, now the US Food and Drug Administration has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. 11 March 2019
In a move that is not totally surprising, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave a mixed reaction following its review of Sanofi’s dengue fever vaccine. 11 March 2019