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
A European Commission (EC) approval means that GlaxoSmithKline’s Nucala (mepolizumab) is the only monthly anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate. 1 August 2019
Privately-held Boehringer Ingelheim has recorded solid but unspectacular growth in the first half of 2019, a result that shows why the company is prudent to invest in R&D and some significant recent M&A activity. 1 August 2019
Yale University and Mayo Clinic have been awarded a grant for up to $5.3 million over two years by the US Food and Drug Administration (FDA) to study patients’ experiences with pain and use of opioids. 1 August 2019
Canadian drugmaker Bausch Health, has agreed to resolve outstanding intellectual property litigation with Israel’s Teva Pharmaceutical, related to the ulcerative colitis med Apriso (mesalamine). 1 August 2019
Milan-based Italfarmaco has entered into an agreement with fellow Italian company Neupharma, providing for an exclusive option to develop and commercialize an inhalable formulation of teicoplanin. 1 August 2019
German pharma major Bayer is set to receive a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE) for Xarelto (rivaroxaban). 1 August 2019
The National List of Essential Medicines (NLEM) in India, which determines the basis of drug price regulation, is set to add new medicines for the treatment of cardiac diseases and cancer along with certain antibiotics to its list. This would result in a massive slash in prices for these drugs, reports The Pharma Letter’s India correspondent. 1 August 2019
A patent dispute between USA-based pharma major Bristol-Myers Squibb and Indian pharma company Natco Pharma has taken a new turn with the Delhi High Court awarding interim relief to Hyderabad-based Natco, setting aside an injunction filed by B-MS seeking to protect its anti-coagulant Eliquis (apixaban) against Natco’s copy product Apigat. 1 August 2019
Analzying Takeda’s latest quarterly financials is all about perspective, given that it is the first time that they include a full quarter of sales of products from Shire, the firm it acquired for $62 billion. 31 July 2019
The US Department of Health and Human Services (HHS) and the country’s Food and Drug Administration (FDA) have announced a plan to import certain prescription drugs in order to lower prices for patients. 31 July 2019
Sumitomo Dainippon Pharma has at last submitted a new drug application for approval of manufacturing and marketing for lurasidone hydrochloride in Japan for the treatment of schizophrenia and bipolar depression. 31 July 2019
Japanese drugmaker Daiichi Sankyo saw its shares rise 6.45% to 6,647 yen today after it revealed that positive results from the 12-week, pivotal Phase III bempedoic acid/ezetimibe FDC tablet study (Study 053) were published in the European Journal of Preventative Cardiology. 31 July 2019
The US Food and Drug Administration has granted approval to Nubeqa (darolutamide), a non-steroidal androgen receptor inhibitor developed by Finnish drugmaker Orion. 31 July 2019
Robust sales in its HIV business helped California’s Gilead Sciences to better-than-expected revenues and profits in the second quarter of 2019. 31 July 2019
New research indicates that the respiratory syncytial virus (RSV) market is expected to grow from $418.6 million in 2018 to $5.39 billion by 2028 across the seven major markets (7MM: USA, France, Germany, Italy, Spain, UK and Japan) at a compound annual growth rate (CAGR) of 29.1%. 31 July 2019
Sunovion Pharmaceuticals, a subsidiary of Japan's Sumitomo Dainippon, has announced that the US regulator will review its novel treatment option dasotraline, for moderate-to-severe binge eating disorder (BED). 30 July 2019
Robust demand for established brands like cancer med Ibrance (palbociclib), anticoagulant Eliquis (apixaban) and rheumatic drug Xeljanz (tofacitinib) helped Pfizer to a 30% rise in profits, the firm announced on Monday. 30 July 2019
The troubles of the Crop Science division overshadowed the more encouraging figures in Pharmaceuticals in the latest quarterly financial results at German life sciences group Bayer. 30 July 2019
Eli Lilly today posted second-quarter 2019 financial, showing that revenue increased less than 1% to $5.64 billion from $5.59 billion driven by 6% volume growth, and beating Wall Street estimates of $5.6 billion. 30 July 2019