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 Japanese-developed treatment for gout, which was twice rejected by the US medicines regulator, has come under by the non-for-profit consumer advocacy group Public Citizen. 22 June 2018
Conference attendees gathered in the cavernous RAI Amsterdam convention center last week to hear the latest data from a therapy area valued at around $44 billion last year, and expected to reach over $50 billion by 2022. 22 June 2018
When US pharma major Eli Lilly and Anglo-Swedish drugmaker AstraZeneca earlier this month announced that they were discontinuing the global Phase III studies of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor that was being trialled in Alzheimer’s disease, it was not only a disappointment for the companies, but also for the whole class of drugs. 22 June 2018
Roche today announced that Sophie Kornowski-Bonnet, head of Roche Partnering and member of the enlarged corporate executive committee (CEC) since 2012, has accepted a new opportunity and will be leaving the company effective July 31, 2018. 22 June 2018
The National Institute for Health and Care Excellence (NICE) published a positive final appraisal determination (FAD) on Friday for Ocrevus (ocrelizumab) to treat people living with relapsing-remitting multiple sclerosis (RRMS). 21 June 2018
An Expert View from Lynn Lewis, chief commercial officer of contract research organization Envigo, on why she believes that successful collaboration needs to embrace both proactivity and beginning-with-the-end-in-mind. 21 June 2018
In London, Takeda takeover target Shire jumped more than 2% in morning trading on Thursday, after the rare disease expert revealed US regulators had approved a potentially lucrative label expansion for Cinryze (C1 esterase inhibitor). 21 June 2018
Spending on medicines is growing at the slowest rate in years, but according to a new IQVIA Institute for Human Data Science article, at the pharmacy, commercially insured patients with a deductible have their seen out-of-pocket costs for brand medicines increase 50% since 2014. 21 June 2018
Stolberg-based drugmaker Grünenthal has entered into a collaboration with fellow German groups Lead Discovery Center, Max-Planck Innovation and Max Planck Institute of Experimental Medicine (MPI-EM) to develop novel therapies for the neurological disorder Charcot-Marie-Tooth 1A (CMT1A). 21 June 2018
US biopharma company CASI Pharmaceuticals has announced a strategic and long-term manufacturing agreement with Yiling Wanzhou International Pharmaceutical for the manufacturing of entecavir and cilostazol. 21 June 2018
Anika Therapeutics has revealed that a study of Cingal, which combines cross-linked hyaluronic acid and triamcinolone hexacetonide, in patients with osteoarthritis in the knee, missed its primary endpoint in the active-comparator Phase III trial being conducted to support US registration. 21 June 2018
Following a deal late last year that gave Bayer access to valuable customer data, Chinese e-commerce platform Alibaba has entered into another collaboration with a German pharma major, this time Darmstadt’s Merck,. 20 June 2018
As part of an agreement called the EFPIA Code, European drugmakers will in the next ten days release details of payments to healthcare professionals made in 2017. 20 June 2018
London-based buyout fund CVC Capital Partners is in advanced discussions to acquire a controlling stake worth more than 3 billion euros ($3.5 billion) in Italian drugmaker Recordati, the Financial Times reported this morning, citing three people familiar with the transaction. 20 June 2018
India’s Glenmark Pharmaceuticals has been granted approval by the US Food and Drug Administration to manufacture a generic version of GlaxoSmithKline's Malarone (atovaquone/proguanil hydrochloride) at its facility in North Carolina, USA. 20 June 2018
Jesus Gomez-Navarro, vice president, head of oncology clinical research and development at Takeda Oncology, talks of three elements to the unit’s R&D strategy and three highlights in its pipeline when talking to The Pharma Letter about the most exciting abstracts being presented on the company’s cancer candidates at two major conferences this month. 20 June 2018
French pharma major Sanofi has appointed Jean-Baptiste Chasseloup de Chatillon as executive vice president, chief financial officer (CFO) and member of the executive committee, effective October 1, 2018. 19 June 2018
Swiss pharma giant Roche has entered into a definitive merger agreement for Roche to acquire the outstanding shares of Foundation Medicines common stock not already owned by Roche and its affiliates at a price of $137.00 per share in cash. 19 June 2018
Medivir has decided to continue the discussions with the US Food and Drug Administration to agree on the design of the planned pivotal Phase III clinical study of its lead compound remetinostat for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). 19 June 2018