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 US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) has posted a Protocol outlining how it will conduct its third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. 13 April 2023
A newly-published cost effectiveness analysis for Tarpeyo (budesonide) could help developer Calliditas Therapeutics increase sales in the USA, where the therapy was approved at the end of 2021. 12 April 2023
India’s Delhi High Court has refused to grant an interim injunction to German family-owned pharma major Boehringer Ingelheim in patent litigation concerning its patent-protected diabetes drug linagliptin, which is marketed under the brand names Trajenta and Trajenta Duo. 12 April 2023
Australian drug developer Paradigm Biopharmaceuticals (ASX PAR) saw its shares gain 4% to A$1.27 in early trading, as it announced that analysis of six-month trial data shows injectable pentosan polysulfate sodium (iPPS) may slow the progression of osteoarthritis of the knee. 11 April 2023
US pharma major Eli Lilly has become the second American drugmaker, after Bristol-Myers Squibb, that has decided to exit the Russian market, reports The Pharma Letter’s local correspondent. 11 April 2023
Pharma manufacturers will be challenged by the effects of high inflation and declining US Food and Drug Administration (FDA) drug approvals in 2023. 11 April 2023
China’s National Medical Products Administration (NMPA) has announced that China will downgrade its COVID-19 insurance reimbursement management level to a Class B infectious disease in line with its management of the disease starting Saturday, April 8. 11 April 2023
A Texas federal judge on Friday ruled that the US Food and Drug Administration (FDA) "stonewalled judicial review" of its decades-old approval of the ‘morning after’ abortion pill mifepristone (marketed by Danco Laboratories under the trade name Mifeprex) and agreed to stay the effective date of the drug's approval. 11 April 2023
The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma. 7 April 2023
There have been huge changes in the way highly regulated markets operate in recent years – caused by new regulations, technologies and demands. 6 April 2023
In what is being seen as a double blow to UK pharma major AstraZeneca's non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib mesylate), the Indian Patent Office has granted a patent to the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, for its nano-formulation of drug osimertinib mesylate. 6 April 2023
US immunology focussed biotech Immunic saw its shares soar more than 23% to $1.80 in early trading today, as it reported positive data from the maintenance phase of its Phase IIb CALDOSE-1 trial of its lead asset, vidofludimus calcium (IMU-838), in patients with moderate-to-severe ulcerative colitis (UC). 5 April 2023
UK-based iron deficiency specialist Shield Therapeutics today revealed that Andy Hurley will be joining the firm’s executive team as chief commercial officer (CCO), effective April 10, 2023. 5 April 2023
The value of treatments for obesity is set to grow considerably in the next decade, with industry analyst GlobalData forecasting a market value of around $37 billion by 2031. 5 April 2023
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023