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 UK’s reimbursement agency has recommended against using the novel multiple sclerosis (MS) therapy Mayzent (siponimod), in draft guidance. 25 June 2020
The European Medicines Agency (EMA) Management Board has announced its nomination for the new executive director of the Agency to replace the outgoing Professor Guido Rasi, who is due to end his term in the position that he has held since 2011 (minus an off-stint due to a controversy over the selection procedure). 25 June 2020
Japanese pharma major Eisai has received marketing approval of Equfina (safinamide mesylate) for treatment of idiopathic Parkinson’s disease as adjunctive therapy with levodopa-containing products in patients with end of dose motor fluctuations from South Korea’s Ministry of Food and Drug Safety). 25 June 2020
The Institute for Clinical and Economic Review (ICER), a Boston, USA-based cost effectiveness watchdog, has updated its pricing model for remdesivir in COVID-19. 25 June 2020
German crop sciences and pharma major Bayer has announced a series of agreements that will substantially resolve major outstanding Monsanto litigation, notably the US Roundup weedkiller product liability claims, that have plagued the company, as well as, dicamba drift litigation and PCB water litigation. 25 June 2020
Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). 25 June 2020
Faced with the unprecedented international urgency of the COVID-19 pandemic, global regulators have again held a meeting to discuss what they can do to ensure a quick, safe and effective vaccine. 24 June 2020
French drugmaker Sanofi has certainly been on a public relations drive this year, using every chance possible to show off the progress of its pipeline and its investments in innovation and manufacturing. 24 June 2020
Biohaven Pharmaceutical’s shares were down 4.3% at $69.91 in morning trading today, after it reported mixed top-line results from its proof-of-concept study of troriluzole in the treatment of obsessive-compulsive disorder (OCD). 24 June 2020
Authorities in the UK have reclassified Epidyolex (cannabidiol) as a Schedule 5 drug, the lowest level of control, making it easier for the company to distribute the therapy. 24 June 2020
The US Food and Drug Administration yesterday launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). 24 June 2020
The launch of new therapies between 2018 and 2028, including new classes of drugs with novel mechanisms of action (MOAs), and an anticipated increase in the prevalence of dry eye syndrome (DES) are expected to lead to an expansion of the global DES market. 24 June 2020
The COVID-19 pandemic in Russia has resulted in an increase of drug sales in the local market and led to liberalization of the domestic legislation for pharma products, according to recent statements by some leading Russian drugmakers and local analysts, reports The Pharma Letter’s correspondent. 23 June 2020
Akili, a funded entity of London-listed biotech firm PureTech Health, today announced that it has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in pediatric patients with attention deficit hyperactivity disorder (ADHD). 23 June 2020
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone for patients with Duchenne muscular dystrophy (DMD) in respiratory function decline who are not taking glucocorticoids. 23 June 2020
Regulators from the European and American medicines agencies have agreed to strengthen cooperation, following the 2020 bilateral regulatory dialogue meeting. 23 June 2020
The US Food and Drug Administration has granted accelerated approval to Xpovio (selinexor) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. 23 June 2020
After receiving the green light from the US Food and Drug Administration to move forward, Gilead Sciences is about to start trials of an inhaled version of remdesivir, said the US biotech’s chairman and chief executive Daniel O’Day in an open letter on Monday. 23 June 2020
Two initial Phase III studies of V114, an investigational pneumococcal conjugate vaccine, show a positive immune response across all 15 serotypes included in the vaccine. 23 June 2020