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
Sunovion Pharmaceuticals, a subsidiary of Japan's Sumitomo Dainippon, has announced that its sublingual film has hit its target in Phase III trials for the treatment of Parkinson's disease. 27 June 2018
According to the analytical study carried out by RNC Pharma, deliveries of imported finished pharmaceutical products to Russia in the period from January to April 2018 were up 0.9% in Russian rouble terms, and down 7.9% in terms of packages. 27 June 2018
The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration have voted 14 to 3 against the approval of Remoxy (oxycodone extended-release capsules). 27 June 2018
The US Supreme Court yesterday granted Swiss drugmaker Helsinn’s petition for certiorari to review a Federal Circuit Panel decision, holding that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Israeli generics drug giant Teva Pharmaceutical Industries’ generic palonosetron product. 26 June 2018
The US Food and Drug Administration has accepted a New Drug Application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older. 26 June 2018
Given that it was the first treatment that contains a purified drug substance derived from marijuana to receive regulatory approval in the USA, one might have expected the Food and Drug Administration’s (FDA) green light for Epidiolex (cannabidiol) to lift shares in GW Pharmaceuticals. 26 June 2018
Blockbuster drug Ibrance (palbociclib) combined with fulvestrant was not statistically significant in extending overall survival (OS) in certain patients breast cancer patients, the secondary endpoint of a late-stage trial. 26 June 2018
Russia’s President Vladimir Putin has ordered the national government to ease the process of certification of foreign drugs in Russia this year, according to recent statements of the Russian Presidential Administration, reports The Pharma Letter’s local correspondent. 26 June 2018
US health care giant Johnson & Johnson plans a significant expansion of a global portfolio of its drugs during the next several years, according to chief scientific officer of the company Paul Stoffells speaking at an exclusive meeting with Russian media. 26 June 2018
Privately-held Boehringer Ingelheim and its partner Eli Lilly have added to the case for their drug Jardiance (empagliflozin) at the American Diabetes Association Scientific Sessions. 25 June 2018
The European Commission’s (EC) proposals for cooperation across states on clinical assessments and scientific consultations have been welcomed by trade groups in Europe. 25 June 2018
The Irish Pharmaceutical Healthcare Association (IPHA) is hopeful that, as it signs up to BeNeLuxA, Ireland will start to mirror the rates of adoption of innovative medicines that are present in the initiative’s other countries. 25 June 2018
Privately-held US firm Alvogen and UK-based Theramex have entered into a binding agreement for an exclusive partnership and distribution deal for the commercialization of certain women’s health products in Russia, Central and Eastern Europe (CEE) as well as countries within the Commonwealth of Independent States (CIS). 25 June 2018
Earlier this month, Jiao Hong, Commissioner of the National Drug Administration of China (CNDA), met with the visiting deputy Secretary General of the United Nations and the executive director of the UNAIDS Program, Michel Sidibe, and his party. 25 June 2018
The ESMO (European Society for Medical Oncology) 20th World Congress on Gastrointestinal Cancer came to a successful conclusion after four days of practice-changing research and education, according to the organizers. 25 June 2018
Genkyotex saw its shares gain 4.29% to 1.70 euros this morning, having hit a high of 1.78 euros, after the French leader in NADPH oxidase (NOX) therapies announced an expanded deal. 25 June 2018
Xultophy (insulin degludec and liraglutide injection) provided superior blood sugar reduction (HbA1c) compared to insulin glargine U-100 (1.94% versus 1.68% respectively; p 25 June 2018