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 US Food and Drug Administration has approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. 25 July 2019
US drugmaker Vertex Pharmaceuticals today revealed that its board has approved a planned transition of chairman, president and chief executive Dr Jeffrey Leiden, into the role of executive chairman of the board, effective April 1, 2020. 25 July 2019
In the first half of 2019, group sales at Roche rose 9% at constant exchange rates to 30.47 billion Swiss francs ($30.92 billion) and core earnings per share (EPS) grew 13% to 11.12 francs, ahead of sales, the Swiss pharma giant announced this morning. 25 July 2019
Almost two years after the US Food and Drug Administration (FDA) snubbed Correvio Pharma Corp’s filing for Brinavess (vernakalant hydrochloride, IV), the agency has accepted the New Drug Application (NDA). 25 July 2019
Lunch will have tasted good on Thursday for AstraZeneca shareholders, following the presentation of the Anglo-Swedish pharma major’s latest financial results. 25 July 2019
Privately-held Italian drugmaker Zambon has announced what it describes as a “transformational” acquisition of Germany-based Breath Therapeutics and its subsidiaries from current owner Sofinnova Partners, a leading European venture capital company. 25 July 2019
Belgium’s largest pharma company UCB today released financial results for the first six months of 2019, noting that revenues grew 2% (+4% at constant exchange rates) to 2.3 billion euros ($2.56 billion), with net sales rising 3% (+5% CER) to 2.2 billion euros. 25 July 2019
Markets have reacted warmly to GlaxoSmithKline’s second quarter results statement, lifting the value of shares in the British drugmaker half a percentage point on the London Stock Exchange. 24 July 2019
Melonie Warfel, vice president and general manager for life sciences at software company Model N, provides an Expert View column on pharma's hottest topic. 24 July 2019
The leading members of the USA’s Senate Finance Committee on Tuesday unveiled a long-awaited bipartisan bill to ease drug prices by increasing drugmaker rebates and demanding more scrutiny of price hikes, which is projected to save the federal government $85 billion on drug spending over the next decade. 24 July 2019
The European Medicines Agency (EMA) has accepted a Type II Variation Application for regulatory review for the use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients. 24 July 2019
The US District Court for the District of Columbia (District Court) granted Braeburn Pharmaceutical’s (Nasdaq: BBRX) motion for summary judgment, vacating the US Food and Drug Administration’s December 2018 exclusivity determination which blocked Brixadi (buprenorphine) extended release injection from final approval through November 30, 2020. 24 July 2019
Massachusetts, USA-based rare and chronic disease specialist Chiasma has revealed positive top-line data from the Phase III CHIASMA OPTIMAL trial of Mycapssa (octreotide). 23 July 2019
Shares of Myovant Sciences, a clinical-stage healthcare firm that is part of the Roivant family of companies, leapt 17.8% at $9.61 in pre-market trading after releasing positive results for its uterine fibroids treatment. 23 July 2019
A Swiss pharma giant is expanding its global access program beyond HIV to also include diagnostic tests for tuberculosis, hepatitis and human papillomavirus (HPV) for low and middle income country programs where the disease burden is the highest. 23 July 2019
California’s Gilead Sciences has presented Phase III data for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) at the International AIDS Society congress in Mexico City. 23 July 2019
The Russian government is considering easing the existing restrictions on the participation of foreign drugmakers during public procurements in the domestic market, according to recent statements of some sources close to the Russian Ministry of Health and industry analysts, reports The Pharma Letter’s local correspondent. 23 July 2019
For our latest Special Report, Adriaan Fruijtier from CATS Consultants, gives an account of major talking points at one of the year’s major events in the calendar of the Regulatory Affairs Professionals Society (RAPS), which took place in Brussels earlier in the summer. 22 July 2019
Tthe European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have granted the marketing authorization transfer to Netherlands-headquartered drugmaker Mylan for TOBI Podhaler and TOBI Solution in the UK for patients with cystic fibrosis. 22 July 2019