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
Roche has been granted US Food and Drug Administration approval for a combination of Tecentriq (atezolizumab) and Avastin (bevacizumab), plus chemo, for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). 7 December 2018
An exclusive Expert View column written for The Pharma Letter by Thomas Cueni, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) director general and co-chair of the APEC Biopharmaceutical Working Group on Ethics. 6 December 2018
The most important M&A news of the month was arguably the giant step taken by Japanese drugmaker Takeda towards taking over rare diseases specialist Shire in the year's biggest deal, with shareholders voting in favor of the acquisition. 6 December 2018
A more robust approach will be taken to enforcing intellectual property (IP) in China, new punishments announced by the National Development and Reform Commission show. 6 December 2018
A new survey from NORC at the University of Chicago finds that two-thirds of adults in the USA do not intend to get the flu vaccine this season. 6 December 2018
Shionogi is the sole investor in the Series A funding round of Vast Therapeutics, a privately-owned US company that focuses on research and development of inhaled antimicrobial drugs enabling spontaneous and controlled nitric oxide release. 6 December 2018
An analysis from cryptocurrency broker GlobalBlock outlines the potential value of blockchain to the pharmaceutical industry, calling the two “an almost perfect match.” 6 December 2018
US biopharmaceutical services firm Parexel has entered into a new collaboration with US pharma major Eli Lilly to launch a clinical research learning and development program in China. 6 December 2018
Roche’s Kadcyla (trastuzumab emtansine) has passed a Phase III test comparing the antibody-drug conjugate (ADC) with Herceptin (trastuzumab) as a therapy for certain breast cancers. 6 December 2018
The well-documented case of Medicaid being overcharged over EpiPen (epinephrine), the emergency allergy treatment from Mylan, has led two Senators to propose a bipartisan bill. 5 December 2018
Drug-making is sometimes pictured as one of the last surviving “traditional” industries, successfully resisting waves of change that have overtaken other businesses. 5 December 2018
Today the UK government has published the second Life Sciences Sector Deal, the extension of a previous set of deals announced alongside the UK’s Industrial Strategy in November 2017. 5 December 2018
Approval by the US Food and Drug Administration of a highly potent opioid has garnered national attention and criticism from physicians, politicians, and others concerned about the increasing numbers of Americans dying from opioid overdoses, notes Dr Nicola Davies in her latest exclusive blog for The Pharma Letter. 5 December 2018
Janssen Pharmaceutical, the pharma business of US healthcare company Johnson & Johnson, has announced positive Phase III data for Darzalex (daratumumab) at the annual meeting of the American Society of Hematology. 5 December 2018
Leverkusen's Bayer has announced new growth and margin targets, including overall sales growth of approximately 4% in 2019 and an annual average rate of 4-5% in the following years, through to 2022. 5 December 2018
The worth of extended-release treatments for opioid use disorder has been questioned in analysis from the Institute for Clinical and Economic Review (ICER). 4 December 2018
Finnish drugmaker Orion Corp and Swiss pharma giant Novartis have agreed that Novartis will return the sales and distribution rights in certain European countries for Parkinson's disease drug Stalevo (levodopa, carbidopa, entacapone). 4 December 2018
London-listed drugmaker GlaxoSmithKline has divested its Horlicks brand and other consumer healthcare nutrition brands to Unilever, as part of a previously-announced strategic overhaul. 4 December 2018