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
GlaxoSmithKline and Innoviva have announced positive headline results from the pivotal Phase III CAPTAIN study of already marketed once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients living with uncontrolled asthma. 3 May 2019
Danish diabetes giant Novo Nordisk pleased markets this morning with first-quarter 2019 financial results that beat analysts’ consensus expectations, and sending the firm’s shares up 0.72% to 329.40 Danish kroner by late morning trading. 3 May 2019
Amid multiple Congressional investigations into drug pricing in the USA, and a febrile political atmosphere around the role of the state in insurance and pricing negotiations, the nonpartisan Congressional Budget Office (CBO) released a report into so-called “Medicare for all” on Thursday. 2 May 2019
The UK government has unveiled improvements to its Accelerated Access Collaborative (AAC) with the promise of making it the new umbrella organization for UK health innovation. 2 May 2019
The US House Committee on Rules held the first hearing on Medicare for all legislation this week, and, while the subject matter was familiar, the hearing itself was unusual, according to Stephanie Kennan of McGuireWoods Consulting. 2 May 2019
The UK’s healthcare authority has published a new guideline for healthcare professionals, indicating the symptoms and signs which should prompt a referral for further neurological assessment. 2 May 2019
As pivotal changes in healthcare and drug development gain traction, new analysis from management consultancy Arthur D Little (ADL) highlights that all sectors of the industry must evolve their business and operating models in the coming decade. 2 May 2019
The US Food and Drug Administration yesterday announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. 2 May 2019
Propelled by positive results from a novel two-drug HIV regimen and a new shingles therapy, London’s GlaxoSmithKline posted sales of £7.7 billion ($10 billion) for the first quarter of the year, higher than the some £7.5 billion analysts had expected. 2 May 2019
Heron Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain. 1 May 2019
The US Justice Department (DoJ) announced yesterday that US WorldMeds (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs, Apokyn (apomorphine) and Myobloc (botulinum toxin type B). 1 May 2019
Ireland-headquartered drugmaker Allergan has shown its commitment to its home country by pledging 65 million euros ($73 million) for the continued expansion of the company’s laboratories and manufacturing sites at Westport in County Mayo and Clonshaugh in north Dublin. 1 May 2019
The US Food and Drug Administration (FDA) has accepted that regulators from two further European Union (EU) countries are capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to the USA. 1 May 2019
Japanese drug major Eisai says that its US subsidiary has bought out Purdue Pharma's rights in the worldwide collaboration for the evelopment and commercialization of investigational dual orexin receptor antagonist lemborexant. 1 May 2019
The US Food and Drug Administration has issued a new Boxed Warning for certain common prescription insomnia medicines, due to “several reports of rare, but serious injuries and deaths.” 1 May 2019
The US Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. 1 May 2019
US pharma major Eli Lilly posted financials this morning, showing that, for the first quarter of 2019, worldwide revenue was $5.092 billion, an increase of 3% compared with the first quarter of 2018, but missing the consensus forecast of $5.2 billion. 30 April 2019
Strong sales performance for breast cancer drug Ibrance (palbociclib) and pneumonia vaccine Prevnar (pneumococcal 7-valent conjugate) helped New York’s Pfizer on its way to a 9% bump in profits for the first quarter of 2019. 30 April 2019