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
In October, Brazil’s Fiocruz and the Murdoch Children’s Research Institute, in Australia, will begin testing the BCG vaccine (normally used to prevent tuberculosis) on healthcare professionals, to verify the protection of the immunizer against COVID-19 as well. 25 September 2020
The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have announced the implementation of an element of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada. 25 September 2020
The Russian Direct Investment Fund (RDIF) and LAXISAM, one of the leading pharmaceutical companies in the Republic of Uzbekistan, have agreed to supply to the country up to 35 million doses of the Sputnik V vaccine. 25 September 2020
French drugmaker Ipsen today announced the appointment of Philippe Lopes-Fernandes as executive vice president, chief business officer, effective October 1, 2020. 25 September 2020
Guyana’s pharmaceutical industry is important for the neighboring Caribbean, mainly as these small islands are usually overlooked by international pharma companies when it comes to doing business. 24 September 2020
Durbin, part of Ireland-headquartered Uniphar Group, has been appointed to design and implement a global Early Access Program (EAP) on behalf of Jazz Pharmaceuticals for a new medicine containing the active substance, solriamfetol, and known commercially as Sunosi. 24 September 2020
Swiss kidney specialist Vifor Pharma has announced topline data from its AFFIRM-AHF study evaluating Ferinject (ferric carboxymaltose). 24 September 2020
Fujifilm Toyama Chemical has said that primary endpoint has been met in a Phase III clinical trial of Avigan (favipiravir) conducted in Japan for patients with novel coronavirus infections (COVID-19). 24 September 2020
The first coronavirus vaccine candidate requiring a single dose has entered into global Phase III trials, recruiting 60,000 people in South America, the USA and Europe. 24 September 2020
The US Food and Drug Administration has announced it will require a Boxed Warning for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions. 24 September 2020
Privately-held Danish medical dermatology specialist LEO Pharma today said that Becki Morison will join the company, effective October 1 in the position of executive vice president, global therapeutics and value strategy. 23 September 2020
The overwhelming focus of media reports on COVID-19 vaccine candidates is on whether they will provide positive Phase III data and meet the approval of regulators, and also whether they can be manufactured in sufficient quantity to cope with demand. 23 September 2020
ARS Pharmaceuticals has entered into an exclusive licensing agreement with Recordati for marketing rights in the EU, UK and several other countries for ARS-1, an epinephrine nasal spray. 23 September 2020
Canada’s Minister of Public Services and Procurement Anita Anand yesterday announced that the government has signed agreements with France’s Sanofi and UK-based GlaxoSmithKline to secure up to 72 million doses of their COVID-19 adjuvanted recombinant protein-based vaccine candidate. 23 September 2020
An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Matthew Birkett, partner, Hoffmann Eitle, on the granting of two patents for a single invention in the USA and Europe. 22 September 2020
CARB-X announced today it is awarding up to $7.51 million to GlaxoSmithKline, to develop a new drug to treat and prevent recurrent urinary tract infections (UTIs) caused by the Escherichia coli (E. coli) bacteria. 22 September 2020
Vaccine makers, and the biopharmaceutical industry more generally, are encouraged to see the broad international support the COVAX Facility has received. 22 September 2020
Canada’s Bausch Health has entered into an agreement to acquire an option to purchase all ophthalmology assets of USA-based Allegro Ophthalmics, including global rights for Luminate (risuteganib). 21 September 2020