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 on Wednesday approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. 28 March 2019
The UK Supreme Court has handed down a unanimous decision in a case between generics firm Actavis and Eli Lilly subsidiary ICOS, finding that discoveries from routine research can be rewarded with a patent. 27 March 2019
The National Institute of Care and Health Excellence (NICE) has issued a final appraisal determination (FAD) recommending Steglatro as a monotherapy in British adults with type 2 diabetes (T2DM) for whom metformin is contraindicated or not tolerated, or as part of a dual therapy with metformin. 27 March 2019
Privately-held Purdue Pharma has agreed to pay for the establishment of the USA’s leading addiction research center in a settlement with the state of Oklahoma over the opioid crisis that its drug Oxycontin (oxycodone) contributed to. 27 March 2019
Most commercial executives in the industry thought the discussions over Obamacare were finally at an end, after a monthslong war of attrition between the White House and Congress early in Mr Trump’s presidency. They may need to think again. 27 March 2019
New research highlights the continued differences between the USA and European to drug approval, and the need for a global approach, to drug development to ensure success across both continents. 27 March 2019
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). 27 March 2019
Several multinationals in India continue to be sole sellers of certain cancer drugs even after product patents expire, with generic companies unwilling or unable to enter the market due to various barriers including manufacturing and regulatory. 27 March 2019
A new alliance between the UK-based charities Cancer Research UK and LifeArc and Japanese drugmaker Ono Pharmaceutical will seek to discover and progress new targets in immuno-oncology. 27 March 2019
Organizers of the CPhI Japan have said that a consensus coming out of the event among drugmakers was for the removal of long-list products. 26 March 2019
Germany-based Biofrontera has entered into an agreement to acquire all shares in Cutanea Life Sciences through its subsidiary Biofrontera Newderm LLC as the acquirer, with Maruho Co Japan as the seller. 26 March 2019
More than five years after the blood thinner Xarelto (rivaroxaban) litigation began, and with Germany’s Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of $775 million. 25 March 2019
In what seems to be rare these days, USA-based Avanir Pharmaceuticals has presented positive new late-stage data for its AVP-786 in the Alzheimer’s setting. 25 March 2019
AstraZeneca’s Forxiga (dapagliflozin) has become the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes. 25 March 2019
The share of domestic drugs in the public procurements in Russia has reached record figures for the last four years and currently continues to grow, according to recent statistics, published by the Russian Ministry of Health and statements of some local analysts in the field of pharmaceutics. 25 March 2019
Péter Holchacker, director of Hungary’s Association of Innovative Pharmaceutical Manufacturers (AIPM), has said that the country’s medicines budget is 20 billion Hungarian forint ($71 million) behind what it was a decade ago. 25 March 2019
Botox (onabotulinumtoxinA) manufacturer Allergan has accepted calls to shake up its management structure, agreeing to create a new position to stand alongside the chief executive at the time of the next leadership change. 25 March 2019
A company that is seeking non-opioid solutions for acute pain is a step further from finding one after receiving a second complete response letter (CRL) relating to one of its candidates. 25 March 2019
The Australian government is providing almost A$25 million ($17.8 million) so Australians with cancer and rare diseases have access to clinical trials no matter where they live including regional and remote Victoria. 25 March 2019
At a meeting between Minister of Health of Paraguay, Julio Mazzoleni, and Consul General of the country, Hernando Arteta, during a visit to Brazil’s Fiocruz Foundation last week health cooperation between Paraguay and Fiocruz was discussed. 25 March 2019