Mindful that the next two years will be massively important for the company and how closely pharma will be watching its progress, it is not surprising that Realm Therapeutics has been keen to let the world know its plans for 2017. 31 January 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. 28 January 2017
Swiss pharma giant Novartis’ subsidiary Sandoz might have received US approval for Erelzi, a biosimilar to US biotech major Amgen’s Enbrel (etanercept), in August 2016, but it will not go on sale until 2018 at the earliest. 25 January 2017
The US Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for TXA127 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. 18 January 2017
Valeant Pharmaceuticals has released positive top-line results from a confirmatory Phase III trial of a new product to treat plaque psoriasis. 13 January 2017
Shares of Ireland-headquartered Shire were down 3.3% at £45.26 mid-morning following the news that it will pay $350 million to settle US federal and state False Claims Act allegations. 12 January 2017
Valeant Pharmaceuticals International has entered into a definitive agreement to sell all of the outstanding equity interests in Dendreon Pharmaceuticals. 10 January 2017
The UK’s National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of Otezla (apremilast). 22 December 2016
Leading Spanish drugmaker Almirall will pay privately-held Netherlands-based CRO Mercachem up to 6.5 million euros ($6.8 million) for exclusive rights to its cytokine blockers program to identify and develop novel small molecule therapeutics for inflammatory skin diseases. 21 December 2016
Swiss pharma giant Novartis has announced that it has agreed to buy UK-based Ziarco Group, a privately-held company focused on the development of new treatments in dermatology. 16 December 2016
Troubled Valeant Pharmaceuticals has announced the departure of three executives, as the business continues to restructure at the close of a punishing 2016. 14 December 2016
Privately-held US firms Purdue Pharma and Exicure have announced a new research collaboration and license agreement aimed at discovering and developing a treatment for psoriasis in a deal that could eventually be worth up to $790 million plus royalties on successful products. 13 December 2016
A strategic global collaboration focusing on the development and commercialization of a novel RORyt inverse agonist (inhibitor) program for treatment of inflammatory skin diseases and disorders as well as for treatment of psoriatic arthritis has been announced. 12 December 2016
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
Sienna Biopharmaceuticals has acquired Creabilis, a company focused on developing first-in-class topical treatments for common inflammatory skin conditions. 7 December 2016
Following swiftly on a US regulatory filing, US healthcare giant Johnson & Johnson (NYSE: JNJ) has now applying to get clearance for its blockbuster-potential plaque psoriasis drug. 25 November 2016
Valeant has issued a statement after learning that a criminal complaint was filed in relation to Philidor, a specialty pharmacy which is accused of pushing the products of the Canadian drugmaker. 18 November 2016
Janssen Biotech has filed a Biologics License Application (BLA) with the US Food and Drug Administration approval of its investigational anti-interleukin-23 monoclonal antibody. 17 November 2016
Spain’s leading drugmaker Almirall has reported revenues for 2016’s first three quarters which are 6.7% higher than in the same period last year. 7 November 2016
The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) from US biotech giant Amgen for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages four-17) with chronic moderate-to-severe plaque psoriasis. 5 November 2016
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Danish dermatology specialist LEO Pharma today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo (delgocitinib) cream. 14 November 2024
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Almirall, the Spain-based biopharma, reported a 7.9% increase in net sales for the first nine months of 2024, reaching 728 million euros ($775 million), and an EBITDA rise of 2.9% to $152 million. 11 November 2024
New research has been published in the Journal of Allergy and Clinical Immunology (JACI) that shows treatment with amlitelimab, an anti-OX40 ligand antibody, significantly reduced symptoms of atopic dermatitis (AD) and was maintained even after treatment stopped. 9 November 2024
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Denmark’s privately-held dermatology specialist LEO Pharma and Japan’s Kyowa Kirin have revealed that they will terminate the distribution and co-promotion agreement for the psoriasis vulgaris treatment Dovobet Ointment, Gel, and Foam (calcipotriol hydrate / betamethasone dipropionate) in Japan on December 31, 2024. 1 November 2024
Regeneron Pharmaceuticals today announced financial results for the third quarter of 2024 that beat expectations, but still saw its share price fall more than 6% to $866 in early trading. 31 October 2024
Treatment with Tremfya (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment, says US healthcare giant Johnson & Johnson. 25 October 2024
New results show Eli Lilly Ebglyss (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Dupixent (dupilumab). 25 October 2024
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s Bimzelx (bimekizumab-bkzx), to treat psoriasis. 14 October 2024
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024