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Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
Aclaris Therapeutics has announced an exclusive licensing agreement with Biosion for broad rights to two new antibodies. 19 November 2024
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biosimilars
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
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
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
Biotechnology
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
Biosimilars
Bio-Thera Solutions and Hungary’s Gedeon Richter have reached an exclusive commercialization and license agreement. 14 October 2024
Biotechnology
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Biotechnology
Shares in UK-based antibiotics developer Motif Bio are now worth just a tenth of their value of four months ago after more bad news about iclaprim, the company’s lead product. 7 June 2019
Biotechnology
Germany-headquartered clinical-stage biotech InflaRx (Nasdaq: IFRX) saw its shares crash nearly 92% to $3.06 by close of trading on Wednesday, after the company revealed that IVX-1, its potential treatment for an inflammatory skin disorder, failed to demonstrate statistical significance compared to placebo. 6 June 2019
Pharmaceutical
Patients must always be the center around which the entire innovation process revolves, while seeking to satisfy unmet patient needs, writes Alfredo Barón de Juan, Executive Vice President, Global Commercial Operations at Almirall, in an Expert View piece. 5 June 2019
Pharmaceutical
Privately-held Danish medical dermatology specialist LEO Pharma today announced that Gitte Aabo will step down as president and chief executive after 27 years in the company, 11 of which were as CEO. 4 June 2019
Pharmaceutical
Spanish dermatology specialist Almirall and its US affiliate, formerly known as Aqua Pharmaceuticals, have agreed to pay the United States $3.5 million to resolve allegations that they used kickbacks to induce physicians to purchase their dermatology products. 30 May 2019
Pharmaceutical
Shares of US biopharma company Cara Therapeutics, which were suspended ahead of the announcement, leapt as much as 21% after it released positive top-line data from the KALM-1 pivotal Phase III trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). 29 May 2019
Biotechnology
Russia’s first original drug for the treatment of severe psoriasis has been registered by one of the leading local drugmakers Biocad, according to the company. 22 May 2019
Pharmaceutical
Breakthrough Therapy-designated abrocitinib, a JAK1 blocker under development by Pfizer, has passed a Phase III test with flying colors. 15 May 2019
Pharmaceutical
Almirall’s first quarterly results of 2019 suggest a continuation of the previous year’s theme, by pointing to rising revenue and growth. 13 May 2019
Biotechnology
US biotech Regeneron missed the expectations of Wall Street analysts in both its first-quarter sales and earnings, sending its share price tumbling on Tuesday. 7 May 2019
Pharmaceutical
Ireland incorporated drugmaker Allergan today reported its first quarter 2019 financial results including generally accepted accounting principles (GAAP) net revenues of $3.60 billion, a 2.0% decrease from the prior year quarter, but beating Wall Street’s average estimates of $3.54 billion. 7 May 2019
Biotechnology
Hot on the heels of approvals in North America and Japan, Skyrizi (risankizumab) has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 30 April 2019
Pharmaceutical
Important regulatory news last week included US Food and Drug Administration approval for the combination of Merck & Co’s Keytruda and Pfizer’s Inlyta, which is seen as a challenge for Bristol-Myers Squibb’s Opdivo and Yervoy in kidney cancer. Also, FDA approval of AbbVie’s plaque psoriasis drug Skyrizi was notable and generated discussion at the drugmaker’s financial results conference call. On the clinical trial front, Israel’s Teva Pharmaceutical Industries revealed it was scrapping development of Ajovy (fremanezumab) in cluster headache and Eli Lily presented positive new data on its spondyloarthritis drug Taltz. 28 April 2019
Pharmaceutical
Carrying on from where the firm left off in 2018, the first quarter of 2019 has been a positive one for Sanofi. 26 April 2019
Biosimilars
Samsung Bioepis has received another approval for a biosimilar in the USA. 26 April 2019
Biotechnology
New data supporting the long-term safety of Cimzia (certolizumab pegol), the only Fc-free, PEGylated anti-tumor necrosis factor (TNF), in patients with moderate-to-severe plaque psoriasis, and new efficacy data for patients who show signs of psoriasis-related nail disease and those who had an inadequate early treatment response to Cimzia, were released today. 25 April 2019
Biotechnology
As was largely anticipated, the US Food and Drug Administration late on Tuesday approved Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 24 April 2019
Biotechnology
A Phase III study of atopic dermatitis candidate nemolizumab, which enrolled people with moderate-to-severe pruritus, has achieved its primary endpoint. 18 April 2019
Pharmaceutical
Privately-held Danish medical dermatology specialist LEO Pharma has inked a new deal with US-based Elektrofi, a drug formulation and delivery firm. 10 April 2019
Biotechnology
China’s state council last August announced reform goals, which included speeding up the approval process for imported drugs, and seeking to include more oncology drugs in the national reimbursement drug list. 2 April 2019
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