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Pharmaceutical
Almirall has released solid first-half 2015 performance in line to achieve yearly guidance, with like for like growth of net sales up 4.0% and earnings before interest, taxes, depreciation and amortization (EBITDA) rising 35.5% driven by dermatology. 28 July 2015
Pharmaceutical
KYTHERA Biopharmaceuticals has received authorization from drug regulator Health Canada to market Belkyra (deoxycholic acid) “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults.” 27 July 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued final guidance for Vargatef (nintedanib) from German family-owned pharma major Boehringer Ingelheim. 22 July 2015
Biotechnology
Anacor Pharmaceuticals revealed that its crisaborole cleared eczema skin rash better than a placebo. 13 July 2015
Pharmaceutical
US pharma giant Johnson & Johnson says that its guselkumab showed improvements in primary and secondary endpoints versus placebo and against AbbVie’s Humira (adalimumab) in plaque psoriasis at Phase IIb. 10 July 2015
Pharmaceutical
USA-based Anacor Pharmaceuticals has amended its distribution and commercialization agreement with Sandoz, a subsidiary of Swiss pharma giant Novartis. 29 June 2015
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of us drugmaker AbbVie’s Humira (adalimumab) to include treatment of adults with active moderate to severe hidradenitis suppurativa (acne inversa), who have failed to respond to conventional systemic treatments. 26 June 2015
Pharmaceutical
US aesthetic medicine specialist KYTHERA Biopharmaceuticals (Nasdaq: KYTH) on Friday announced the US availability of Kybella (deoxycholic acid) injection. 20 June 2015
Pharmaceutical
Botox maker Allergan has reached a definitive agreement to acquire KYTHERA Biopharmaceuticals (Nasdaq: KYTH), a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. 17 June 2015
Pharmaceutical
Swiss drug major Novartis has announced new analyses from pivotal Phase III registration studies showing Xolair (omalizumab) helps patients with chronic spontaneous urticaria achieve significant improvements in quality of life measures. 12 June 2015
Pharmaceutical
In draft guidance issued today for consultation, the UK Institute for Health can care Excellence (NICE) has asked Danish CNS drug specialist Lundbeck to provide more information about its drug vortioxetine (trade name Brintellix) for treating major depressive episodes in adults. 10 June 2015
Pharmaceutical
Danish pharma company LEO Pharma has announced new data showing Enstilar in the treatment of psoriasis vulgaris provides rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. 9 June 2015
Pharmaceutical
The Scottish Medicines Consortium has issued positive advice for Cosentyx (secukinumab) from Novartis for the treatment of moderate to severe plaque psoriasis. 8 June 2015
Pharmaceutical
The National Institute for Health and care Excellence (NICE) today issued guidance recommending Xolair (omalizumab) as an option for treating severe chronic spontaneous urticaria (also known as hives) in some adults and young people aged 12 years and over. 8 June 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today issued a Final Appraisal Determination (FAD) recommending Cosentyx (secukinumab) from Swiss drug major Novartis for use on the National Health Service for the treatment of severe plaque psoriasis. 29 May 2015
Pharmaceutical
Japanese drug major Chugai Pharmaceutical has submitted a New Drug Application to Japan’s Ministry of Health, Labor and Welfare for a combination topical drug preparation of maxacalcitol and betamethasone butyrate propionate (Development Code: M8010). 26 May 2015
Biotechnology
Amgen said on Friday it has commenced termination of its participation in the co-development and commercialization of brodalumab with Anglo-Swedish pharma major AstraZeneca. 25 May 2015
Biotechnology
Belgium-based biotech firm arGEN-X N (Euronext Brussels: ARGX) has entered into an alliance with independent Danish dermatology specialist LEO Pharma. 21 May 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined two dossier relating to US biotech firm Celgene’s Otezla (apremilast) as to whether this drug offers an added benefit over the respective appropriate comparator therapy. 19 May 2015
Generics
Indian drugmaker Torrent Pharmaceuticals has signed a share purchase agreement to acquire 100% stake in Zyg Pharma. 7 May 2015
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
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