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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
Pharmaceutical
Sweden-based Meda has acquired exclusive European rights to a new formulation of imiquimod from US drugmaker Graceway Pharmaceuticals. The new formulation is 3.75% imiquimod topical cream indicated for the treatment of actinic keratosis (AK). This product approved in the USA, under the trade name Zyclara, in March this year, and it has also been cleared in Canada. 14 May 2010
Pharmaceutical
California, USA-based Valeant Pharmaceuticals International is on the acquisition trail again, revealing that its wholly-owned subsidiary, Valeant Canada, has signed an agreement to buy Vital Science, a leading over-the-counter (OTC) dermatology company located in Toronto, Ontario, Canada for approximately C$10.5 million ($10.3 million). 29 April 2010
Pharmaceutical
California, USA-based Valeant Pharmaceuticals International has entered into an agreement with Spear Pharmaceuticals for rights to commercialize Refissa, a prescription-based topical tretinoin cream used to diminish fine wrinkles and fade irregular pigmentation due to sun damage. 2 March 2010
Biotechnology
Switzerland-based drug developer Basilea Pharmaceutica has entered into a license, co-development and co-promotion agreement with the US subsidiary of Japanese drug major Astellas for Basilea's azole antifungal agent isavuconazole, which is in Phase III clinical development for the treatment of life-threatening invasive fungal infections, on a worldwide basis, including an option for Japan. 24 February 2010
Pharmaceutical
Following a review of the available data on a possible risk of cancer in patients using Regranex (becaplermin), from Janssen-Cilag International (part of US drugs major Johnson & Johnson) the European Medicines Agency (EMEA) has concluded that the drug must not be used in patients who have any form of cancer. A similar restriction previously applied, but only for patients who had a skin cancer close to the area where the gel was to be applied. 19 February 2010
Pharmaceutical
California-based Anacor Pharmaceuticals says that US drugs giant that Merck & Co has returned full worldwide development and commercialization rights for AN2690 to Anacor, a topical anti-fungal therapy being developed for onychomycosis, a fungal infection of the nail and nail bed, estimated to affect around 35 million people in the USA. 15 February 2010
Biotechnology
As a result of increasing competition from other biologic agents, Amgen/Pfizer/Takeda's Enbrel (etanercept) - the leading therapy in the psoriasis drug market in 2008 - will account for less than one-fifth of sales in the overall market in 2018, according to a new study from research and advisory firm Decision Resources. 12 February 2010
Pharmaceutical
In draft guidance, published today, the UK's National Institute for Health and Clinical Excellence (NICE) says it has been unable to recommend Swiss drug major Novartis' Afinitor (everolimus) for the second line treatment of advanced renal cell carcinoma. 9 February 2010
Pharmaceutical
Indian drug maker Ranbaxy Laboratories, which is majority owned by Japan's Daiichi Sankyo, has launched a New Chemical Entity drug, Lulifin (luliconazole), in the Indian dermatology market. 5 January 2010
Biotechnology
The European Medicines Agency (EMEA) has been formally notified by Swiss biotechnology firm Arpida A/S (now in the throes of a merger with fellow Switzerland-based Evolva) of its decision to withdraw its application for a centralized marketing authorization for the medicine Mersarex (iclaprim), 12.8mg/ml concentrate for solution for infusion. 28 October 2009
Pharmaceutical
After a long rough patch, things are looking up for Basle-based Basilea Pharmaceutica. The company's once-daily oral treatment for adults with severe chronic hand eczema, Toctino (alitretinoin), has been approved by Swissmedic, the Swiss regulatory authority. Analysts estimate that annual sales of the drug, which has already been launched in Germany, Denmark and the UK, could potentially reach several hundred million Swiss francs, reports the Swiss newspaper Neue Zurcher Zeitung. 26 October 2009
Pharmaceutical
UK specialty drugmaker Sinclair Pharma has acquired two major revenue-generating dermatology products for a total consideration of 17.5 million euros ($25.9 million) from Belgium's Solvay Pharmaceuticals. The latter firm is currently the subject of a 4.5 billion-euro takeover deal from US drug major Abbott Laboratories (The Pharma Letter September 28). 13 October 2009
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream submitted by Arcutis Biotherapies.
Pharmaceutical
Mumbai, India-based Ipca Laboratories Ltd has launched esmolol hydrochloride, branded as Diulcus, a drug for treatment of diabetic foot ulcers.
Biotechnology
The Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), Belgium’s largest drugmaker UCB announced today.
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