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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
Privately-held Spanish drugmaker Ferrer Internacional says that it has successfully completed a Phase III clinical trial in adult and paediatric patients with impetigo involving Ozenoxacin formulated as a topical treatment for dermatological infectious conditions. The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea and Taiwan. 5 June 2013
Pharmaceutical
West Chester-based, USA, Aqua Pharmaceuticals says it has acquired the US rights to, and re-launch of, Verdeso (desonide) Foam, 0.05% from Stiefel, a subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK). Financial terms of the deal were not disclosed. 5 June 2013
Pharmaceutical
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism (formation of blood clots in the veins and arteries). 17 May 2013
Pharmaceutical
The psoriasis market experienced approximately 36.5 million prevalent cases across the USA, France, Germany, Italy, Spain, the UK, Japan, China and India in 2012. By 2022, epidemiologists forecast that this figure will reach around 40.93 million cases, following a 12.1% increase based on projected population growth, according to a new report added to the offering of companies and markets.com. 19 April 2013
Generics
Indian drugmaker Lupin (BSE: 500257) saw its shares gain 2.3% to 659.65 rupees by close of trading on Friday (April 12), when the company said that its US subsidiary has received final approval for its Daysee (levonorgestrel and ethinyl estradiol) tablets, from the US Food and Drugs Administration to market a generic version of Israel-based Teva Pharmaceutical Industries' (NYSE: TEVA) branded contraceptive drug Seasonique. Lupin has already commenced shipping the product, the company said. 15 April 2013
Biotechnology
US biotech firm Gilead Sciences (Nasdaq: GILD) says it has submitted a New Drug Application to the US Food and Drug Administration for approval of sofosbuvir, its once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. 9 April 2013
Pharmaceutical
German drug major Bayer's (BAYN: DE) investigational drug ATX-101 can significantly and sustainably reduce unwanted fat under the chin, also known as submental fat (SMF), or double chin. More than two years after treatment with ATX-101 in Phase IIa clinical trials, levels of SMF reduction were sustained in more than 90% of patients who had initially responded to treatment, while treatment satisfaction was maintained or improved in over 80% of these patients, according to the results of a long-term follow up study presented at the 11th Anti-Aging Medicine World Congress (AMWC) being held in Monaco. 4 April 2013
Generics
Acquisitive Canadian drugmaker Valeant Pharmaceuticals International (TSX: VRX) today (April 3) announced that its takeover target Obagi Medical Products (Nasdaq: OMPI) has accepted its increased offer of $24.00 per share (up from an original $19.75 made last month , which tops that of German family-owned Merz Pharma's $22.00 per share counter offer (The Pharma Letters April 2 and March 20). 3 April 2013
Generics
Indian drugmaker Dr Reddy's Laboratories (NYSE: RDY) says it launched Zenatane (isotretinoin capsules USP) in 20mg and 40mg, a therapeutically equivalent generic version of Swiss drug major Roche's now off patent severe acne drug Accutane in the US market on March 28, 2013, following the approval by the US Food & Drug Administration of Dr Reddy's ANDA. 29 March 2013
Pharmaceutical
Researchers at Ben-Gurion University of the Negev (BGU), in collaboration with Israel largest drugmaker Teva Pharmaceutical Industries (NYSE: TEVA), have developed a promising drug candidate to treat psoriasis. The finding was reported in a new paper published in Chemistry and Biology. 21 March 2013
Pharmaceutical
Canada-based Valeant Pharmaceuticals International (TSX: VRX) is on the acquisition trail again, announcing a definitive agreement to buy all the outstanding common stock of USA-based Obagi Medical Products (Nasdaq: OMPI), which develops, markets and sells proprietary skin care systems in the physician-dispensed skin care market, for $19.75 per share in cash, or around $344 million. 20 March 2013
Generics
Indian drugmaker Glenmark Generics confirms that it seeking US Food and Drug Administration approval for azelaic acid, gel 15%, a generic version of German drug major Bayer's (BAYN: DE) Finacea, which is used to treat rosacea. 18 March 2013
Pharmaceutical
Privately-held US biotech firm KYTHERA Biopharmaceuticals announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin. 4 March 2013
Biotechnology
The European subsidiary of US biotech firm Celgene Corp (Nasdaq: CELG) presented the results from ESTEEM 1 with its drug candidate apremilast, the company's first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida. 4 March 2013
Biotechnology
Privately-held Danish dermatology specialist LEO Pharma has entered into an exclusive research and license agreement with the German biotech company 4SC Discovery with the primary aim of jointly researching, developing and commercializing an oral treatment for inflammatory skin diseases such as psoriasis. 26 February 2013
Biotechnology
Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase III trial, ASTERIA II, which demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses. 25 February 2013
Generics
Ireland-based drugmaker Shire (LSE: SHP) says it has settled all pending litigation with Impax Laboratories (Nasdaq: IPXL) over Shire's supply of an authorized generic version of Adderall XR (mixed amphetamine salts). Shire has been supplying Impax with authorized generic Adderall XR since October 2009 pursuant to a supply agreement between the parties. 10 February 2013
Pharmaceutical
Following a recent investigation (The Pharma Letter January 29), the French medicines agency (ANSM) announced yesterday its plan to suspend the marketing authorization for German drug major Bayer's (BAYN: DE) Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics for acne treatment in France. 1 February 2013
Pharmaceutical
The European Medicines Agency has been asked by France to review third- and fourth-generation combined oral contraceptives to determine whether there is a need to restrict the use of these medicines to women who cannot take other combined oral contraceptives. 29 January 2013
Biotechnology
USA-based privately-held Kinex Pharmaceuticals has entered a licensing agreement granting Taiwan's PharmaEssentia exclusive rights in certain Asian territories for the dermatology preparations of Kinex' dual Src/Pretubulin Inhibitor, KX01. 3 December 2012
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