Lilly submits New Drug Application to the FDA for lasmiditan for acute treatment of migraine, receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for prevention of episodic cluster headache
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- Category: Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity.
Abbott recommends rejection of below-market mini-Ttender offer by Baker Mills LLC
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- Category: Abbott
Abbott (NYSE: ABT) received notice of an unsolicited mini-tender offer by Baker Mills LLC (Baker Mills) to purchase up to 60,000 Abbott common shares, representing approximately 0.003 percent of the company's outstanding shares.
AstraZeneca to divest US Synagis rights to Sobi
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- Category: AstraZeneca
AstraZeneca has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) to Swedish Orphan Biovitrum AB (publ) (Sobi). Sobi will commercialise Synagis in the US and around 130 AstraZeneca employees will transfer to Sobi as part of the transaction.
Embark and Novo Nordisk enter collaboration to discover novel therapeutics for obesity and metabolic disease
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- Category: Novo Nordisk
Embark Biotech ApS and Novo Nordisk A/S have entered into a research collaboration focusing on the discovery of novel treatments for obesity and its associated metabolic pathologies through mechanisms that increase energy expenditure.
FDA grants priority review for Dupixent® (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis
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- Category: Sanofi
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable.
Divestment of rights to Alvesco, Omnaris and Zetonna to Covis Pharma
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- Category: AstraZeneca
AstraZeneca has entered into an agreement with Covis Pharma B.V. (Covis Pharma) to sell its rights to the medicines Alvesco (ciclesonide), used for the treatment of persistent asthma, and Omnaris and Zetonna (ciclesonide), used for the treatment of nasal symptoms associated with rhinitis.
Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms
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- Category: Novartis
Throughout 2018, Novartis took strong action to focus the company and its capital towards the Innovative Medicines Division, resulting in an industry leading pipeline. Today Novartis holds an R&D and investor update in London which will provide deeper insights into the pipeline including the below.
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- Novartis announces clinical collaboration with Pfizer to advance the treatment of NASH
- Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza
- AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma
- Alcon to develop SMART Suite digital health platform for cataract surgery