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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Read the latest overview of people coming and going from executive positions at biopharma companies covered by BioSpace.
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Viatris to Report First Quarter 2024 Financial Results on May 9, 2024
4/16/2024
Viatris Inc. (NASDAQ: VTRS) will report its first quarter 2024 financial results on Thursday, May 9, 2024, before the open of the U.S. financial markets.
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Active Pharmaceutical Ingredients Market Size to Increase USD 416.15 Billion By 2033
4/15/2024
The global active pharmaceutical ingredients market size was evaluated at USD 237.48 billion in 2023 and it is expected to increase around USD 416.15 billion by 2033 with a CAGR of 5.77% from 2024 to 2033.
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Viatris Appoints Corinne Le Goff as Chief Commercial Officer
4/15/2024
Viatris Inc. today announced that Corinne Le Goff has joined the company as Chief Commercial Officer and will become a member of the company's Executive Leadership Team, effective today.
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Revance to Present New DAXXIFY® Data at the American Academy of Neurology 2024 Annual Meeting
4/12/2024
Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced two poster presentations on DAXXIFY® for the treatment of cervical dystonia at the annual meeting of American Academy of Neurology (AAN), taking place April 13-18, 2024, in Denver, Colorado.
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First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the Treatment of Decreased Visual Acuity Under Low Light Conditions Following Keratorefractive Surgery
4/11/2024
Ocuphire Pharma, Inc. today announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery.
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Theravance Biopharma, Inc. to Host Virtual Key Opinion Leader (KOL) Event to Discuss Ampreloxetine's Potential for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension (nOH) in Patients with Multiple System Atrophy on May 23, 2024
4/10/2024
Theravance Biopharma, Inc. announced it will host a virtual KOL event on Thursday, May 23, 2024 from 10:00 AM to 11:30 AM ET, featuring Horacio Kaufmann, MD, FAAN and Italo Biaggioni, MD, who will discuss the unmet need and current treatment landscape for MSA patients with symptomatic nOH.
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A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna.
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Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States
4/1/2024
Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States.
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Ocuphire Announces the U.S. Commercial Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution 0.75%) by its Partner Viatris
4/1/2024
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS).
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Revance Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 27, 2024
3/27/2024
Revance Therapeutics, Inc. announced new hire grants totaling an aggregate of 222,452 inducement restricted stock units to 29 employees.
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Viatris Hosts R&D Event Focusing on its Collaboration with Idorsia, Phase 3 Assets Selatogrel and Cenerimod and Key Elements of its Pipeline
3/27/2024
At a meeting with the investment community today, Viatris Inc. (NASDAQ: VTRS), a global healthcare company, will outline how it is continuing to evolve its R&D strategy to deliver on its goal of building a more durable, higher-margin portfolio of patented innovation on the foundation of its strong base business.
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Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
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Monoclonal Antibodies Industry is Rising Rapidly
3/22/2024
According to Vision Research Reports, the monoclonal antibodies market is poised to grow at a CAGR of 11.07% from 2024 to 2033.
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Lifecore Biomedical Concludes Strategic Evaluation Process, Announces Management Succession and Board Changes
3/20/2024
Lifecore Biomedical, Inc. today announced that its Board of Directors unanimously approved the conclusion of its review of strategic alternatives that was initiated in March 2023, and, concurrently therewith, announced several strategic updates related to its operations on a stand-alone basis.
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With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
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Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update
3/8/2024
Ocuphire Pharma, Inc. today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
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The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
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Revance Announces Proposed Public Offering of Common Stock - March 04, 2024
3/4/2024
Revance Therapeutics, Inc. announced a proposed underwritten public offering of $100 million of its common stock.