New York Governor, Attorney General Ask Three Pharmacy Operators’ Commitment Over Abortion Drug Access
New York government officials Governor Kathy Hochul and Attorney General Letitia James have sent a letter to CVS Health…
FDA Seeks 10% Increase In Biden’s FY 2024 Budget, Proposes Enhancing Regulatory Authorities
The FDA has requested $7.2 billion as part of the president’s fiscal year 2024 budget, $128.2 million of which the…
Annji Pharmaceutical Has Entered Into An Exclusive License Agreement With Avenue Therapeutics For AJ201 For Spinal And Bulbar Muscular Atrophy, Also Known As Kennedy’s Disease; Upfront Payment Of $3M, Milestone Payments Of Upto $250M
The deal covers the U.S., Canada, European Union, Great Britain, And Israel.
Avenue will also issue 831,618 shares as equity upfront and additional shares upon the achievement of a clinical milestone, aggregating
FDA Casts Doubts Over Roche’s Polivy Label Expansion For Untreated Lymphoma Setting
Today, the FDA Oncologic Drugs Advisory Committee is discussing the supplemental marketing application for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab)…
William Blair Initiates Mesoblast Soon After Its Lead Product Goes Under FDA Review In Pediatric Indication
William Blair has initiated coverage on Mesoblast Ltd (NASDAQ:MESO) with an Outperform rating and a price target of $8. Mesoblast’s lead product,…
Clene’s Amyotrophic Lateral Sclerosis Candidate Delays Disease Progression, New Data Shows
Clene Inc (NASDAQ:CLNN) announced new results from exploratory analyses, including delayed time to key clinical progression events in amyotrophic lateral sclerosis…
AstraZenceca’s Tagrisso Shows Survival Benefit In Early-Stage Lung Cancer Settings
AstraZeneca Plc (NASDAQ:AZN) released topline data from the ADAURA Phase 3 trial demonstrating Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement…
AstraZeneca’s Immunotherapy Imfinzi Shows Improvement In Survival Chances In Lung Cancer Patients
In a trial, lung cancer patients treated with AstraZeneca plc’s (NASDAQ:AZN) immunotherapy Imfinzi (durvalumab) pre- and post-surgery lived significantly longer without the…
The FDA has Cleared Vertex Pharmaceuticals’ Investigational New Drug Application For VX-264, Stem Cell-Derived Fully Differentiated Pancreatic Islet Cell Therapy Encapsulated Into Vertex-Developed, Immunoprotective Device For Type 1 Diabetes
Vertex plans to initiate a Phase 1/2 clinical trial in the first half of 2023 to study the safety, tolerability and efficacy of VX-264 in patients with T1D. The company previously received approval from Health Canada
ANI Pharmaceuticals Sees FY23 Adjusted EPS of $2.09-$2.59 Vs. Consensus Of $2.62; Forecasts Revenues Of $360M-$385M Vs. $352.49M Estimate
2023 Cortrophin specific revenue guidance is between $80.0 million to $90.0 million, representing 92% to 116% growth as compared to $41.7 million recognized in