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Lilly Treatment for Early Symptomatic Alzheimer’s Disease Approved by FDA
Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.
LenioBio and Labscoop’s Strategic Partnership Aimed at Enhancing Access to Cell-Free Protein Synthesis
A strategic partnership between LenioBio and Labscoop is aimed at making scalable cell-free protein synthesis technology more accessible across North America.
Edity, Aurigene to Collaborate on Cell Therapy Discovery Services for Clinical Development
This collaboration aims to support and accelerate clinical development of advanced and novel technologies.
New Drug Delivery Systems and Treatment Solutions Sought by Angelini Pharma
The company is referring to its search for innovative approaches as crowdsourcing and will award at least one cash prize.
First Nasal Adrenaline Spray Among EMA Approvals in June
EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.
Mitigation of US Pharma Supply Chain Risk is Goal of New NIPTE Strategy
The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.
EMA Accepts GSK’s Application for Use of Jemperli Plus Chemotherapy for All Endometrial Cancer Patients
EMA has accepted GSK’s application seeking treatment with Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer.
Teva’s Ajovy Studied for Possible Change to Migraine Treatment Pause Protocols
The typical cycle of ceasing and then reinitiating fremanezumab treatments may actually result in increased monthly migraine days, the study said.
FDA Selects Participants for START Pilot Program
The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.
AbbVie Acquires Celsius Therapeutics, Gains Anti-Inflammatory Disease Antibody
The Celsius Therapeutics acquisition will add CEL383, a potential first-in-class anti-TREM1 antibody for IBD, to AbbVie’s portfolio.
Chinese Authority Approves AstraZeneca Lung Cancer Treatment
Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.
Johnson & Johnson Boosts Bispecifics Portfolio with Proteologix Acquisition
With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.
FDA Provides Update on New Drugs Regulatory Program
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
Guidance Document from FDA Advises Sponsors on Diversity Action Plans
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.
Novo Nordisk Targets $4.1 Billion Expansion of US Manufacturing Capacity
Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.
Metastatic Colorectal Cancer Monotherapy Gains EC Approval
Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.
Abzena and Argonaut Announce Strategic Manufacturing Partnership
The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.
FDA Expands Approval of Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.
FDA Approves VYVGART Hytrulo, argenx’s Anti-Inflammatory Biologic, for Treating CIDP
Immunology company argenx gets its third FDA-approved indication for VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy.
USP Collaborates with African Institutions to Provide Free Access to Pharma Production Resources
A new initiative will advance access to quality medicines and vaccines in Africa.
Falsified Ozempic Batches Trigger WHO Warning
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
Bora Pharmaceuticals Acquires Baltimore Manufacturing Facility from Emergent
The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.
FDA Releases Facility Readiness Guidance
The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.
AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients
Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.
Thermo Fisher Opens New Building at Wisconsin GMP Lab
The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.
WACKER and CordenPharma Consortium Enters Pandemic Readiness
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
Ascidian Therapeutics Collaborates with Roche on Treatments for Neurological Diseases
The collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.
FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies
Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.
EMA Reviews Risks Associated with Painkillers and CAR T-Cell Medicines
The agency is evaluating risks associated with the painkiller metamizole. It is also reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.
Ecolab Life Sciences and Repligen Launch New Affinity Resin for Commercial Biologics Manufacturing
Ecolab Life Sciences and Repligen introduce DurA Cycle, a new affinity resin for large-scale biologics manufacturing.
