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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.
Participants for START Pilot Program Selected by FDA
The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.
AbbVie Advances Inflammatory Disease Portfolio with Celsius Therapeutics Acquisition
This acquisition will give AbbVie acces to Celsius Therapeutics' lead drug candidate, CEL383, a potential first-in-class anti-TREM1 antibody for treating IBD.
Roche Attains European Recommendation for Retinal Vein Occlusion Treatment
Vabysmo, already approved for patients with RVO in the US and Japan, would be the first bispecific antibody treatment for the condition in Europe.
Data from Study of Teva’s Ajovy Suggests 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.
Johnson & Johnson Completes Proteologix Acquisition, Gains Bispecific Antibody Assets
Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.
Lantheus Acquires Rights to Life Molecular’s RM2 Targeting GRPR for Prostate and Breast Cancers
GRPR, or gastrin-releasing peptide receptor, is part of the bombesin G protein-coupled receptor family and has been found to be overexpressed in multiple cancers.
Kite to Evaluate Cellares’ Manufacturing Platform for Wider Use
No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.
AstraZeneca Lung Cancer Treatment Approved in China
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%.
Novo Nordisk Aims to Invest $4.1 Billion to Expand Manufacturing Capacity in US
This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.
European Commission Approves Metastatic Colorectal Cancer Monotherapy
Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.
FDA Drafts Guidance Document to Assist Sponsors with 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.
Sarepta’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval
Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.
CDER Gives 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.
argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication
FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.
CDMOs Announce Strategic Partnership for Fully Integrated Manufacturing Solutions
The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.
WHO Warns About Falsified Ozempic Batches
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.
USP and African Institutions Provide Free Access to Pharma Production Resources
A new initiative will advance access to quality medicines and vaccines in Africa.
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.
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.
CordenPharma and WACKER Consortium Enters Pandemic Readiness
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
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.
EMA Reviews Risks of CAR T-Cell Medicines and Painkillers
PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.
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.
Roche and Ascidian Therapeutics Collaborate on Treatments for Neurological Diseases
The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.
The Benefit of Long-Read Sequencing in Gene Therapies
Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.
Lamassu Pharma Bridges Scientific Knowledge and Patient Care
Gabi Hanna, MD, CEO and co-founder of Lamassu Pharma talks about a novel oncology platform and the link between science and patient care.
Pushing Boundaries to Revolutionize Chronic Inflammation Therapy
Novel approaches against chronic inflammation could potentially prevent certain inflammatory diseases and neurological conditions.
New Affinity Resin Launched by Ecolab Life Sciences and Repligen for Biologics Manufacturing
Ecolab Life Sciences and Repligen have launched a new affinity resin, DurA Cycle, for large-scale biologics manufacturing.
New Syngene Platform Aims for Rapid Protein Production
Syngene's new production platform offers rapid protein synthesis with lower risk.
