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Thermo Fisher Scientific Expands Proteomics Services with Olink Acquisition
Thermo Fisher will add Olink to its Life Sciences Solutions business.
Pfizer and Evotec Partner for Drug Discovery
Pfizer and Evotec will focus on early discovery research for therapeutics targeting metabolic and infectious diseases.
uniQure to Sell Its Commercial Gene Therapy Manufacturing Operations in Massachusetts to Genezen
The acquisition of uniQure’s Lexington, Mass., manufacturing operations will boost Genezen’s late-phase and commercial gene therapy development and manufacturing services.
Roche to Reintroduce nAMD Treatment in US After FDA Approves Updates
Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.
EU Makes First-in-World Approval of Dupixent as Targeted Therapy for Uncontrolled COPD
Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.
GSK and CureVac Enter into Licensing Agreement
The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.
Cell-Free Protein Synthesis Technology to be Made More Accessible Through LenioBio and Labscoop Partnership
LenioBio and Labscoop's new strategic partnership is aimed at increasing access to scalable cell-free protein synthesis technology across North America.
FDA Approves Lilly Treatment for Early Symptomatic Alzheimer’s Disease
Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.
Angelini Pharma Seeks Solutions for New Drug Delivery Systems and Treatments
The company is referring to its search for innovative approaches as crowdsourcing and will award at least one cash prize.
Aurigene to Provide Cell Therapy Discovery Services to Edity to Support Clinical Development
This collaboration aims to support and accelerate clinical development of advanced and novel technologies.
GSK’s Application for Jemperli Plus Chemotherapy for Use in All Patients with Endometrial Cancer Accepted by EMA
GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.
NIPTE Strategy Aims to Mitigate US Pharma Supply Chain Risk
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.
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.
