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FDA Grants Xtandi Application Priority Review for Additional Indication in Prostate Cancer
The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.
Bristol-Myers Squibb, Celgene to Divest Otezla to Amgen for $13.4 Billion
The transaction is part of Bristol-Myers Squibb’s proposed acquisition of Celgene.
AstraZeneca Announces Positive Results from Farxiga Phase III Trial
AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.
Industry Stresses Importance of Tackling Vaccine Hesitancy
ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.
Analysis Shows that EU and US are Highly Aligned for Marketing Decisions
Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.
Innovate UK Awards Thousands for Development of Cell Stabilization Technologies
Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.
GSK Applies for Approval of Daprodustat in Japan
GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.
Biosimilar Teriparatide Launches Across Europe
A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
EAG Launches New Lab in China for Product Improvement
The new lab will be dedicated to improving materials and electronics using advanced imaging and surface analysis expertise.
Alligator Bioscience Enters into License Agreement with Biotheus
The agreement gives Biotheus access to Alligator’s antibody, Alligator-Gold, for the creation of up to three bispecific molecules.
New Coalition to Raise Awareness of Superbugs
Working to Fight AMR will work to raise public awareness of the threat of antimicrobial resistance, the third-leading cause of death in the United States.
Bayer to Sell Animal Health Biz to Elanco for $7.6 Billion
The divestiture is in line with Bayer’s strategy to focus on its life sciences business.
Data Integrity Violations Found at China Facility
FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.
Enable Injections Enter into Development Agreement with Genentech
The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.
Thermo Fisher Bets on Augmented and Virtual Reality
The company’s new training center in Greenville, NC, will use virtual and augmented reality to train employees on its sterile injectables manufacturing line, which is expected to cut training time in half.
Pfizer Invests $500 Million into Its Gene Therapy Facility
Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.
FDA Approves Regeneron’s Eylea for Eye Disease
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.
USP Proposes Change to Reporting Thresholds
The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.
FDA Approves Pneumonia Treatment
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
ACG Capsules Introduces New Line of HPMC Capsules
The ACGcaps H+ capsules work to meet pharmaceutical and nutraceutical needs while remaining gelatin-free.
Generics: Getting Beyond “File First, Figure it Out Later”
A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues
Sarepta Therapeutics Receives Complete Response Letter for Golodirsen NDA
FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.
FDA Agrees to Accelerated Approval of Small Cell Lung Cancer Treatment
The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.
FDA Grants Accelerated Approval to Janssen’s Tuberculosis Drug
The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.
Parker Bioscience Filtration Expands Single-Use System Facility in UK
The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.
FDA Approves New Rheumatoid Arthritis Drug
RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA
Olympus to Present Light Microscopy Award
Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.
FDA Approves Roche’s New Cancer Drug
FDA has approved Roche’s new cancer drug for treating metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors and neurotrophic tyrosine receptor kinase gene fusion-positive solid tumors.
India Facility Receives Warning Letter
FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
Cytena Owners Agree to Sell All Shares to Cellink
A strategic agreement has been announced that will see all shares of Cytena be sold to Cellink for a purchase price of EUR30.25 million (US$33.79 million).
