Bio/Pharma News
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.
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.
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.
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.
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.
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.
FDA Approves Pneumonia Treatment
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
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.
FDA Approves New Rheumatoid Arthritis Drug
RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA
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.
GNA Biosolutions Closes Latest Financing Round Backed by US/EU Consortium
GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.
European Commission Extends Use of Dupixent to Include Adolescents
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
Pfizer Recalls Two Lots of Relpax
The company is recalling the product because of potential microbiological contamination.
Amgen Wins Enbrel Patent Case, Sandoz to Appeal Ruling
A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).
GSK US Pharma Head Steps Down
Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
Bayer Acquires BlueRock Therapeutics, Boosts Cell Therapy Stake
The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb
The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Alizé Pharma 3 Completes €67 Million Series A Financing Round for Boost in Portfolio
Alizé Pharma 3 completed a €67 million Series A financing round led by LSP to boost its product portfolio in rare endocrine and metabolic diseases.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
CURE Pharmaceutical Receives Patent for Oral Thin Film Technology
Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.
Hikma and Civica Rx Sign Long-Term Agreement to Reduce US Generic Drug Shortages
Hikma will supply 14 essential medicines to US hospitals and patients.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
FDA Approves Nine Generic Versions of Lyrica
The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.
Partnership Addresses Rift Valley Fever Vaccine
The Coalition for Epidemic Preparedness Innovations is partnering with Colorado State University to develop a single-dose vaccine candidate against Rift Valley Fever.
