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Finch and Takeda Collaborate on IBD Therapies
The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.
Janssen Signs Deal with PeptiDream
Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.
Patient Groups Challenged on Pharma Ties
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
Debate Over New Cancer Therapies
FDA is in the center of the debate over developing and pricing new cancer therapies.
Study Compares Regulatory Review at FDA with EMA
A new study in NEJM compares the regulatory review processes of FDA and EMA.
Prices, Opioids, and Ethics Dominate FDA Confirmation Hearing
Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
Sartorius Acquires Umetrics for $72.5 Million
Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.
EMA to Collaborate More Closely with Academia
EMA has developed a framework and action plan to foster relationships with the academic community.
Mylan Announces Expansion of EpiPen Recall to the US
The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.
Now Arriving: CPhI North America
Philadelphia plays host to the exhibits, conferences, and networking activities of CPhI North America on May 16-18, 2017.
Novartis Receives FDA Priority Review for CAR-T Therapy
The company received priority review for its investigational CAR-T therapy to treat leukemia.
FDA Approves First Treatment for Primary-Progressive Forms of Multiple Sclerosis
The mAb is the first approved treatment that targets the progressive form of the disease.
Parker Domnick Hunter to Manufacture Automated Bioprocessing Systems at UK Facility
The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.
FDA Approves Dupixent for Atopic Dermatitis
FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.
MilliporeSigma Launches Supply Program for Single-Use Systems
The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.
Singapore Facility Receives FDA Warning Letter
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
Experts Propose Licensing Deal to Expand Access to Hep C Therapies
A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
Plasticell Collaborates with Singaporean Institutions on Stem Cell Research
The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.
Regulators and Industry Seek Agreement on ICH Lifecycle Management Standard
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
Permira Funds to Acquire LSNE
Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.
Novimmune Opens Branch Office in Basel
The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.
EMA Recommends Three Orphan Drugs for Approval
The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.
EMA Suspends Drugs Associated with Micro Therapeutic Research Labs
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
FDA Approves Avelumab for Rare Skin Cancer
FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.
Lilly Invests $850 Million in US Manufacturing Operations
The company said it plans to expand diabetes manufacturing facilities in the United States.
EMA Creates Taskforce on Big Data
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
Sanofi and Regeneron File Suit Against Amgen in Patent Case
Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.
More Generic Drug Approvals Not Enough
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
Regenerative Medicine Advanced Therapy Designation Launches
In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.
Another Company Receives FDA Warning Letter Citing Repeat Violations
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
