Top News
BIO Stresses Innovation with Name Change
The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
FDA Advisory Panel Backs Amgen's Repatha
An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.
FDA Panel Recommends Approval of Praluent
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
Will New PCSK9 Drugs Affect Overall Drug Spending?
As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.
Biosimilar Labeling Practices Under Fire in New Citizen Petition
In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
Contamination Shuts Down NIH Pharma Development Facility
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
Baxter Partners with Mayo Clinic and Velocity to Form New Company
Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.
EDQM Releases 2014 Annual Report
The directorate highlights achievements accomplished during the year of its 50th anniversary.
Generic Opioids Create Policy Issues
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
House Committee Approves 21st Century Cures Legislation
The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.
EMA Revises Guideline on Clinical Development Requirements for Fixed Combination Products
The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.
Compounding Center to Pay $200 Million for Meningitis Outbreak
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
Endo Acquires Par for $8.05 Billion
The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.
BASF Shifts Focus to Excipients
BASF announces that it will sell its custom synthesis business and parts of its API business to focus its expertise on pharmaceutical excipients.
Court Blocks First FDA-Approved Biosimilar, for the Time Being
The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.
Alexion Acquires Synageva for $8.4 Billion
Alexion announces it will expand its rare disease pipeline with a definitive agreement to acquire Synageva.
Biosimilar Giants Launch Biosimilars Forum
Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.
The Acquisition Battle Continues with Another Perrigo Rejection
Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.
Takeda Faces Cancer Lawsuits with $2.4 Billion in Settlements
Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.
Mylan Rejects Teva’s $40 Billion Offer
In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.
Mylan Ups Offer to Perrigo to More than $32 Billion
After rejecting Teva’s unsolicited $40 billion purchase offer, Mylan has increased its own offer to purchase Perrigo from $29 billion to over $32 billion in cash in stocks.
FDA Releases Final Biosimilar Guidance
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
Biosimilars May Spur Improvements in Reference Product Manufacturing Processes
Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.
A Franchise Approach to the Modular Industry
Prequalified manufacturing suites could benefit from a new business model, say some industry executives.
Highlights from INTERPHEX 2015
INTERPHEX 2015 is under way and Pharmaceutical Technology and BioPharm International are in the middle of the action!
Teva Proposes $40 Billion to Acquire Mylan
Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan.
WHO Pushes for Prompt Reporting and Public Disclosure of Clinical Trial Data
WHO says that results from clinical trials should be reported within 12 months of completion of the study
Positive Phase III Results Ends Pfizer’s Ibrance Trial Early
Pfizer announces that its Phase III trial for Ibrance met its primary endpoint and was ended early due to efficacy based on an assessment by an independent Data Monitoring Committee.
EMA and HMA Reveal Network Strategy for Next Five Years
This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.
Study Finds Prescription Drug Spending Rose 13% in 2014
Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.
