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FDA Releases Guidance Documents on Risk Information and IND Applications
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.
Will Economic Returns from Drugs Continue to Disintegrate?
The recent mergers, partnerships, and incentive-laden deals in pharma may keep the industry from continuing to experience diminishing returns, according to IMS’ Michael Kleinrock.
Pfizer to Acquire Hospira for Nearly $17 Billion
The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.
Thermo Fisher Scientific Acquires Advanced Scientifics
Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.
FDA Commissioner Margaret Hamburg Announces She Will Step Down
Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.
CDER Discusses Drug Shortage Prevention
FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.
FDA Grants Accelerated Approval to Pfizer's Palbociclib
The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.
Sanofi Launches first Inhalable Insulin in the US
Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.
Mylan Announces Partnership with Theravance to Develop an Investigational Treatment for COPD
Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.
Obama Sends Mixed Message on Support for Biopharmaceutical R&D
President Obama unveils his “Precision Medicine Initiative”.
Shantha Constructs Insulin Facility in India
The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.
Obama Budget Blueprint Seeks Drug Pricing Authority, Shortened Data Exclusivity Period for Biologics
The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.
Precision Biologics Enlists the Help of EMD Millipore for Upstream Process Development
EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.
Precision Medicine Initiative Brings News Tasks to FDA
FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.
Patent Exclusivity for Biologics: Seven or Twelve Years?
Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.
FDA Approves BMS and J&J HIV Treatments
Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.
AstraZeneca Signs on for CRISPR Gene Editing Technology
AstraZeneca will team up with various organizations to employ CRISPR technology for precise gene editing in recombinant cell lines.
Catalent Expands High-Potency Handling Capability
Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.
GlaxoSmithKline Promises to Keep Vaccine Prices Low for Gavi Members
The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.
FUJIFILM Diosynth Begins Work on Bioprocess Innovation Center
The new facility will feature new research and development capabilities.
SAFC Expands Irvine Facility
The new facility will feature dry powder cell-culture media capabilities.
PCSK9 Inhibitor from Sanofi and Regeneron Snags Priority Review
The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.
FDA Names New Deputy Commissioner for Medical Products and Tobacco
Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.
EMA Launches Drug Safety Assessment Platform
The agency creates an electronic central repository to facilitate drug safety assessment reports.
FDA Releases Photosafety Evaluation Guidance
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
Ebola Treatments Ramp Up for Clinical Trials
Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.
Australia to Revise its Biosimilar Naming Conventions
Following a proposal by the World Health Organization, Australia will abandon a previously proposed update in biosimilar nomenclature.
EMA Sets Elemental Impurities Implementation Dates
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
Compounding Committee Meets to Discuss Drugs Approved for Compounding
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
Investments into T-Cell Therapies Continues to Grow
Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.
