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USP Elemental Impurities Implementation Set for January 2018
USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.
Sanofi Forms Strategic Pact with Boehringer Ingelheim for Biologics Manufacture
Sanofi has entered into a strategic manufacturing collaboration with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies (mAbs).
Catalent and Sanofi to Collaborate on ADC Development
Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.
EFPIA and IMI Announce New Projects to Fight Ebola
Eight new projects will focus on the diverse needs of the Ebola epidemic, such as new vaccine development, production and distribution, and new diagnostic methods.
US Consumer Product Safety Commission Postpones Enforcement of Child-Resistant Packaging Requirements
Child-resistant packaging requirements for products containing a specified imidazoline will come into effect June 10, 2015.
Boehringer Ingelheim and Yale Collaborate to Investigate Immunotherapies
Boehringer Ingelheim announced that it would collaborate with Yale University to research novel therapeutic targets in immune-modulation.
Shire Acquires NPS Pharma for $5.2 billion
Shire adds rare-disease portfolio with acquisition of NPS Pharma.
Mexichem Acquires License for DuPont’s Medical Propellant
Mexichem announced that it acquired the distribution and sale license for HFC-227ea/P from Du Pont.
Bristol-Myers Squibb Celebrates Superior Overall Survival for Opdivo
Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.
New Antibiotic Puts up a Fight Against Superbugs
NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.
Argos and Saint-Gobain Partner on Single-Use Components for Immunotherapy Manufacturing
Single-use components aid efficiency in automated personalized therapy manufacturing.
FDA Extends Enforcement Deadline for Track and Trace
A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
AMRI Acquires Two Aptuit Facilities
The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.
FDA Advisors Unanimously Approve Sandoz Biosimilar
An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.
Impax Pharmaceuticals Announces FDA Approval of Parkinson’s Treatment
Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.
Cardio3 BioSciences Acquires OnCyte CAR T-Cell Portfolio for $180 million
Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.
SK Capital Partners Invests in Halo Pharmaceutical
SK Capital Partners announced that it completed a strategic investment in Halo Pharmaceutical.
CDER Announces 2015 Guidance Plan
The FDA center released a list of the guidance documents it plans to publish in 2015.
CVS Health Announces Hepatitis C Drug Exclusivity Deal with Gilead
The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.
Janssen to Pay Up to $835 Million for Antisense Therapy
Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.
PDA Publishes Technical Report on Drug Shortages
The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.
Great Expectations from New European Commission
The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.
Sterile Vent Increases Precision
FDA Delays Enforcement of Product Tracing Requirements
FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.
Chinese API and Drug Manufacturer Issued Warning Letter
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
Valeant Voluntarily Recalls One Lot of Virazole Due to Sterility Problems
Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.
Hospira Announces Voluntary Recall Due to Subpotency and Impurity Levels
Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.
Roivant Neurosciences Acquires GSK’s Novel Neurological Disorder Treatment
Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.
Anti-PD-1 Therapies: Immune to Pricing Wars?
Although competing therapies will continue to be released in the immuno-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.
FDA Approves First Ebola Test for Emergency Use
Roche’s LightMix Ebola test can give results in around three hours.
