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GSK Announces Shareholders Meeting to Discuss Novartis Deal
GSK and Novartis announced a meeting on Dec. 18, 2014 to discuss the $20 billion asset swap between the two companies.
Lundbeck CEO Resigns Due to Code of Conduct Breach
Ulf Wiinberg has resigned as Lundbeck's CEO over unapproved acceptance of shares in a biotech company.
GSK Leads Big Pharma in Making Its Medicines Accessible
An index from the Access to Medicine Foundation ranks GSK as most effective in making products accessible.
FDA to Increase its Ties to China
Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting
IMS: Global Spending on Medicines to Rise 30% by 2018
Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
USP and ChP jointly host two-day meeting to strengthen cooperation.
Manufacturing Issues Crucial to Combating Ebola
The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.
FDA Requests Comments on Generic Drug Submission Criteria
FDA opens public docket on proposed criteria for “first generic” ANDAs.
GPhA Issues Statement on Generic Drug Costs
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.
Amgen Opens Single-Use Manufacturing Plant in Singapore
The $200-million project will expand Amgen's single-use/disposable manufacturing capabilities.
FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper
A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.
Grand River Aseptic Manufacturing Secures Two Contracts
Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.
Pfizer and Merck KGaA Announce Strategic Alliance
Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.
FDA Issues Draft Guidance on Rare Pediatric Diseases
FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.
Roche's Avastin Gains Ovarian Cancer Indication
Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.
FDA Approves Lemtrada for the Treatment of Multiple Sclerosis
After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.
Actavis to Acquire Allergan for $66 Billion
The transaction provides Allergan stockholders with immediate value and enhanced commercial opportunities, according to a company statement.
Bristol-Myers Squibb to Open New Biologics Facility in Ireland
The new location will increase Bristol-Myers Squibb's biologics manufacturing capacity.
ValiRx Collaborates with German Cancer Research Center
ValiRx entered into a collaboration agreement with the Deutsches Krebsforschungzentrum cancer research center.
AstraZeneca and Isis Pharmaceuticals Develop Novel Oligonucleotide Delivery Methods
The new partnership will focus on RNA biology for the discovery and manufacture of new therapies.
FDA Issues Warning Letter to Cadila Pharmaceuticals for CGMP Deviations
The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.
Johnson & Johnson Completes Alios Biopharma Acquisition
The Alios Biopharma acquisition strengthens J&J's infectious disease pipeline.
USP Releases Compounding Compendium
USP releases compendium of quality standards for compounded medicines.
Amgen's Psoriasis Candidate Bests Stelara in Head-to-Head Comparison
Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.
GE Partners with Takeda to Develop Therapeutic Drugs for Liver Disease
GE Healthcare and Takeda Pharmaceutical Company announced an alliance to develop therapeutic drugs in the field of hepatic fibrosis to treat various liver diseases.
EMA Responds to Questions about Confidential Information
The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.
France Agency Seeks Data from Roche on Use of Avastin in Macular Degeneration
ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.
SGS Lab in Italy Earns cGMP Accreditation
SGS Life Science Services has been awarded cGMP accreditation from AIFA for its analytical laboratory in Livorno, Italy.
Perrigo Agrees to Acquire Omega Pharma for $4.5 Billion
The deal between the two companies will strengthen Perrigo's presence in Europe.
Catalent Expands Highly Potent Drug Packaging Capabilities
Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.