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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FDA Issues Draft Guidance on Rare Pediatric Diseases
FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.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.
FDA Grants Orphan Drug Designation to Pancreatic Cancer Treatment
FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.
Combination Products Challenge Biopharma Manufacturers
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.
Novo Nordisk Builds New Labs in Denmark, Adds to US Staff
Construction has started on Novo Nordisk's laboratories for diabetes research in Denmark.
Amgen Requests FDA Require Certification of Compliance with Biosimilar Pathway
Amgen wants the regulatory agency to ensure biosimilar applicants follow the rules of the patent dispute resolution process delineated by the BPCIA.
MedImmune Acquires Definiens
MedImmune enters into an agreement to acquire the image analysis and data mining company.
M&A Activity in Pharma Still Strong Despite New Tax Rules
M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.
