Bio/Pharma Business

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.

The bio/pharma industry enjoys success, but it cannot ignore patient access to medications.

Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association speaks with Pharmaceutical Technology.

Gordon Haines, Chief Executive Officer, and Kay Thiele, Head of Product Optimization, at Rottendorf Pharmaceuticals, spoke with Pharmaceutical Technology about the human element in pharmaceutical manufacturing.

EvaluatePharma's report shows upward trends in R&D and drug approvals.

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The company’s new corporate name will be simply Biogen.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.

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.

Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.

The acquisition will enhance Merck's "superbug" medication portfolio.

Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.

The US Federal Trade Commission will require Novartis AG to divest its nicotine replacement therapy patch business to continue the joint venture with GlaxoSmithKline.

Japanese drugmaker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

Despite recent changes in corporate tax law, Ireland remains a valuable and attractive partner in the development and manufacture of biopharmaceuticals.

Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

Thermo Fisher Scientific announced a collaboration with Samsung to design, develop, and market new solutions for point-of-care.

An index from the Access to Medicine Foundation ranks GSK as most effective in making products accessible.

GSK and Novartis announced a meeting on Dec. 18, 2014 to discuss the $20 billion asset swap between the two companies.

Spanish-based healthcare company, Grifols, announced that FDA approved the expansion of the plasma fractionation unit at its Clayton, North Carolina facility.

GE Healthcare and Takeda Pharmaceutical Company announced an alliance to develop therapeutic drugs in the field of hepatic fibrosis to treat various liver diseases.

The deal between the two companies will strengthen Perrigo's presence in Europe.