Evaluating the Pieces in Big Pharma's Manufacturing Investments
The pharmaceutical majors target biologics and emerging markets in their manufacturing expansion activities and plans.

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Report from India
Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

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True Pharma Innovation Lies in Quality, not Quantity, of Approvals, say FDA Analysts
Will FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market?

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Alice E. Till Selected AAPS President-Elect
Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.

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FDA Reviews Outdated Guidance Documents
CDER withdraws some outdated guidance documents and makes plans to finalize others.

ViiV Healthcare Receives FDA Approval of HIV Drug Tivicay
ViiV Healthcare, a specialist HIV pharmaceutical company of GSK, Pfizer, and Shionogi gains approval for new HIV-1 treatment.

GSK Invests $50 million in Bioelectronic Medicines
The fund's first investment will be in SetPoint Medical, a California company.

ABPI Sets Guidelines on Clinical Trial Disclosure
ABPI toolkit provides guidance to pharmaceutical companies on how to meet clinical trial transparency requirements.

INTERPHEX and PDA Announce Sponsorship Agreement
INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.

Novartis Receives Third FDA Breakthrough Designation
FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.

FDA and EMA Publish Assessment of QbD for Marketing Applications
Agencies collaborate to ensure consistent product quality.