Regulatory Beat - BioPharm International

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Regulatory Beat

FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma

November 25, 2014

FDA will delay its decision regarding the new drug application for panobinostat.

Roche's Avastin Gains Ovarian Cancer Indication

November 17, 2014

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

November 17, 2014

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

Amgen's Psoriasis Candidate Bests Stelara in Head-to-Head Comparison

November 12, 2014

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.

Combination Products Challenge Biopharma Manufacturers

November 5, 2014

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.

New Era for Generic Drugs

November 1, 2014

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B

October 30, 2014

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session

October 16, 2014

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

Biopharma Manufacturers Respond to Ebola Crisis

October 1, 2014

Demand for new therapies and vaccines spotlights production challenges.

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