Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

AstraZeneca is being pursued in court for compensation over what a health insurer calls the “unnecessarily high price” that the company charged for Seroquel.

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Department of Justice clears insurer Cigna to acquire PBM Express Scripts with no divestitures or other actions required by the two giants; American Antitrust Institute says it will "trigger a fundamental restructuring of the US healthcare system."

As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.

Contract development and manufacturing organizations are fielding requests from sponsors to ramp up for emerging novel treatment modalities like CAR-T cells and gene therapies but shouldn't "over-invest," consultant advises. Meanwhile, MAb production capacity, already huge, is growing 50% over the next five years to meet surging demand.

Agreement with Focus Laboratories includes all Freshkote formulations in multi-dose bottles and single-unit vials to market and commercialize the line worldwide.

Latest consumer health investment was $36m upgrade to a Canadian facility, which by mid-2019 will begin making Voltaren OTC topical gel products. GSK's next move in consumer health divestment is its pending sale of its Horlicks business.

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.