The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

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."

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.