The House passage of a Democratic bill authorizing the federal government to negotiate drug prices in Medicare has sharpened the debate over how prices feed innovation, but the underlying policy stands little chance of being enacted without a Democratic wave in the next election. Pink Sheet's table highlights the key provisions of HR 3 and other pending pricing legislation.

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

The Turkish government’s drive to establish domestic manufacturing for vaccines is showing tentative signs of getting off the ground. New partnerships are forming between Turkish and international partners. However, lack of local know-how is hampering progress.

Vertex has finally managed to reach an agreement to bring its cystic fibrosis drugs Orkambi and Symkevi to patients in England, which constitutes an important slice of what is the second biggest market for the drugs.

Pharmaceutical Research and Manufacturers of America describes report as “flawed” and designed to advance the “false narrative that spending on medicines in increasing.”

On the cusp of US approval, Amarin must wait until late 2020 for EMA judgement

The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Merck Sharp & Dohme will begin manufacturing licensed doses of Ervebo in Germany and will continue to send investigational vaccine doses to Democratic Republic of Congo.