Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

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.

Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.

Sales of the triglyceride-lowering medicine soared to $112.4m in the third quarter even before a label expansion that depends on the outcome of a vital US FDA advisory committee meeting on 14 November.

The drug outperformed investor expectations, generating $79m in the US in its first full quarter on the market, after Pfizer had set low expectations for the initial launch.

Karuna Therapeutics’ top-line Phase II data for a combination of a centrally acting muscarinic agonist, xanomeline, and a peripherally acting muscarinic antagonist, trospium, were greeted with enthusiasm by investors and the Boston, MA-based biotech.

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

The deal worth up to $576m gives Merck what Calporta founding investor Avalon believes is the most advanced program targeting TRPML1, a lysosomal ion channel implicated in neurodegenerative diseases when the lysosome stops clearing debris from cells.

"We're not resting on our laurels," pRED head William Pao said in an early R&D overview. The company's R&D leaders highlighted drugs in oncology, neuroscience and ophthalmology.

GlaxoSmithKline’s interleukin-5 inhibitor, Nucala (mepolizumab), is the first treatment shown to reduce the hypereosinophilic syndrome flare-ups in a 100-patient pivotal study.

2019 has seen European biotech companies making waves in the US IPO space. Genmab’s listing was a blockbuster, but many more companies have proven their ability to go public on the NASDAQ.

Having recovered from a late-stage fail last year, AstraZeneca has fleshed out results from a positive second Phase III trial of anifrolumab which it hopes will be the second new lupus treatment to hit the market in 60 years.

Sci-B-Vac was shown more effective at fewer doses than Engerix-B in a Phase III study. VBI Vaccines sees its hepatitis B vaccine hitting potential markets by 2021.

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.

Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.

Long-anticipated findings for Japanese firm’s dengue vaccine show efficacy rates above its only rival, including in those not previously exposed to the virus, but results for different strains were mixed and experts are awaiting additional data due in the next few weeks.

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.

Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

Zealand Pharma’s recently installed CEO says it is building US operations to prepare for four potential approvals there in 2020, with commercial launches starting in 2021, its first ever.

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.

Despite its Monsanto woes, Bayer is sticking with its diversified portfolio, and is branching out into patient-facing digital health services.

New top-line results from Japanese study set stage for submission of esaxerenone in additional high-need indication.

Lilly’s newer diabetes drugs are selling well, although Trulicity numbers disappointed analysts, and are among the firm’s growth-drivers. Longtime diabetes head Enrique Conterno will be succeeded by insider Mike Mason.

Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.

2019 has seen European biotech companies making waves in the US IPO space. Genmab’s listing was a blockbuster, but many more companies have proven their ability to go public on the NASDAQ.

Despite its Monsanto woes, Bayer is sticking with its diversified portfolio, and is branching out into patient-facing digital health services.

"We're not resting on our laurels," pRED head William Pao said in an early R&D overview. The company's R&D leaders highlighted drugs in oncology, neuroscience and ophthalmology.

ASLAN’s pivotal Phase II TreeTopp study of varlitinib in biliary tract cancer missed its co-primary endpoints of progression-free survival and overall response rate.

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

GlaxoSmithKline’s interleukin-5 inhibitor, Nucala (mepolizumab), is the first treatment shown to reduce the hypereosinophilic syndrome flare-ups in a 100-patient pivotal study.

GlaxoSmithKline said its increasingly streamlined operations are on a growth trajectory, but that capacity constraints mean demand for its popular shingles vaccine will keep outstripping supply.

Ruud Dobber oversees AstraZeneca’s biopharmaceuticals division, which generates some 40% of group total revenues. He tells Scrip to “Watch this space.”

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.