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Home » Newsletters » BioWorld

BioWorld

March 8, 2018

View Archived Issues

Regulatory front

U.S. Sen. Claire McCaskill (D-Mo.) blasted Jerusalem-based Teva Pharmaceutical Industries Ltd. Tuesday for stonewalling a Senate investigation into the role opioid manufacturers and distributors have played in the ongoing opioid epidemic by repeatedly refusing to turn over requested information. Read More

Other news to note

Protagonist Therapeutics Inc., of Newark, Calif., said the FDA granted orphan drug designation to PTG-300, a subcutaneous injectable hepcidin mimetic for the treatment of beta-thalassemia. Read More

In the clinic

Ultragenyx Pharmaceutical Inc., of Novato, Calif., reported longer-term safety and efficacy data from the first dose cohort of a phase I/II trial testing the 2 × 10^12 GC/kg dose of its gene therapy, DTX-301, in patients with ornithine transcarbamylase deficiency. Read More

Appointments and advancements

Vertex Pharmaceuticals Inc., of Boston, appointed Reshma Kewalramani chief medical officer and executive vice president, global medicines development and medical affairs. Read More

Financings

Clearside Biomedical Inc., of Alpharetta, Ga., said it intends to offer and sell, subject to market conditions, $75 million of shares of its common stock in an underwritten public offering. Read More

Australia builds national innovation database to chart course of new health tech

PERTH, Australia – Australia is launching an online "innovation showcase" that aims to catalogue and track the progress of innovations in the pharmaceutical, medical technology and digital health space across Australia in real time on a public platform open to investors, health practitioners and the public. Read More

EMA officially suspends Zinbryta sales; MS drug linked to three deaths

LONDON – The EMA called for the official suspension of the marketing authorization for Biogen Inc.'s multiple sclerosis treatment, Zinbryta (daclizumab), and said all stocks should be immediately withdrawn, after three deaths were linked to immune reactions caused by the drug. Read More

Innate immunity may best epigenetics in draining HIV's swamp

BOSTON – Curing HIV infection has become a realistic goal, and one of the major areas of HIV research, since the first Conference on Retroviruses and Opportunistic Infections (CROI) was held in 1993. But for such a cure to become a reality, it will be necessary to eliminate the viral reservoir. Read More

Tip: Waiter getting served, Ligand's patience pays off in deal worth up to $548M

By signing the potential $548.8 million deal for the oral, small-molecule glucagon receptor antagonist LGD-6972 with Ligand Pharmaceuticals Inc., Roivant Sciences Inc. brings aboard a type 2 diabetes candidate that "should surpass blockbuster status" if approved, in the view of one analyst. Read More

Novartis expands Science 37 alliance to cover virtual trials

Novartis AG and Science 37 Inc., a virtual trials specialist long backed by dRx Capital, the drugmaker's joint investment company with Qualcomm Inc., have agreed to initiate up to 10 new clinical trials over the next three years. Read More

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