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Home » Newsletters » BioWorld

BioWorld

Oct. 17, 2018

View Archived Issues

Rebate extinction event looming on horizon for U.S. drug prices

In an industry where survival of the fittest has resulted in escalating drug prices that threaten the livelihood of patients, one way to reverse what's been an inevitable course is to change the environment, forcing biopharma companies to adapt to a new climate that values access over price. Read More

Pharnext shares rise on phase III readout in CMT1A disease

DUBLIN – Shares in Pharnext SA gained 25 percent Tuesday after the company announced that its lead drug, PXT-3003, hit the primary endpoint of a phase III trial in type 1A Charcot-Marie-Tooth disease (CMT1A). Pharnext now plans to file for approval in the U.S. and Europe in the second half of 2019. Read More

ROMAN candle lights way for Galera's mucositis bid: radiotherapy 'beachhead'

With a just-begun phase III trial, Malvern, Pa.-based Galera Therapeutics Inc. is testing its small-molecule mimicker of superoxide dismutase, avasopasem manganese (GC-4419), against severe oral mucositis (SOM) in patients with head and neck cancer. Read More

Immunicum lines up institutional investors for ilixadencel directed issue

Immunicum AB raised SEK351 million (US$39.5 million) through a directed issue of approximately SEK178 million to institutional investors and a fully guaranteed rights issue of approximately SEK173 million to existing holders of the company's shares, which trade on Nasdaq Stockholm. The twofold goal was to bring Swedish institutions into the company's fold and to secure sufficient funding to move lead candidate ilixadencel – a vaccine based on allogeneic dendritic cells from healthy individuals that's designed to prime the immune system against solid tumors – into phase Ib/II studies in head and neck, non-small-cell lung (NSCLC) and stomach cancers. Read More

'History-making' U.S.-Cuba Cimavax JV bringing novel lung cancer drug to the U.S.

BOGOTA, Colombia – After seven years of continuous work developing a strategic alliance with Cuban scientists, Roswell Park Comprehensive Cancer Center (RPCCC) in Buffalo, N.Y., has created a joint venture with the Havana-based Center for Molecular Immunology to bring the Cimavax vaccine to American lung cancer patients. Read More

Other news to note

Oncbiomune Pharmaceuticals Inc., of Baton Rouge, La., enlisted Princeton, N.J.-based Theradex Oncology to run a phase II study of its Proscavax vaccine for the treatment of prostate-specific antigen-recurrent prostate cancer in hormone-naive patients. Read More

Financings

Allogene Therapeutics Inc., of South San Francisco, said it closed its IPO of 20.7 million shares, including 2.7 million shares sold to underwriters exercising their full overallotment option, priced at $18 each. Gross proceeds totaled $372.6 million. Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Co. LLC and Jefferies LLC acted as the joint book-running managers.  Read More

Earnings

Genmab A/S, of Copenhagen, Denmark, said worldwide sales of multiple myeloma drug Darzalex (daratumumab) totaled $498 million for the third quarter, as reported by partner Johnson & Johnson, of New Brunswick, N.J., an increase of 57 percent over the third quarter of 2017. Genmab receives royalties under the companies' collaboration agreement. Read More

Clinical data for Oct. 16, 2018

Read More

Regulatory actions for Oct. 16, 2018

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