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Home » Newsletters » BioWorld

BioWorld

Aug. 21, 2018

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Clinical data for Aug. 20, 2018

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Other news to note

Nuvo Pharmaceuticals Inc., of Mississauga, Ontario, said it extended the period of exclusive negotiations with Aralez Pharmaceuticals Inc., of Vancouver, British Columbia, and Deerfield Management Co. LP related to Nuvo's proposed acquisition of a portfolio of more than 20 revenue-generating products as well as associated personnel and infrastructure from Aralez and its affiliates. Read More

Financings

Genkyotex SA, of Geneva, secured an up to €7.5 million gross financing through the issuance of notes convertible into shares with share subscription warrants attached to YA II PN Ltd., an investment fund managed by Yorkville Advisors Global LP, a U.S.-based management firm. The company will receive €4.9 million and controls the right to call an additional €2.45 million from 80 to 95 days post transaction.  Read More

Regulatory front

Zhejiang Tianyu Pharmaceutical Co. Ltd., of Taizhou, China, is no longer authorized to manufacture valsartan for drugs marketed in the EU following the suspension of its certificate of suitability (CEP). The European Directorate for the Quality of Medicines and Healthcare suspended the certificate after low levels of a potential carcinogen, N-nitrosodimethylamine (NDMA), were found in the API produced by the company.  Read More

Immunocore moves its second asset into the clinic, triggering milestone in Glaxo deal

LONDON – Five years on from sealing the deal, Immunocore Ltd. has steered its first partnered program into phase I, allowing the company to bolster the clinical data file for its soluble T-cell receptor technology. Read More

Chemocentryx graduating to rare skin condition with avacopan trial as Inflarx exams continue

Chemocentryx Inc. recently hit an important milestone with the finish of enrollment in the Advocate phase III trial testing avacopan in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), and that's where many investor eyes are focused. Read More

Canbridge to start phase III trial for esophageal squamous cell cancer drug candidate

HONG KONG – Canbridge Life Sciences Ltd., of Beijing, said it would soon initiate a phase Ib/III clinical study of its monoclonal antibody candidate CAN-017 in esophageal squamous cell cancer (ESCC). The multicenter study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CAN-017 in combination with chemotherapy as the second-line treatment for patients with locally advanced or metastatic ESCC. Read More

Big pharma-backed biotechs Principia, Entasis look to Nasdaq with $86M IPO filings

Hours apart, two biotechs with big pharma connections – Principia Biopharma Inc. and Entasis Therapeutics Holdings Inc. – each filed for IPOs of up to $86.25 million, including overallotments, and listings on the Nasdaq Global Market as PRNB and ETTX, respectively. Read More

Oncolytic virus bids lining runway; can t-vec's team fly again with Replimune?

Even with continued jostling inside the larger immuno-oncology space, the oncolytic virus (OV) approach may be more firmly staking its claim to drug-developer interest. Already this year, Johnson & Johnson inked a potentially massive deal to take over Benevir Biopharm Inc. The arrangement disclosed in early May brought the latter $140 million up front and up to $900 million in milestone payments. Rockville, Md.-based Benevir boasts a platform called T-Stealth, designed to engineer OVs to infect and destroy cancer cells. Read More

Who's telling the truth about high Rx drug prices?

In the escalating blame game over who's responsible for high prescription drug prices in the U.S., someone must be lying. That's the gist of an eight-page letter Sens. Elizabeth Warren (D-Mass.) and Tina Smith (D-Minn.) sent to Health and Human Services (HHS) Secretary Alex Azar Friday. Read More

Regulatory actions for Aug. 20, 2018

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