CLEVELAND – A technology so promising it took the FDA barely 100 days to clear it for marketing approval topped the Cleveland Clinic's list of 10 innovations expected to have significant impacts on health care in 2018. Unveiled on the last day of the 15th annual Medical Innovation Summit, the list leads with the closed-loop insulin delivery system for type 1 diabetes and includes advances such as gene therapy and telehealth that have been years in the making. Read More

DUBLIN – Ablynx NV joined the great European biopharma migration to Nasdaq, grossing just over $200 million in an upsized IPO of 11.43 million shares, which it priced at $17.50 per American Depository Share (ADS). The offering brings its total number of shares outstanding to over 72.8 million and implies a market cap just shy of $1.3 billion. Read More

U.S. Democratic lawmakers delivered on a long-touted promise Wednesday as they introduced legislation to allow Medicare to directly negotiate Part D prescription drug prices. Now they're calling on President Donald Trump to keep his promise to support Medicare negotiations. Read More

HONG KONG – For the first time in 16 years, China is planning to implement an updated version of its drug administration law. The CFDA also is set to revise the country's provisions for drug registration in efforts to upgrade its health care industry. Major proposed changes to the drug administration law which covers both pharmaceuticals and medical devices –are intended to reduce regulations in line with other major markets. Read More

Two separate papers reported advances in nucleic acid editing today that further expand the read of such editing, which has already been transformed since the onset of CRISPR in ways that are only beginning to be understood, and exploited. Read More

The Medicines Co.'s ongoing quest to narrow its focus, free up cash and reduce burn in the face of multiple challenges headlined its third quarter earnings announcement. By year's end, the Parsippany, N.J.-based company said that it expects to announce a transaction to sell its infectious disease business, to slash its workforce to fewer than 60 staff, and to start all trials in the LDL-C lowering program for inclisiran, a protein convertase subtilisin/kexin type 9 (PCSK9) candidate it expects to file with the FDA by the end of 2019. Read More

A degree of investor fretting over Immune Design Corp.'s interaction with the FDA on the subject of phase III plans with CMB-305 in synovial sarcoma didn't stop the Seattle-based firm from pricing a public offering of 19.5 million shares at $4.10 each. Read More

Apexigen Inc. announced the initiation of patient enrollment in a phase II trial in collaboration with the University of California San Francisco. The trial is designed to evaluate Apexigen's CD40 agonistic antibody, APX-005M, in combination with chemotherapy and radiation therapy in patients with resectable esophageal and gastro-esophageal junction cancers. Read More

Doing its part to increase competition so as to lower drug prices, the FDA launched a new biosimilars education campaign this week aimed at health care providers. The campaign includes a biosimilars website and educational materials in the form of fact sheets and graphics that define key terms, describe the standards a biosimilar must meet, explain the FDA approval path for the follow-ons and provide information about the data the agency reviews to determine biosimilarity. As its next step to promote market acceptance of biosimilars, the FDA said it is planning additional research to learn more about the types of information prescribers need to properly communicate with their patients about the follow-ons. Read More

United Therapeutics Inc., of Silver Spring, Md., reported net revenues of $445.5 million for the third quarter. Sales of pulmonary arterial hypertension drugs Remodulin (treprostinil injectable), Tyvaso (treprostinil inhaled), Orenitram (treprostinil extended-release tablets) and Unituxin (dinutuximab) reached $187.3 million, $88.9 million, $52.5 million and $17 million, respectively. United reported net income of $276.3, and non-GAAP net earnings of $206.9 million, or $4.69 per diluted share, beating analyst estimates of $3.87 per share. The company ended the quarter with total cash and equivalents of about $1.6 billion. Shares of United (NASDAQ:UTHR) rose $4.24, to close Wednesday at $123.14. Read More

Hutchison China Meditech Ltd., of London, said intends to offer $262 million of American Depositary Shares (ADSs), each representing one-half of one ordinary share, par value $1 each of Chi-Med on the Nasdaq Global Select Market. The company intends to grant the underwriters a 30-day option to purchase up to $39.3 million of additional ADSs at the offering price. The proceeds from the offering, if completed, are expected to be used to fund the on-going research and development of the Chi-Med innovation platform drug pipeline and for working capital and general corporate purposes. Read More

Cellect Biotechnology Ltd., of Tel Aviv, Israel, reported results from a study of 20 patients testing Aprograft on stem cells derived from fat tissue. Apograft increased the number and activity of the fat-derived stem cells from samples obtained through liposuction. Cellect plans to test the process in additional clinical programs and establish licensing deals for the technology. Read More