Merck & Co. Inc. declared a phase III win with its antiviral, letermovir, to treat cytomegalovirus (CMV), reporting the therapy met the primary endpoint in the global, multicenter, randomized, placebo-controlled study. Read More

DUBLIN – Ogeda SA, the company formerly known as Euroscreen SA, celebrated its change of moniker with a €2 million (US$2.2 million) add-on to its series B round, taking the total to €18 million (US$20 million). Read More

Hemispherx Biopharma Inc., of Philadelphia, said it completed its technology transfer of the Ampligen manufacturing processes to Avrio Biopharmaceuticals LLC, of Irvine, Calif. The transfer consists of providing Avrio with all information that is relevant to the manufacturing process of Ampligen and associated assays. The first cGMP lot is expected to be compounded, filled and finished in November and released in December for use in the company’s early access program in Europe and Turkey. Read More

Puma Biotechnology Inc., of Los Angeles, is commencing an underwritten public offering of $150 million of shares of its common stock. Puma intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock. Citigroup and J.P. Morgan are acting as lead book-running managers for the offering. Read More

Pharmaengine Inc., of Taipei, Taiwan, said the first patient was dosed in a phase Ib/II trial of PEP503 (NBTXR3), a nanoparticle formulation of hafnium oxide crystals, in head and neck squamous cell carcinoma (SCC) patients. The prospective, open-label, single-arm, nonrandomized study is designed to determine the optimal dose, safety and preliminary efficacy of PEP503 through intratumor injection in combination with the standard treatment of concurrent chemoradiotherapy in SCC of the oral cavity. A maximum of 42 patients may be enrolled. Read More

SAN FRANCISCO – Significant and justified excitement in the microbiome therapeutics space remains tempered by very real challenges in the field’s R&D and business pursuits, executives said Tuesday during the first day of the BIO Investor Forum. Read More

DUBLIN – Crispr Therapeutics AG pulled in $56 million in an IPO on Nasdaq, alongside a concurrent private placement with strategic partner Bayer AG, which raised another $35 million. The combined transactions take the company’s total funding raised from inception to $384.4 million, including private and public equity investment, convertible loans and collaboration revenues. Read More

LONDON – The first randomized control trial investigating the effect of switching patients from the anti-TNF alpha antibody Remicade to a biosimilar version of infliximab did not show any difference between the two. Read More

In 2008, Eli Lilly and Co. picked up the pieces of Imclone Systems Inc. following a failed hostile takeover bid from Bristol-Myers Squibb Co. Olaratumab (IMC-3G3, LY-3012207) – an early stage asset during that $6.5-billion deal, whose centerpiece was the EGFR inhibitor Erbitux (cetuximab) – on Wednesday gained accelerated approval from the FDA to treat adults with soft tissue sarcoma (STS). Read More

Cerulean Pharma Inc. CEO Christopher Guiffre told BioWorld Today his firm’s potential $1.1 billion agreement with Novartis AG could be “the deal that put us back on the map after the setback that we had in August” in phase II with lead nanoparticle-drug conjugate (NDC) CRLX101 for advanced renal cell carcinoma (RCC). Read More