Eli Lilly and Co. Inc. tapped 3-year-old Nextcure Inc. for a multiyear immuno-oncology (I-O) deal designed to exploit the newco's Functional, Integrated, Nextcure Discovery in Immuno Oncology, or FIND-IO, technology. Nextcure, of Beltsville, Md., stands to receive $25 million up front in addition to a $15 million equity stake by Lilly, of Indianapolis. Both participants reserved options to exclusively license antibodies resulting from the arrangement, and Nextcure is eligible for development and commercial milestones and royalty payments if its first pharma partner develops and markets resulting cancer therapies.
Pfizer Inc. looked to secure its future in the anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC) market with FDA approval of Lorbrena (lorlatinib), a third-generation ALK tyrosine kinase inhibitor (TKI), to treat individuals whose disease progressed on its first-line treatment, Xalkori (crizotinib), and at least one other ALK inhibitor for metastatic disease or on Alecensa (alectinib, Genentech/Roche Holding AG) or Zykadia (ceritinib, Novartis AG) as first-line ALK inhibitor therapy for metastatic disease.
Until recent years, polycystic kidney disease (PKD) was a renal indication in search of solutions – a situation even truer for its autosomal dominant (ADPKD) and autosomal recessive (ARPKD) subgroups. That dearth of drug development in the space is beginning to change, however, thanks to greater understanding of the genetic drivers of kidney disease and of the molecular pathways that
The development program for Sage Therapeutics Inc.'s brexanolone for the treatment of postpartum depression (PPD) received a ringing endorsement during a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM). Voting 18-0 with no abstentions, members indicated that Sage presented "substantial evidence" to support effectiveness of the type A gamma-aminobutyric acid (GABAA) receptor modulator in the indication, which has no approved medications.
Sage Therapeutics Inc. becomes the second biopharma this week to face a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which on Friday will review efficacy and safety data from the NDA for lead candidate brexanolone in the initial indication of postpartum depression (PPD). If the agency's briefing documents are a guide, the discussion is likely to focus on loss of consciousness (LOC) events that occurred during the drug's development program and the appropriate setting to administer the type A gamma-aminobutyric acid (GABAA) receptor modulator, which requires a 60-hour infusion.
Two months to the day before its Dec. 24 PDUFA date, Xofluza (baloxavir marboxil, previously S-033188, RG-6152), gained a nod from the FDA to treat acute uncomplicated influenza in individuals 12 and older who became symptomatic within the previous 48 hours.
Year-old cross-border biopharma Terns Pharmaceuticals Inc. put some lift behind its pipeline of molecularly targeted, oral small-molecule candidates with an $80 million series B financing led by new investors Vivo Capital and Orbimed. New investor Decheng Capital joined the round, along with existing investor Lilly Asia Ventures, which led the company's $30 million series A earlier this year.
A day after Biogen Inc. and Eisai Inc. thoroughly confused and mainly disappointed the Alzheimer's disease (AD) field with updated data on BAN-2401, Anavex Life Sciences Corp. took the podium at the 2018 Clinical Trials on Alzheimer's Disease (CTAD) meeting in Barcelona for an oral presentation on lead candidate ANAVEX-2-73. In a starkly different turn from the amyloid beta approach, the oral sigma-1 receptor (S1R) agonist, a tetrahydrofuran derivative, binds to muscarinic acetylcholine 1, seeking to improve measures such as Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), psychomotor function, attention and working memory.
Multiple myeloma (MM) wasn't exactly a headliner at last week's European Society for Medical Oncology (ESMO) 2018 Congress, and maybe that was fortuitous for the space. For the most part, ESMO presentations didn't set the biopharma world on fire. Instead, a number of companies – Adaptimmune Therapeutics plc, Aduro Biotech Inc., Biolinerx Ltd., Clovis Oncology Inc., Deciphera Pharmaceuticals Inc., Idera Pharmaceuticals Inc. and Merck & Co. Inc., among them – were singed by investors on unexciting data, sometimes from others simply in the same class.