To say that the discovery leading to Aobiome LLC's approach to treat disease by targeting the microbiome came via an unconventional method is an understatement. As the story goes, founder David Whitlock, a Massachusetts Institute of Technology chemist, during a stroll at a local farm, began wondering why horses rolled around in the dirt.
NEW YORK – The Affordable Care Act (ACA) will be repealed, PDUFA VI will almost certainly be passed and the pressure on drug pricing will not go away in the coming year. While panelists during a panel on policy outlook under the new Trump administration largely agreed on those predictions, some noted that gaining a bit of certainty could be the biggest boon for the industry in 2017.
NEW YORK – The 21st Century Cures Act signed into U.S. law last year included a provision for $500 million in funding for prevention and treatment programs targeting the opioid epidemic.
Despite all the advances in drug research and development, the human proteome remains largely untapped – of the estimated 20,000 proteins, only about 600 are currently targeted by FDA-approved drugs. That leaves a lot of opportunity on the table for Vividion Therapeutics Inc., a San Diego-based firm launching Thursday with a $50 million series A investment co-led by Arch Venture Partners and Versant Ventures.
Had higher doses of ammonia-scavenging agent OCR-002 (ornithine phenylacetate) been administered, the phase IIb STOP-HE trial in hospitalized patients with hepatic encephalopathy (HE) might have hit its endpoint, according to executives at Ocera Therapeutics Inc., who said the dose-related response, combined with the drug's safety profile and confirmed mechanism of action, provided enough confidence to advance into phase III.
Though still considered "correctable" by company execs, the manufacturing troubles that have beset lead acute myeloid leukemia (AML) candidate APTO-253 since late 2015 prompted Aptose Biosciences Inc. to make the tough decision to shift its resources to a preclinical-stage AML asset in-licensed last year.
SAN FRANCISCO – For the first time since emerging from stealth mode last year, 2015 startup Kiniksa Pharmaceuticals disclosed its $80 million series A round and introduced the first compound in its pipeline, an antibody targeting inflammation and fibrosis.
SAN FRANCISCO – Exelixis Inc. was 2015's top biopharma gainer on Wall Street and one of the top firms in 2016, according to BioWorld Insight. Riding high on the approval and strong launch for renal cell carcinoma drug Cabometyx (cabozantinib) and with a solid financial position of $379.6 million as of Sept. 30, the South San Francisco-based firm looks to build out its pipeline – or rebuild, rather.
SAN FRANCISCO – Concerns that launch expectations for Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen) might be too ambitious were largely put to rest Tuesday, as CEO Ed Kaye provided updates on patient starts and reimbursement efforts and reported higher-than-expected fourth-quarter revenue.
SAN FRANCISCO – In a sign that could bode well for the industry going into 2017, attendees hadn't even begun plodding through crowded halls at the Westin St. Francis Hotel when a flurry of deals hit the news Monday morning. All of them were dwarfed by Takeda Pharmaceutical Co. Ltd.'s $5.2 billion bid for Ariad Pharmaceuticals Inc.
