Shares of Clearside Biomedical Inc. (NASDAQ:CLSD) fell 62.8 percent to $2.07 Monday on news that combining its suspension of triamcinolone acetonide (TA) with Regeneron Pharmaceuticals Inc.'s Eylea (aflibercept) failed to help people with retinal vein occlusions (RVO) see any better than treatment with Eylea alone. The Alpharetta, Ga.-based company is discontinuing the RVO program to focus on an application of the same suprachoroidally administered drug as a monotherapy for treating uveitis-associated macular edema. Plans to submit a new drug application in that indication by year-end remain on track, said CEO and President Daniel White. Read More
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. Read More
COPENHAGEN – The fog that wafted in from the Baltic and shrouded the city of Copenhagen early Monday was just a fog. It had no additional significance as a metaphor for the current state of Europe's biotechnology sector. European firms – particularly those listed on Nasdaq – are playing their part in what will be a record-breaking or near-record-breaking year for the global biotech industry in terms of equity financing, M&A transactions, drug licensing deals and drug approvals. The confidence among some of Europe's biotech industry leaders was palpable during the opening sessions of BIO-Europe, notwithstanding the downward stock market plunge in October, triggered by President Trump's and Health and Human Services Secretary Alex Azar's pledge to introduce international reference pricing to the Medicare Part B drug payment scheme. Read More
SAN DIEGO – As gene therapy advances in the eye and hematopoietic stem cells, researchers are going after the harder-to-treat diseases of the central nervous system (CNS). At the Neurosciences 2018 conference, preclinical data showed the right vector and delivery technique can improve symptoms in mouse models of amyotrophic lateral sclerosis (ALS), Parkinson's disease (PD) and Batten disease as the treatments advance to the clinic. Read More
LONDON – Themis Bioscience GmbH has announced positive phase II results for its vaccine against Chikungunya virus, as it moves to complete an IPO later this week to raise up to €55 million (US$62.6 million) to fund the launch of a pivotal phase III trial. Read More
LONDON – Biontech AG is expanding beyond cancer immunotherapy, sealing a research agreement in which researchers at the University of Pennsylvania will apply the company's mRNA platform technologies to discover infectious diseases vaccines. Read More
BRISBANE, Australia – Australia is considered one of the first movers in the regenerative medicine (RM) space, with more than 70 institutes and companies working in the sector across the country. But to capitalize on its technical capabilities, it will need to be strategic if it is to reach its potential to be a major player in Asia Pacific. Read More
Biotime Inc., of Alameda, Calif., received the second installment payment of $10.8 million pursuant to the previously disclosed sale of shares of Agex Therapeutics Inc., also of Alameda,, Calif., to Juvenescence Ltd., an investment firm in the British Virgin Islands. Read More
Under the final Medicare Physician Fee Schedule that goes into effect Jan. 1, new Part B drugs will be reimbursed at a lower rate. Part B drugs, in their first quarter of sales, have been covered based on the wholesale acquisition cost plus a 6 percent add-on. In 2019, they will receive only a 3 percent add-on. Read More
Orchard Therapeutics plc, of London, closed its IPO of about 16 million American depositary shares (ADSs), each representing an ordinary share at $14 each. The gross proceeds from the offering were $225.5 million, and that includes the partial exercise by the underwriters of their option to purchase up to about 1.8 million ADSs from Orchard. J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering, and Wedbush Pacgrow is serving as co-manager. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., reported total revenue in the third quarter of $20.6 million, a year-over-year increase of 89 percent from total revenue of $10.9 million in the third quarter of 2017. Read More
