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Home » Newsletters » BioWorld

BioWorld

Aug. 10, 2016

View Archived Issues

‘Array’ narrowed: Selumetinib NSCLC trial fail de-SELECTs indication

Hopes that MEK inhibitor selumetinib might rise above an earlier failure to improve a rare eye cancer were dashed as the Astrazeneca plc-backed candidate fell short of improving progression-free survival during SELECT-1, a phase III trial targeting NSCLC. Read More

Ablynx boasts positive phase IIb results in RA; Abbvie decision on tap

LONDON – Ablynx NV improved the prospect of triggering a phase III opt-in and €75 million (US$83.1 million) option payment from Abbvie Inc., turning in positive top-line results in a phase IIb combination study of its anti-interleukin-6R (IL-6R) nanobody, vobarilizumab (ALX-0061), in the treatment of rheumatoid arthritis. Read More

Progress made toward beating chronic viral infections

HONG KONG – Two research teams have independently identified a specialized cytotoxic killer T-cell population and shown that boosting the number and killing ability of those cells may lead to an effective treatment for currently incurable lifelong viral infections, notably HIV. Read More

CDER scrambling to complete long list of drug guidances

With just a few months to go, the FDA’s drug center is still hoping to push out more than 100 new and revised draft guidances before the year ends and a new administration comes on board. Read More

India’s NPPA adds 24 essential drugs to price-capping list

NEW DELHI – India’s drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has fixed price caps on 24 essential drugs used for the treatment of cancer, HIV, bacterial infections, anxiety and cardiac conditions, a move that is expected to cut the government’s costs by a quarter. Read More

China shuts down online drug sales

HONG KONG – China is shutting down online drug sales for the time being, despite rapid growth. Read More

Paying to play in clinical trials involves much more than entry fees

The notion of pay to play clinical trials is subtler and more problematic than charging research subjects to participate in studies. Read More

Financings

Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., priced a private offering of approximately 7.63 million common shares at $5.90 apiece, even with the stock’s (NASDAQ:ARWR) closing price on Monday, Aug. 8. Read More

Earnings

Amag Pharmaceuticals Inc., of Waltham, Mass., reported record second-quarter sales of $78.4 million for Makena (hydroxyprogesterone caproate injection), approved to lower the risk of pre-term birth, and $24.3 million for Feraheme (ferumoxytol), the iron deficiency anemia drug indicated to treat patients with chronic kidney disease, leading to product and service revenues of $127.4 million on a GAAP basis compared with $123.9 million in the second quarter of 2015 – a period that included $39.2 million of collaboration revenue. Read More

Other news to note

Pluristem Therapeutics Inc., of Haifa, Israel, said its critical limb ischemia (CLI) program in the EU has been awarded an $8 million grant. Read More

In the clinic

Prometic Life Sciences Inc., of Laval, Quebec, said it completed enrollment of the adult population (50 adults) in its pivotal intravenous immunoglobulin (IVIG) phase III trial in primary immunodeficiency disease. Read More

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