DUBLIN – ADC Therapeutics Sarl, an emerging powerhouse in the development of antibody-drug conjugates (ADCs) for cancer, has made its first clinical data disclosures in hematological malignancies, which will propel the company into the heart of the battle for supremacy against both developers of ADCs and of chimeric antigen receptor (CAR) T-cell therapies. Read More
After a spate of upbeat news, Basilea Pharmaceutica International Ltd. is not slowing down, CEO Ronald Scott said, and the company is “very active in talking to potential partners for our assets at all stages.” Read More
A pivotal study of the rheumatoid arthritis (RA) candidate sirukumab in patients whose needs aren’t met by standard RA therapies has shown that a year of treatment with the anti-interleukin (IL)-6 antibody improved the signs and symptoms of moderate to severe RA. The results help lay further groundwork for an anticipated FDA approval and launch of the medicine later this year. Janssen-Cilag International NV and its partner, Glaxosmithkline plc, initiated the phase III program for sirukumab in August 2012. The candidate’s lineage dates back to Janssen precursor Centocor Ortho Biotech Inc. (See BioWorld Today, Aug. 24, 2012.) Read More
Teva Pharmaceuticals USA Inc., part of Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, extended its recall of one lot of paliperidone ER tablets, 3 mg, to the consumer/user level due to failing test results for dissolution. Read More
Adamis Pharmaceuticals Corp., of San Diego, said the FDA approved its epinephrine (adrenaline) injection (0.3 mg pre-filled single dose syringe) for the emergency treatment of type I allergic reactions, including anaphylaxis, and also approved the trade name Symjepi. The product includes two single-dose syringes. The company did not disclose pricing but said it expected a “lower cost, small size and user-friendly design” in comparison to the Epipen (epinephrine injection) auto-injector marketed by Mylan NV, of Canonsburg, Pa. Adamis said it was exploring commercialization options and is in discussions with potential partners to optimize patient access while beginning to build inventory levels to prepare for an anticipated launch in the second half of the year. Following disclosure of FDA approval, shares of Adamis (NASDAQ:ADMP) spiked to a 52-week high, gaining $2, or 53.3 percent, to close at $5.75. In June 2016, Adamis received a complete response letter from the FDA, which questioned the volume of dosage the syringe delivered, including what was claimed in the label and required by the agency. Read More
Ocugen Inc., of Malvern, Pa., closed a $7.5 million series B round co-led by the Turkish pharmaceutical company Abdi Ibrahim and the JSC Lancaster Group, a holding company based in Kazakhstan. Read More
Beigene Ltd., of Beijing, presented updated phase I data at the International Conference on Malignant Lymphoma meeting in Lugano, Switzerland, showing that BTK inhibitor BGB-3111 continues to be well-tolerated in patients with Waldenström’s macroglobulinemia (WM), with a very good partial response rate of 43 percent and with an overall response rate of 90 percent (38 of 42 efficacy-evaluable patients), with a median follow-up time of 12.3 months. Read More
