April 3, 2019
Sandoz resubmitting BLA for chemotherapy drug to the FDA
Sandoz is resubmitting its Biologics License Application for a proposed biosimilar pegfilgrastim to the US FDA
Pharmaceuticals, Biotechnology and Life Sciences
Author: Dino Mustafić
April 2, 2019
FDA issues three warning letters to companies dealing with cannabis related products
In a statement from the US FDA commissioner, the FDA on Tuesday said it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies – Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. – in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites.
April 2, 2019
Centogene names new board members
Centogene has appointed Dr. Flemming Ornskov to the Supervisory Board and he has also been elected Non-Executive Chairman, effective April 1, 2019.
April 2, 2019
Johnson & Johnson buy Auris Health for $3.4B, plus milestons payments
Johnson & Johnson has bought Auris Health, Inc. for about $3.4 billion in cash, with additional payments of up to $2.35 billion, in the aggregate, which may be payable upon reaching certain predetermined milestones, JJ said in a statement Monday.
April 2, 2019
Sterling Pharma buys CiVentiChem in the US
UK-based contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions, has announced its acquisition of CiVentiChem’s US facility located in Cary, North Carolina, US.
April 2, 2019
Novartis’ Cosentyx approved in China for adult psoriasis patients
Novartis got approval from the China Health Authority NMPA for
Cosentyx, its the first-in-class interleukin-17A inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
April 2, 2019
Molecular Partners, Allergan to file abicipar BLA in USA in the first half of 2019
Allergan and Molecular Partners revealed Tuesday the topline safety results from MAPLE, study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process, which showed lower incidence and type of IOI.
April 2, 2019
BergenBio shows bemcentinib’s potential to reverse tumour immunosuppression and therapy resistance
BergenBio said Tuesday that preclinical data strengthen bemcentinib’s potential in reversing tumour-mediated immunosuppression and therapy resistance, ina presentation by its academic collaborators at the American Association for Cancer Research (AACR) Annual Meeting 2019.
April 1, 2019
Titan with enough to fund planned operations through the third quarter of 2019, Probuphine well-positioned for global success
Titan’s President and CEO, Sunil Bhonsle said that the second half of 2018 as the company’s rapid advancement toward becoming a commercial-stage company following its assumption of responsibility for Probuphine sales in the U.S. starting mid-June.
April 1, 2019
Novartis buys IFM Tre for $1.575 Billion from IFM Therapeutics
Novartis has purchased a subsidiary of IFM Therapeutics LLC focused on developing ani-inflammatory medicines targeting the NLRP3 inflammasome, which will add one clinical and two preclinical programs targeting the NLRP3 inflammasome, a key component of the innate immune system.