news – Page 3422 – pharmaceutical daily

August 11, 2017 Off

FDA grants priority review designation to Gilead Sciences’s HIV drug

The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.

August 10, 2017 Off

ConfirmMDx study provides further validation of epigenetic risk profile

By Dino Mustafić

MDxHealth has announced that results from a study published in The Prostate further validated ConfirmMDx for Prostate Cancer and showed that the test can provide treating urologists with deeper insights into a patient`s risk for aggressive prostate cancer.

August 9, 2017 Off

Bard shareholders approve proposed merger with Becton, Dickinson

By Dino Mustafić

C. R. Bard and Becton, Dickinson have announced the results of Bard’s special meeting of shareholders, held on August 8, 2017 and at which a quorum was present, for Bard shareholders to consider and vote upon the proposed merger of Bard with BD.

August 8, 2017 Off

Cancer drug screening process saves discovery time and limits use of mice

By Dino Mustafić

A method of testing drugs thatprompt the immune system to attack and destroy cancer cells has been developed which can speed up drug discovering andreducethe unnecessary use of mice in drug screening programmes.

August 8, 2017 Off

Vifor Pharma with strong first half financial results

By Dino Mustafić

Vifor Pharma has posted strong net sales in the first half of 2017, driven by its three medium-term strategic growth drivers. It had net net profit after minorities of CHF1,094 M, ($1,124M)in the first half, compared to the same period last year of CHF158.9.

August 7, 2017 Off

FDA’s input on product-specific guidances for generic drug development

By Dino Mustafić

FDA has published 48 finalized product-specific guidances describing its current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

August 7, 2017 Off

BioMarin in offering of $450 M

By Dino Mustafić

BioMarin Pharmaceutical issued a press release on Mondayan in which it announced underwritten offering of $450 million of senior subordinated convertible notes due 2024. BioMarin has also granted the underwriters a 13-day option to buy up to an additional $50 million aggregate principal amount of Notes.

August 7, 2017 Off

Mylan gets tentative approval for “TLD” under PEPFAR

By Dino Mustafić

Mylan got Monday receipt of tentative approval from the U.S. Food and Drug Administration under the U.S.President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets.

August 4, 2017 Off

Bristol-Myers Squibb strengthens its oncology pipeline – buys IFM Therapeutics

By Dino Mustafić

Bristol-Myers Squibb and IFM Therapeutics have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.

August 4, 2017 Off

Portola Pharmaceuticals resubmits biologics license application for AndexXa

By Dino Mustafić

Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.