Industry News

- Read more about Health Canada grant Baxter's AMIA APD System with SHARESOURCE connectivity platform
Baxter International Inc. is expanding the introduction of its AMIA Automated Peritoneal Dialysis (APD) System with the SHARESOURCE Connectivity Platform to Canada with the announcement that Health Canada recently approved the system.
- Read more about Lonza Acquires Triangle Research Labs
Lonza announced that it recently acquired Triangle Research Labs (TRL) from PBM Capital Group. TRL is a fast-growing hepatocyte provider with products supporting in vitro evaluation of metabolism, drug-drug interactions, drug transporter activity, toxicity of drug candidates and other applications. Triangle Research Labs has facilities based in Research Triangle Park, North Carolina (USA).
- Read more about Novartis PKC412 pivotal Phase II study result published in NEJM
Novartis announced that The New England Journal of Medicine (NEJM) published data for PKC412 (midostaurin) demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval [CI], 49-70%; P<0.001) in patients with advanced systemic mastocytosis (SM). The median duration of response for all responders in the primary efficacy population was 24.1 months (95% CI, 10.8-not estimated [NE].
- Read more about Torrent Pharma acquires Glochem Industries Limited
Ahmedabad-based Torrent Pharmaceuticals Ltd entered a binding agreement to acquire a manufacturing unit of Hyderabad-based Glochem Industries Ltd. The Visakhapatnam unit, approved by the US Federal Drug Administration (FDA) and European regulatory authorities, is a multi-product facility which can manufacture advance intermediates and active pharmaceutical ingredients (APIs). With the latest acquisition, Torrent Pharma, which currently has five formulation manufacturing units, will have three API units for the regulated markets. The acquisition will help the firm in vertically integrating its abbreviated new drug application (ANDA) filings in the future, it said in a statement.

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- Read more about AbbVie’s Ibrutinib receive Fourth Breakthrough Therapy Designation by the U.S.FDA
AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
- Read more about Genentech’s OCREVUS Biologics License Application reviewed by FDA
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), and granted the application Priority Review Designation with a targeted action date of December 28, 2016.
- Read more about Pfizer 2 additional phase 3 bococizumab trials show positive results
Pfizer Inc. announced two additional phase 3 bococizumab trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a maximally tolerated dose of a highly effective statin.
- Read more about U.S.FDA give Complete Response Letter (CRL) to Lipocine’s LPCN 1021
Lipocine Inc., a specialty pharmaceutical company, announced that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
- Read more about Astrazeneca Zavicefta approved in the Europe
AstraZeneca announced that the European Commission (EC) has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.

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- Read more about Gilead’s Epclusa receive U.S. Food and Drug Administration Approval
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).