Industry news

08 June 2017

Clearside Biomedical’s TANZANITE Extension Study in Patients with Macular Edema Associated with Retinal Vein Occlusion Presented at the 40th Annual Macula Society Meeting

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced that, today Charles C. Wykoff , MD, PhD, presented preliminary results from a non-interventional and retrospective trial (the “Extension Study”) of patients who had participated in the completed Phase 2 trial of CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”). 74% of RVO Patients Receiving CLS-TA for Suprachoroidal Administration Together with Intravitreally Administered EYLEA® Did Not Receive Any Additional Treatment Over 9 Months.

Why biosimilars are changing the pharmaceutical industry

Ho-ung Kim / European Pharmaceutical Review

We caught up with Celltrion Healthcare‘s Ho-ung Kim to find out how biosimilars cut costs, increase access to medicine and are ultimately changing the industry…

Drug Prices Become Target for FDA as Chief Expands Purview

Anna Edney / Bloomberg

The head of the U.S. Food and Drug Administration is considering using the agency’s powers to bring more price competition to the market for generic drugs, targeting high-priced products by prioritizing the approval of additional competing treatments.

EMA Issues Brexit Guidance

BioPharm International

On May 31, 2017, the European Medicines Agency (EMA) and the European Commission published guidance on how pharmaceutical companies can prepare for Brexit. The guidance offers information on centralized procedures and other agency activities. The guidance is one in a series of guidance documents the agency plans to publish on the effects of the United Kingdom’s withdrawal from the European Union.

Checkpoint combos for cancer are all the rage as trial sponsors line up hundreds of new studies — report

John Carroll / Endpoints News

Over the last few months it hasn’t been un­usual to see new com­bi­na­tion stud­ies being an­nounced on a daily basis, match­ing one of the 5 ap­proved PD-(L)1 check­point drugs with an­other can­cer ther­apy. Some morn­ings they come in pairs.

Investments in the new Russian plant will reach 5.3 billion rubles

GMP News

The investments in Pharmoslavl, the plant for manufacturing the active pharmaceutical substances, which will be launched in the Yaroslavl region before the end of 2017, will amount to 5.3 billion rubles. This was announced at the St. Petersburg Economic Forum (SPIEF) by Dmitry Mironov, the acting Governor of Yaroslavl region.

02 June 2017

NovaDigm Therapeutics Awarded $6 Million by U.S. Department of Defense to Conduct a Phase 2a Staphylococcus aureus Vaccine Trial

NovaDigm Therapeutics, a company developing innovative immunotherapeutics and preventative vaccines for fungal and bacterial infections, today announced awards totaling $6 million from the U.S. Department of Defense to conduct a clinical study of NDV-3A in military personnel at high risk for skin and soft tissue infections due to Staphylococcus aureus (“S. aureus”), including methicillin-resistant S. aureus (MRSA). NovaDigm will collaborate with the Uniformed Services University of the Health Sciences (USU) on the execution of the Phase 2a study among U.S. Army Infantry trainees at Fort Benning, GA.

New report heralds a revolution in cancer R&D trends – and the sticker shock that comes with it

John Carroll / Endpoints News

There’s a revolution playing out in cancer R&D. Over the last decade drug developers focused on oncology have teamed with regulators on designing a shorter R&D path for new cancer drugs, using trial designs that have sped clinical work and slashed the number of patients needed to demonstrate safety and efficacy.

Drugmakers Brace for Trump's Proposals to Tackle U.S. Prices

James Paton and Cynthia Koons / Bloomberg

Two top pharmaceutical CEOs say they expect President Donald Trump, a frequent critic of industry pricing practices, to take steps soon to address high U.S. drug costs.

Pfizer bows first Ibrance TV spot as Novartis revs up with rival breast cancer med Kisqali

Beth Snyder Bulik / FiercePharmaMarketing

Pfizer has launched its first TV ad for breast cancer drug Ibrance, joining a larger mainstream push for cancer drugs in TV ads and coming hot on the heels of the FDA approval of Novartis' first-ever in-class competitor.