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The most hated man in biotech is still confident of a comeback

CommentsPharmacodia.com2015-10-09 00:00 Read   191

He's been described as the most hated man in America. He's been kicked out of BIO, condemned by every biotech executive who's been queried by the media, lampooned on Saturday Night Live and subjected to the taunts of an online mob.

Biogen, Sanofi, Novartis tout long-term benefits at ECTRIMS as new competition advances

CommentsPharmacodia.com2015-10-09 00:00 Read   210

Biogen, Sanofi and Novartis are all trumpeting new data showing long-term benefits for their respective meds at this year's European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS meeting)--and with tough new competition on the way, they may need it.

Experts push for trials to evaluate Roche, GSK flu drugs' pandemic potential

CommentsPharmacodia.com2015-10-09 00:00 Read   253

Critics have long questioned the effectiveness of Roche and GlaxoSmithKline's flu drugs, asking whether their benefits justify the estimated $2 billion spent to stockpile them for potential epidemics. Now, heading into flu season, scientists are pushing for randomized clinical trials to find out once and for all.

Indian court blocks generic of Merck's Januvia

RegulatorPharmacodia.com2015-10-09 00:00 Read   290

India's Supreme Court has prevented Glenmark Pharmaceuticals from making and selling a generic of Merck & Co's diabetes blockbuster Januvia.

Treatment Effects Maintained Over Five Years in Majority of Patients with Relapsing Remitting Multiple Sclerosis who Received Genzyme's Lemtrada® (alemtuzumab) in Clinical Trials

R&DPharmacodia.com2015-10-09 00:00 Read   339

October 8, 2015, Sanofi and its subsidiary Genzyme today announced positive new five-year investigational data from the extension study of Lemtrada(alemtuzumab) for patients with relapsing remitting multiple sclerosis (RRMS).

Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis

R&DPharmacodia.com2015-10-09 00:00 Read   391

October 8, 2015, Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY) today announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).

Nektar Submits Investigational New Drug Application (IND) for NKTR-214 To Treat Solid Tumor Malignancies

R&DPharmacodia.com2015-10-08 00:00 Read   707

Nektar Therapeutics today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-214, its lead immuno-oncology candidate. NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to stimulate the patient's own immune system to destroy cancer cells. The company plans to initiate a Phase 1/2 clinical study by the end of 2015. The study will evaluate the safety, tolerability and efficacy of NKTR-214 in patients with solid tumor malignancies and will include expansion cohorts that will evaluate NKTR-214 both as a single-agent and in combination with a checkpoint inhibitor.

Immune Pharmaceuticals Submits Investigational New Drug Application (IND) in the U.S. for its Lead Product Candidate Bertilimumab for the Treatment of Bullous Pemphigoid

R&DPharmacodia.com2015-10-08 00:00 Read   204

Immune Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for its first in class lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP).

Ascend Announces Patients with Nodular Basal Cell Carcinoma Receives First Dose of ASN-002 in Phase 1/2a Study

R&DPharmacodia.com2015-10-08 00:00 Read   201

Ascend Biopharmaceuticals, a Melbourne-based immunotherapy company focused on developing innovative cancer therapeutics, today announced the first nodular Basal Cell Carcinoma patient (nBCC) dosed with ASN-002 (an injectable immunotherapy) in a Phase 1/2a clinical study. BCC is a type of non-melanoma skin cancer diagnosed in an estimated two million people worldwide every year. It is the most prevalent form of cancer in Australia, the United States and Europe. Surgery is currently the primary treatment for BCC, however for many patients it can be a poor treatment option for both clinical and cosmetic reasons.

The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews

CommentsPharmacodia.com2015-10-08 00:00 Read   227

Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.

New Data Show Strong, Sustained Effects of TECFIDERA® (Dimethyl Fumarate) in Newly-Diagnosed and Early Disease Course Multiple Sclerosis Patients

R&DPharmacodia.com2015-10-08 00:00 Read   502

Biogen's new data show that TECFIDERA significantly reduced multiple sclerosis (MS) relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course; these effects were sustained over six years of follow-up.

Advaxis Reports Clinical Hold of Investigational Agent Axalimogene Filolisbac

R&DPharmacodia.com2015-10-08 00:00 Read   283

Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced that last Thursday the company received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for axalimogene filolisbac (formerly ADXS-HPV) has been placed on clinical hold, affecting four clinical trials.