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Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer

R&DPfizer 2015-11-05 13:40 Read   781

Trial marks second Phase III study of avelumab in non-small cell lung cancer (NSCLC) initiated by Merck KGaA, Darmstadt, Germany, and Pfizer in just over six months.

ViiV Healthcare Announces Positive Headline Results from a Study of Two Drug Injectable Regimen for HIV Maintenance Therapy

R&DViiV Healthcare2015-11-04 10:02 Read   371

ViiV Healthcare, today announced that the Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32 weeks.These results show that the investigational, long acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)

Merck Receives Breakthrough Therapy Designation from FDA for KEYTRUDA® (pembrolizumab) in Advanced Colorectal Cancer

R&DMerck2015-11-03 17:39 Read   340

November 2, 2015 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy Designation granted for KEYTRUDA.

Anacor Pharmaceuticals Announces Top-Line Results From Long-Term Safety Study of Crisaborole Topical Ointment, 2% in Patients With Mild-to-Moderate Atopic Dermatitis

R&DAnacor 2015-11-02 19:10 Read   453

risaborole, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.Anacor now expects to submit a New Drug Application for crisaborole to the U.S. Food and Drug Administration in the first quarter of 2016.

The storm clouds began to build around Verastem's cancer drug defactinib

R&Dfiercebiotech2015-10-30 13:00 Read   242

The storm clouds began to build around Verastem's cancer drug defactinib when Twitter got hold of some ugly safety and efficacy data related to non-small cell lung cancer.

Roche's latest attempt to develop a new drug for Alzheimer's has gone the way of gantenerumab

R&Dfiercebiotech2015-10-30 12:53 Read   351

Alzheimer's disease remains the Holy Grail for Big Pharma, but sembragiline's failure underscores just how hard it is developing drugs for this disease.

Merck's sugammadex remains mired in regulatory woes at the FDA

R&Dfiercebiotech2015-10-30 12:28 Read   359

While the rest of Merck's pipeline has been refocused and driven forward, sugammadex remains mired in regulatory woes at the FDA.

Alisertib's flop raised fresh questions over Takeda's future in cancer drugs

R&Dfiercebiotech2015-10-30 11:36 Read   319

Just as it needed to score some positive news on the cancer R&D front, alisertib's flop raised fresh questions over Takeda's future in cancer drugs.

Celladon’s the Phase IIb of Mydicar failed the primary as well as secondary endpoints

R&Dfiercebiotech2015-10-30 11:25 Read   249

A late-stage disaster in biotech these days could trigger the trapdoor for small companies with limited pipeline prospects, as Celladon proved all too well.

A key midstage failure of SHP625 raises doubts about Shire

R&Dfiercebiotech2015-10-30 11:10 Read   403

A key midstage failure raises doubts about Shire CEO's picks as the biotech reaches a crucial crossroad.

AstraZeneca’s drug Selumetinib failed a Phase III study for uveal melanoma

R&Dfiercebiotech2015-10-30 10:49 Read   344

Not the biggest of AstraZeneca's experimental cancer drugs, but a flop for selumetinib still stings.

AstraZeneca started to hunt for a buyer to take on brodalumab

R&Dfiercebiotech2015-10-30 10:36 Read   450

After Amgen bowed out, AstraZeneca quietly started to hunt for a buyer to take on brodalumab. Valeant stepped up to the task.