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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.

Shire is paying $5.9B for Dyax in a defensive rare disease deal

Trendstatement2015-11-03 17:39 Read   223

Shire ($SHPG) signed a deal to buy Dyax ($DYAX) for $5.9 billion, planning to snatch up a smaller competitor and fortify its rare disease business without taking its eyes off of acquisition target Baxalta ($BXLT).

Everybody's talking about the Pfizer-Allergan courtship. Here's the juiciest chat we overheard

CommentsPfizer2015-11-03 17:39 Read   304

Despite opposition from politicians, despite the tricky nature of pulling off a tax inversion that size, Pfizer ($PFE) and Allergan ($AGN) may well be engaged before the month is out, giving Pfizer its long-sought tax reduction and its answer to the who-will-you-buy question that's popped up on every earnings call since AstraZeneca's ($AZN) final rejection last year.

Bristol-Myers Squibb to Acquire Cardioxyl Pharmaceuticals, Inc.

TrendBristol-Myers Squibb2015-11-03 17:36 Read   258

Bristol-Myers Squibb gains full rights to Cardioxyl’s novel nitroxyl (HNO) donor in Phase 2 development for acute decompensated heart failure.Strengthens Bristol-Myers Squibb’s pipeline and strategic focus on heart failure.

Drugged up: GSK, Roche and Sanofi to set out their stalls

EVENTSThomson Reuters Cortellis2015-11-02 19:11 Read   274

Three of Europe's top drugmakers - GlaxoSmithKline, Roche and Sanofi - face health checks this week at high-profile presentations designed to show they can overcome looming market threats.

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 top 10 biopharma pipeline disasters of 2015

Commentsfiercebiotech2015-10-30 13:17 Read   222

Drug R&D is a tough business. The odds are almost always against success, and the price to be paid for being wrong is cruelly high.

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.