News

Boehringer's next-gen COPD treatment hits the mark in Phase III

Boehringer Ingelheim met its main goals in a late-stage study on a new COPD treatment, clearing the way for regulatory approvals and a bout with rival GlaxoSmithKline.

PRA lines up a $375M IPO after a string of CRO deals

Fresh off a year full of multibillion-dollar acquisitions, CRO conglomerate PRA is looking to make its Wall Street debut, filing for a $375 million IPO.

Christoph Westphal launches another biotech, with the help of some wealthy friends

Proving once again that Christoph Westphal has some of the best connections in the biotech industry, the controversial entrepreneur has pieced together a $40 million financing round for his new startup Flex Pharma. And he did it by tapping a long lineup of investors, including some high profile individuals in the Boston area.

GlaxoSmithKline's Ebola vaccine aces an animal study amid R&D fervor

GlaxoSmithKline is looking to set some drug development records as it races to the clinic with an Ebola vaccine, posting promising results in preclinical study as a public health crisis unfolds in Africa.

Ophthotech wins a $50M milestone from Novartis

Ophthotech says it won a $50 million enrollment milestone from Novartis for reaching a goal on its Phase III Fovista study for wet, age-related macular degeneration.

A respiratory expert undermines GSK's case for new asthma drug mepolizumab

Investigators for GlaxoSmithKline detailed their promising Phase III data for the IL-5 biologic mepolizumab in asthma today, noting that the injectable halved the rate of exacerbations among a group of patients with uncontrolled cases of the respiratory disease. But while the pharma giant was making its case for a lower dosage of the drug for a particular profile of asthma patient, an expert in the field raised the prospect that GSK's biggest competitor in the real world may simply be cheaper therapies applied with proper compliance to the medical guidelines already in place.

Hyperion claims it was duped by fraudulent data into $570M Andromeda buyout

Back last April when Brisbane, CA-based Hyperion agreed to pay $20 million in cash and stock for Israel's Andromeda Biotech, while promising $550 million more in milestones, company execs made much of the late-stage data already in hand for a new Type 1 diabetes drug. Today, though, Hyperion's team threw up their hands and surrendered, claiming that they had been duped by a group of Andromeda staffers and an outside biostatistics firm in Israel which had cooked the books on the data to come up with a favorable result.

FDA warning dampens Keryx's parade for newly approved kidney drug

When the FDA came through with their expected approval for Keryx's ferric citrate (formerly Zerenex), a new treatment to deal with complications of kidney disease, on Friday, a label warning that the drug could wind up triggering iron overload dampened analysts' enthusiasm for this treatment considerably, with Keryx's stock price ending Friday down 5%.

AstraZeneca's self-styled 'blockbuster' benralizumab tanks in severe COPD study

AstraZeneca was forced to concede a clinical defeat on Monday, noting that one of its top respiratory drugs in the clinic failed a study for severe chronic obstructive pulmonary disease. But while investigators also flagged a higher rate of adverse events for benralizumab than the placebo arm, the pharma giant shows no signs of backing away from a treatment it's billed as a potential $2 billion per year product.

Report: Google's Calico going on hiring spree after AbbVie tie-up

Calico, Google's semi-secretive biotech venture, stepped into the spotlight with a high-dollar collaboration this week, and now the California startup is mounting a big recruitment effort, according to a report.

WHO calls on drug industry, governments to get Ebola therapies to patients

In a desperate attempt to control the ongoing Ebola outbreak in West Africa, the World Health Organization is appealing to drug companies and international regulatory bodies to work together to get experimental therapies and vaccines out of the lab and into the clinic as soon as possible.

Merck KGaA dives into allergy R&D with platform pact

Facing dwindling sales and a thin late-stage pipeline, Merck KGaA is looking to accelerate its efforts in allergy drug development, signing a deal with an Austrian biotech with hopes of quickly seeding new programs in the field.

OncoMed gets back on track as FDA clears another clinical hold

OncoMed is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the company's oncology candidates, clearing it to resume enrollment in a Phase I study.

Recro tanks after hitting the brakes on its lead pain drug

Recro Pharma is planning to halt a midstage study of its lead candidate, a nonopioid pain drug, after an interim analysis revealed it had little hope of meeting its goals, sending the company's shares tumbling more than 45%.

AZ strikes Alderley cancer pact, Cerenis mulls IPO, 4D to start microbiome trials in 2015

In this week's EuroBiotech Report, having spent much of 2014 touting the potential of its clinical-stage oncology candidates, AstraZeneca struck a deal with Redx Pharma to work on the next generation of cancer drugs. And more.

Merck wins breakthrough FDA approval for blockbuster cancer contender pembrolizumab

Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.

Calico's Levinson leaves Roche board to focus on AbbVie R&D deal

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

Merck's new antibiotic hops on the FDA fast track

Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.

Edison's orphan drug misses the mark in Phase II

Edison Pharmaceuticals' in-development rare disease treatment missed its primary endpoint in a mid-stage trial, denting the company's plans for an expansive take on CNS R&D.

Lilly claims another head-to-head victory over Lantus in PhIII diabetes showdown

Eli Lilly took another big step toward filing its long-acting insulin peglispro for an approval, racking up some more positive HbA1c Phase III data in a head-to-head showdown with Sanofi's bestselling Lantus.