News

Valeant bids $296M on Dendreon; AstraZeneca pairs with MD Anderson;

@FierceBiotech: Obama wants $215M to kick off 'precision medicine' project. More | Follow @FierceBiotech @JohnCFierce: $ICPT up 38% this a.m., which is nuts. Article | Follow @JohnCFierce...

Tracon raises $36M in a downsized IPO

Cancer drug developer Tracon Pharmaceuticals pulled in $36 million in an IPO, pricing well below its expected range as it works to get its top drug into late-stage trials.

Obama wants $215M to kick off 'precision medicine' project

President Barack Obama is asking Congress for $215 million to sequence the genomes of 1 million Americans and help develop a new generation of medicines, part of a sweeping plan to accelerate biomedical R&D.

Pfizer bails on a $70M rare disease deal with Repligen

Pfizer is walking away from a $70 million collaboration with Waltham, MA's Repligen, handing back some early-stage treatments for the rare spinal muscular atrophy.

Alexion names David Hallal its next CEO

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)...

Spark nails a $161M IPO to fund its 'breakthrough' gene therapy

Spark Therapeutics, at work on one-time treatments for rare diseases, pulled off a $161 million IPO, pricing above its range and keeping biotech's Wall Street hot streak rolling.

Astellas bets on Immunomic's allergy vaccine in a $75M deal

Astellas Pharma is teaming up with biotech Immunomic Therapeutics on a vaccine that could relieve a common allergy that affects millions in its native Japan.

Intercept Pharma soars after nabbing 'breakthrough' title for blockbuster NASH contender

Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.

Novartis pins weak Jetrea sales on PhIII, KDEV CEO leaves after 3 months, Cantargia plans IPO

In this week's EuroBiotech Report, Belgian biotech ThromboGenics, having seen its stock price peak at €45 two years ago, has experienced a series of share slides, the latest of which was triggered by its partner Novartis. And more.

One big reason why CNS drug development has foundered

When you want to develop a drug for, say, cancer, objective measures such as survival rate can tell regulators just how effective it is compared to a standard drug or placebo. But in diseases involving the brain, scientists often have to settle for crude measures for assessing how patients perform or feel after treatment. And the wild card here is a placebo effect that can be very difficult to factor into studies and has been fingered for the death of multiple development programs.

Buzz: Obama's 'precision' plan involves a major genomic database

President Barack Obama's plot to bolster personalized medicine research would lean heavily on a planned bank of patient genetic information, Science magazine reports, pooling existing databases to create a huge R&D utility. But the promise of a so-called Precision Medicine Initiative has left some scientists cold, hearkening back to overblown efforts past.

Biogen Idec quietly carves out a leading role in developing gene therapy for hemophilia

Biogen Idec and its newly named in-house expert Olivier Danos have executed a research deal with the San Raffaele-Telethon Institute for Gene Therapy to develop what they believe promises to be a durable treatment for hemophilia.

Merck KGaA abandons Symphogen's cancer drug ahead of Phase III

Merck KGaA, in the process of paring down its pipeline, is walking away from a $625 million deal with Symphogen and handing back the company's lead asset, a targeted cancer treatment in midstage trials.

India tweaks presubmission rules on drugs, trials, devices and other regulated products

India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.

AstraZeneca bolts together a top transatlantic team for CRISPR R&D

In a broad-ranging slate of tech collaborations, AstraZeneca is allying itself with several top research institutions to hone its ability to apply CRISPR gene editing techniques to its drug development work. And the pharma giant used this alliance to pick some of the best brains in the business, without turning to any of the pioneers who have recently spawned a lineup of upstart biotechs.

AnaMar rethinks pipeline after analyzing ashes of failed trial

AnaMar has rejigged its pipeline priorities after digging through the data from its failed Phase IIa trial. The trial missed its primary endpoint of reducing pain in people with mild to moderate osteoarthritis pain, but a post hoc subgroup analysis has persuaded AnaMar it was trialling the right drug in the wrong indication.

Karolinska Development CEO leaves 3 months after taking the job

In October, Karolinska Development's board of directors was convinced Bruno Lucidi was the right person to lead the company's turnaround strategy. Now, Lucidi is out of the door, having disagreed with the board over the implementation of the plan.

Flex Pharma pulls off an $86M IPO for its cramp-treating spice cocktail

In another sign last year's bull market for biopharma has survived into 2015, Flex Pharma, at work on a biotech dietary supplement, priced an $86.4 million IPO above its expected range.

Basilea eyes blockbuster sales after antifungal gets FDA panel OK

After years of setbacks for the antibiotic ceftobiprole, Basilea Pharmaceutica's antifungal isavuconazole is now on the cusp of winning FDA approval. And Basilea thinks it and partner Astellas Pharma have a potential blockbuster on their hands.

Cantargia hits go on Swedish IPO

Cantargia is moving ahead with plans to list on Nasdaq First North in Stockholm, Sweden. The IPO is intended to give Cantargia the cash to push ahead with development of its lead candidate, an antibody-based cancer therapy that is on the cusp of entering the clinic.