Latest Biotechnology, Pharmaceutical and Healthcare News from BioPharmaDive

17:35 EST 18th February 2018 | BioPortfolio

Here are the most relevant search results for "BioPharmaDive" found in our extensive news archives from over 250 global news sources.

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Showing News Articles 1–25 of 1,000+ from BioPharmaDive

Friday 16th February 2018

Apricus plummets after ED drug rejection

Already approved in Europe, Vitaros didn't gain favor with U.S. regulators, who found CMC and safety issues with the erectile dysfunction drug.

Prescribed Reading: Landscape-changing deals and Alzheimer's shake-ups

A relatively large research collaboration could change the deal landscape. Elsewhere, the Alzheimer's development picture is getting a makeover. 

Roche buys cancer data company Flatiron Health for $1.9B

Acquiring the tech unicorn will help Roche better use real-world evidence in the development of cancer drugs, while building its data analytics expertise. 

FDA pushes pharma to continue efforts in Alzheimer's

In new guidance to industry, the regulator signaled greater flexibility around the use of biomarkers in studying the neurodegenerative disease.

Thursday 15th February 2018

Bayer plant flagged by FDA for poor GMP practices

As a result of the warning letter, the German giant expects a temporary effect on the supply of certain mature products.

Charles River boosts CRO chops with $800M deal for MPI

Acquiring MPI Research should raise Charles Rivers' profits as early as this year and expand its business with biotech.

Biogen shares fall after unexpected 'variability' in Alzheimer's studies

Company executives insisted the pre-planned check did not change their confidence in aducanumab, which has become Biogen's key pipeline asset.

Pfizer, Merck KGaA lung cancer drug fails

The duo's checkpoint inhibitor Bavencio failed to beat out chemotherapy in the key setting of non-small cell lung cancer. 

Bioverativ taps new manufacturer as it steps out of Biogen's shadow

The spinoff-turned-Sanofi-company could pay more than $100 million to Oxford BioMedica for lentiviral vector production.

LakePharma launches biomanufacturing center with new facility

The biologics specialist plans to add 100 jobs by 2020 to staff the new center, which will focus on supporting Phase 1 clinical trials. 

DBV shares jump as peanut allergy patch heads to filing

Eight years on from its first U.S. clinical trial, DBV Technologies' immunotherapy patch to combat peanut allergy could be submitted for U.S. approval in the second half of 2018.

Wednesday 14th February 2018

J&J gets first-of-its-kind prostate cancer approval

The FDA greenlighted apalutamide for non-metastatic CRPC based on a new endpoint: metastasis-free survival. 

Fresh data sets up showdown for Lilly's Taltz vs Cosentyx

In the highly competitive IL-inhibitor space, securing new indications has been a key strategy for drugmakers looking to gain an edge.

Industry touts savings potential of generics and biosimilars

The trade body for generics and biosimilar manufacturers warns of barriers to entry for its products.

Merck delivers latest Alzheimer's disappointment

The big pharma discontinued another trial, acknowledging its drug doesn't work in early patients. 

BIO: Pain pipeline lacking as opioid crisis continues

The analysis comes as a new Senate report calls into question drugmaker ties to advocacy groups in fighting the epidemic.

Shire's pushing its growth potential, but investors aren't sold

The Irish pharma faces headwinds in immunology, neuroscience and blood disorders, and its unclear whether new product launches can offset them.

Bristol-Myers bets $1.85B on combo potential of Nektar cancer drug

It's a substantial upfront sum to gain access to Nektar's early-stage candidate, reflecting the growing importance of building an edge in combination immunotherapy.

Tuesday 13th February 2018

Ramaswamy has no regrets about Axovant

The CEO says he wouldn't change a thing, despite the high-profile failure and sharp decline of the company. 

New approval helps Vertex's 'cleanest growth story in biotech'

Symdeko, a combination treatment for cystic fibrosis, holds a price tag of $292,000 and could provide Vertex up to $200 million in revenue by year's end.

Teva's Copaxone sales hit hastened with OK of Novartis copy

U.S. approval of Novartis' version of Copaxone 40 mg came earlier than Teva had assumed, putting further pressure on the Israeli drugmaker's top seller. 

Trump pitches changes to 180-day generic exclusivity

The administration's budget includes a proposal to prevent generic drugmakers from abusing the current system.

Create brand sustainability with softgel technology

Three emerging trends that are shaping society and the pharmaceutical industry create a convincing argument for the use of softgel technology.

Oncologie snaps up Avid's cancer assets

The Boston biotech's latest deal builds up its internal pipeline and gives troubled drug bavituximab another shot at success.

Roivant and Poxel sign $650M diabetes deal

While Roivant has programs in endocrinology, the licensing pact for imeglimin pulls the Swiss biotech into the diabetes arena.

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