The Latest
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With FDA decision near, Novartis bolsters SMA gene therapy case
Zolgensma could be approved by the FDA within weeks. Fresh clinical data give further evidence of the therapy's benefit, although reports of two deaths invite questions.
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Roche's pharma business is booming, for now
Drug sales jumped 10% in the first quarter, spurring Roche to raise its forecasts for the year.
UPDATED: April 17, 2019 at 12:50 p.m. -
Sarepta may have seen off another rival in Wave
Toxicity observed with Wave's DMD drug raises questions over whether the biotech can find a safe and effective dose.
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Gilead taps into machine learning to find new NASH drugs
A three-year research deal between Gilead and California-based Insitro aims to create disease models and discover targets for the fatty liver disease.
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J&J drugs sales outperform despite generic hit
Kicking off first quarter earnings for the industry, J&J managed to post better-than-expected pharma results despite falling Zytiga sales in the U.S.
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Its ambitions restrained, Amgen sets modest Evenity price
The bone-building osteoporosis drug will carry a list price of $21,900 for a full course of treatment, a discount to competitors from Eli Lilly and Radius.
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Clovis shares slide on Rubraca trial discontinuation
An independent review concluded the biotech's PARP inhibitor was unlikely to provide a meaningful clinical benefit to metastatic bladder cancer patients.
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Pfizer posts positive data for 20-strain pneumococcal vaccine
If approved, the candidate could help to bolster the pharma's $6 billion pneumococcal franchise over the next decade.
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Achaogen files for bankruptcy protection, seeks asset sale
The California-based drugmaker has filed for Chapter 11, less than a year after gaining FDA approval for its antibiotic Zemdri.
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Allergan wins support of influential advisory firms in shareholder fight
Appaloosa, the activist investor urging change, appears willing to battle on, calling the recommendation of ISS supporting Allergan "baffling."
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Catalent to buy Paragon for $1.2B as gene therapy demand grows
The deal follows close on the heels of Thermo Fisher's buy of Brammer Bio, a peer of Paragon in making the viral vectors needed for gene therapy.
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Kidney data may give J&J diabetes drug an edge
Study shows Invokana keeps patients from needing dialysis or kidney transplantation, potentially handing J&J a marketing advantage.
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J&J wins FDA OK for first targeted therapy in bladder cancer
Balversa is also the first drug cleared by the regulator that targets mutations in a gene called FGFR.
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Alnylam looks to next RNAi approval, but safety questions linger
With givosiran's efficacy clear, safety looks to be Alnylam's remaining question as one in five patients on the drug experienced a serious adverse event.
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Unblinded: Hervé Hoppenot on solving Incyte's 'single asset syndrome'
Last April, a closely watched study of an Incyte cancer drug failed, sending the biotech back to the drawing board. This year could help answer what's next.
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Bristol-Myers wins shareholder backing for Celgene buyout
Opposition from Starboard Value and Wellington had lent some drama to the vote, which makes the roughly $74 billion tie-up between the two companies an all but done deal.
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Gilead and Novo Nordisk pair up to take on NASH
Combinations are seen as the best way to combat the disorder, which is believed to be growing in prevalence thanks to rising obesity rates.
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'Female Viagra' keeps alcohol black box warning amid FDA dispute with Sprout
The regulator was dissatisfied with the design of a post-marketing study that tested the effects of drinking alcohol while on the Addyi pill.
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Q&ALonza's CEO on keeping up with microbiome, gene therapy boom
Marc Funk told BioPharma Dive manufacturing has been an obstacle for microbiome drugmakers, something the Swiss CDMO hopes to solve with a new joint venture.
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Why Alder thinks its late-comer migraine drug can succeed
Yet, with three competitors already on the market, carving out a niche will be a tall task for the Washington state-based biotech.
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Keytruda widens reach in lung cancer with new approval
Merck's flagship cancer drug is now cleared for use in previously untreated patients with Stage 3 non-small lung cancer not suited for surgery or chemoradiation.
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Intercept sputters as it reveals full Ocaliva NASH data to doctors
Side effects and a competitive threat from Gilead derailed what should have been a good day for Intercept.
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Wave delays key data readout for Huntington's therapy
Screening and administration challenges are pushing back expected readouts as much as six months, helping to reaffirm Roche and Ionis' leading position.
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Sanofi expands insulin savings program, but affordability still an issue
Starting in June, the program will offer up to 10 boxes of pens, insulin vials or a combination of the two for $99 per month for certain patients.
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Indivior draws criminal indictment for opioid marketing practices
The federal government is seeking a $3 billion judgment and forfeiture of all assets, raising concerns about whether the company can survive.
