Page 2
-
FDA finds another carcinogen in valsartan products
The impurities continue a summer-long effort by regulators to assess the risk from tainted API of the heart drug.
Manufacturing -
Amgen, Sandoz begin biosimilar trial with top-selling Enbrel at stake
In the still unsettled biosimilar market, the result could hold far-reaching consequences. "You are going to start hearing about this," one top Wall Street analyst predicted.
Regulatory / Compliance -
Sanofi looks to China in business restructure
China is now Sanofi's second largest market after the U.S., reflecting its fast growth and improving regulatory climate.
Corporate News -
Inbrija delay poses question: How far can Acorda fall?
Regulators need more time to assess the biotech's Parkinson's drug. Their final decision, when it comes, will be the difference between Acorda shares trading at $5 or $30 apiece, according to one analyst.
Regulatory / Compliance -
FINCH-2 data bodes well for Gilead, Galapagos JAK inhibitor
The rheumatoid arthritis study showed no patients taking filgotinib experienced deep venous thrombosis, a key concern leading up to Tuesday's readout.
UPDATED: Sept. 12, 2018 at 10:42 a.m.
Clinical Trials -
Boehringer bets on oncolytic viruses in ViraTherapeutics deal
The German pharma paid $245 million to acquire the Austrian biotech, boosting a partnership the two companies inked in 2016.
Mergers and Acquisitions / Deals -
Bristol-Myers' psoriasis drug proves itself in mid-stage study
Known for its prowess in cancer, the pharma trails rivals in developing new drugs for inflammation-related conditions.
Clinical Trials -
Vital Therapies plunges on liver treatment failure
Shares of the San Diego biotech plummeted 90% as its only product candidate flopped in a pivotal trial, leaving the company in a precarious position.
Clinical Trials -
Gottlieb rebuffs pharma CEO who claimed price hikes were 'moral requirement'
In a flashback to Martin Shkreli, the head of Missouri drugmaker Nostrum Laboratories unabashedly defended a 400% price increase on an old antibiotic.
Marketing -
As Florence approaches, Pfizer pauses operations at North Carolina plant
Erring on the safe side, Pfizer is suspending normal operations at the sterile injectables plant ahead of the expected impact from Hurricane Florence.
Manufacturing -
Bavencio combo shows benefits in kidney cancer
Pfizer and Merck KGaA are playing catch up with Bavencio as the rest of the checkpoint inhibitor market charges ahead.
Clinical Trials -
Alcon to shift HQ to Switzerland after Novartis spinoff
The eye care unit already has operations in Geneva, and plans to list on Swiss stock exchanges upon becoming a standalone company.
Corporate News -
Appeals court upholds CRISPR patent ruling in win for Broad Institute
It's a blow to the University of California, which hoped to reverse an earlier decision in the long-running legal battle over inventorship of the technology.
Legal -
Merck's pneumonia antibiotic stacks up in pivotal study
Dubbed ASPECT-NP, the study showed Zerbaxa was non-inferior to meropenem in treating two kinds of bacterial pneumonia.
Clinical Trials -
GSK touts Nucala data after COPD miss
After last week's bruising slate of news, GSK was quick to highlight research showing a competitive edge for its lung drug in severe asthma.
Clinical Trials -
Federal court rules Ampyra patents invalid, sinking Acorda stock
In a 2-1 vote, a U.S. appeals court upheld a previous ruling to toss out four patents on grounds of obviousness for the biotech's lead drug.
Regulatory / Compliance -
FDA closes door to speedy OK for Amicus rare disease drug
Amicus had hoped positive data from an early study of its Pompe disease therapy would support accelerated approval. Yet the biotech isn't giving up.
Regulatory / Compliance -
Roche hits roadblock in UK over Ocrevus price
Final guidance from NICE advised against covering the MS drug for primary progressive patients, despite a lack of other disease-modifying therapies.
Regulatory / Compliance -
Merck extends I/O lead as EU OKs Keytruda in first-line lung cancer
Even as the immuno-oncology race between Keytruda and Opdivo remains tight, Merck's drug has secured a dominant position in treating lung cancer.
Regulatory / Compliance -
GSK's pitch for Nucala in COPD turned down by FDA
The Complete Response Letter GSK received Friday isn't entirely unexpected: An FDA advisory panel last month found the lung drug's data in COPD lacking.
Clinical Trials -
Biotech billionaire Phillip Frost charged by SEC, sending Opko shares sliding
The SEC alleged the Opko CEO and ex-Teva chairman, along with nine others, manipulated stock prices in "classic pump-and-dump schemes."
UPDATED: Sept. 8, 2018 at 2:19 p.m.
Regulatory / Compliance -
Akcea to reduce workforce 10% following Waylivra rejection
The biotech currently employs around 270, and said the layoffs will primarily affect field teams dealing with the rare disease drug.
Corporate News -
As EpiPen struggles, Walgreens, Kaleo ink Auvi-Q partnership
Auvi-Q will now be offered at Walgreens' roughly 9,800 locations at no cost for commercially insured patients eligible for Kaleo's patient support programs.
Mergers and Acquisitions / Deals -
BlueCross BlueShield Tennessee drops Oxycontin in favor of Collegium's competitor
While still tiny next to the Oxycontin franchise, Xtampza has gained momentum as a challenger to Purdue's market dominance.
UPDATED: Sept. 7, 2018 at 2:10 p.m.
Regulatory / Compliance -
Invokana gains heart labeling in Europe
Among diabetes drugs, competition has increasingly been driven by the ability of companies to demonstrate the cardiovascular safety of their medicines.
Regulatory / Compliance