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ColumnPrescribed Reading: Shire on the block; FDA flip-flops
There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.
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SponsoredTop trends impacting your pharma packaging decisions
Biological drugs and wearable devices are growing in tandem with an aging, longer-living population. Glass containers are an important solution to the challenges of stabilization and administration these drugs present.
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Q&AGE brings antibody know-how to viral vector production
The corporate giant aims to adapt its manufacturing tech for the cell and gene therapy world, a GE exec tells BioPharma Dive.
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Tagrisso wins first-line lung cancer approval, boosting AstraZeneca
Securing the FDA OK is a key step in AstraZeneca's plan to turn Tagrisso into a multi-billion dollar drug franchise.
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Deep DiveTwo years after cancer setback, Bristol-Myers' new biomarker bet pays off
The success of CheckMate-227 is a step toward validating tumor mutational burden, but questions remain about how easily the test could be adopted.
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Lilly's baricitinib to face tough questions at AdComm
FDA staff reviewers raised doubts about the safety of the once-rejected rheumatoid arthritis drug ahead of an advisory committee meeting Monday.
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ApolloBio picks up I/O therapies for China market
Rising cancer rates in China have drawn the attention of drugmakers, spurring increased R&D for therapies designed for Chinese patients.
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J&J reshaping its supply chain around therapies of the future
Newer technologies like those used in biologics and CAR-T development are spurring the overhaul, as are hundreds of millions in potential cost savings.
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FDA seeks info on DMD drug as hold remains
Solid Biosciences said it will respond within weeks to the latest agency questions regarding its experimental gene therapy.
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GSK brings on Roche exec to lead pipeline growth
It's the latest get by new CEO Emma Walmsley from a pharma rival as GSK looks to move beyond its three new drug launches.
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Ultragenyx gets thumbs up for first inherited rickets therapy
Crysvita's FDA approval for X-linked hypophosphatemia also hands Ultragenyx a Priority Review Voucher — a valuable asset in the pharma world.
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FDA staff positive on GW Pharma drug for seizures
Agency documents on the first whole-plant-based cannabis drug Epidiolex appear favorable for GW ahead of the Thursday advisory meeting.
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DEA seeks to more strictly manage opioid manufacturing
A proposed rule would allow the agency to consider drug misuse when setting the annual quotas that govern production of the painkillers.
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ImmuPharma dives on late-stage lupus failure
A high placebo response threatens to squash interest from larger pharma companies in the U.K. biotech's drug, Lupuzor.
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Pushing 'value,' Harvard Pilgrim tests outcomes deals
An agreement with AstraZeneca for the pharma's lung drug Symbicort is the ninth value-based contract publicly announced by the regional insurer.
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Sanofi nears deal to sell EU generics unit for $2.4B
The French drugmaker's decision to divest the business is yet another sign of the pressures facing the generic drug industry.
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Rigel secures FDA approval for rare disease drug
News of the OK helped shares in the biotech recover from the effect of a clinical setback earlier this month.
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J&J unfazed by falling Remicade sales
Revenues from the company's best-selling drug were down in Q1, but the drug still commands 95% of the volume in the market for infliximab drug products.
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Deep DiveI/O combos inch forward in pharma's lung cancer quest
An impressive survival benefit could lift Merck's Keytruda plus chemo regimen, while Bristol-Myers hopes its checkpoint inhibitor pairing can help it catch up.
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Amazon reportedly drops plan to distribute drugs to hospitals
The report is not entirely unexpected. Amazon previously canceled a wholesaler application in Maine and has told other state regulators it does not intend to sell drugs.
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In win for generics makers, court knocks back Maryland price gouging law
Wording was a key concern for the court of appeals, as the law's text would have allowed it to unconstitutionally regulate interstate commerce.
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Celldex cancer drug crashes out at Phase 2b
The biotech will ditch further development after the drug failed to meet its primary endpoint in a triple-negative breast cancer study.
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Shire's oncology exit weighs on potential Takeda bid
Analysts expect a $2.4 billion deal with Servier to give Shire more negotiating power with Takeda, but it likely won't keep the suitor at bay.
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Alkermes up after FDA reversal on depression drug
The agency's about-face comes just two weeks after it issued a Refusal to File letter to the company.
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Merck looks to catch Bristol with new melanoma data for Keytruda
In one of several successes for Keytruda at AACR, the immunotherapy helped reduce the risk of melanoma recurring following surgery.
