The FDA updates Gilenya's label over definite case of PML; generic drug companies are consolidating for negotiating power; the FDA revises guidance on DTC risk information
Novartis appeals the ban on its biosimilar Zarxio; AbbVie petitions for distinct biosimilar labels; Sanofi will study Toujeo in a real-world setting
The study indicates patients discount wording that indicates the FDA has not approved supplement claims.
At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.
The new label will reflect the RA pill's superiority to methotrexate and placebo in inhibiting the progression of structural joint damage.
Analysts gave the infusion therapy a warm reception in RA, despite stiff competition in this category.
GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.
The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer.
The FDA approval of 23-mg donepezil (Aricept) conflicted with the opinions of its own reviewers and breached the agency's own regulatory standard, authors write in a BMJ article, leading to misleading consumer and physician ad campaigns that put patients at risk.
Johnson & Johnson/Bayer's Xarelto (rivaroxaban) received FDA approval for stroke prevention in atrial fibrillation (SPAF), the second novel anticoagulant to gain US marketing approval for SPAF.
The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
Monthly Prescribing Reference (MPR) has relaunched its website with a number of enhancements to functionality and design, as well as a new, easier-to-remember URL, www.eMPR.com.
Career staffers at the FDA objected to new drug labeling regulations that favor pre-emption of state liability lawsuits, according to a report from Rep. Henry Waxman's Committee on Oversight and Government Reform.
FDA will initiate a pilot project to help manufacturers choose safer proprietary drug names.
The FDA on Wednesday announced it is proposing revisions to physician labeling for Rx drugs to include more info about their use by pregnant and/or breast-feeding mothers.
King Pharmaceuticals will cut 20% of its 2,600 employee workforce after a federal appeals court judge ruled against a patent extension on the company's blood pressure treatment Altace.
With reimbursement limits the latest threat to its anemia franchise, Amgen moved to shore up investor confidence yesterday.
The newest indication for Reclast -- postmenopausal osteoporosis -- ups its market potential considerably, analysts said.
FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by BMS under the Coumadin brand.
Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.
As the FDA keeps up the pressure on marketers for making unsubstantiated claims in their professional promotions, a Pfizer legal expert says companies may be able to avoid such notices by supporting all advertising claims with substantial evidence.
Federal advisors recommended keeping GlaxoSmithKlines embattled type 2 diabetes drug Avandia on the market but said its label should include strict warnings on use.
An advisory group is set to meet Monday to discuss the cardiovascular safety of GlaxoSmithKline’s type 2 diabetes drug Avandia, and the drug may be in for a rough time.
Pfizers ability to reach what may be an untapped population of people suffering from fibromyalgia got a boost last week when Lyrica became the first FDA-approved therapy for the condition.
FDA has asked GSK and Takeda to place boxed warnings of congestive heart failure risks on the labeling for their type 2 diabetes drugs, Avandia and Actos.
The war of words between GlaxoSmithKline and critics of the firm’s oral diabetes drug escalated yesterday, as the marketer took additional steps to shore up confidence in Avandia.
A promotional piece distributed on behalf of Cephalon to the Maryland Department of Health and Mental Hygiene Pharmacy and Therapeutics Committee suggested uses for the company’s Provigil (modafinil) tablets that have not been approved by FDA, creating new intended uses for which the product lacks adequate directions.
Cracking the patient-physician interaction has long proved elusive for pharma. But by combining patient chart data with actual audio conversations, marketers can better understand how to impact the exchange, says Carolyn Choh Fleming
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- Merck educates doctors about biosimilars, long before it will sell one in the U.S.
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- The FDA denies approval of abuse-deterrent opioid after promotional warning
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- The FDA, Astellas, and Accenture use innovation competitions to help address business challenges
- The FDA approves Amgen's biosimilar version of Humira
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