Label

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

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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.

FDA approves sNDA for Xeljanz

The new label will reflect the RA pill's superiority to methotrexate and placebo in inhibiting the progression of structural joint damage.

With RA indication, J&J's Simponi an up-and-comer

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Analysts gave the infusion therapy a warm reception in RA, despite stiff competition in this category.

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

GSK gets 2 cancer pills approved, but a deeper question is left unanswered

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GSK's newest cancer approvals highlight a problem that stalks progress with personalized medicines.

FDA gut-checks DTC clarity

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The new survey will study whether patients understand how efficacy is calculated and experiment with ways to make communications clearer.

Journal article targets FDA misstep on Aricept

Journal article targets FDA misstep on Aricept

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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.

Company news: J&J, Bayer and Siemens Healthcare

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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.

Supremes deny Wyeth in pre-emption bid

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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.

MPR rolls out revamped website

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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.

Waxman: FDA career staff objected to preemption policies

Waxman: FDA career staff objected to preemption policies

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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 to launch drug name review pilot project

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FDA will initiate a pilot project to help manufacturers choose safer proprietary drug names.

FDA proposes Rx label revisions for moms

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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 reduces workforce by 20%, cuts mostly sales jobs

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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.

Amgen seeks to ease investor concerns as staff cuts loom

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With reimbursement limits the latest threat to its anemia franchise, Amgen moved to shore up investor confidence yesterday.

New approval for drug gives Novartis excuse to up promotion

The newest indication for Reclast -- postmenopausal osteoporosis -- ups its market potential considerably, analysts said.

Warfarin label change advises on genetic factors

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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.

Timing of FDA notice on diabetes meds leads to confusion

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Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.

Avoiding the DDMAC letter: Advice from a Pfizer counselor

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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.

Panel votes to keep Avandia on the market with tougher label

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Federal advisors recommended keeping GlaxoSmithKlines embattled type 2 diabetes drug Avandia on the market but said its label should include strict warnings on use.

Avandia meeting could be rough one for GSK

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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.

New indication could see Pfizer expand Lyrica ads

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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.

Avandia hearings: FDA black-boxes TZD drugs

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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.

GSK again on defensive with Avandia

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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.

Promo piece for Provigil lists unapproved uses

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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.

Turning Dialogue into Data

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


Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.

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