Approval

Vivus in talks to out-license ED drug Stendra

April 30, 2012

Rather than test the waters for faster-than-Viagra drug Stendra, Vivus wants another firm to handle marketing.
 

Journal article targets FDA misstep on Aricept

March 22, 2012

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.
 

Shire exits Fabry's market, citing costs as FDA weighs more research

March 15, 2012

Shire has pulled its drug, Replagal, from FDA review. The company was set to go before the agency next month, but preliminary talks indicated the FDA was going to require more testing.
 

Bydureon approval a shot across bow for Victoza

January 30, 2012

The FDA's go-ahead for Bydureon gives maker Amylin a much-needed win in the GLP-1 market.
 

Since Vioxx scare, tough times for industry R&D, study finds

December 01, 2011

A review of 450 New Molecular Entities spanning a decade and a half found two distinct eras of drug R&D - one of abundance and one of scarcity, hinging on the September, 2004 withdrawal of Merck's Vioxx.
 

Company news: J&J, Bayer and Siemens Healthcare

November 08, 2011

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.
 

FDA, industry agree on PDUFA deal to speed NME reviews

September 01, 2011

The FDA and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act (PDUFA), by which pharmas provide nearly two-thirds of what the agency spends on drug reviews.
 

Pfizer's Xalkori and Abbott test show promise in personalized medicine, companion diagnostics

August 30, 2011

The FDA's approval of Pfizer's Xalkori (crizotinib) represents a leap forward for both personalized medicine and Pfizer's R&D turnaround, but its commercial success hinges on a pricey diagnostic array by Abbott's Vysis.
 

FDA to IOM: More work? No thanks

August 11, 2011

The FDA is moving cautiously on a call by the Institute of Medicine to scrap the approvals process for many medical devices.
 

Brilinta boosts AstraZeneca, but can it carry them over the cliff?

July 21, 2011

The FDA gave the green light to AstraZeneca's Brilinta (ticagrelor) anti-platelet for heart attack prevention, but the brand will carry a black box warning, a Risk Evaluation and Mitigation Strategy requirement and an obligation to educate doctors about possible risks of use in users of high-dose aspirin.
 

Vertex versus Goliaths in HCV drug duel

May 23, 2011

Vertex has succeeded in bringing one heck of a new drug to market in Incivek (in-SEE-veck, or telaprevir), a hepatitis C drug 15 years in the making which promises to cut treatment time in half. Selling the drug against the combined might of Roche and Merck could be nearly as tricky.
 

For Tradjenta, a tough climb, and for Lilly, a vital one

May 05, 2011

Lilly/Boehringer Ingelheim's third-to-market DPP-4 inhibitor Tradjenta, approved earlier this week for the treatment of type 2 diabetes, faces an uphill battle for market share against Merck's entrenched market leader Januvia and BMS/AstraZeneca's Onglyza.
 

FDA approves BMS skin cancer biologic Yervoy

March 25, 2011

The FDA approved Bristol-Myers Squibb's cancer biologic Yervoy (ipilimumab) for the treatment of late-stage melanoma, a particularly deadly form of skin cancer for which treatment options are few. One analyst projected that sales of the drug could top $1.7 billion by 2015.
 

King Pharma resubmits abuse-resistant oxycodone to FDA

December 28, 2010

Two years after receiving a Complete Response letter from FDA about Remoxy, King Pharmaceuticals and Pain Therapeutics announced that they had resubmitted the drug for approval yesterday. A thumbs up or thumbs down from FDA is expected in June.
 

Obama's FDA more responsive but still s-l-o-w, says industry

November 30, 2010

Drug and device firms feel FDA has provided better guidance under Obama, but remain frustrated over the slow pace of approvals, a PricewaterhouseCoopers survey found.
 

Company news: Boehringer Ingelheim

October 21, 2010

Boehringer Ingelheim won FDA approval for blood thinner Pradaxa (dabigatran) to prevent stroke in patients with atrial fibrillation (AFib), beating two other potential warfarin replacements to the US market.
 

FDA OKs Merck's Dulera for asthma

June 24, 2010

FDA approved Merck's Dulera, a combination inhaler, for asthma patients 12 years and older, the company announced today.
 

FDA BLA approvals rose in 2009 while NMEs stumbled

December 31, 2009

The FDA approved 17 new molecular entities and seven biologics license applications in 2009. That's a substantial improvement in large molecule approvals -- the agency granted just three BLAs last year -- and a slight downturn in new chemical compounds, from last year's 21 NMEs.
 

Backlash builds against prasugrel panel decision

February 17, 2009

Dr. Steven Nissen is the latest high-profile physician to join the pile-on over an FDA advisory panel's decision to exclude an outspoken critic of the antiplatelet drug prasugrel.
 

MPR rolls out revamped website

January 20, 2009

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.
 

NME approvals up a tic in 2008

December 30, 2008

The FDA rang out 2008 with the approval of Ferring's degarelix, for prostate cancer, capping another slow year for new drug approvals.
 

Thomson Reuters names five most promising Q1 drugs

August 18, 2008

A Thomson Reuters study forecasts five of the "most promising drugs launched or receiving approval" during the first quarter of 2008.
 

FDA consolidates drug application responses

July 09, 2008

The FDA will change the way it responds to drug applications, eliminating "approvable" and "not approvable" letters.
 

IMS projects seven potential blockbusters

May 22, 2008

Seven potential blockbusters could emerge in 2008, according to IMS Health.
 

Oncologists expect Avastin Rxs to more than double: survey

March 11, 2008

A recent survey of oncologists indicates market share for Genentech's Avastin could more than double as a first-line and second-line breast cancer therapy following last month's approval to treat the disease.
 

Product news

March 06, 2008

Genzyme announced the US launch of phosphate binder Renvela (sevelamer carbonate) for dialysis patients.
 

Product news

February 28, 2008

The FDA approved AstraZeneca's Nexium (esomeprazole magnesium) for short-term use in children ages one -11 years for the treatment of gastroesophageal reflux disease (GERD).
 

Avastin approval surprises Wall Street; may change future of cancer drug approvals

February 25, 2008

Friday's approval of Genentech's Avastin to treat breast cancer caught many on Wall Street off guard and could represent a change in the way the agency measures the effectiveness of cancer medicines.
 

FDA approves Abbott's Simcor cholesterol combo drug

February 19, 2008

The FDA granted approval to Abbott's NDA for Simcor, a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin, the generic version of Merck's Zocor.
 

Product news

January 24, 2008

Astellas Pharma won FDA approval for their sNDA for the use of Mycamine (micafungin sodium) for injection in the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses.
 

Video Exclusive

Web Exclusives

Five industry experts advise specialty pharma company on digital strategy

April 20, 2012

Specialty pharma company POZEN assembled a crack team of experts to help shape its digital strategy. Not only did POZEN share with us the text from their contributions, but you can watch exclusive video clips of their valuable perspectives right here.
 

MM&M Awards 2011 HIghlights

The Best MM&M Awards Ever!

MAHF Ceremony 2012

Photos from the Medical Advertising Hall of Fame Awards ceremony
 
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