RSS | Login | Register

Approval

Bydureon approval a shot across bow for Victoza

Deborah Weinstein 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

Matthew Arnold 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

Marc Iskowitz 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

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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?

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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

Ben Comer 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

Matthew Arnold 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

Ben Comer 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

Matthew Arnold 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

Anthony Vecchione 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

James Chase 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

Matthew Arnold 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

Ben Comer 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

Ben Comer 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

Ben Comer May 22, 2008

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

Oncologists expect Avastin Rxs to more than double: survey

Stephen McGuire 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

Stephen McGuire 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

Stephen McGuire 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.

Product news

January 17, 2008

Nycomed said the FDA has approved Alvesco (ciclesonide) inhalation aerosol in the US for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older.

Product news

January 10, 2008

Canadian health officials have approved Merck's Januvia (sitagliptin phosphate monohydrate), a once-daily, oral medication in a new class of anti-hyperglycemic agents known as DPP-4 (dipeptidyl peptidase-4) inhibitors.

Dossier offers one-stop shop for new drug insights

December 06, 2007

Introduced last week, MM&M's New Drug Dossier is enjoying a successful debut, as pharmaceutical marketers continue to recognize the utility of this business intelligence tool.