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Approval

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

Marc Iskowitz May 30, 2013

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

GSK adds competitor to COPD market

Deborah Weinstein May 10, 2013

The FDA approved the Breo/Ellipta combo, but analysts are wary about its potential to go beyond the COPD indication in the US.

Business briefs: Arena, Takeda, Teva, Cubist

May 08, 2013

Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status.

FDA streamlines patient access information

Deborah Weinstein May 06, 2013

A new FDA site gives patients a one-stop shop for commenting on pending regulations, finding clinical trials and navigating treatment options.

Pfizer pipeline breast cancer drug gets fast tracked

Deborah Weinstein April 11, 2013

FDA is accelerating review of Pfizer's experimental breast cancer drug palbociclib, which analysts say already has a fan base among KOLs.

J&J's Invokana clears FDA

Matthew Arnold March 29, 2013

The FDA has approved Janssen's Invokana (canagliflozin) for type 2 diabetes, giving J&J a first-to-market advantage in the SGLT-2 class.

Business briefs: Sobi and Savient; Novartis; Saatchi & Saatchi Wellness

February 19, 2013

Sobi and Savient Pharmaceuticals inked a co-promote agreement for RA drug Kineret in the US.

Business briefs: J&J, Genzyme, Roche

January 30, 2013

Johnson & Johnson is said to be shopping its women's division; Genzyme lands a rare disease drug approval; Roche says Avastin had a comeback in 2012; promotions at Ogilvy CommonHealth and McCann Complete Medical

J&J OTC sales slipped 3% in 2012 worldwide

Deborah Weinstein January 22, 2013

CEO Alex Gorsky said OTC brands are coming back. Meanwhile, pharmaceutical sales provided ballast to the year's numbers.

Egg-free, mercury-free flu vaccine approved

Deborah Weinstein January 17, 2013

The FDA approved a flu vaccine that can be produced quickly, and lacks many elements that make patients skittish.

Eliquis: the third shoe drops in the blood-thinner category

Deborah Weinstein January 10, 2013

Generic Plavix was just the beginning of blood-thinner transformation. Eliquis is poised to benefit from lessons learned and pre-existing goodwill.

Congress spares pharmas from going over another cliff—for now

Matthew Arnold January 02, 2013

For the drug industry, the big news in the "fiscal cliff" deal is that the next big congressional showdown—one that could have big implications for the healthcare industries—has been kicked down the road a couple months.

Year-end approval clears Eliquis for US launch

Marc Iskowitz January 02, 2013

Eliquis was approved Friday for preventing strokes in patients with nonvalvular atrial fibrillation, becoming the third oral anticoagulant to reach the US market.

Company news: Janssen, Quest, IMS Health

January 02, 2013

Janssen scores an approval for its TB drug; Quest sells off OralDNA; telehealth use poised to rise

FDA ends year with 39 approvals

Deborah Weinstein January 02, 2013

Eight December approvals helped the agency pass its 2011 total with ease. But it's not all about the pace—the agency needs drugs to approve to keep tallies climbing.

Drug for ultrarare lipid disorder OK'd by FDA

Marc Iskowitz December 26, 2012

Aegerion's Juxtapid is first to market for treating the ultrarare inherited cholesterol condition HoFH, or homozygous familial hypercholesterolemia.

Study: Pharma getting more drugs approved, but less money for them

Deborah Weinstein December 17, 2012

Researchers said the industry closed 2012 with a mixed bag of results. The upside: more approvals than last year. The downside: projected sales for these new drugs is less.

Company news: Janssen, Pfizer, BMS and Boehringer Ingelheim

December 11, 2012

Janssen's prostate cancer pill Zytgia got an OK for use in an earlier line of therapy, and drugmakers Pfizer, Bristol-Myers Squibb and Boehringer Ingelheim released new data on blood thinners Eliquis and Pradaxa.

Company news: Valeant and Regeneron

September 24, 2012

Valeant scoops up QLT's Visudyne, and Regeneron's Eylea scores another indication

Drugs elude cookie-cutter approval process

Deborah Weinstein September 19, 2012

A new nonprofit seeks to speed drugs to market, but experts tell MM&M the drug approval process will remain a fuzzy equation.

FDA approves new cancer drugs from Pfizer, Medivation/Astellas

Matthew Arnold September 05, 2012

Pfizer Oncology racked up its third FDA approval of a new drug in 13 months as the agency green lighted leukemia drug Bosulif (bosutinib).

Forest's one-a-day IBS drug Linzess to take on Amitiza

Matthew Arnold September 04, 2012

Forest and Ironwood IBS drug Linzess (linaclotide), which won FDA approval last week for treatment of chronic constipation and irritable bowel syndrome with constipation, is expected by some analysts to become a blockbuster.

Company news: Medivation/Astellas and Teva

August 08, 2012

A cancer drug being developed by Medivation and Astellas gets its closeup, and Teva launches in to Phase III trials of its oral MS drug laquinimod.

Vivus in talks to out-license ED drug Stendra

Marc Iskowitz 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

Deborah Weinstein 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

Deborah Weinstein 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

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.

Web Exclusive

What NOT to say to an MS Patient

Dorothy Wetzel June 07, 2013

It is often hard to find the right words when talking to a patient, friend or family member with MS. Even with training and awareness of the disease, we often blurt out something we think is innocuous only to find out later that we have deeply offended. The Health Activists that Extrovertic spoke to had some suggestions for having positive conversations with someone with MS.

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma.

Slideshows

Peter Frishauf, founder of Medscape, delivers his acceptance speech.

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner

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