Pipeline

Company news: Gilead, Pfizer and Wolters Kluwer

December 29, 2011

Two potential blockbusters in the pharma pipeline took another step toward reaching market, as US regulatory authorities assigned PDUFA dates for Gilead Sciences' Quad pill and for Pfizer's tofacitinib.

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.

New indication may give Xarelto a sales boost

Marc Iskowitz October 04, 2011

Will Xarelto become the first Factor Xa inhibitor with an indication for use in patients who have had a heart attack or similar symptoms?

European meeting may clear the air on Eliquis

Marc Iskowitz August 23, 2011

Experts are looking forward to an international cardiology meeting this weekend to help answer a key question: Will Eliquis become the leading substitute for warfarin?

Renewed focus on Alzheimer's could help new drugs to market

Ben Comer December 16, 2010

The House's passage of the National Alzheimer's Project Act yesterday - should it be signed into law by President Obama - could help expedite the approval process for new drugs targeting the disease, sources say.

Merck Serono calls for short film scripts in global MS effort

Ben Comer May 26, 2010

Merck Serono announced the launch of a global MS awareness campaign calling for "script concepts" on the topic of multiple sclerosis. The winning script will be developed into a short film and distributed later in 2010. The contest is not open to US residents.

Pfizer aborts investigational compounds, reprioritizes

Ben Comer February 24, 2009

Pfizer terminated phase 3 development on two investigational compounds today after halting trials on axitinib, a phase 3 pancreatic cancer treatment, in January.

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.

Merck makes a play for generic biologics market

Matthew Arnold December 11, 2008

Merck is betting on Democratic plans to speed development of generic biologics, making a play for the market with a new unit tasked with designing the products and promising, in the words of president and CEO Dick Clark, a "new Merck built for the new era that our industry has entered."

Pfizer brags of pipeline, refocuses R&D

Matthew Arnold October 02, 2008

Pfizer announced that the number of compounds it has in Phase 3 development has grown from 16 to 25 over the past six months, including eight cancer treatments.

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.

IMS projects seven potential blockbusters

Ben Comer May 22, 2008

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

Product news

March 18, 2008

Hawthorn Pharmaceuticals announced the FDA approval of the company's Granisol (granisetron HCl) oral solution. Granisol is an oral solution for the prevention of nausea and vomiting associated with cancer therapy.

Alkermes: Lilly to end inhaled insulin deal

Stephen McGuire March 07, 2008

Biotech firm Alkermes said today it expects Eli Lilly to soon back out of its inhaled insulin development deal between the companies.

Ambling toward patent cliff, flinty Pfizer boasts of pipeline

Matthew Arnold March 06, 2008

Pfizer delivered a low-key analyst day, offering no surprises as it advances toward a "cliff" of patent expirations on major products.

FDA delays Requip XL approval

Stephen McGuire February 06, 2008

The FDA has delayed approval of GlaxoSmithKline and SkyePharma's reformulated Requip XL (ropinirole) as a treatment for Parkinson's disease.

FDA approves fewest novel drugs in 24 years: reports

Stephen McGuire January 08, 2008

The FDA approved 19 novel drugs last year, the lowest number since 1983, according to published reports.

Takeda submits NDA for Actos replacement as DPP-IV pipeline heats up

Stephen McGuire January 07, 2008

Takeda Pharmaceutical has submitted a new DPP-IV diabetes drug candidate -- Alogliptin -- in hopes the drug will replace its major earner Actos which loses patent protection in 2011.

Sepracor in licensing pact for anti-epileptic compound

Stephen McGuire January 03, 2008

Sepracor has entered a licensing deal with Bial for the development and commercialization of Bial's anti-epileptic compound BIA 2-093 in the US and Canada.

Company news

January 03, 2008

Merck and Addex Pharmaceuticals entered a deal to develop a drug candidate for schizophrenia, under which Merck will pay Addex up to $702 million in cash plus royalties.

Wyeth sees generic threats, another delay on Viviant

Marc Iskowitz December 26, 2007

Competitors have stepped up efforts to market generic versions of some of Wyeth's biggest drugs, threatening to sap hundreds of millions of dollars in sales.

FDA seeks more info on Cervarix

Stephen McGuire December 17, 2007

GlaxoSmithKline said approval of Cervarix will be delayed in the US after FDA regulators requested more information on the vaccine in a "complete response letter" to the drugmaker.

Novartis planning four new cancer drugs: Oncology president says

Stephen McGuire December 05, 2007

David Epstein, president of Novartis Oncology, said he hopes the drug maker will be able to start selling four new cancer treatments by the year 2011.

MM&M launches New Drug Dossier

November 30, 2007

MM&M's New Drug Dossier is designed to give pharmaceutical marketers authoritative promotional and clinical insights on the latest new molecular entities in one online resource.

Amylin presents strong results for long-acting Byetta at R&D day

Stephen McGuire November 29, 2007

Positive results of a study involving Amylin's long-acting release (LAR) version of Byetta (exenatide) were the highlight of the company's R&D day in New York yesterday.

Novartis dealt another Galvus setback

Stephen McGuire November 07, 2007

Newly discovered liver safety problems with high doses of Novartis' diabetes treatment Galvus are expected to delay the European launch of the drug and have raised questions about whether the FDA will back its approval here in the US.

Study: torcetrapib ills not class effect

Marc Iskowitz November 06, 2007

A Pfizer analysis released this week brought new hope to a class of drugs designed to clear arteries by boosting the protective form of cholesterol. The findings could help firms like Roche and Merck determine whether to continue developing similar agents.

High hopes for prasugrel hit by safety worries

Marc Iskowitz November 06, 2007

Clinical trials of a much-anticipated compound from Eli Lilly brought mixed results, causing analysts to further cool on the drug.

As generics gain, slower growth forecast for 2008

Matthew Arnold November 01, 2007

Global pharmaceutical sales will slow in 2008, growing 5%-6% compared to 6%-7% in 2007, as the recent wave of patent expirations continues, according to an IMS Health forecast.

FDA deals Takeda pipeline setback

Stephen McGuire October 31, 2007

The FDA recommended that Takeda halt high-dose clinical studies of its TAK-475 cholesterol drug due to possible liver side effects, asking for additional data on the drug.