The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change

1 09 2013

New Drug Approvals

Susan Desmond-Hellmann

There’s one factor that, as much as anything else, determines how many medicines are invented, what diseases they treat, and, to an extent, what price patients must pay for them: the cost of inventing and developing a new drug, a cost driven by the uncomfortable fact than 95% of the experimental medicines that are studied in humans fail to be both effective and safe.

A new analysis conducted at Forbes puts grim numbers on these costs. A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale. In part because so many drugs fail, large pharmaceutical companies that are working on dozens of drug projects at once spend $5 billion per new medicine.

read all at

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

How Much They Cost: R&D Spending Per New Drug

Company Number of new drugs 10 year R&D spending…

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NATURE’S VIAGRA-Health benefits of pomegranate by – By Dr. Janardhana V Hebbar, Ayurveda Expert

1 09 2013

New Drug Approvals

Image

Countless studies have shown the seemingly countless benefits of fruits for a person’s health.

The U.S. Government recommends that people get some servings of fruits every day. Of all the fruits ready in the shop today,

one fruit is at its height of popularity because of its legendary Greek mythology connection and its exoticism-the pomegranate fruit.

READ COMPLETE ARTICLE AT

http://www.askveda.in/blog/health-benefits-of-pomegranate/

 

 

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European Commission Approves Genzyme’s Once-Daily, Oral Multiple Sclerosis Treatment Aubagio® (teriflunomide)

1 09 2013

New Drug Approvals

Teriflunomide,

Teriflunomide, HMR-1726, 1726, A-771726, RS-61980, SU-0020,
(Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-butenamide
108605-62-5, 282716-73-8 (monosodium salt)
C12-H9-F3-N2-O2
270.2091
Aventis Pharma (Originator), Sanofi-Aventis U.S. Llc
Sugen (Licensee)
Antiarthritic Drugs, Disease-Modifying Drugs, Immunologic Neuromuscular Disorders, Treatment of, IMMUNOMODULATING AGENTS, Immunosuppressants, Multiple Sclerosis, Agents for, NEUROLOGIC DRUGS, TREATMENT OF MUSCULOSKELETAL & CONNECTIVE TISSUE DISEASES, Dihydroorotate Dehydrogenase Inhibitors

CAMBRIDGE, Mass.–Aug. 30, 2013–(BUSINESS WIRE)–Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission has granted marketing authorization for Aubagio® (teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).

read all at

http://www.pharmalive.com/ec-approves-genzyme-s-aubagio-for-ms

Teriflunomide (trade name Aubagio, marketed by Sanofi, also known as A77 1726) is the active metabolite of leflunomide.[1]Teriflunomide was investigated in the Phase III clinical trial TEMSO as a medication for multiple sclerosis (MS). The study was completed in July 2010.[2] 2-year results were…

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Hope In A Pill- A crop of small-molecule drugs in development could double the treatment options for people with multiple sclerosis in coming years

1 09 2013

New Drug Approvals

READ ALL AT

PROMISING PIPELINE Numerous small-molecule drugs are in late-stage development to treat MS

READ ALL AT

New Crop: Research into multiple sclerosis has yielded a host of drug candidates.EMD Serono

NEW CROP Research into multiple sclerosis has yielded a host of drug candidates.
READ ALL AT
For people with MS, oral drugs that could address both the immune and neurological components of the disease represent a beacon of hope. “If I could take a pill, I almost wouldn’t mind having this disease,” Sommers says. Mentally gearing up for the weekly shot and the possible side effects takes its toll over the years, he says. Putting aside the syringes “would make it a lot more tolerable,” he says. “I am very excited that there might be some oral drugs down the road.”

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Roche reports positive Phase II results for experimental eye drug

30 08 2013

New Drug Approvals

Lampalizumab

Roche reports positive Phase II results for experimental eye drug
Lampalizumab, an experimental eye drug from Roche, has helped slow down the progression of an advanced form of age-related macular degeneration (AMD) in a Phase II study, the company announced this week.

READ ALL AT

 http://www.pharmaceutical-technology.com/news/newsroche-reports-positive-phase-ii-results-experimental-eye-drug?WT.mc_id=DN_News

SEE ALSO

Lampalizumab effective in Phase II clinical trial for macular degeneration

Roche’s new drug for age-related macular degeneration, lampalizumab, showed effective in slowing the progression of AMD in patients with advanced disease, shrinking the area of geographic atrophy by 20%. Read More >>

 

Lampalizumab (INN) is a humanized monoclonal antibody designed for the treatment of geographic atrophy secondary to age-related macular degeneration. It binds to CFD.[1][2]

This drug was developed by Genentech/Roche.

References

  1. ^World Health Organization (2012). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 107” (PDF). WHO Drug…

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FDA grants priority review to Pharmacyclics drug

30 08 2013

New Drug Approvals

ibrutinib

FDA grants priority review to Pharmacyclics drug

Pharmacyclics is getting a priority review of its blood cancer treatment by federal regulators. A priority review shortens a drug evaluation by the U.S. Food and Drug Administration from 10 months to six. The acceptance of the application triggers a $75 million milestone payment to Pharmacyclics from Johnson & Johnson’s Janssen unit.

http://www.rdmag.com/news/2013/08/fda-grants-priority-review-pharmacyclics-drug?et_cid=3451362&et_rid=523036890&type=cta

Ibrutinib (USAN[1]), also known as PCI-32765, is an experimental drug candidate for the treatment of various types of cancer. It is an orally-administered, selective and covalent inhibitor of the enzyme Bruton tyrosine kinase (Btk).[2][3][4] Ibrutinib is currently under development by Pharmacyclics, Inc and Johnson & Johnson’s Janssen Pharmaceutical division for B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma, and multiple myeloma.[6][7][8]. Ibrutinib was first designed and synthesized at Celera Genomics by Zhengying Pan, who along with a team of chemists and…

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Breakthrough Therapy Designation for Firdapse to treat Lambert-Eaton Myasthenic Syndrome (LEMS)

28 08 2013

TGI: Thrive Health

Recently, Catalyst Pharmaceutical Partners Received Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS.

Company announced that its investigational product Firdapse(TM) (amifampridine phosphate) has received “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst’s investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.

“We are very pleased to have received Breakthrough Therapy Designation for Firdapse(TM) and we are excited by the FDA’s decision to place our product in a category that may enable expedited development and review for patients with LEMS,” said Patrick McEnany, President and Chief Executive Officer of Catalyst. “With no approved or effective symptomatic treatment currently available for LEMS, Firdapse(TM) has the potential to be the first-line treatment option for patients with this rare condition.”

Breakthrough Therapy…

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