Latest News in the pharma Industry

Policy & Regulation

Synthon Submits ANDA for Glatiramer Acetate Dossier

Synthon Submits ANDA for Glatiramer Acetate Dossier

14 Dec 2011

Synthon has submitted an Abbreviated New Drug Application for Glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes to the FDA.

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Scientists to Develop New Antibiotics from Frog Skin

Scientists to Develop New Antibiotics from Frog Skin

13 Dec 2011

Researchers have found that foul smelling frogs not only offer clues to prepare a new range of antibiotics but boost human immune system against bacterial attacks.

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EMA and FDA to Share Manufacturing Site Inspections

EMA and FDA to Share Manufacturing Site Inspections

12 Dec 2011

The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.

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HHS Official Overrules FDA Decision on Plan B Pill

HHS Official Overrules FDA Decision on Plan B Pill

9 Dec 2011

Health and Human Services Secretary has overruled the decision by the FDA to make Teva Pharmaceuticals' Plan B morning-after pill available to young teens without a prescription.

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FDA Warning Letter Cites Novartis Plants

FDA Warning Letter Cites Novartis Plants

9 Dec 2011

The letter follows inspections between April and August this year, which uncovered ‘significant violations’ of cGMP regulations, including microbiological contamination of drug products purporting to be sterile.

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India's DHR Launches Supportive Scheme for Public Health Researches

India's DHR Launches Supportive Scheme for Public Health Researches

8 Dec 2011

This scheme covers promotion and co-ordination of basic, applied and clinical research including clinical trials and operational research in areas related to health, medical, biomedical and medical profession and education and management of related inf...

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UK Government Provides £90M to Support Life Sciences

UK Government Provides £90M to Support Life Sciences

7 Dec 2011

The aim of the Biomedical Catalyst fund will be to deliver growth to the UK life sciences sector through supporting and driving the development of innovative life sciences products and services.

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EU Grants Approval for Expanded Use of Galvus

EU Grants Approval for Expanded Use of Galvus

7 Dec 2011

Galvus is currently available for patients with no or mild renal impairment and this approval expands treatment options for patients with moderate or severe renal impairment1.

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Spectrum Submits IND Application for SPI-014

Spectrum Submits IND Application for SPI-014

6 Dec 2011

The company expects to commence Phase I studies of the drug candidate used for ESRD patients as soon as possible after FDA review.

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BIO Welcomes Senate Passage of SBIR Program Reauthorization

BIO Welcomes Senate Passage of SBIR Program Reauthorization

5 Dec 2011

SBIR grants are critical for supporting small companies with promising scientific innovation to continue critical research and development of medical advancements and breakthroughs.

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Russian Drugmakers Question Pricing Strategy

Russian Drugmakers Question Pricing Strategy

5 Dec 2011

Russian pharmaceutical industry has questioned the country's list of vital and essential drugs (ZHMVLP) that forbids price increases.

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Teva Wins Tentative Approval of Generic Lipitor

Teva Wins Tentative Approval of Generic Lipitor

2 Dec 2011

The FDA has granted tentative approval for the Company's Abbreviated New Drug Application for Atorvastatin Calcium Tablets.

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