Pharmaceuticals

Generic Versions of Contraceptive Pills can be Sold without Age Restrictions, Says FDA

Generic Versions of Contraceptive Pills can be Sold without Age Restrictions, Sa

An increase in access to use of generic versions of most popular form of emergency contraceptive pill, Plan B One Step, has been proposed by the US government’s Food and Drug Administration (FDA). The organization has decided to allow the sale of morning after pill over the counter without having any age restrictions.

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Increase in Shares of InterMune on Success of Pirfenidone to Treat IPF

Increase in Shares of InterMune on Success of Pirfenidone to Treat IPF

Success of the InterMune Inc. lead drug Pirfenidone has given support to the stock. The rise in shares of the company after the positive announcement more than doubled the market capital of the company. The stock ended at $37.80 in New York. The drug has been successful in reducing progression of fatal lung diseases in the late stage trial, making its base for the US FDA approval.

With the success of the drug, the Company is planning to file for US clearance of this drug in third quarter of 2014. The drug was rejected by the US regulatory authority in May, 2010.

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Bristol-Myers Body Fat Drug Myalept Approved by FDA

Bristol-Myers Body Fat Drug Myalept Approved by FDA

The U.S. Food and Drug Administration has approved rare body fat drug Myalept application by Bristol-Myers Squibb. The metabolic disorder causes very low level of body fat and can further cause diabetes. Generalized lipodystrophy caused very low levels of leptin which is essential to regulate food intake.

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Pfizer Prevnar 13 Shows Impressive Results in Post-approval Study

Pfizer Prevnar 13 Shows Impressive Results in Post-approval Study

Pfizer Inc has reported successful results for pneumonia drug Prevnar 13 in a large study conducted on 85,000 patients. The vaccine protects against Streptococcus pneumoniae bacteria infection in children and adults over 65 years of age.

The drug trial involving 85,000 patients, termed as CAPiTA, has shown impressive results for community-acquired pneumonia. More than 300,000 adults over 50 years of age are hospitalized for treatment of pneumococcal pneumonia every year. The company announced that Prevnar 13 has met the targets in post-approval study conducted in the Netherlands.

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FDA Commissioner signs ‘Statement of Intent’ with Indian Drug Regulator

FDA Commissioner signs ‘Statement of Intent’ with Indian Drug Regulator

The U.S. Food and Drug Administration will employ more resources on monitoring the drugs imported to the country by Indian pharmaceutical majors. The FDA Commissioner Dr. Margaret Hamburg visited India recently and signed a non-binding ‘statement of intent’ with Indian drug regulator.

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Agila Specialties Recalls Etomidate Injection

Agila Specialties Recalls Etomidate Injection

Mylan Inc. subsidiary Agila Specialties has initiated nationwide recall of Etomidate injection manufactured at pharmaceutical facility in Warsaw, Poland. The company first informed about the recall on February 13.

The injections have possibility of containing small black particles. The intravenous administration of Etomidate could lead to infection, embolism or phlebitis. The injections are used for the induction of general anesthesia. The injections were marketed by Pfizer.

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Adcock Ingram Chairman Resigns

Adcock Ingram Chairman Resigns

Adcock Ingram holdings Chairman Khotso Mokhele resigned due to pressure from Bidvest and PIC. The biggest investors in the company demanded the resignation yesterday. Bidvest and PIC also asked for reconstitution of the board of directors.

Bidvest CEO Brian Joffe is expected to be the new chairman of Adcock Ingram Holdings. Also, as per directions of Bidvest, Mr Lindsay Peter Ralphs, Dr Anna Mokgokong and Mr Roshan Morar are expected to join the board.

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FDA Approves Northera from Chelsea Therapeutics

FDA Approves Northera from Chelsea Therapeutics

U.S. Food and Drug Administration has approved blood pressure drug Northera (droxidopa) for symptomatic neurogenic orthostatic hypotension (NOH) treatment. The condition is rare but causes debilitating drop in blood pressure. FDA panel voted 16-1 in favor of Northera.

The treatment options for patients suffering from NOH are very limited. The treatment approved by FDA will be applicable in cases of orthostatic dizziness, lightheadedness, blurred vision and ‘feeling of black out’. As per Chelsea records, there are 80,000 to 140,000 patients in the United States.

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FDA Raises Safety and GMP Issue for “Made in India’ Drugs

FDA Raises Safety and GMP Issue for “Made in India’ Drugs

US FDA raised alarm over drugs manufactured at Indian facilities of many Indian and multinational pharmaceutical majors. India is one of the largest exporters of drugs to US market. FDA teams have inspected many local pharmaceutical plants in India to ensure the safety of drugs exported from the country.

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FDA Approval for BioMarin’s Vimizim

FDA Approval for BioMarin’s Vimizim

US FDA has approved genetic disorder BioMarin Pharmaceutical Morquio A Syndrome drug Vimizim as per company statement filed on Friday. The rare genetic disorder drug will come with a warning of allergic reactions in some patients.

As per official FDA release, the first even approved treatment for Mucopolysaccharidosis Type IVA has been approved after the drug was found effective in clinical trials. The company estimates nearly 800 people suffering from rare genetic condition in United States.

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