Pharmaceuticals

U.S. Food and Drug Administration Approves AstraZeneca Farxiga Tablets

U.S. Food and Drug Administration Approves AstraZeneca Farxiga Tablets

The U.S. Food and Drug Administration review team has approved Farxiga (dapaglifozin) tablets to enhance glycemic control with diet and exercise in adults suffering from type 2 diabetes.

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U.S. FDA Rejects Sanofi’s MS Treatment Drug, Lemtrada

U.S. FDA Rejects Sanofi’s MS Treatment Drug, Lemtrada

Sanofi arm Genzyme announced that it has failed to get approval for launch of its multiple sclerosis drug, Lemtrada, by the U.S. regulatory authority FDA. This failure has put a halt on company’s ambitions to grab a larger share of $20 billion market for the disease treatment in United States.

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Contraceptive Patch from Actavis Plc Rejected by FDA

Contraceptive Patch from Actavis Plc Rejected by FDA

US FDA has rejected the New Drug Application for transdermal contraceptive patch for women by Actavis Plc. The US regulator has asked the company to provide more data to support the claims for the patch. Ireland-based generic drug market Actavis said that the company will closely work with FDA and address their concerns.

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Pharmacy to Pay $100 Million to Meningitis Victims

Gov. Deval Patrick: Pharmacy to Pay $100 Million to Meningitis Victims

The owners of bankrupt Compounding Pharmacy Inc. of Framingham, Massachusetts and the insurers have agreed to pay compensation to victims of the fungal meningitis outbreak due to faulty injections. It has been reported that this steroid caused a meningitis outbreak among 20 patients in United States.

According to latest news reports, in order to resolve this issue, the company has announced a preliminary settlement on Monday. It has been reported that the company will pay more than $100 million to compensate victims, who suffered because of steroid injections.

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U.S. Food and Drug Administration Approves Novo Nordisk's drug Tretten

U.S. Food and Drug Administration Approves Novo Nordisk's drug Tretten

On Monday, the U.S. Food and Drug Administration revealed that it has approved the use of Novo Nordisk's drug named Tretten. The drug is used to prevent bleeding in people who suffer from a rare blood clotting disorder.

The body of patients, who suffer from congenital Factor XIIIA-subunit deficiency, is not capable of making sufficient amount Factor XIII protein. This protein is essential in case of normal blood clotting. Factor XIII is made up of subunits A and B. The deficiency of Factor XIII is usually caused because of lack of the A subunit.

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Tesaro Drug Rolapitant Shows Positive Results in Late-State Trials

Tesaro Drug Rolapitant Shows Positive Results in Late-State Trials

Tesaro Inc. informed success in late stage trial of drug rolapitant, which can help patients receiving chemotherapy causing nausea and vomiting. Phase 3 trial of patient receiving moderately Emetogenic Chemotherapy (MEC) has shown positive results. The biopharmaceutical major with focus on oncology said that investigational neurokinin-1 drug rolapitant was carried out internationally on 1,369 cancer patients receiving MEC treatment.

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FDA Approves Ariad Pharmaceuticals Cancer Drug Iclusig

FDA Approves Ariad Pharmaceuticals Cancer Drug Iclusig

Ariad Pharmaceuticals Inc. cancer drug Iclusig has been approved by US FDA after the company will have restrictive drug labels and will reveal more information on the safety risks to patients. The company was forced in October by FDA to stop selling leukemia drug in United States. The reason for sales halt was increased risk of blood clots and higher heart failures among patients.

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Merck Recalls Gardasil HPV Vaccine Batch

Merck Recalls Gardasil HPV Vaccine Batch

Pharmaceutical major Merck has issued voluntary recall of HPV vaccine Gardasil vaccine due to fears of contamination of vials with glass particles. The company said that only 10 vials among 743,360 total of the lot (lot no. J007354) could have been affected during the manufacturing process.

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Vertex Pharmaceuticals Cystic Fibrosis Drug Misses Phase 3 Trials

Vertex Pharmaceuticals Cystic Fibrosis Drug Misses Phase 3 Trials

Vertex Pharmaceuticals Inc. informed that the phase 3 trial of cystic fibrosis drug ivacaftor (sold under trade name Kalydeco) has not generated desirable results. The study involved 69 persons with cystic fibrosis due to presence of R117H gene mutation.

The company informed that it will meet US FDA regarding the submission of drug for people having R117H gene mutation in early 2014. The company still has two separate studies underway.

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PIC Pauses CFS's Bid For Adcock

PIC Pauses CFS's Bid For Adcock

According to a latest report, a bid by Chile's CFR Pharmaceuticals has stalled recently due to a heated and very public exchange between CFR and the Public Investment Corporation (PIC).

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