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AstraZeneca

AstraZeneca haults COVID-19 vaccine trials after a participant’s illness

AstraZeneca haults COVID-19 vaccine trials after a participant’s illness

NEW YORK — AstraZeneca  has suspended global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant. The vaccine, developed with the University of Oxford, has been described by the World Health Organization as probably the world’s leading candidate and the most advanced in terms of

Vaccine makers sign safety pledge in race for COVID-19 vaccine

Vaccine makers sign safety pledge in race for COVID-19 vaccine

NEW YORK — According to published reports, nine drug companies pledged Tuesday that they will not submit vaccine candidates for FDA review until their safety and efficacy is shown in large clinical trials. The move is intended to bolster public confidence amid the rush to make a COVID-19 vaccine widely available, and counter fears of

AstraZeneca advances response to global COVID-19 challenge as it gets commitment for Oxford’s potential new vaccine

AstraZeneca advances response to global COVID-19 challenge as it gets commitment for Oxford’s potential new vaccine

CAMBRIDGE, U.K. — AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organizations to make the University of Oxford’s vaccine widely accessible around the world in an equitable manner. The company has concluded the first agreements for at least 400 million doses and

Farxiga approved in treatment for heart failure with reduced ejection fraction

Farxiga approved in treatment for heart failure with reduced ejection fraction

NEW YORK — AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). The approval by the Food and Drug Administration (FDA) was based

FDA approves use of Lynparza for pancreatic cancer

FDA approves use of Lynparza for pancreatic cancer

SILVER SPRING, Md. — Pancreatic cancer patients will now have a new treatment option. The Food and Drug Administration has approved the use of AstraZeneca’s  Lynparza for patients with tumors that didn’t grow after 16 weeks of chemotherapy. The drug is currently used to treat ovarian and breast cancer. Pancreatic cancer is the third largest cause

AstraZeneca releases Bydureon BCise to U.S. pharmacies

AstraZeneca releases Bydureon BCise to U.S. pharmacies

WILMINGTON, Del. — AstraZeneca announced that Bydureon BCise (exenatide extended-release injectable suspension 2 mg) is now available in pharmacies across the United States. Bydureon BCise was recently approved by the U.S. Food and Drug Administration for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral antidiabetic medicines in addition to

AstraZeneca cleared to market Fasenra biologic for asthma

AstraZeneca cleared to market Fasenra biologic for asthma

WILMINGTON, Del. — AstraZeneca plans to release Fasenra, its newly approved biologic drug for severe asthma, to U.S. pharmacies in the coming weeks. Fasenra (benralizumab), approved this week by the Food and Drug Administration, is indicated for the add-on maintenance treatment of patients ages 12 and older with severe asthma and an eosinophilic phenotype. AstraZeneca said

AstraZeneca cleared to market Bydureon BCise

AstraZeneca cleared to market Bydureon BCise

  WILMINGTON, Del. — Early next year, AstraZeneca plans to release Bydureon BCise, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector for adults with type 2 diabetes. The company said this week that it has received Food and Drug Administration approval for Bydureon BCise, indicated to improve glycemic

Aurobindo releases Nexium 24HR generic

Aurobindo releases Nexium 24HR generic

HYDERABAD, India — Aurobindo Pharma Ltd. has received Food and Drug Administration approval to manufacture over-the-counter 20-mg esomeprazole magnesium delayed-release capsules, an antacid. Aurobindo said its esomeprazole OTC product, being shipped immediately, is a generic version of Nexium 24HR capsules from Pfizer Consumer Healthcare. A proton pump inhibitor (PPI), Nexium 24HR capsules are indicated for

Camber ships generic of Crestor

Camber ships generic of Crestor

PISCATAWAY, N.J. — Camber Pharmaceuticals has released rosuvastatin tablets, a cholesterol-lowering medication. Camber said Monday that its product, a generic version of Crestor tablets from AstraZeneca Pharmaceuticals, comes in strengths of 5 mg, 10 mg, 20 mg and 40 mg. The 5-, 10- and 20-mg dosages are available in 90-count bottles, while the 40-mg dosages is

Allergan launches Crestor generic in U.S.

Allergan launches Crestor generic in U.S.

DUBLIN, Ireland — Allergan plc has received final approval from the Food and Drug Administration for rosuvastatin calcium tablets, a cholesterol-lowering medication. The company said its rosuvastatin calcium product comes in dosages of 5 mg, 10 mg, 20 mg and 40 mg and is a generic version of Crestor tablets from AstraZeneca. Allergan noted that

AstraZeneca buys Takeda respiratory business

AstraZeneca buys Takeda respiratory business

LONDON and OSAKA, Japan — AstraZeneca plans to acquire the core respiratory business of Takeda Pharmaceutical Co. Ltd. for $575 million. Under the agreement, approximately 200 Takeda staff will transfer to AstraZeneca after the closing of the transaction, expected in the first quarter of 2016. AstraZeneca said the deal will include the expansion of rights

AstraZeneca ships reduced Brilinta dosage

AstraZeneca ships reduced Brilinta dosage

WILMINGTON, Del. — AstraZeneca has released Brilinta (ticagrelor) 60-mg tablets, a smaller dose of the anticoagulant medication, to U.S. pharmacies. The pharmaceutical company said Tuesday that the Food and Drug Administration approved the new 60-mg strength for Brilinta for use in patients with a history of heart attack beyond the first year. The dosing of