Mylan has confirmed that it and several subsidiaries have been sued by several Baxter subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Esmolol HCl in Sodium Chloride Injection.
Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...
Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will...
BMS and Five Prime Therapeutics to Evaluate Investigational Immunotherapies Opdivo and FPA008 in Six Tumor TypesNovember 24, 2014 4:09 pm | News | Comments
Bristol-Myers Squibb Company and Five Prime Therapeutics have entered into an exclusive clinical...
Amgen is ending late-stage trials of its gastric cancer treatment rilotumumab because patients who took the drug were more likely to die. Amgen said more patients died after treatment with rilotumumab and chemotherapy than with chemotherapy alone.
AstraZeneca has announced plans to expand its biologics manufacturing center in Frederick, Md. The more than $200M project will increase production capacity at the facility to support AstraZeneca’s maturing pipeline, and will help position the company to keep pace with a growing demand for the development and use of biologics, which currently represent nearly 50% of AstraZeneca’s overall pipeline.
Merck and NewLink Genetics Corporation have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.
A New York couple who said Botox treatment of their son's cerebral palsy left him with life-threatening complications and sued its manufacturer won a $6.75 million verdict from a federal jury on Thursday.
Shire has announced plans to relocate over 500 positions to Massachusetts from its Chesterbrook, Pennsylvania site and establish Lexington, Massachusetts as the company's U.S. operational headquarters. The transition is a continuation of the company's 'One Shire' efficiency program and will streamline business globally through two principal locations - Massachusetts and Switzerland.
Knight Therapeutics today announced the sale of its Neglected Tropical Disease Priority Review Voucher ("PRV"). Knight will receive US$125 million in cash from Gilead Sciences, Inc. in exchange for the PRV.
A major study lifts a cloud around Zetia and Vytorin, blockbuster drugs for lowering cholesterol. The study found that these pills modestly lower the risk of heart attacks and other problems in people at high risk for them — evidence that's been missing for more than a decade as the drugs racked up billions in sales.
Clovis Oncology has entered into a clinical trial collaboration with GlaxoSmithKline to evaluate a novel combination therapy targeting mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).
Actavis will pay $66 billion to buy fellow drugmaker Allergan in a deal that could finally stop a months-long takeover push from Valeant Pharmaceuticals for the Botox maker.
Zoetis today announced an agreement to purchase animal health assets of Abbott for a purchase price of $255 million. Abbott Animal Health is a companion animal health business focused on the veterinary surgical suite.
Bristol-Myers Squibb Company has announced plans to construct a new state-of-the-art, large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland, that will produce multiple therapies for the company’s growing biologics portfolio.
The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.
Merck announced today that it has entered into a global agreement with Pfizer to co-develop and co-commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck as a potential treatment for multiple tumor types to accelerate the two companies’ presence in immuno-oncology.
Shares of Allergan jumped in premarket trading Monday after several reports surfaced over the weekend that specialty drugmaker Actavis was preparing to buy the maker of Botox, which is embroiled in a takeover battle with Valeant Pharmaceuticals.
Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
Isis Pharmaceuticals and AstraZeneca today announced a strategic alliance to discover and develop novel delivery methods for antisense oligonucleotides. The new delivery approaches seek to target the desired tissue more effectively. The agreement builds on an existing collaboration between AstraZeneca and Isis Pharmaceuticals.
AstraZeneca has begun a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452, to rapidly and specifically reverse the antiplatelet effects of ticagrelor in rare emergency situations such as urgent surgery, or in the event of major bleeding.
Scientists have discovered some rare gene mutations that give people naturally lower cholesterol levels and cut their risk of heart disease in half. The news is of great interest because a drug that mimics these mutations has long been sold without evidence that it cuts the chance of heart disease, even though it lowers cholesterol.
Missouri House Speaker Tim Jones on Wednesday created a committee of lawmakers to review allegations that Attorney General Chris Koster has been influenced by lobbyist perks and campaign contributions.
AstraZeneca and Amgen today announced that AMAGINE-3TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12
Allergan today announced that its Board of Directors has approved amendments to the company’s bylaws that streamline the process associated with calling a special meeting of stockholders. The Board determined to amend the bylaws after meetings with many of the Company’s major stockholders and other governance organizations to solicit their input and perspectives.
GE Healthcare and Takeda Pharmaceutical Company announced that they have entered into an alliance agreement for research and development in the field of hepatic fibrosis, a key factor in the diagnosis and treatment of liver diseases.
Dendreon is seeking Chapter 11 bankruptcy protection and has reached a financial restructuring agreement with investors holding more than $520 million in debt. The Seattle company listed more than $664 million in total debts and $364.6 million in assets in a U.S. Bankruptcy Court filing on Monday.
AstraZeneca has entered into a definitive agreement with Aegerion Pharmaceuticals, Inc. to divest Myalept™ (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy.
Isis Pharmaceuticals has earned a $7.5 million milestone payment, the first of two milestone payments totaling $15 million, from AstraZeneca for the advancement of ISIS-STAT3Rx, also referred to as AZD9150, in patients with advanced cancers.
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