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Hospira Announces U.S. Launch of Generic Bivalirudin for Injection

LAKE FOREST, Ill., July 16, 2015 /PRNewswire/ — Hospira, Inc. (NYSE: HSP), the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today announced it had obtained U.S. Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company’s Angiomax™. Branded […]

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India’s top court seeks review of drug pricing policy

India’s Supreme Court has asked the federal government to reexamine its pricing policy for essential medicines after a group of non-governmental organizations challenged the provisions, a lawyer involved in the case said. The Supreme Court labeled the formula by which prices of essential medicines are currently being fixed in India as “unreasonable and irrational”, the […]

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With One Billion Prescriptions, UnitedHealth Prescribes Future PBM Growth

UnitedHealth Group (UNH), buoyed by growth potential of its expanding pharmacy benefit business, raised its earnings outlook with the coming addition of a much larger drug management operation. The nation’s largest health insurer raised its net earnings outlook for 2015 to between $6.25 to $6.35 per share, up from $6.15 to $6.30, thanks to new […]

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Your Google Searches May Help the FDA Find Drug Side Effects

The Food and Drug Administration is talking to Google about how the search engine could help the agency identify previously unknown side effects of medications. Agency officials held a conference call on June 9 with a senior Google researcher who co-wrote a 2013 paper about using search query data to identify adverse drug reactions, according […]

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Swedish Orphan Biovitrum Exercises Opt-In Right For Alprolix

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Alprolix is a recombinant factor IX Fc fusion protein product candidate […]

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Celgene Swallows Up SoCal’s Receptos in $7.2 Billion Deal

July 14, 2015By Alex Keown, BioSpace.com Breaking News Staff SUMMIT, N.J. – Celgene Corporation (CELG) has struck again, acquiring Receptos, Inc. (RCPT) for $7.2 billion to enhance the company’s inflammation and immunology portfolio. The acquisition was announced Tuesday afternoon. The acquisition brings some key drugs into Celgene’s pipeline, including Ozanimod, an oral once-daily, selective sphingosine […]

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AstraZeneca lung cancer drug approved as first-line treatment

The U.S. Food and Drug Administration approved AstraZeneca Plc’s drug, Iressa, as a first-line treatment for a common form of lung cancer. The FDA said on Tuesday the approval was based on results from a trial of 106 patients with previously untreated non-small cell lung cancer. (1.usa.gov/1Sjw5eo) The drug was previously approved for use only […]

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Anacor skin cream succeeds in studies, fuels takeover expectations

Anacor Pharmaceuticals Inc’s experimental skin ointment succeeded in late-stage studies, taking the drugmaker a step closer to having a potential blockbuster in its portfolio and raising expectations that it could be taken over. The company’s shares, which have more than quadrupled in the past year up to Friday’s close, rose more than 50 percent on […]

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Genentech’s Breakthrough Atezolizumab Joins Club of Successful Anti-PD-L1 Drugs, Shrinks Tumors in Bladder Cancer

July 13, 2015By Mark Terry, BioSpace.com Breaking News Staff South San Francisco, Calif.-based Genentech (RHHBY) announced positive results today for its urothelial bladder cancer (UBC) drug atezolizumab, or MPDL3280A. On Feb. 2, 2015, the U.S. Food and Drug Administration (FDA) granted the drug a second Breakthrough Designation. The drug, a monoclonal antibody that interferes with […]

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Otsuka Pharma, H. Lundbeck A/S Beat Competitors With FDA Approval of Schizophrenia Drug

TOKYO & VALBY, Denmark–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI® (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia. REXULTI was discovered by Otsuka and […]

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