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EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

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Novartis wins EU approval for blood cancer therapy Kymriah

Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.

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FDA Rejects Allergan’s Uterine Fibroid Treatment Following EMA Concerns Over Liver Damage

The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for ulipristal acetate.

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Toxin at heart of drug recall shows holes in medical safety net

A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

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EU says second China company made tainted heart drug

The European Medicines Agency said a second Chinese contract manufacturer, Zhejiang Tianyu, produced a common blood pressure and heart drug with an impurity that could cause cancer.

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JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer

JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.

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European Committee Recommends Approval For Alnylam’s Rare Disease Drug

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a Positive Opinion over Alnylam Pharmaceuticals’ patisiran for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy.

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GSK’s severe pediatric asthma drug wins European panel thumbs-up

GlaxoSmithKline’s Nucala won a key recommendation from a European Medicines Agency panel for use in the treatment of children with severe asthma.

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AstraZeneca’s key lung cancer drug wins European panel thumbs-up

AstraZeneca’s cancer drug Imfinzi won a key recommendation from a European Medicines Agency (panel less than six months after the first global approvals in Western markets.

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Puma breast cancer drug likely to win EU approval

Puma Biotechnology said a European Medicines Agency committee was likely to give a positive opinion on its breast cancer drug neratinib five months after the regulator recommended against it.

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European Medicines Agency to review Sanofi-Regeneron’s Dupixent, Cemiplimab

The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said.

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Janssen Submits MAA for Apalutamide

J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.

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Novo Nordisk wins EU panel’s backing for key diabetes drug

Novo Nordisk came closer to winning European approval for the company’s diabetes drug Ozempic, the Danish drugmaker’s largest growth prospect, when a European Medicines Agency experts’ panel issued a positive recommendation.

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UK approves world’s first OTC Viagra

Pfizer’s big-selling erectile dysfunction drug Viagra was given a green light for sale without a prescription in Britain, the first country to grant it over-the-counter status.

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Novartis seeks EU approval for cell therapy Kymriah

Novartis submitted its cell therapy Kymriah for European approval in two forms of blood cancer, seeking to expand the use of the new treatment.

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EU drugs head fears delays, health hazards as agency uprooted

Access to new medicines and safety checks on existing treatments will be jeopardized if politicians pick a new home for Europe’s London-based drugs regulator that is unacceptable to staff, its executive director told Reuters.

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Roche receives EU approval for Gazyvaro, Actemra

Roche received European approval for its Actemra medication in giant cell arteritis (GCA) and Gazyvaro for people with previously untreated advanced follicular lymphoma.

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Merck KGaA, Pfizer’s cancer drug Bavencio gets EU nod

European regulators granted market approval for Merck KGaA and Pfizer’s immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.

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Biosimilar version of Humira approved in Europe

A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.

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EU approves breast cancer drug Kisqali

Novartis AG’s Kisqali (ribociclib) received European Union approval as first-line treatment for a tough-to-treat breast cancer.

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