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Pharmaceutical Business Review

US House passes $1.1bn bill to fight Zika virus The US House of Representatives has approved a bill to provide $1.1bn funding to combat the mosquito-borne Zika virus. Drug Research > Drug Delivery > News
Antares Pharma announces settlement of patent litigation for key alliance business product By PBR Staff Writer
Antares Pharma announced that Teva Pharmaceuticals USA, Inc. has settled the patent litigation with AstraZeneca Pharmaceuticals LP, AstraZeneca AB and Amylin Pharmaceuticals, LLC (AstraZeneca) relating to AstraZeneca’s US Patent Nos. 6,858,576, 6,872,700, 6,956,026, 7,297,761, 6,902,744, 7,521,423, and 7,741,269 and AstraZeneca’s BYETTA® (exenatide).
News Boston Biomedical gets orphan drug designation for Napabucasin in gastric/GEJ cancer By PBR Staff Writer
Boston Biomedical announced that its lead investigational compound, napabucasin, has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in the treatment of gastric cancer, including gastroesophageal junction (GEJ) cancer
News NICE issues preliminary decision not to recommend Tagrisso for locally advanced or metastatic lung cancer By PBR Staff Writer
AstraZeneca announced that the National Institute for Health and Care Excellence (NICE) published an Appraisal Consultation Document (ACD) for Tagrisso™ (osimertinib), a medicine recognised internationally and in the UK as an innovative, effective medicine for a subset of patients with non-small cell lung cancer (NSCLC).
News
Incyte secures FDA breakthrough therapy for ruxolitinib to treat acute GVHD Incyte has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its ruxolitinib (Jakafi) JAK1/JAK2 inhibitor to treat patients with acute graft-versus-host disease (GVHD).
Production & Manufacturing > Process & Production > News US authorities recommended against AstraZeneca’s flu vaccine Quadrivalent By PBR Staff Writer
The Advisory Committee on Immunization Practices (ACIP) of US Centers for Disease Control and Prevention (CDC) has recommended not to use live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine during the 2016-2017 flu season.
Drug Research > Drug Delivery > News US House passes $1.1bn bill to fight Zika virus By PBR Staff Writer
The US House of Representatives has approved a bill to provide $1.1bn funding to combat the mosquito-borne Zika virus.
Drug Research > Drug Delivery > News

Latest News and Insight by Sector

Production & Manufacturing

Incyte secures FDA breakthrough therapy for ruxolitinib to treat acute GVHD
Incyte has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its ruxolitinib (Jakafi) JAK1/JAK2 inhibitor to treat patients with acute graft-versus-host disease (GVHD).
Production & Manufacturing > Process & Production > News
FDA grants orphan drug status to Anavex 2-73 to treat infantile spasms
By PBR Staff Writer
Biopharmaceutical firm Anavex Life Sciences has secured US orphan drug status for Anavex 2-73 to treat infantile spasms.
Production & Manufacturing > Process & Production > News

Drug Research

US authorities recommended against AstraZeneca’s flu vaccine Quadrivalent
By PBR Staff Writer
The Advisory Committee on Immunization Practices (ACIP) of US Centers for Disease Control and Prevention (CDC) has recommended not to use live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine during the 2016-2017 flu season.
Drug Research > Drug Delivery > News
US House passes $1.1bn bill to fight Zika virus
By PBR Staff Writer
The US House of Representatives has approved a bill to provide $1.1bn funding to combat the mosquito-borne Zika virus.
Drug Research > Drug Delivery > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

TB Alliance, Takeda partner to investigate novel compounds for tuberculosis treatment
The Global Alliance for TB Drug Development (TB Alliance) and Takeda Pharmaceutical Company have entered into an agreement that further explores hits generated from a high-throughput screening program conducted to find novel compounds to improve treatment of tuberculosis (TB).
Contract Research & Services > Contract Research > News
Dimension gets National Institutes of Health Panel’s approval for phase 1/2 study of DTX301
By PBR Staff Writer
Dimension Therapeutics has secured approval from the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) for a phase 1/2 study protocol for DTX301 to treat Ornithine Transcarbamylase (OTC) deficiency.
Contract Research & Services > Clinical Trials > News

Automation

Pfizer selects Oracle Cloud for clinical data management and trial management
Pfizer has selected Oracle Cloud for clinical data management and trial management across its clinical trial portfolio.
Automation > IT & Software > News
Virtual reality smartphone app provides glimpse into life with dementia
An innovative virtual reality smartphone app – A Walk Through Dementia – will launch at a three-day public installation at St Pancras International Station from 2 June.
Automation > IT & Software > News

Regulatory Affairs

Perrigo secures FDA approval for generic version of Ofirmev acetaminophen injection
Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev (acetaminophen) injection 1000 mg/100 mL.
Regulatory Affairs > News
FDA approves expanded label for emphysema treatment Glassia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded label for self-infusion of Glassia to treat emphysema due to serious Alpha-1 Antitrypsin (AAT) deficiency.
Regulatory Affairs > News



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