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Pharmaceutical Business Review

Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study. Contract Research & Services > Clinical Trials > News
FDA extends review period by three months for rheumatoid arthritis candidate baricitinib By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months for investigational rheumatoid arthritis treatment, Baricitinib.
Production & Manufacturing > Process & Production > News Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study By PBR Staff Writer
Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
Contract Research & Services > Clinical Trials > News Heron submits CINVANTI NDA to FDA for CINV prevention Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Production & Manufacturing > Process & Production > News
Clinical-stage biopharmaceutical firm OncoImmune raises $15m funding OncoImmune, a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases, has secured $15m in Series A round of fundraising led by 3E Bioventures Capital.
Drug Research > Drug Discovery & Development > News FDA grants QIDP status for RedHill's RHB-104 to treat nontuberculous mycobacteria infections By PBR Staff Writer
RedHill Biopharma has secured the Qualified Infectious Disease Product (QIDP) fast-track designation from the US Food and Drug Administration (FDA) for its candidate RHB-104 to treat nontuberculous mycobacteria (NTM) infections.
Production & Manufacturing > Process & Production > News Novartis to commence phase 2 trial with bimagrumab in obese patients with type 2 diabetes MorphoSys said its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients having type 2 diabetes.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

FDA extends review period by three months for rheumatoid arthritis candidate baricitinib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months for investigational rheumatoid arthritis treatment, Baricitinib.
Production & Manufacturing > Process & Production > News
Heron submits CINVANTI NDA to FDA for CINV prevention
Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Production & Manufacturing > Process & Production > News

Drug Research

Clinical-stage biopharmaceutical firm OncoImmune raises $15m funding
OncoImmune, a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases, has secured $15m in Series A round of fundraising led by 3E Bioventures Capital.
Drug Research > Drug Discovery & Development > News
Merck expands oncology portfolio with four Vertex cancer programs
By PBR Staff Writer
Merck has agreed to license four oncology research and development (R&D) programs from Vertex Pharmaceuticals.
Drug Research > Drug Discovery & Development > 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

Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study
By PBR Staff Writer
Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
Contract Research & Services > Clinical Trials > News
Novartis to commence phase 2 trial with bimagrumab in obese patients with type 2 diabetes
MorphoSys said its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients having type 2 diabetes.
Contract Research & Services > Clinical Trials > News

Automation

Pfizer, IBM partner to advance immuno-oncology research
By PBR Staff Writer
Pharmaceutical major Pfizer and technology giant IBM have partnered to accelerate immuno-oncology research.
Automation > IT & Software > News
Menarini-Silicon’s DEPArray technology aids researchers in lung cancer study
Menarini-Silicon Biosystems said its DEPArray single-cell isolation technology played an important role in a study carried out by researchers from The University of Manchester to develop a model for predicting whether small-cell lung cancer patients will be sensitive or resistant to initial chemo­therapy treatment.
Automation > IT & Software > News

Regulatory Affairs

Gilead gets European approval for hepatitis B drug Vemlidy
Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Regulatory Affairs > News
FDA grants orphan drug status for Sangamo’s SB-318 genome editing treatment for MPS I
Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).
Regulatory Affairs > News



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