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Pharmaceutical Business Review

Dicerna begins Phase I trial of DCR-MYC to treat solid tumors, hematological malignancies US-based biopharmaceutical firm Dicerna Pharmaceuticals has started a Phase I dose-escalating clinical trial of its drug candidate DCR-MYC, (also known as DCR-M1711), in patients with solid tumors, multiple myeloma, or lymphoma. Drug Research > Drug Delivery > News
FDA, European Commission grant orphan drug status to Boehringer's volasertib By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Commission (EC) have granted orphan drug designation for Germany-based Boehringer Ingelheim's volasertib to treat patients with acute myeloid leukaemia (AML), an aggressive cancer of the bone marrow and blood.
Regulatory Affairs > News Impax introduces Renvela for patients with chronic kidney disease By PBR Staff Writer
Impax Laboratories has started shipment of authorized generic Renvela (sevelamer carbonate 800mg tablets), through its generics division Global Pharmaceuticals.
Production & Manufacturing > Manufacturing > News Islet Sciences reports results from two Phase IIb clinical studies for type 2 diabetics drug By PBR Staff Writer
Islet Sciences and BHV Pharma have reported positive data from the two 12-week Phase IIb clinical studies of SGLT2 inhibitor remogliflozin etabonate in type 2 diabetics.
Drug Research > Drug Discovery & Development > News
Kyowa Hakko begins Phase III trial of asthma drug benralizumab in Japan By PBR Staff Writer
Japan-based Kyowa Hakko Kirin has started a Calima, one of several trials in the Phase III program for benralizumab, and also plans to initiate Sirocco, another Phase III trial in South Korea.
Contract Research & Services > Clinical Trials > News OxThera secures $10m investment to continue clinical programs By PBR Staff Writer
Swedish biopharmaceutical firm OxThera has received SEK70m ($10m) from a syndicate of new investors, led by Kurma Partners, including IdInvest Partners and Mayo Clinic, to continue its major clinical programs.
Drug Research > Drug Discovery & Development > News Astellas, MSD launch Suglat tablets in Japan to treat type 2 diabetes By PBR Staff Writer
Japanese pharmaceutical firm Astellas Pharma and MSD K.K., a subsidiary of Merck, have introduced the selective SGLT2 (Sodium-Glucose Co-Transporter 2) inhibitor Suglat tablets 25mg and 50mg in Japan for the treatment of type 2 diabetes.
Production & Manufacturing > Manufacturing > News

Latest News and Insight by Sector

Production & Manufacturing

Impax introduces Renvela for patients with chronic kidney disease
17 April 2014 | By PBR Staff Writer
Impax Laboratories has started shipment of authorized generic Renvela (sevelamer carbonate 800mg tablets), through its generics division Global Pharmaceuticals.
Production & Manufacturing > Manufacturing > News
Astellas, MSD launch Suglat tablets in Japan to treat type 2 diabetes
17 April 2014 | By PBR Staff Writer
Japanese pharmaceutical firm Astellas Pharma and MSD K.K., a subsidiary of Merck, have introduced the selective SGLT2 (Sodium-Glucose Co-Transporter 2) inhibitor Suglat tablets 25mg and 50mg in Japan for the treatment of type 2 diabetes.
Production & Manufacturing > Manufacturing > News

Drug Research

Islet Sciences reports results from two Phase IIb clinical studies for type 2 diabetics drug
17 April 2014 | By PBR Staff Writer
Islet Sciences and BHV Pharma have reported positive data from the two 12-week Phase IIb clinical studies of SGLT2 inhibitor remogliflozin etabonate in type 2 diabetics.
Drug Research > Drug Discovery & Development > News
OxThera secures $10m investment to continue clinical programs
17 April 2014 | By PBR Staff Writer
Swedish biopharmaceutical firm OxThera has received SEK70m ($10m) from a syndicate of new investors, led by Kurma Partners, including IdInvest Partners and Mayo Clinic, to continue its major clinical programs.
Drug Research > Drug Discovery & Development > News

Inward Investment

Amgen to buy Onyx Pharmaceuticals for $10.4bn
26 August 2013 | By PBR Staff Writer
Biotechnology company Amgen has reached a deal to buy all outstanding shares of California-based Onyx Pharmaceuticals for $125 per share in cash.
Inward Investment > News
Johnson & Johnson completes purchase of Aragon Pharmaceuticals
20 August 2013 | By PBR Staff Writer
Johnson & Johnson has completed the acquisition of Aragon Pharmaceuticals, a pharmaceutical discovery and development company focused on drugs to hormonally-driven cancers.
Inward Investment > News

Packaging

Biologics adds frozen storage capabilities to clinical research services
30 October 2013 | By PBR Staff Writer
Biologics’ Clinical Research Services has announced the addition of frozen storage capabilities to its state-of-the-art facilities and cold-chain packaging and distribution.
Packaging > News
ATMI, D-Lab launch new Sterile Pyrofree vials
19 September 2013 | By PBR Staff Writer
US-based technology firm ATMI in partnership with Disposable Lab (D-Lab), a French contract-manufacturing company, has launched a line of pyrogen-free vials in order to meet biopharmaceutical filling and final packaging needs.
Packaging > News

Contract Research & Services

Kyowa Hakko begins Phase III trial of asthma drug benralizumab in Japan
17 April 2014 | By PBR Staff Writer
Japan-based Kyowa Hakko Kirin has started a Calima, one of several trials in the Phase III program for benralizumab, and also plans to initiate Sirocco, another Phase III trial in South Korea.
Contract Research & Services > Clinical Trials > News
AMRI realigns discovery and development services to support customer demand
17 April 2014
Albany Molecular Research (AMRI) has announced that it will be transitioning Discovery and Development Services (DDS) activities at its Syracuse, New York site to other sites within AMRI and will cease operations in Syracuse by the end of June 2014.
Contract Research & Services > Contract Services > News

Automation

RainTree launches new cloud-based analytics portal for pharmaceutical industry
16 April 2014 | By PBR Staff Writer
RainTree Oncology Services and Information Builders have launched OncoExplorer, a new cloud-based analytics portal that offers unprecedented decision-support capabilities to pharmaceutical companies.
Automation > IT & Software > News
Surrey Clinical Research Centre signs five year agreement for OmniComm Systems' Promasys
15 April 2014
OmniComm Systems has announced the signing of a five year agreement for its Promasys investigator initiated trials (IITs) technology with Surrey Clinical Research Centre (Surrey CRC) at the University of Surrey, a UK based research center focused on the design and execution of Phase I and IIa trials in sleep, psychopharmacology, oncology, immunology and vaccines.
Automation > IT & Software > News

Regulatory Affairs

FDA, European Commission grant orphan drug status to Boehringer's volasertib
18 April 2014 | By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Commission (EC) have granted orphan drug designation for Germany-based Boehringer Ingelheim's volasertib to treat patients with acute myeloid leukaemia (AML), an aggressive cancer of the bone marrow and blood.
Regulatory Affairs > News
FDA accepts NDA for combination drug to treat type 2 diabetes
15 April 2014 | By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for Boehringer Ingelheim and Eli Lilly's investigational combination tablet of empagliflozin and linagliptin to treat adults with type 2 diabetes (T2D).
Regulatory Affairs > News

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