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Pharmaceutical Business Review

Celgene strengthens I&I portfolio with $7.2bn Receptos acquisition US-based biotechnology firm Celgene has expanded its inflammation and immunology (I&I) portfolio with the acquisition of Receptos for around $7.2bn. Production & Manufacturing > Manufacturing > News
WuXi PharmaTech's STA subsidiary gets first approval from Japanese regulatory authorities WuXi PharmaTech (Cayman), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, announced that its small-molecule process development and manufacturing subsidiary Shanghai SynTheAll Pharmaceutical (STA) received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug in July.
Contract Research & Services > Contract Research > News Horizon Pharma gets USPTO issuance of additional notice of allowance with claims covering Pennsaid 2% Horizon Pharma received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/705,636 (US publication number 2015-0231263), entitled 'Diclofenac Topical Formulation' that covers Horizon's US approved product PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).
Production & Manufacturing > Process & Production > News Symbiomix completes enrollment in second pivotal trial of SYM-1219 for bacterial vaginosis Symbiomix announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV).
Contract Research & Services > Clinical Trials > News
Soligenix gets additional NIAID funding to advance development of OrbeShield in GI ARS Soligenix (SNGX), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP).
Drug Research > Drug Discovery & Development > News Minerva licenses Sendai Virus technology for stem cell generation Minerva Biotechnologies and ID Pharma (formerly DNAVEC) announced that they have signed an agreement granting Minerva worldwide rights to use and commercialize their non-integrating Sendai virus vectors, together with Minerva’s proprietary technology, for generating Induced Pluripotent Stem (iPS) cells.
Automation > IT & Software > News Sucampo launches tender to buy R-Tech Ueno for $278m By PBR Staff Writer
US-based Sucampo Pharmaceuticals has launched an all-cash tender offer through its Japanese subsidiary to acquire Japan-based pharmaceutical company R-Tech Ueno for around JPY33bn ($278m).
Production & Manufacturing > Manufacturing > News

Latest News and Insight by Sector

Production & Manufacturing

Horizon Pharma gets USPTO issuance of additional notice of allowance with claims covering Pennsaid 2%
Horizon Pharma received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/705,636 (US publication number 2015-0231263), entitled 'Diclofenac Topical Formulation' that covers Horizon's US approved product PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).
Production & Manufacturing > Process & Production > News
Sucampo launches tender to buy R-Tech Ueno for $278m
By PBR Staff Writer
US-based Sucampo Pharmaceuticals has launched an all-cash tender offer through its Japanese subsidiary to acquire Japan-based pharmaceutical company R-Tech Ueno for around JPY33bn ($278m).
Production & Manufacturing > Manufacturing > News

Drug Research

Soligenix gets additional NIAID funding to advance development of OrbeShield in GI ARS
Soligenix (SNGX), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP).
Drug Research > Drug Discovery & Development > News
Symic Biomedical gets $1.5m NIH Phase II SBIR grant to develop proteoglycan mimetic therapeutics
Platform therapeutic company Symic Biomedical (Symic) announced that it has received a $1.5m Phase II SBIR grant from the National Institutes of Health (NIH) to further develop its therapeutic agent to reduce arteriovenous fistula (AVF) failures, a significant unmet clinical need in end stage renal disease (ESRD) patients undergoing hemodialysis.
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

WuXi PharmaTech's STA subsidiary gets first approval from Japanese regulatory authorities
WuXi PharmaTech (Cayman), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, announced that its small-molecule process development and manufacturing subsidiary Shanghai SynTheAll Pharmaceutical (STA) received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug in July.
Contract Research & Services > Contract Research > News
Symbiomix completes enrollment in second pivotal trial of SYM-1219 for bacterial vaginosis
Symbiomix announced the completion of patient enrollment in a Phase 3 clinical study, the second pivotal trial of SYM-1219, which is a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV).
Contract Research & Services > Clinical Trials > News

Automation

Minerva licenses Sendai Virus technology for stem cell generation
Minerva Biotechnologies and ID Pharma (formerly DNAVEC) announced that they have signed an agreement granting Minerva worldwide rights to use and commercialize their non-integrating Sendai virus vectors, together with Minerva’s proprietary technology, for generating Induced Pluripotent Stem (iPS) cells.
Automation > IT & Software > News
Allied-Bristol Life Sciences licenses Yale University's platform technology and lead molecules
By PBR Staff Writer
Allied-Bristol Life Sciences (ABLS) has entered into a worldwide licensing agreement with Yale University for a proprietary platform technology and associated lead molecules to further developed new treatments for diseases such as prostate cancer.
Automation > IT & Software > News

Regulatory Affairs

Audentes gets orphan status for At001 to treat XLMTM in US and Europe
By PBR Staff Writer
US-based Audentes Therapeutics has received orphan drug designation from the FDA and the European Medicines Agency (EMA) for its AT001, an investigational product being developed to treat X-Linked Myotubular Myopathy (XLMTM), a rare, severe, inherited disorder.
Regulatory Affairs > News
FDA, EMA accept regulatory applications for Boehringer's Giotrif/Gilotrif to treat advanced squamous cell carcinoma of lung
Boehringer Ingelheim announced that both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy.
Regulatory Affairs > News



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